ESHA Research - TraceGains TGCon/Final... · 2020. 5. 8. · ESHA Research ESHA Research was established in 1981 with the goal of providing a comprehensive nutrition database with
ESHA ResearchESHA Research was established in 1981 with the goal of providing a comprehensive nutrition database with few missing values Today ESHArsquos suite of nutritional software products services and databases are recognized as the industryrsquos top choice for food and supplement formulation recipe development labeling nutritional analysis and regulatory compliance
Timeline for ComplianceThe compliance date for the updated Nutrition Facts labels will be January 1 2020 for companies with more than 10 million dollars in annual food sales
OR
January 1 2021 for companies with less than 10 million dollars in annual food sales
3
Final Rule issued May 3 2018 confirming January 1 2020 and 2021 compliance date
What Do We Need From Our Suppliers
4
We need at least the mandatory nutrients an ingredient statement amp allergens
Labeled Items Already In Distribution Chain
5
ldquoProducts that are labeled before July 26 2018 (and July 26 2019 for manufacturers with less than $10 million in annual food sales) do not need to be in compliance with the new labeling requirements and therefore do not need to bear the new nutrition label To determine the compliance date for a particular food product we would not consider the location of a food in the distribution chain For example the food product whether labeled before or after the compliance date may be at the manufacturing facility awaiting distribution at a warehouse awaiting further distribution in transit to the United States to be offered for import or on the store shelf of a US retail establishment We consider the date the food product was labeled for purposes of determining the compliance daterdquo
Note Both formats will be available in Genesis as we transition through effective and compliance date timelines Format options will include the appropriate regulations for both
Nutrition Facts (1990 NLEA)
Nutrition Facts (2016)
Missing Mandatory Nutrientshellip
7
Missing Mandatory Nutrients are displayed here with a dashed line ndash NOT COMPLIANT
NOTE If only 1 out of 9 of your ingredients contain the required dietary fiber information only that one ingredientrsquos dietary fiber nutrients will appear on the label Potentially showing inaccurate results on the Nutrition Facts Panel
8
Font
9
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
10
bull Corrected label graphicsbull Fat regulations added back in
(that were inadvertently deleted in final rule)bull Italicized ldquotransrdquo is an option
but not mandatorybull Corrected font size for Calories
on Supplement Labels
11
Nutrient Listing Changes
Nutrient DV Changes
12
Nutrient DV Changes
13
Nutrient Unit ChangesNiacin (Voluntary Nutrient)bull Change from mg of Niacin to mg of Niacin Equivalents (NE)
Vitamin A (Voluntary nutrient - previously mandatory)bull Change from 5000 IU to 900 mcg RAE
Vitamin E (Voluntary nutrient)bull Change from 30 IU to 15 mg a-tocopherol
Folate (Voluntary nutrient)bull Change from 400 mcg to 400 mcg DFE
Vitamin D (Mandatory nutrient - previously voluntary)bull Change from 400 IU to 20 mcg
14
Nutrient Conversion Calculations
15
Nutrient Conversion Calculations
16
Nutrient Conversion Calculations
17
Nutrient Calculator Assists in Calculating the Following Nutrients
bull Carbohydratesbull The New Dietary Fiber Fieldsbull Vitamin Abull Vitamin B3bull Niacin Equivalentsbull Tryptophanbull Vitamin Dbull Vitamin Ebull FolateFolic Acid
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Timeline for ComplianceThe compliance date for the updated Nutrition Facts labels will be January 1 2020 for companies with more than 10 million dollars in annual food sales
OR
January 1 2021 for companies with less than 10 million dollars in annual food sales
3
Final Rule issued May 3 2018 confirming January 1 2020 and 2021 compliance date
What Do We Need From Our Suppliers
4
We need at least the mandatory nutrients an ingredient statement amp allergens
Labeled Items Already In Distribution Chain
5
ldquoProducts that are labeled before July 26 2018 (and July 26 2019 for manufacturers with less than $10 million in annual food sales) do not need to be in compliance with the new labeling requirements and therefore do not need to bear the new nutrition label To determine the compliance date for a particular food product we would not consider the location of a food in the distribution chain For example the food product whether labeled before or after the compliance date may be at the manufacturing facility awaiting distribution at a warehouse awaiting further distribution in transit to the United States to be offered for import or on the store shelf of a US retail establishment We consider the date the food product was labeled for purposes of determining the compliance daterdquo
Note Both formats will be available in Genesis as we transition through effective and compliance date timelines Format options will include the appropriate regulations for both
Nutrition Facts (1990 NLEA)
Nutrition Facts (2016)
Missing Mandatory Nutrientshellip
7
Missing Mandatory Nutrients are displayed here with a dashed line ndash NOT COMPLIANT
NOTE If only 1 out of 9 of your ingredients contain the required dietary fiber information only that one ingredientrsquos dietary fiber nutrients will appear on the label Potentially showing inaccurate results on the Nutrition Facts Panel
8
Font
9
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
10
bull Corrected label graphicsbull Fat regulations added back in
(that were inadvertently deleted in final rule)bull Italicized ldquotransrdquo is an option
but not mandatorybull Corrected font size for Calories
on Supplement Labels
11
Nutrient Listing Changes
Nutrient DV Changes
12
Nutrient DV Changes
13
Nutrient Unit ChangesNiacin (Voluntary Nutrient)bull Change from mg of Niacin to mg of Niacin Equivalents (NE)
Vitamin A (Voluntary nutrient - previously mandatory)bull Change from 5000 IU to 900 mcg RAE
Vitamin E (Voluntary nutrient)bull Change from 30 IU to 15 mg a-tocopherol
Folate (Voluntary nutrient)bull Change from 400 mcg to 400 mcg DFE
Vitamin D (Mandatory nutrient - previously voluntary)bull Change from 400 IU to 20 mcg
14
Nutrient Conversion Calculations
15
Nutrient Conversion Calculations
16
Nutrient Conversion Calculations
17
Nutrient Calculator Assists in Calculating the Following Nutrients
bull Carbohydratesbull The New Dietary Fiber Fieldsbull Vitamin Abull Vitamin B3bull Niacin Equivalentsbull Tryptophanbull Vitamin Dbull Vitamin Ebull FolateFolic Acid
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
We need at least the mandatory nutrients an ingredient statement amp allergens
Labeled Items Already In Distribution Chain
5
ldquoProducts that are labeled before July 26 2018 (and July 26 2019 for manufacturers with less than $10 million in annual food sales) do not need to be in compliance with the new labeling requirements and therefore do not need to bear the new nutrition label To determine the compliance date for a particular food product we would not consider the location of a food in the distribution chain For example the food product whether labeled before or after the compliance date may be at the manufacturing facility awaiting distribution at a warehouse awaiting further distribution in transit to the United States to be offered for import or on the store shelf of a US retail establishment We consider the date the food product was labeled for purposes of determining the compliance daterdquo
Note Both formats will be available in Genesis as we transition through effective and compliance date timelines Format options will include the appropriate regulations for both
Nutrition Facts (1990 NLEA)
Nutrition Facts (2016)
Missing Mandatory Nutrientshellip
7
Missing Mandatory Nutrients are displayed here with a dashed line ndash NOT COMPLIANT
NOTE If only 1 out of 9 of your ingredients contain the required dietary fiber information only that one ingredientrsquos dietary fiber nutrients will appear on the label Potentially showing inaccurate results on the Nutrition Facts Panel
8
Font
9
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
10
bull Corrected label graphicsbull Fat regulations added back in
(that were inadvertently deleted in final rule)bull Italicized ldquotransrdquo is an option
but not mandatorybull Corrected font size for Calories
on Supplement Labels
11
Nutrient Listing Changes
Nutrient DV Changes
12
Nutrient DV Changes
13
Nutrient Unit ChangesNiacin (Voluntary Nutrient)bull Change from mg of Niacin to mg of Niacin Equivalents (NE)
Vitamin A (Voluntary nutrient - previously mandatory)bull Change from 5000 IU to 900 mcg RAE
Vitamin E (Voluntary nutrient)bull Change from 30 IU to 15 mg a-tocopherol
Folate (Voluntary nutrient)bull Change from 400 mcg to 400 mcg DFE
Vitamin D (Mandatory nutrient - previously voluntary)bull Change from 400 IU to 20 mcg
14
Nutrient Conversion Calculations
15
Nutrient Conversion Calculations
16
Nutrient Conversion Calculations
17
Nutrient Calculator Assists in Calculating the Following Nutrients
bull Carbohydratesbull The New Dietary Fiber Fieldsbull Vitamin Abull Vitamin B3bull Niacin Equivalentsbull Tryptophanbull Vitamin Dbull Vitamin Ebull FolateFolic Acid
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquoProducts that are labeled before July 26 2018 (and July 26 2019 for manufacturers with less than $10 million in annual food sales) do not need to be in compliance with the new labeling requirements and therefore do not need to bear the new nutrition label To determine the compliance date for a particular food product we would not consider the location of a food in the distribution chain For example the food product whether labeled before or after the compliance date may be at the manufacturing facility awaiting distribution at a warehouse awaiting further distribution in transit to the United States to be offered for import or on the store shelf of a US retail establishment We consider the date the food product was labeled for purposes of determining the compliance daterdquo
Note Both formats will be available in Genesis as we transition through effective and compliance date timelines Format options will include the appropriate regulations for both
Nutrition Facts (1990 NLEA)
Nutrition Facts (2016)
Missing Mandatory Nutrientshellip
7
Missing Mandatory Nutrients are displayed here with a dashed line ndash NOT COMPLIANT
NOTE If only 1 out of 9 of your ingredients contain the required dietary fiber information only that one ingredientrsquos dietary fiber nutrients will appear on the label Potentially showing inaccurate results on the Nutrition Facts Panel
8
Font
9
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
10
bull Corrected label graphicsbull Fat regulations added back in
(that were inadvertently deleted in final rule)bull Italicized ldquotransrdquo is an option
but not mandatorybull Corrected font size for Calories
on Supplement Labels
11
Nutrient Listing Changes
Nutrient DV Changes
12
Nutrient DV Changes
13
Nutrient Unit ChangesNiacin (Voluntary Nutrient)bull Change from mg of Niacin to mg of Niacin Equivalents (NE)
Vitamin A (Voluntary nutrient - previously mandatory)bull Change from 5000 IU to 900 mcg RAE
Vitamin E (Voluntary nutrient)bull Change from 30 IU to 15 mg a-tocopherol
Folate (Voluntary nutrient)bull Change from 400 mcg to 400 mcg DFE
Vitamin D (Mandatory nutrient - previously voluntary)bull Change from 400 IU to 20 mcg
14
Nutrient Conversion Calculations
15
Nutrient Conversion Calculations
16
Nutrient Conversion Calculations
17
Nutrient Calculator Assists in Calculating the Following Nutrients
bull Carbohydratesbull The New Dietary Fiber Fieldsbull Vitamin Abull Vitamin B3bull Niacin Equivalentsbull Tryptophanbull Vitamin Dbull Vitamin Ebull FolateFolic Acid
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Note Both formats will be available in Genesis as we transition through effective and compliance date timelines Format options will include the appropriate regulations for both
Nutrition Facts (1990 NLEA)
Nutrition Facts (2016)
Missing Mandatory Nutrientshellip
7
Missing Mandatory Nutrients are displayed here with a dashed line ndash NOT COMPLIANT
NOTE If only 1 out of 9 of your ingredients contain the required dietary fiber information only that one ingredientrsquos dietary fiber nutrients will appear on the label Potentially showing inaccurate results on the Nutrition Facts Panel
8
Font
9
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
10
bull Corrected label graphicsbull Fat regulations added back in
(that were inadvertently deleted in final rule)bull Italicized ldquotransrdquo is an option
but not mandatorybull Corrected font size for Calories
on Supplement Labels
11
Nutrient Listing Changes
Nutrient DV Changes
12
Nutrient DV Changes
13
Nutrient Unit ChangesNiacin (Voluntary Nutrient)bull Change from mg of Niacin to mg of Niacin Equivalents (NE)
Vitamin A (Voluntary nutrient - previously mandatory)bull Change from 5000 IU to 900 mcg RAE
Vitamin E (Voluntary nutrient)bull Change from 30 IU to 15 mg a-tocopherol
Folate (Voluntary nutrient)bull Change from 400 mcg to 400 mcg DFE
Vitamin D (Mandatory nutrient - previously voluntary)bull Change from 400 IU to 20 mcg
14
Nutrient Conversion Calculations
15
Nutrient Conversion Calculations
16
Nutrient Conversion Calculations
17
Nutrient Calculator Assists in Calculating the Following Nutrients
bull Carbohydratesbull The New Dietary Fiber Fieldsbull Vitamin Abull Vitamin B3bull Niacin Equivalentsbull Tryptophanbull Vitamin Dbull Vitamin Ebull FolateFolic Acid
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Missing Mandatory Nutrients are displayed here with a dashed line ndash NOT COMPLIANT
NOTE If only 1 out of 9 of your ingredients contain the required dietary fiber information only that one ingredientrsquos dietary fiber nutrients will appear on the label Potentially showing inaccurate results on the Nutrition Facts Panel
8
Font
9
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
10
bull Corrected label graphicsbull Fat regulations added back in
(that were inadvertently deleted in final rule)bull Italicized ldquotransrdquo is an option
but not mandatorybull Corrected font size for Calories
on Supplement Labels
11
Nutrient Listing Changes
Nutrient DV Changes
12
Nutrient DV Changes
13
Nutrient Unit ChangesNiacin (Voluntary Nutrient)bull Change from mg of Niacin to mg of Niacin Equivalents (NE)
Vitamin A (Voluntary nutrient - previously mandatory)bull Change from 5000 IU to 900 mcg RAE
Vitamin E (Voluntary nutrient)bull Change from 30 IU to 15 mg a-tocopherol
Folate (Voluntary nutrient)bull Change from 400 mcg to 400 mcg DFE
Vitamin D (Mandatory nutrient - previously voluntary)bull Change from 400 IU to 20 mcg
14
Nutrient Conversion Calculations
15
Nutrient Conversion Calculations
16
Nutrient Conversion Calculations
17
Nutrient Calculator Assists in Calculating the Following Nutrients
bull Carbohydratesbull The New Dietary Fiber Fieldsbull Vitamin Abull Vitamin B3bull Niacin Equivalentsbull Tryptophanbull Vitamin Dbull Vitamin Ebull FolateFolic Acid
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
ldquonon-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human healthrdquo
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Polydextrose Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon commonly added as a bulking agent and texturizer
D-Glucose Polymer
Psyllium Husk Psyllium husk is the seed coat that has been removed from the psyllium seed and milled
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
4 calories per gram of
Protein
4 calories per gram of
Total Carbs
(Less amount of non-digestible carbs and sugar alcohols) total fat
9 calories per gram of
Protein
You substract non-digestible carbs from total carbs
subtract all non-digestible carbs not just beneficial fibers amp then calculate the Calories from soluble non-digestible carbs to add back to the total Calories They dont state dietary fiber in this method so that implies careful record keeping with regards to Calories
21 CFR 1019(g)(10) The manufacturer must make and keep written records (eg analyses of databases recipes formulations information from recipes or formulations or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows
(i) When a mixture of dietary fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
(iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber
I think its worthy mention for a presentation though that if a supplier is declaring Calories specifically adjusted for soluble fiber then it is most helpful for them to provide supporting values for the fibers amp non-digestible carbs so that the manufacturers can understand amp document appropriately
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
High Amylose CornMaize Starch (Resistant Starch 2)
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
Insoluble Pea Fiber Pea Hull Fiber and Soluble Pea Fiber
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
InulinOligofructoseSynthetic Short Chain Fructooligosaccharides
Karaya Gum
Karaya Gum
Locust bean gum
Locust bean gum
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Oat Hull (Insoluble Oat) Fiber
Pectin
Pectin
Polydextrose
Polydextrose
Polydextrose
Potato Fibers
Potato Fibers
Potato Fibers
Psyllium husk
Psyllium husk
Pullulan
Pullulan
Resistant Wheat and Maize Starch (Resistant Starch 4)
Resistant Wheat and Maize Starch (Resistant Starch 4)
Retrograded Corn Starch (Resistant Starch 3)
Retrograded Corn Starch (Resistant Starch 3)
Rice Bran Fiber
Rice Bran Fiber
Rice Bran Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soluble Corn Fiber
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Soy Fiber (Soy Polysaccharide) Soluble Soybean Polysaccharide and Soy Hull
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Beet Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Sugar Cane Fiber
Wheat Fiber
Wheat Fiber
Wheat Fiber
Xanthan Gum
Xanthan Gum
Xylooligosaccharides
Xylooligosaccharides
NON-DIGESTIBLE CARBOHYDRATE
DESCRIPTIONFUNCTION
COMMON NAMES
Carboxymethylcellulose
Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants Primarily used as a emulsifier or thickening agent foods such as ice cream dressings toppings etc
A complex polysaccharide indigestible to both humans and animals Primarily used as emulsifier or thickening agent in foods such as candy soft drinks and other confectionary
Acacia Gum Arabic Gum Gum Acacia Gum Arabic
Karaya Gum
A natural gum exudation obtained by the incision of the stems and branches of Sterculia trees Primarily used as a stabilizer for limitation of ice crystals in ice creams improve spreadability and as a binder in dough pasta and bread
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans and used a binder for coatings and protects active ingredients and flavors
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Resistant WheatMaize Starch Resistant Starch 4
If the Wheat or Maize Starch has been chemically modified to artificially inhibit digestion
Hi-Maize Resistant Starch
Xanthan Gum
Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
NON-DIGESTIBLE CARBOHYDRATE
Description
Function
Common Names
Citation
Carboxymethylcellulose
Carboxymethyl Cellulose is a thickener binder and stabilizer in a variety of foods (see Found In) It is considered a fiber source and as such is used in over-the-counter laxatives Cellulose is the carbohydrate that makes up the woody parts and cell walls of plants CMC is a thickening agent made by reacting cellulose (wood pulp cotton lint) with a derivative of acetic acid It is not absorbed or digested and is sometimes included in the dietary fiber on food labels - however it is not as healthful as fiber obtained from real natural foods
Emulsifier or thickening agent primarily used in ice cream dressings toppings and gelatinous desserts Food Items ice cream dressing cheese icing toppings gelatinous desserts infantbaby formula candy cottage cheese cream cheese spread
National Center for Biotechnology Information PubChem Compound Database CID=24748 httpspubchemncbinlmnihgovcompound24748 (accessed Jan 3 2019) httpwwwbefoodsmartcomingredientscarboxymethyl-cellulosephp httpswwwncbinlmnihgovpmcarticlesPMC3570285
Gum Acacia
Gum Arabic (acacia Senegal) is a complex polysaccharide indigestible to both humans and animals It has been considered as a safe dietary fiber by the United States Food and Drug Administration (FDA) since the 1970s
Emulsifier or thickening agent primarily used in candy soft drinks and other confectionary
National Center for Biotechnology Information PubChem Substance Database SID=134223473 httpspubchemncbinlmnihgovsubstance134223473 (accessed Jan 3 2019)
Karaya Gum
Taking into account these properties gum karaya is used in concentrations from 02ndash04 as a stabilizer for aerated dairy products and frozen desserts controlling the formation of ice crystals It is used as an acid resistant stabilizer for sherbets fruit ices and similar low pH products in stabilizing packaged whipped cream products and meringue toppings It is also used to prevent syneresis and improve the spreadability characteristics ofcheese spreads when used in concentrations up to 08 It is a good emulsion stabilizer for French-style salad dressings because it increases the viscosity of the aqueous phase of the oil-water emulsion It is used as a binder for making low calorie dough-based products such as pasta bread and other bakery products In addition is very effective in preparation of special quick-cooking farina cereals and ground meat products as it provides good water-holding and -binding properties to yield good quality finished products
Used as an emulsifier or thickening agent found in ice cream soft candy and milk products Food-grade gum is usually a white to pinkish gray powder with a slight vinegar odour
National Center for Biotechnology Information PubChem Substance Database SID=135356493 httpspubchemncbinlmnihgovsubstance135356493 (accessed Jan 3 2019) httpswwwsciencedirectcomtopicsfood-sciencekaraya
Pullulan
Pullulan is an extracellular polysaccharide excreted by the fungus Aureobasidium pullulans
Used as a binder for coatings and protects active ingredients and flavors
Pullulan palmitateO-Palmitoylpullulan53572-58-0 dried exudate (karaya gum) of the tree sterculia urens sterculiaceae dried exudate (karaya gum) of the tree sterculia urens sterculiaceae firmiana simplex gum gum karaya kadaya karaya gum katilo kullo kuteeral mucara sterculia gum sterculia setigera gumindian tragacanth gum tragacanth indianPullulan hexadecanoateAC1MJ3R2[(2R3S4R5R6S)-45-dihydroxy-3-[(2R3R4S5S6R)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-[[(2R3S4S5R6R)-345-trihydroxy-6-[(2R3S4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-2-yl]methoxy]oxan-2-yl]methyl hexadecanoate
National Center for Biotechnology Information PubChem Compound Database CID=3085039 httpspubchemncbinlmnihgovcompound3085039 (accessed Jan 3 2019) httpwwwthegoodscentscompanycomdatars1031651html
Retrograded Corn Starch Resistant Starch 3
Resistant Wheat and Maize Starch Resistant Starch 4
Xanthan Gum
Xanthan is an emulsion stabilizing and gelling agent Since xanthan gum is sometimes produced by a bacterium that is fed corn to grow some people allergic to corn may also react to it[citation needed] Yellow Phrygian Husk is a common source of bacterium in which xanthan gum is created However some xanthan gum is not corn-derived Xanthan gum is a common ingredient in fake blood recipes and in Gunge Xanthan gum is a polysaccharide used as a food additive and rheology modifier It is produced by fermentation of glucose or sucrose by the Xanthomonas campestris bacterium
Used as an emulsifier or thickening ageing in dressings and pastry fillings
Biozan Rxanthanxanthan gum
National Center for Biotechnology Information PubChem Compound Database CID=131750926 httpspubchemncbinlmnihgovcompound131750926 (accessed Jan 3 2019)
Xylooligosaccharides (XOS)
Xylooligosaccharides are sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber
XOS D-xylose-hexulose
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
RESISTANT STARCHES
DESCRIPTION FUNCTION
COMMON NAMES
RS1
Resistant Starch 1 delver resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2
Resistant Starch 2 retains its natural granular shape yet resist digestion due to crystallinity within the granule
Resistant Starch 3 occurs if the starch granule has been broken apart and the starch chains are crystallized cooked or heat processed
Breakfast cereals
RS4
Resistant Starch 4 occurs when it has been chemically modified to artificially inhibit digestion
Hi-maize resistant starch used in baked goods
FIBER
DESCRIPTIONFUNCTION
COMMON NAMES
Alginate
Alginate is a natural polymer extracted from brown seaweeds and used as an emulsifier stabilizer and thickener commonly found in ice cream and pie fillings
Algin Sodium Alginate
Arabinoxylan
Arabinoxylan is a hemicellulose and a major component of the cell walls of cereal grains
AX
Beta-Glucan
Beta-Glucan is major component in the cell walls of oats barley and rye and smaller quantities in wheat
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals
Microcrystalline Cellulose Cellulose Gel and Cellulose Powder Deae-Cellulose Cellulose DEAE Diethylaminoethyl cellulose
Guar Gum
Extracted from guar beans and used as a thinkening and stabilising agent in food
Guaran Cyamopsis Gum Galactasol
Locust Bean Gum
Macerated endosperm of the seed of the locust bean tree used as a thickening and gelling agent in food
LBG Caragum Ceratonia Siliqua Gum
Pectin
Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectins are primarily used as emulsifiers and stabilizers in food
Hydrolyzed Pectin Fruit Pectin Citrus Pectin and Modified Pectin Calcium Pectinate Methoxy Pectin Pectinic Acid Zimc Pectinate
Hydroxypropylmethylcellulose
is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group Used as an emulsifier thickening and suspending agent and as an alternative to animal gelatin
Psyllium husk is the seed coat that has been removed from the psyllium seed and milled The psyllium seed includes nutrients that are not components of psyllium husk (63 FR 8103 at 8105
ispaghula isabgol or Psyllium psyllium psyllium seed husk and ispaghlua husk Gum IspaghuleIsogelIspaghulaIspaghule GumMetamucilPlantaglucidePlantago SeedPsylliumReguvalSeed Plantago
Mixed Plant Cell Wall Fibers
Ingredients that contain two or more of the following plant cell wall fibers in varying proportions Cellulose Pectin Lignin Beta-glucan and Arabinoxylan
Barley Fibers Cocoa Fibers Sugar Can Fiber Apple Fiber Sugar Beet Fiber Corn Hull Fiber Potato Fiber Oat hull Fiber Pea Fiber (hull and cotyledon) Bamboo Fiber Cottonseed Fiber Rice Bran and Hull Fiber Soy Fiber (Cotyledon and Hull) Citrus Fiber Wheat Fiber
Arabinoxylan
is a hemicellulose and is a major component of the cell walls of cereal grains
AX
Alginate
Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species It is used as an emulisifier stabilizer and thickener commonly found int in ice cream and pie fillings
Sodium Alginate Algin
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Inulin is extracted from numerous plant products such as chicory root agave and Jerusalem artichoke Inulin is used as a bulking agent in foods
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
High-amylose Maize Starch High-amylose Corn Starch (RS2 Starch that is resistant due to physcial compostition)
Galactooligosaccharides (GOS)
Produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths Primarily used as a prebiotic and added to food as a bulking agent
Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon Primarily added as a bulking agent formulation aid humectant and texturizer
D-Glucose Polymer
Resistant MaltodextrinDextrin
Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
Cellulose is a linear homopolymer of β-(1-4) linked glucose units Cellulose is the main structural component of the cell wall of most plants and therefore is present in vegetables fruits and cereals Cellulose is not digested by human enzymes nor fermented by the colonic microflora Cellulose meets the dietary fiber definition based on improved laxation8 (21 CFR 1019(c)(6)(i))
Some forms of cellulose are chemically equivalent to isolated cellulose including powdered cellulose andmicrocrystalline cellulose Microcrystalline cellulose is purified partially depolymerized celluloseprepared by using mineral acid to hydrolyze cellulose pulp Microcrystalline cellulose is also calledcellulose gel Powdered cellulose is generally obtained by mechanically micropulverizing cellulose
microcrystalline cellulose cellulose gel and cellulose powder DEAE-CELLULOSECellulose DEAEDiethylaminoethyl celluloseDiethylaminoethyl-cellulosecelluloseCellulose 2-(diethylamino)ethyl etherCellulosepulverDEAE-Sephacel(R)DEAE-SephacelampregDiethylaminoethyl-Sephacel(R)Diethylaminoethyl CSephacelampregSBB058705AKOS015895024AN-6602BC682287M158SC-21746Express-Ionamptrade exchanger D free baseFT-0624878I05-3373Express-Ion(TM) exchanger D free base 60-130 mum(5S)-6-(hydroxymethyl)-5-[(2S)-345-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-234-triol(5S2R3R4R6R)-5-[(2S4S5S3R6R)-345-trihydroxy-6-(hydroxymethyl)(2H-34 56-tetrahydropyran-2-yloxy)]-6-(hydroxymethyl)-2H-3456-tetrahydropyran-2 34-triol(6S)-2-(hydroxymethyl)-6-[(3S)-456-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-345-triolDiethylaminoethyl-Sephacel(R) aqueous ethanol suspension 40-160 mum (wet) exclusion limit ~1000000 Da
2
Beneficial
Guar Gum
Guar gum is a linear chain of β 14-linked mannose residues to which galactose residues are 16-linked at every second mannose forming short side-branches Guar gum is hydrophilic and with gel-forming properties (IOM 2002)
As a food ingredient guar gum is obtained from the maceration of the seed of the guar plant Cyamopsis tetragonoloba or Cyamopsis psoraloides Guar gum is added to foods as an emulsifier formulation aid thickener and firming agent (21 CFR 1841339) Guar gum meets the dietary fiber definition based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
3
Locust Bean Gum
Locust bean gum is primarily the macerated endosperm of the seed of the locust bean tree Locust bean gum is a galactomannan that meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
Pectic polysaccharides have a backbone chain of α- (1rarr 4)-linked D-galacturonic acid units interrupted by the insertion of (1rarr 2)-linked L-rhamnopyranosyl residues in adjacent or alternate positions Pectins are present in cell walls and intracellular tissues of fruits and vegetables While pectin is most abundant in fruits it is also present in vegetables legumes and nuts Pectin meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
They are used as emulsifiers and stabilizers in the food industry They have been tried for a variety of therapeutic uses including as antidiarrheals where they are now generally considered ineffective and in the treatment of hypercholesterolemia
hydrolyzed pectin fruit pectin citrus pectin and modified pectin calcium pectinatemethoxy pectinmethoxylpectinmethoxypectinpectinPectin MethoxyPectinate CalciumPectinate Zincpectinic acidPectinszinc pectinate
National Center for Biotechnology Information PubChem Compound Database CID=441476 httpspubchemncbinlmnihgovcompound441476 (accessed Jan 3 2019)
5
Hydroxypropylmethylcellulose
Hydroxypropylmethylcellulose (HPMC) is a propylene glycol ether of methylcellulose containing methoxyl groups and hydroxypropyl group HPMC is a gum that has multiple technical effects including use as a film former stabilizer and thickener HPMC meets the definition of dietary fiber based on its effect of attenuating blood cholesterol levels (FDA 2016 21 CFR 1019(c)(6)(i))
As a food additive HPMC is an emulsifier thickening and suspending agent and an alternative to animal gelatin HPMC is used in deep fried batter HPMC is a thickening and binding agent approved for food use in the USA and the EU
HPMC as an ingredient is hypromellose E464HPMCHydroxypropyl methyl celluloseHydroxypropyl methylcelluloseHypromellose
National Center for Biotechnology Information PubChem Substance Database SID=348288606 httpspubchemncbinlmnihgovsubstance348288606 (accessed Jan 3 2019)
6
Beta-Glucan
Mixed-link (1-3 1-4) beta-glucans are a major component in the cell walls of oats barley and rye and smaller quantities in wheat Beta-glucans in these plants are considered to be a form of hemicellulose Beta-glucans are isolated and added to foods (eg barley betafiber) Beta-glucan soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
barley beta fiber and barley betaglucan beta-Glucanbeta-D-Glucanbeta-Glucans9041-22-9Epiglucanbeta-GlucosylglucanBeta Glucan 70AC1L96ZZCCRIS 89989012-72-0(2S3R4S5S6R)-2-[(2R4R5R6S)-45-dihydroxy-2-(hydroxymethyl)-6-[(2R4R5R6S)-456-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-345-triolss-D-glucopyranosyl-(1-gt4)-(4)-ss-D-xylo-hexopyranosyl-(1-gt4)-(4)-a-D-xylo-hexopyranose
National Center for Biotechnology Information PubChem Compound Database CID=439262 httpspubchemncbinlmnihgovcompound439262 (accessed Jan 3 2019)
7
Psyllium Husk
Psyllium seed husks also known as ispaghula isabgol or psyllium are portions of the seeds of the plant Plantago ovata (genus Plantago) February 18 1998) Psyllium husk is a concentrated source of the soluble fiber arbinoxylan (a form of hemicellulose) and is used as a food or food component in a number of foods in the United States (62 FR 28234 at 28235 May 22 1997) Psyllium husk as a source of soluble fiber meets the definition of dietary fiber based on its effect of reducing the risk of coronary heart disease (21 CFR 10181)
Psyllium Husk is the husk of the dried ripe seeds of the Plantago psyllium P Indica P Ovata and P Arenaria plants with laxative and cholesterol lowering activities The husks contain mucilage that swells on exposure to water and provides an indigestible mucilaginous mass in the intestines thereby causing lubrication contraction of the smooth muscles of the intestinal walls and thus stimulating bowel movement Psyllium husk is rich in soluble fiber and has a cholesterol-lowering effect Dried ripe seeds of PLANTAGO PSYLLIUM PLANTAGO INDICA and PLANTAGO OVATA Plantain seeds swell in water and are used as demulcents and bulk laxatives
National Center for Biotechnology Information PubChem Compound Database CID=181572 httpspubchemncbinlmnihgovcompound181572 (accessed Jan 3 2019)
8
Mixed Plant Cell Wall Fibers
Many plants contain a variety of fibers with common ones primarily being present in plant cell walls (ie cellulose hemicelluloses and pectin) as well as lignin (Marlett et al 1992 Kumar et al 2012) Fiber ingredients obtained from plant cell walls in whole or in part often contain a mixture of cellulose hemicellulose and pectin The content and profile of these mixed plant cell wall fibers can vary depending on the processing methods that are used to isolated the fibers from a particular type of plant which in turn often makes it difficult to determine whether or not a particular fiber is intact and intrinsic particularly when the processing methods used to extract the fiber or the composition of the ingredient are unknown The distinction is relevant for purposes of determining whether a plant cell wall fiber is included in the definition of ldquodietary fiberrdquo An ldquointrinsic and intactrdquo fiber is defined as a ldquodietary fiberrdquo and therefore must be included in the declaration of dietary fiber on the Nutrition and Supplement Facts labels (21 CFR 1019(c)(6)(i)) For a plant cell wall fiber that is not intrinsic and intact FDA must determine whether the carbohydrate provides a physiological effect that is beneficial to human health and if so complete rulemaking to include the carbohydrate as a ldquodietary fiberrdquo in sect 1019(c)(6)(i)
Cellulose pectin β-glucan are found in plant cell walls and meet the definition of dietary fiber based on their physiological effects that are beneficial to human health (21 CFR 1019(c)(6)(i) 21 CFR 10181) Plant cell wall fibers also contain a category of non-digestible carbohydrates referred to as ldquohemicellulosesrdquo There are various types of hemicelluloses found in different plant-based foods and at different levels β-Glucan is present in the plant cell walls of barley oats and rye and is considered to be a form of hemicellulose (Kumar et al 2012) The hemicellulose fibers may be considered ldquointrinsic and intactrdquo in plants9 or may be isolated after undergoing different types of processing For example the dietary fiber β-glucan may be intrinsic and intact (eg whole oat flour) or may be an isolated fiber added to food as an ingredient (eg barley betafiber) Similarly the soluble fiber in psyllium husk arabinoxylan is another form of hemicellulose that is abundant in the walls of cereal grains and is an example of an isolated non-digestible carbohydrate We intend to propose mixed plant cell wall fibers as a category of isolated fibers because they are generally processed using methods that result in the plant cell being disrupted andor various nutrients being removed from the plant such that they are no longer intrinsic and intact as indicated in a number of notifications submitted to FDA about a manufacturersrsquo determination that certain plant cell wall fibers added to food provide a technical effect and are generally recognized as safe (GRAS)10 Examples of processing methods that have been provided to FDA by manufacturers in GRAS notifications that have been used for isolating various plant cell wall fiber ingredients include enzymatic digestion aqueous extractions and hydrolyses extractions and precipitations using various chemicals (eg sodium hydroxide alkaline peroxide sulfuric acid and alcohol) Plant cell wall fibers are generally composed of fibers that include cellulose pectin β-glucan andor arabinoxylan and based on our review of the science we consider that each of these fibers provides a beneficial physiological effect The non-digestible carbohydrates from the plant cell wall fiber ingredients extracted from food are generally mixed and can contain variable amounts of vitamins minerals and macronutrients based on the methods that may be used for isolating and extracting the fiber Examples of mixed plant cell wall fibers that we intend to consider enforcement discretion for as a dietary fiber are those obtained from whole or parts of fruits vegetables grains legumes pulses nuts and other plants that undergo processing methods11 The interrelatedness of cellulose pectin β-glucan andorarabinoxylan within the plant cell wall and the scientific evidence for each supports our decision to consider enforcement discretion for declaring these mixed plant cell wall fibers as well as lignin as dietary fiber if any of these plant cell wall fibers is present in a food We can extrapolate the physiological effects of these individual fibers to these same fibers when found in combination as part of a mixed plant cell wall These mixed plant cell wall fiber ingredients contain two or more plant cellwall fibers and the proportions can vary
Arabinoxylan (AX) is a diversely composed (1rarr4)-β-D-xylan polymer that contains arabinose and varying uronic acid residues AX is a hemicellulose and is a major component of the cell walls of cereal grains The non-starch polysaccharide content in wheat bran is approximately 65 AX and 15 to 31 cellulose whereas the non-starch polysaccharide content in wheat endosperm is approximately 85 AX AX is a predominant non-digestible carbohydrate found in the alkali soluble fraction of psyllium husk (Bernstein et al 2013)
10
Alginate
Alginate is a soluble fiber composed of β-14-D-mannuronic acid and α-14-L-guluronic acid organized in homopolymeric compounds of either mannuronate or guluronate or as heteropolymeric compounds expressed as mannuronic acid to guluronic acid ratio Alginate is extracted from brown seaweeds as the calcium magnesium and sodium salts of alginic acid of various species (eg Ascophyllum Durvillaea Ecklonia Laminaria Lessonia Macrocystis and Sargassum) (McHugh et al 2003) Alginate is widely used in the food industry to improve texture of salad dressings yogurts and jellies because of its gelling viscosifying and stabilizing properties (Jensen et al 2013) Common names used to identify alginate as an ingredient include sodium alginate and algin
Alginates are used to improve food texture e g in ice cream pie fillings Emulsifier stabiliser thickener Alginic acid also called algin or alginate is an anionic polysaccharide distributed widely in the cell walls of brown algae where it through binding water forms a viscous gum In extracted form it absorbs water quickly it is capable of absorbing 200-300 times its own weight in water [1] Its colour ranges from white to yellowish-brown It is sold in filamentous granular or powdered forms
National Center for Biotechnology Information PubChem Compound Database CID=131704328 httpspubchemncbinlmnihgovcompound131704328 (accessed Jan 3 2019)
11
Inulin and Inulin-Type Fructans
Inulin is a naturally occurring polysaccharide that belongs to a class of carbohydrates known as fructans Individual fructan products may be distinguished by their source method of production chemical structure and degree of polymerization (DP) (the number of fructose or glucose residues in the chain) Inulin is a mixture of fructose polymers that varies from 3 to 60 DP with longer chain products being predominant (approximately 70) (Food Chemicals Codex 10th Edition) Inulin may or may not have a terminal glucose residue The characteristic aspect of inulin structure is its linear β (21) linkages Inulin is not digested by human enzymes in the gastrointestinal tract because of these linkages but rather is fermented by microorganisms in the colon While inulin is a soluble fiber it does not possess some of the typical properties of other soluble dietary fibers such as viscosity (Schneeman 1999) Inulin is extracted from numerous plant products many of which typically are not consumed as part of the US diet (eg chicory root agave and Jerusalem artichoke) Inulin is used as a bulking agent in foods (FDA GRAS Notification No 118)Oligofructose (OF) is a shorter chain inulin that is extracted from plants OF refers to fructans that have a DP lt 10 and accounts for approximately 30 of total inulin present in chicory root extract OF also can be produced from extracted inulin that is enzymatically hydrolyzed (Niness 1999) OF is not digested by human enzymes in the gastrointestinal tract because of its β (21) linkages but rather is fermented by microorganisms in the colon Short chain fructooligosaccharides (short chain FOS) can be manufactured from sucrose and fructose by an enzymatic process (FDA GRAS notification No44) Short chain FOS also contain β (21) linkages and are fermented in the colon The number of fructose units varies from two to four
inulin chicory root extract chicory root chicory root fiber inulin from chicory chicory vegetable fiber fructooligosaccharide and oligofructose Branded inulin and inulin-type fructans ingredients include Frutafit and Frutalose from Sensus America Inc Lawrenceville NJ Oliggo-Fiber from Cargill Minneapolis and Orafti from Beneo Inc Parsippany NJ (Found in more than 36000 plant species inulin is most often sourced from chicory when it is used in food production httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
12
High Amylose Starch (Resistant Starch 2)
Resistant starch 2 (RS2) is uncooked native starch that is comprised primarily of α-14 glycosidic links that are inaccessible to enzymes it is found in products such as raw green bananas raw potatoes and uncooked high amylose maizecorn and potato starch
high-amylose maize starch and high-amylose corn starch ldquoHigh-amyloserdquo can also be used to describe other sources of RS2 (ie high-amylose [source] starch) (eg Hi-Maize resistant starch) Resistant starches breakdownRS1 - intrinsicintact - eg seedsRS2 - starch that is resistant because of physical composition - eg high amylose starchRS3 - cookingheat processed = non-digestibleRS4 - chemically processed = non-digestible
13
Galactooligosaccharides (GOS)
GOS is produced by the enzymatic treatment of lactose to produce oligosaccharides of varying lengths (typically between 2 and 8 saccharide units) including various linkages of galactose (eg β-(1-4) β-(1-6) galactose) and a terminal glucose (Macfarlane et al 2008) GOS is a prebiotic and is used to improve the texture of foods and as a bulking agent
National Center for Biotechnology Information PubChem Compound Database CID=165512 httpspubchemncbinlmnihgovcompound165512 (accessed Jan 3 2019)
14
Polydextrose
Polydextrose is a synthetic and partially metabolizable water-soluble polymer which primarily consists of D-glucose Polydextrose is highly branched and contains α- and β- 1-2 1-3 1-4 and 1-6 linkages with the 1-6 linkage predominating in the polymer Polydextrose is added to foods for multiple technical effects including as a bulking agent a formulation aid a humectant and a texturizer (21 CFR 172841) Polydextrose is a soluble non-digestible carbohydrate that is partially fermented in the colon (Roytio and Ouwehand 2014)
(eg Sta-Lite polydextrose) (Polydextrose on the other hand another common entry on food labels is a synthetic fiber It may sound familiar if yoursquove read the food labels on products ranging from breakfast cereals and baked goods to ice cream salad dressing and even certain beverages httpschicagosuntimescomhealthask-the-doctors-fda-considers-what-counts-as-dietary-fiber-on-food-labels)
15
Resistant MaltodextrinDextrin
Resistant maltodextrindextrin is a glucose oligosaccharide Resistant maltodextrin and dextrin products are composed of non-digestible oligosaccharides of glucose molecules that are joined by digestible linkages and non-digestible α-12 and α-13 linkages
NON-DIGESTIBLE CARBOHYDRATE DESCRIPTIONFUNCTION COMMON NAMES
Retrograded Corn Starch Resistant Starch 3
If the Corn Starch granule has been broken apart and the starch chains are crystalized
Certain breakfast cereals
Xanthan Gum Xanthan gum is a polysaccharide used as an emulsion stabilizer in dressings and pastry fillings
Biozan R
Xylooligo-saccharides (XOS)
Sugar oligomers made up of xylose units which are produced from the xylan fraction in plant fiber primarily used as a thickener and emulsifier
XOS
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
Resistant Starches
31
RESISTANT STARCHES DESCRIPTION FUNCTION COMMON NAMES
RS1Resistant Starch 1 delivers resistant starch because it is protected by hulls seeds and other barriers that are not fully digested in the small intestine They are intrinsicintact
Whole Grains Seeds
RS2Resistant Starch 2 retains its natural granular shape yet resists digestion due to crystallinity within the granule
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
36
Sugars that are either added during the processing of foods or packaged as such and includes sugars (free mono- and disaccharides) sugars from syrups and sugars
concentrated from fruit or vegetable juices that are in excess of what would beexpected from the same volume of 100 fruit or vegetable juice of the same type
ON THE LABELAdded Sugars are indentedand listed under Total SugarsRounding Rulesbull Less than 1 g declaration
not required withinsignificant footnote oryou can show ldquoless than 1grdquo or ldquolt 1 grdquo on the label
bull Less than 5 g may beexpressed as zero
MANDATORY NUTRIENTDV 50gThe FDA recommends thatyour added sugar intake Not toexceed 10 of total calories
THESE ITEMS REQUIRESPECIAL CONSIDERATION
Juice concentrates -Example if juice concentrate is added to a product and the sugar content exceeds that contributed by whole foods and 100 juices some of the sugars may be considered added sugars
PureesPastes Sugars after fermenting Corn syrup solids
Dried cranberries and cranberry juices
Single-ingredient sugar products are no longer required to bear the ldquoIncludes X g Added Sugarsrdquo declarationmay use symbol and explanatory text
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
FDA Draft Nonbinding RecommendationsFebruary 2018
37
ldquoGiven the concerns outlined earlier regarding the added sugars declaration on pure honey pure maple syrup and certain cranberry products described here (dried cranberries and cranberry juice sweetened with added sugars that provide an amount of total sugars in a serving that does not exceed the level of total sugars in a serving of a comparable product with no added sugars) we intend to exercise enforcement discretion for such products to use a ldquodaggerrdquo symbol immediately following the added sugars percent Daily Valuerdquo
Added Sugars Label Option
38
bull Show Added Sugars Symbol dagger
bull Added Sugars Statement Text
FDA Guidance on Added Sugars amp Vitamins and Minerals November 2018
39
bull Clarification and examples of added sugars calculations
bull Quantitative amounts of vitamins and minerals ldquolevels of significancerdquo
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
HR 2 Signed into Law December 20 2018
40
SEC 12516 LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS
The food labeling requirements under section 403(q) of the Federal Food Drug and Cosmetic Act (21 USC 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar honey agave or syrup including maple syrup that is packaged and offered for sale as a single-ingredient food bear the declaration ldquoIncludes X g Added Sugarsrdquo
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
bull Artificial Flavor any substance that imparts flavor and not derived from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Spice sect18210 and 184 (Allspice Anise Basil Bay leaves Caraway seed Cardamom Celery seed Chervil Cinnamon Cloves Coriander Cumin seed Dill seed Fennel seed Fenugreek Ginger Horseradish Mace Marjoram Mustard flour Nutmeg Oregano Paprika Parsley Pepper black Pepper white Pepper red Rosemary Saffron Sage Savory Star aniseed Tarragon Thyme Turmeric)
bull Natural Flavor (Contains constituents from spice fruit vegetable plant material meat fish poultry eggs dairy product
bull Artificial Color or Coloring (Any color additive defined in sect703(f)
bull Chemical Preservative common name plus descriptor of function (preservative to help protect flavor etc)
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
11228 = 400 of serving sizeServings per Container 4
The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use of the term about (eg about 2 servings
about 35 servings)
Servings Per Container ndash Discrete Units (2 of 2)
Item Serving Size Declaration Serving Size Example
Large discrete units usually divided for
consumption cake pie pizza melon cabbage)
Serving size shall be the fractional slice of ready to eat product (112 cake 18 pie
frac14 pizza frac14 melon 16 cabbage) closest to RACC
Pies RACC 125 g (_fractional slice (_g) for large discrete unitsDetermine what fraction of pie weighs closest to 125 grams
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Serving size shall be in the household measure closest
to the RACC
Snacks Popcorn RACC 30 gram _cup(_g)Determine how many cups is equivalent to 30 gram Weigh out 30
grams of popcorn place in a measuring cup to find the closest1 frac12 cup (30g) or
1 cup (30g) or 1 cup (28g)34 cup (30g)
In expressing the fractional slice manufacturers shall use 1frasl2 1frasl3 1frasl4 1frasl5 1frasl6 or smaller fractions that can be generated by further division by 2 or 3Cups shall be expressed in 14- or 13-cup increments
Tablespoons shall be expressed as 1 1 13 1 12 1 23 2 or 3 tablespoons Teaspoons shall be expressed as 18 14 12 34 1 or 2 teaspoons
Serving Size ndash Non Discrete Unitsbulk (1 of 2)
Weight Servings Per ContainerServings Per Container
Popcorn RACC 1 cup (30 grams)
Less than 200 of serving size 1 Serving
Popcorn Serving Size 1 Cup (30g)Package size 15 oz (425g)
42530 = 142 of serving sizeServings Per Container 1
200 - 300 of serving size
Dual Colum 1st for serving size closest to the RACC 2nd for package size
Servings round to the nearest 05 serving
Popcorn Serving Size 1 Cup (30g)Package size 25 oz (709g)
70930 = 236 of serving sizeServings Per Container 25
Column 1 (30 g)Column 2 (709g)
More than 300 of serving size Servings rounded to the nearest whole number
Popcorn Serving Size 1 Cup (30g)Package size 12oz (3402) grams340230 = 1134 of serving size
Servings per Container 11
The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random
weight products The number of servings between 2 and 5 servings shall be rounded to the nearest 05 serving Rounding should be indicated by the use
of the term about (eg about 2 servings about 35 servings)
Servings Per Container ndash Non Discrete Unitsbulk (2 of 2)
Dual Column Labelingbull Required on packages that can be
consumed in one or multiple sittings
bull Nutrition information presented per serving and per package
bull For packages that contain 200 and up to and including 300 of the RACC
bull A 3oz (90g) bag of chips would be labeled per serving [1oz (30 g)] and per package [90 g]
55
Dual Column Exemptions (February 2018)
1) Products that meet the requirements for tabular format2) Raw fruits vegetables and seafood that provide voluntary labelingadvertising or when
claims are made3) Products that require further preparation (eg pancake mix) and voluntarily provide an
additional column ldquoas preparedrdquo4) Products that are commonly consumed in combination with another food (eg cereal
and milk)5) Products that provide additional column for two or more groups (eg infants and
children less than 4 years)6) Popcorn (eg one column for popped)7) Varied weight products (eg cheeses sold at random weights)
56
Coffee Tea amp Water
57
FDA intends to exercise discretion (refrain from taking regulatory or compliance action) against
bull Bottled Waterbull Coffee Beans (whole or ground)bull Tea Leavesbull Coffee amp Tea (plain and unsweetened)bull Condiment-type Dehydrated Vegetablesbull Flavor Extracts amp Food Colors (exempt under sect
1019(j)(4)
ldquoWe intend to engage in future rulemaking to address issues of mandatory nutrition labeling of these productsrdquo
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
National Bioengineered Food Disclosure Standard ndash December 20 2018
58
bull Implementation date January 1 2020bull Mandatory Compliance January 1 2022
ldquoThe Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in naturerdquo
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
bull Any food governed by the labeling requirements of the Federal Food Drug and Cosmetic Act (FDCA) the Federal Meat Inspection Act (FMIA) the Poultry Products Inspection Act (PPIA) and the Egg Products Inspection Act (EPIA)
bull Food Manufacturers Dietary Supplements Importers and Retailers must comply
bull Any food that contains genetic material modified through in vitro rDNA
bull Detectability requirements (see link below)bull Record keeping is mandatory (hard or electronic) if requested
must be produced within 5 business days
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
Exceptions for BE Disclosure
60
bull Food served in restaurantsbull Very small food manufacturers (less than $25 million annual
receipts)bull Foods certified under National Organic Programbull Food derived from an animal is not considered BE solely because
it was fed BE substancebull Food that contain 5 or less BE per ingredientbull Mixed Foods If meat poultry or egg is the first ingredientbull Mixed Foods If broth stock or water is the first ingredient and
meat poultry or egg is the second
List of Bioengineered Foods
61
FULL CROP SUMMARIES FOR EACH ITEM LISTED ABOVE httpswwwamsusdagovrules-regulationsbebioengineered-foods-list
BE Disclosure on Principal Display Panel (PDP)
62
1 USDA approved symbol 2 ldquoBioengineered Foodrdquo or ldquoContains a
Bioengineered Ingredientrdquo3 Electronic or digital disclosure ldquoScan here for
more food informationrdquo4 Text message disclosure ldquoText [command word]
for bioengineered food informationrdquo5 Additional options for small businesses (eg
telephone or internet address)6 Modifications available for small packaging
HR 2 Signed into Law December 20 2018
63
bull Removed Cannabis sativa L from definition of marijuana in the Controlled Substances Act (CSA)
bull Removed tetrahydrocannabinols (THC) in hemp from Schedule I of the CSA
bull Cannabinoids derived from hemp including cannabidiol (CBD) are no longer considered illegal substances under federal law
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
in interstate commerce is in violation of the Federal Food
Drug amp Cosmetic Act
FDA Generally Recognized as Safe (GRAS) hulled hemp
seeds hemp seed protein and hemp seed oil
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
DocumentationAs a prudent manufacturer documentation is and has always been a great standard to strive for bull FDA requires a 2 year retention from date of introduction into interstate
commercebull Document how you arrived at your nutritional informationbull Attach document files to your recipes and ingredients in Genesis RampDbull Documentation examples
bull supplier spec sheetsbull analyses of nutrient databases bull recipes or formulationsbull batch records bull Any other records that contain the required information
64
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
Record Keeping Requirement
65
21 CFR 1019(g)(10)
Manufacturer must make and keep written records bull Analyses of databases Recipes Formulations or Batch
Records that verify declared amountbull Fiber Mixtures (beneficial and non-digestible carbohydrates)
bull Written records must be kept to substantiate the amounts declared for both types
bull Total vs added sugar or a combo bull Especially when added sugars are subject to non-
enzymatic browning andor fermentation and the manufacturer is declaring less added sugar than was added to the original recipe
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
Who is Responsible For Accuracy and Record Keeping
66
ldquoWe recognize that a manufacturer may contract with a firm to label a product that is then returned to the manufacturer for distribution may sell a product to a firm that labels the product under the firmrsquos own brand name for distribution (eg ldquoprivate labelerrdquo) or may engage in some other similar arrangement with a packager labeler or distributor A firm that labels the product whether the manufacturer or a private labeler must know for each nutrient declared the amount of a nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand the product We would expect a firm that does not manufacture the product but that is responsible for labeling the product to have access to records that are sufficient to verify the nutrient declarations for which records are required in the final rule and make the records available during an inspectionrdquo
Attachments feature in both Ingredients and Recipes to store all documentation
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
Items to Review for Transition
1 Use Nutrients to View amp Spreadsheet Report ndash to find missing nutrients
2 Contact suppliers for required nutrients 3 Document sources of Beneficial and Non- Beneficial Fiber4 Calculate added sugar value in ingredient and document5 Did the RACC change 6 Does your package require a dual column7 Are you making a nutrient content claim
67
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
Standards of Identity 21 CFR sect101100 Exemptions
Slide Number 47
RACC Changes Overview
Yogurt RACC Change Example
RACC Product Categories
Serving Size ndash Discrete Units (1 of 2)
Slide Number 52
Slide Number 53
Slide Number 54
Dual Column Labeling
Dual Column Exemptions (February 2018)
Coffee Tea amp Water
National Bioengineered Food Disclosure Standard ndash December 20 2018
National Bioengineered Food Disclosure Standard
Exceptions for BE Disclosure
List of Bioengineered Foods
BE Disclosure on Principal Display Panel (PDP)
HR 2 Signed into Law December 20 2018
Documentation
Record Keeping Requirement
Who is Responsible For Accuracy and Record Keeping
Items to Review for Transition
Summary
Questions
Slide Number 70
Summary
68
bull Timeline and what is needed from suppliersbull Formatting Nutrient Rounding amp Units of Measurebull Dietary FiberNon-Digestible Carbohydratesbull Added Sugarsbull Standards of Identitybull RACCDual Columnbull Bio EngineeredHemp
httpswwwfdagovFoodGuidanceRegulationdefaulthtm
Questions
69
70
Slide Number 1
ESHA Research
Timeline for Compliance
What Do We Need From Our Suppliers
Labeled Items Already In Distribution Chain
NUTRITION FACTS 2016 AND 1990
Missing Mandatory Nutrientshellip
Slide Number 8
Nutrient Rounding Rules
FINAL RULE - December 20 2018 Revision of the Nutrition and Supplement Facts Labels
