food label/dietary supplement regulations. nlea nutrition labeling and education act passed by...
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Food Label/Dietary Supplement Regulations
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NLEANutrition Labeling and Education Act
passed by congress in 1990
Regulations written 1993
Manufacturer compliance Spring 1994
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Exceptions Small business Foods for immediate consumption, deli and
bakery items Foods of no nutritional consequence
(spices/coffee/tea) Infant formula/medical food Small packages (require 1-800#)
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Required Elements Serving size (common and g)
-standard reference sizes for 139
products Servings/container Total calories/calories from fat Total fat (g) Saturated fat (g)
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Cholesterol (mg) Sodium (mg) Total carbohydrate (g) (includes starch,
sugar, and fiber) Dietary Fiber (g) Sugars (g) (includes simple sugars from
natural and added sources)
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Trans Fats (g) Will be listed after saturated fat Will not have a %DV Manufacturers must comply by Jan. 2006
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Reference Values Generic Term = Daily Values (DVs)
2 sets of Daily Values
1. RDIs (Reference Daily Intakes) – label
standards for micronutrients Required: Vitamin A and C, iron, calcium
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2. DRVs (Daily Reference Values) – label standards for macronutrients, fiber, sodium, cholesterol
Based on a 2,000 kcal diet 30% of kcals fat 10% of kcals – saturated fat 60% of kcals carbo.
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11-12 g fiber/1,000 kcals 2,400 mg sodium 300 mg cholesterol
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ActivityEstimate calorie needs
Healthy body weight (lb) X 10 = baseline calories Baseline calories X
1.3 – sedentary
1.4 – light activity
1.5 – moderate activity
1.6 or more - active
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Ingredients Still listed by weight (descending order)
Changes: FDA-certified colors additives – use name Sources of protein hydrolysates revealed Caseinate identified as a milk derivative % real juice
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2 Types of Claims1) Nutrient-Content Claims
2) Health Claims
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Nutrient-Content Claims Highlighting and emphasizing something
about the nutritional content of the food (fat, cholesterol, fiber, micronutrient, etc.)
Statements are well-defined.
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Health Claims Approved statements that describe a
relationship between a food or substance in food and a disease or condition
14 approved health claims FDA requires SSA (significant scientific
agreement) in approving claims Food must also have at least 10% of DV for A, C, iron, Ca,
protein, fiber and no more than 20% of DV fat, sat’d fat, cholestol, sodium
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In 1998 – President Clinton approved use of “Authoritative Health Claim Statements” for food labels
May use health claims from groups like NIH, CDC, NAS
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Raw Foods? Voluntary program for markets to provide
information if form of poster/brochures for
20 most commonly consumed fruits/veges 20 most commonly consumed fish 22-23 categories of beef/poultry
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July 1994 – added safe handling of meat instructions
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How accurate are labels? Review results from 1996 study
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Restaurants Are exempt from NLEA unless they make
claims about
1) Nutrient-content
2) Health claim
If customer inquires – they must provide nutritional information
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Other actions Slight changes in labeling of Olestra
products – no more warning label about GI problems (pg 76-77 reader)
Look for a grading system for health claims (pg 83-86 reader)
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Qualified Health ClaimsB-D
Review some examples
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Dietary Supplements
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Dietary Supplement Health and Education Act
DSHEA (1994)
Congress passed law
Regulations written (1997)
Spring 1999
(new labels)
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Provisions of Bill1) Defined what a dietary supplement is “is a product (other than tobacco) that is intended
to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients”
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2) Provides framework for assuring safety
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Safety DSHEA does not require that supplements
are shown to be safe or effective before they are marketed.
Manufacturers must notify FDA of intent to market 75 days prior and submit info. that supports their conclusion that a new supplement can reasonably be expected to be safe.
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True safety burden falls on FDA FDA is only allowed to restrict a
supplement if it poses a “significant and unreasonable risk” under the conditions of use as stated on the label.
FDA must have substantial reports of adverse effects before they may take any action.
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Oct. 2001 - Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) added an amendment (#2013) DSHEA providing $1 million to FDA for safety enforcement
Sales: $17 billion in 2000
safety
sales
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3) Provides for Good Manufacturing Practices
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Quality DSHEA gives FDA authority to establish good
manufacturing practices (GMPs) In review - none currently exist
March 2003 – proposed new regulations for the establishment of current good manufacturing practices (CGMPs)
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Does supplement contain what label claims it has???
-What is appropriate dose for active ingredient? (unclear)-adulteration, substitution, contamination and additives may be present but not listed on the
label -have been some reports of outright fraud
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Quality? Consumer lab provides independent testing
of quality
http://consumerlab.com
US Pharmocopeia – standards that over-the-counter drug companies use
http://www.usp.org/
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National Nutritional Foods Association (NNFA) -- a trade organization encompassing about 1000 producers as well as retailers
http://www.supplementquality.com/testing/NNFA-GMP-seal.html
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4) Established the Office of Dietary Supplements and Alternative Medicine of NIH
http://dietary-supplements.info.nih.gov/
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5) Regulates Label Information
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Required Elements1) Product Name Must identify that product is a dietary
supplement
2) Serving size and daily dose
3) Ingredients List – in supplements fact box and “other ingredients”
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4) Percent Daily Value For nutrients with a DV – must show
mg/g amount and %DV
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5) Claims
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Claims1. Nutrient - content claims must follow regulations as stated in NLEA
“High in calcium” - 200 mg or more/serving
“Excellent source of C” - 25 mg or more
“High potency” - 100% of DV for nutrients
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2. Health Claims May use any of the 14 approved Health
Claims as stated in NLEA FDA required SSA (significant scientific
agreement) in approving claims
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“Calcium reduces the risk of osteoporosis”
“Soluble fibers may reduce the risk of CHD”
“Plant sterols reduce the risk of heart disease”
“Folic acid reduces the risk of having a child with a brain or spinal birth defect”
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The Gray Zone3. Structure/Function Claims Allowed to make claims about how the
supplement supports or promotes healthy functioning of the body
Claim must not suggest that the supplement treats, prevents, or mitigates a disease
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Exemptions: common conditions associated with natural states or processes that do not cause significant or permanent harm
e.g., hot flashes, mild memory problems, hair loss associated with aging, acne
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Must carry disclaimer statement“This statement has not been evaluated by the FDA.
This product is not intended to diagnose, treat, cure, or prevent any disease”
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May sell a product with a claim as long as FDA is notified within 30 days of market
Manufacturer determines if claim is scientifically substantiated
Burden of proving inadequate substantiation of claim in responsibility of FDA.
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Helps maintain cardiovascular function Protects against heart disease
Promotes healthy cholesterol level Lowers cholesterol level
Promotes healthy joints Reduces pain of arthritis
Supports regularity, healthy intestinal flora Alleviates chronic constipation; laxative
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Promotes urinary tract health Prevents urinary tract infections; improves
urine flow in men over the age of 50; diuretic
Reduces stress and frustration Herbal prozac
Improves memory Treats dementia
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Center for Science in the Public Interest (CSPI)
“this proposal was merely a futile bureaucratic exercise in hairsplitting that did little to protect the consumer.”
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Recent Action December 2003 – Immediate consumer
safety alert on ephedra and rule to come on banning the sale of ephedra-containing products
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Suggestions for the practitioners Direct link to FDAhttp://www.cfsan.fda.gov/
Reliable sources on supplements
http://www.quackwatch.com/
http://www.supplementwatch.com/
http://www.herbalgram.org/
http://www.herbs.org/
http://www.herbmed.org/