Special Concerns for Manufacturing and Marketing

Functional FoodsACI Conference on Dietary Supplements, Nutraceuticals

and Functional Foods

Hilton San Francisco Suzan Onel, Partner

May 16, 2007 K&L Gates

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“A rose is a rose is a rose”Gertrude Stein

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What are “functional foods”?

A. Food

B. Drug

C.Dietary Supplement

D.Medical Food

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A. “Food” Articles used for food or drink, including

chewing gum Consumed for taste, aroma or nutritive

value

FFDCA §201(f);

Nutrilab v. Schweiker

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B. “Drug” Intended to diagnose, cure, treat,

mitigate or prevent disease Other than food, intended to affect the

structure or any function of the body

FFDCA §201(g)

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C. “Dietary Supplement”1. A sub-category of food2. Intended to supplement the diet3. Labeled as a “dietary supplement”4. Is not represented as a conventional

food or as the sole item of a meal or the diet FFDCA §201(ff)

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D. “Medical Food”1. A subcategory of food

2. Formulated to be consumed or administered enterally

3. Under supervision of physician

4. Intended for specific dietary management of disease/condition which has distinctive nutritional requirements 21 C.F.R. §101.9(j)(8)

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E. “Functional Food” Conventional food products with health

promoting ingredients or components that go beyond their nutritive value

a/k/a “Designer Food” and “Nutraceuticals” No legal definition Need to assess “intended use,” ingredients

and claims to determine legal category

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Examples:

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Why does it matter?

It determines legal requirements for marketing the product in the U.S.

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Topics

I. Critical issues to consider when positioning a product

Claims Ingredient safety standards Manufacturing requirements

II. SubstantiationIII. Current regulatory status

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I. Critical Issues

A. Claims Product description Structure/function claims Health claims Nutrient content claims

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Product Description – Context Matters Benecol, Organic GingkO’s Cereal,

Kitchen Prescription Creamy Split Pea Medical food “Delicious orange flavored beverage” “Premium Belgium Chocolate Bar” “Smart Cookie”

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Structure/Function Claims Focus on maintaining the healthy

function of the body or on a mechanism of action

Specifically authorized for DS Additional “nutritive value”

requirement for conventional food

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Structure/Function Claims Truthful and not misleading Does not claim to diagnosis, mitigate,

treat, cure or prevent a disease or health related condition

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What is “Nutritive Value”? FDA defines as value in sustaining

human existence by such process as promoting growth, replacing lost nutrients, or providing energy

Ill-defined; since 2001, being broadly interpreted

(21 C.F.R. §101.14(a)(3))

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Structure/Function Examples: “Calcium builds strong bones” “Fiber maintains bowel regularity”

If no link to nutritive value, subject to regulation as a drug

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Health Claims Same requirements for DS and

conventional food Authorized health claims

By regulation By authoritative statements By letter for qualified health claims

Unauthorized health claims are subject to regulation as a drug

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Health Claim Examples: Claims linking a food with a disease

or health-related condition; limited to risk reduction claims

Specific language requirements

Calcium and OsteoporosisFolic Acid and neural tube defect

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Nutrient Content Claims Same requirements for DS &

conventional food Authorized by regulation Characterize the level of a substance

in food based on RDI or DRV Unauthorized claims misbrand the

product

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Nutrient Content Examples: “high” fiber “low” fat “good source” of calcium “healthy” “fortification” with echinachea, ginseng,

etc. not authorized

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I. Critical Issues (cont.)B. Ingredient Safety Standards

Food ingredients in conventional products must be:Approved food additives,Prior sanctioned, orGRAS

Status is specific to particular intended use and use level

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Contrast to dietary supplement dietary ingredients:

Exempt from the food additive definition

Can go to the market with no premarket FDA review unless contains a “new dietary ingredient”

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Requirements for Food Additives

Authorizing regulation Food additive petition

Animal and clinical test data of safetyStandard: Reasonable certainty of

no harmTimeframe: 2-4 years

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GRAS Substances

“Generally recognized as safe” by qualified experts under the conditions of the intended use based on publicly available information

Same safety standard as food additives

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Process GRAS regulation – 21 C.F.R. Parts 182 and 184

Self-affirmation by company itself, expert, or expert panel no communication with FDA necessary some regulatory risk

GRAS notification Pursuant to FDA 1997 Proposed Rule

(62 Fed. Reg. 18937)

FDA 6+ month response time and inventory on website

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GRAS Notification Requirements Description of substance Proposed use and estimated intakes Methods for detecting and quantitating the

substance in food Safety and toxicology data and information,

including unfavorable information, safety studies, adverse reaction reports, consumer complaints, etc.

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Ingredient Examples Gingko St. John’s Wart Echinachea Stevia

Compare to use in dietary supplements

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I. Critical Issues (cont.)

C.Manufacturing Requirements Food – Current GMPS

21 C.F.R. Part 110 et seq.

Dietary Supplements – 2003 proposed rule (68 Fed. Reg. 12158)

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II. Substantiation of Claims

A. Labeling – FDA Product description – context Health claims – regulation or letter of

enforcement discretion Nutrient content claims – regulation Structure/Function claims – “truthful

and not misleading”

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B. Advertising – FTC 1994 FTC Guidance to harmonize

standard with FDA “Competent and reliable scientific

evidence” Flexible standard based on nature of

claim and qualifications

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C. Examples of Substantiation Issues

Cherry Juice Ocean Spray Wonderbread Jogging in a Jug

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III. Current Regulatory Status FDA public meeting on 12/5/06 Key question: adequacy of current regulatory

framework to ensure that food marketed as “functional food” is safe and lawful

Primary issues: notification system for ingredients notification system for labeling claims “nutritive value” limitation on s/f claims

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Why Choose One Category Over Another?

TimingIngredient statusClaimsMarket Sector

A rose by any other name may smell as sweet… but will be regulated differently.

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Any questions ???

Suzan Onel, Partner

K&L Gates

1601 K Street, NW

Washington, DC 20006

(202) 778-9134

suzan.onel@klgates.com