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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. “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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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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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