1. Special Concerns for Manufacturing and Marketing Functional Foods ACI Conference on Dietary Supplements, Nutraceuticals and Functional Foods Hilton San Francisco Suzan Onel, Partner May 16, 2007K&L Gates

2. 2 “A rose is a rose is a rose” Gertrude Stein

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5. 5 What are “functional foods”?  Food  Drug  Dietary Supplement  Medical Food

6. 6 A. “Food”  Articles used for food or drink, including chewing gum  Consumed for taste, aroma or nutritive value FFDCA §201(f); Nutrilab v. Schweiker

7. 7 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)

8. 8 C. “Dietary Supplement”  A sub-category of food  Intended to supplement the diet  Labeled as a “dietary supplement”  Is not represented as a conventional food or as the sole item of a meal or the diet FFDCA §201(ff)

9. 9 D. “Medical Food”  A subcategory of food  Formulated to be consumed or administered enterally  Under supervision of physician  Intended for specific dietary management of disease/condition which has distinctive nutritional requirements 21 C.F.R. §101.9(j)(8)

10. 10 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

11. 11 Examples:

12. 12 Why does it matter? It determines legal requirements for marketing the product in the U.S.

13. 13 Topics  Critical issues to consider when positioning a product  Claims  Ingredient safety standards  Manufacturing requirements  Substantiation  Current regulatory status

14. 14 I.Critical Issues  Claims  Product description  Structure/function claims  Health claims  Nutrient content claims

15. 15 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”

16. 16 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

17. 17 Structure/Function Claims  Truthful and not misleading  Does not claim to diagnosis, mitigate, treat, cure or prevent a disease or health related condition

18. 18 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))

19. 19 Structure/Function Examples:  “Calcium builds strong bones”  “Fiber maintains bowel regularity” If no link to nutritive value, subject to regulation as a drug

20. 20 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

21. 21 Health Claim Examples:  Claims linking a food with a disease or health-related condition; limited to risk reduction claims  Specific language requirements Calcium and Osteoporosis Folic Acid and neural tube defect

22. 22 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

23. 23 Nutrient Content Examples:  “high” fiber  “low” fat  “good source” of calcium  “healthy”  “fortification” with echinachea, ginseng, etc. not authorized

24. 24 I.Critical Issues (cont.)  Ingredient Safety Standards  Food ingredients in conventional products must be:  Approved food additives,  Prior sanctioned, or  GRAS  Status is specific to particular intended use and use level

25. 25 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”

26. 26 Requirements for Food Additives  Authorizing regulation  Food additive petition  Animal and clinical test data of safety  Standard: Reasonable certainty of no harm  Timeframe: 2-4 years

27. 27 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

28. 28 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

29. 29 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.

30. 30 Ingredient Examples  Gingko  St. John’s Wart  Echinachea  Stevia Compare to use in dietary supplements

31. 31 I. Critical Issues (cont.)  Manufacturing Requirements  Food – Current GMPS 21 C.F.R. Part 110 et seq.  Dietary Supplements – 2003 proposed rule (68 Fed. Reg. 12158)

32. 32 II. Substantiation of Claims  Labeling – FDA  Product description – context  Health claims – regulation or letter of enforcement discretion  Nutrient content claims – regulation  Structure/Function claims – “truthful and not misleading”

33. 33  Advertising – FTC  1994 FTC Guidance to harmonize standard with FDA  “Competent and reliable scientific evidence”  Flexible standard based on nature of claim and qualifications

34. 34  Examples of Substantiation Issues  Cherry Juice  Ocean Spray  Wonderbread  Jogging in a Jug

35. 35 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

36. 36 Why Choose One Category Over Another?  Timing  Ingredient status  Claims  Market Sector A rose by any other name may smell as sweet… but will be regulated differently.

37. 37 Any questions ??? Suzan Onel, Partner K&L Gates 1601 K Street, NW Washington, DC 20006 (202) 778-9134 suzan.onel@klgates.com