Hilton San Francisco Suzan Onel, Partner May 16, 2007 K&L Gates

1. 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

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

5. What are “functional foods”? • Food • Drug • Dietary Supplement • Medical Food

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. “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. “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. “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. 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” • Nolegaldefinition • Need to assess “intended use,” ingredients and claims to determine legal category

11. Examples:

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

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

14. Critical Issues • Claims • Product description • Structure/function claims • Health claims • Nutrient content claims

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

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

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

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

31. 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. 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. 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. Examples of Substantiation Issues • Cherry Juice • Ocean Spray • Wonderbread • Jogging in a Jug

35. 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. Why Choose One Category Over Another? • Timing • Ingredient status • Claims • Market Sector A rose by any other name may smell as sweet… butwillberegulateddifferently.

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