Food and Drug Law October 4 , 2010

1. Food and Drug LawOctober 4, 2010 Ralph F. Hall

2. Overview • Current events • Food • Misbranding • Special food types • Food Additives • Dietary supplements • Health claims

3. Three Key Systems • § 341 – Ability to establish standards • Identity • Quality • Specific inclusions and exclusions • No standards for fresh or dried fruits • Except for avocadoes, citrus fruits and melon • § 342 –Adulteration • § 343 - Misbranding

4. Types of Adulteration • Unfit food • Poisonous • Filthy • Production processes or sources • Can cause undetected issues • Consumer expectations • Economic adulteration • “valuable constituent” removal • Substitution • Identify or constituents

5. Misbranding (§343) • Statutory purpose • Financial elements • Economic protection • Anti fraud provision • Marketplace effects • Safety • Not original goal • Allergens • Dietary content • Sodium • Fat content

6. Misbranding • Accuracy • Identity • Content • Quality • Quantity • “False or misleading in any particular” • Information • Label content • Labeling?

7. Misbranding§343 • a) - False or misleading in any particular • b) - Use of wrong name • c) – improperly labeled imitation food • d) – misleading fill • e) – label content • f) – failure to include required labeling • g, h) – Failure to satisfy food standard

8. Labeling Requirements(Misbranding) • §343 • Prohibits “false or misleading statements • No materiality requirement • 95 Barrels of … Apple Cider Vinegar • May mislead or deceive • “Expressed apple juice v. rehydrated juice • No substantive difference • May be factually true but misleading • “made from selected apples”

9. 432 Cartons … Candy Lollipops • Product labeled as candy • Accurate ingredients • Called “liquor sticks” • Labeled Scotch, bourbon & gin • No actual liquor • False “in any particular” • Stricter than FTC “materiality” • False or misleading • True statement doesn’t cure a “false” one • Were these statements “false”? • Consumer protection

10. U.S. v. Manischewitz Diet Thins • Same calories per gram as regular crackers • Smaller cracker • One misrepresentation enough • Label was technically accurate • “Pathetically eager” consumers • How is protected? • Average consumer or lowest common denominator?

11. 21 CFR 101.4 • Dried egg whites, frozen egg whites and liquid egg whites may be declared as “egg whites” • Why do these provisions exist • Impact of 95 Barrels • Certainty and accuracy • Consumer communication?

12. Eggs and Salmonella • Recent controversy • Assume interstate commerce and FDA jurisdiction • Do these eggs violate any FDA requirements? • Is so, which ones?

13. The Challenge of “Organic”7 CFR Part 205 • Part of labeling and covered by §343 • Multiple interests • 4 categories • 100% organic • Organic (95-99%) organic • Made with organic ingredients (70-95%) • Organic component • Complex production, processing and shipping requirements • Third party acceditation

14. Other Challenges • “Natural” • “Fresh” • “Pure” • “Home made” • “Original” • “Traditional” • “Imitation” (see 66 Cases of Jam v. U.S.) • Line between a claim and puffery?

15. Labeling Requirements • Statutory obligations • Name • Manufacturer identity • Ingredients • Quantity • Nutritional information • Regulatory obligations • Detailed labeling regs exist • Food type specific in many cases

16. Required Display Panels • Principal display panel • Mandatory content • Name, manufacturer, etc. • Size, shape, location, font, etc. requirements • Information panel • Similar format requirements • Nutritional labeling • Role of NLSA

17. Other Food Issues

18. Vitamins and Minerals • Major political and policy issue • Challenge: • When do vitamins become drugs? • Safety/efficacy issues with high dose vitamins • Consumer protection • Vitamins in excess of daily recommendations • § 350 • Example of very specific congressional action to stop certain FDA actions • FDA’s view of science and role of Congress and politics • Role of personal choice

19. Vitamins and Minerals • Congress limits FDA • No maximum limits on potency of vitamins • §§ 321 (n), 341 and 343 • Use of “food” • Can’t be classified as a “drug” due to potency • Exception for vitamins represented for use in treatment of a specific disease or disorder • Pregnant/lactating women • Children (under age 12)

20. Vitamins and Minerals • Vitamins not misbranded under 343 • “food to which this section applies” • Label contents • Dietary supplement rules • 350(c) – “food to which this section applies” • Vitamins • Tablet, capsule, etc form or • Not represented as a conventional food • Special dietary use • Man, not animals • Specific disease/condition need

21. Special CategoriesInfant formula (§350a) • Political and health issue • 3rd world controversy • Adequacy of original formulations • Special adulteration definition • Contents • GMP compliance • “Quality factors” • Batch testing • Shelf life testing • In process testing • Auditing

22. Special CategoriesInfant formula (§350a) • Special record retention requirements • Prior notice of “new infant formula” • Formulation • Facility registration • GMP and testing compliance • Test run certification • Then what? • Special notification requirements • “Defective product” • Recall requirements

23. Food to “Treat” Disease • Increasing knowledge about food and treatment • Consumer demand • Choice v. safety • Need for line between drug and food • Opportunity for fraud and medical mismanagement • Food as a preventive • More complex and difficult • Role of traditional misbranding

24. Special Dietary Use Foods21 CFR 105.3 • “particular (as distinguished from general) uses of food …” for • Supplying particular needs due to physical, physiological, or pathological conditions • Infant or special children’s foods • Foods fortified with vitamins, minerals, etc. • Special labeling requirements • What is artificial sweetener?

25. Medical Foods • Little understood or used concept • Even the experts scratch their head • Elements (§360ee(b)) • Specially formulated • Address specific nutrition related diseases, conditions, etc. • Medical oversight and management • Emerging role of nutrigenomics

26. Medicinal Food • FDA’s additional elements • Specially formulated and processed • Impaired capacity to use ordinary foods or other needs ordinary foods can’t satisfy • Unique nutritional needs • Medical supervision • Personal and active supervision • Why these limitations/requirements?

27. Food Additives • §321 (s) • Intended use • Component of food • Could affect food • Includes packaging, treating, transportation • see 350e • Definitional overlap • Historical origins • Later history • PCBs and cardboard

28. Food Additives • 1958 enactment • “Any substance the intended use of which results or may reasonably be expected to result … in its becoming a component or otherwise affecting the characteristics of any food • includes packaging, manufacturing materials, transportation items, etc

29. Food Additives • FDA approval needed for food additives • Grandfathering • Two exceptions to approval requirement • specified items • MSG • Sodium nitrite • pre 1958 GRAS articles • Must establish safety for intended use • Ongoing monitoring

30. Food PackagingNatick Paperboard • Packaging as “food additive” • PCB risk • Not intended to leach • Intent to affect food not required • Ability to seize • Limited to packaging actually to be used for packing • If insulated from “food”, not covered

31. Key Food Additive Provisions • Premarket approval • Petition process • Public input • Safety determination • Link to 342 (a) (2) (C) • Why premarket review for food additives • Why not food • Issue of overlap • Water as food and as additive

32. Food Contact Substances • Subset of food additive (and thus of food) • Defined in 348 (h)(6) • Does it include “component” or incorporation? • No “technical” effect” • Notification requirement • Agency action required to halt

33. Color Additives

34. Color Additives • Definition • dye, pigment or other substance • capable of imparting color • When added to • Prior approval required • “Old” colors also required testing • 90/200 still in use • Two types of color additives • “coal tar” derivatives (batch certification) • Other (no batch certification)

35. Color Additives • Note linkage to 342, 343(c), 351 and 361 • Basis of enforcement • Approval via regulation • Contact requirement for devices • Materials with “natural” color • Listing process • Policy decision • Certainty vs. innovation and speed

36. Dietary Supplements

37. Dietary SupplementsOverview • Dietary Supplement Health and Education Act of 1994 (DSHEA) • Response to consumer and political pressure • Allows “traditional” supplements to bypass drug processes • Maintains some control over “new” supplements • Low safety risk assumption

38. Core Policy Issues • Individual medical choices • Right to take supplements • Reduce control by “modern” medicine • Use of history for safety • If safe, how efficacious must it be? • Patient risk • Risk of product • Risk of delayed treatment • Economic protection

39. Dietary Supplement Battlegrounds • Regulation of health claims • Level of data required • Prior approval • General misbranding • Economic protection • Safety • Ephedra

40. Dietary Supplements21 USC §321 (ff) • Subset of “food” • Product type • vitamin • mineral • herb or botanical • amino acid • substance to increase total dietary intake • concentration, metabolite, extract, etc of the above • Intended to “supplement the diet” • Not conventional food or sole item of a meal • Excludes tobacco

41. Dietary Ingredients21 USC § 350b • Dietary supplement that contains a “new ingredient” • not marketed in US prior to 1994 • Adulterated unless: • article has been a food • history of safe use • 75 day prior notification • Petition for regulation allowing new dietary ingredient

42. Regulatory Structures • General adulteration (§342) • Good manufacturing practices • No filth, rot, etc. • General misbranding (§343) • Accuracy • Content • Specific violations of dietary supplement provisions • Other

43. Dietary SupplementsCurrent issues • Adverse event reporting • GMPs • Define • compliance • Safety database • New dietary ingredients • Traditional/alternative medicines • Definition overlaps

44. Health Claims

45. Health ClaimsBackground and Policies • Increasing knowledge about food, nutrient and health • Old concept – nutrient, taste, aroma • Opportunities for abuse • Health impacts • Actual harm • Diversion from therapy • Consumer protection • Consumer choice • Personal freedom

46. Health ClaimsOverview • NLEA – significant scientific agreement • DSHEA – supplement related claims • FDAMA – authoritative statements • Pearson v. Shalala • 2003 Guidance (response to Pearson v. Shalala) • qualified health claims • Less evidence that other bases for health claims • Recent litigation

47. Key Food Statutes • 343 (q) • Applies to human food • Label must include certain information • Dietary supplements must have certain nutritional information • 343 (r) • Deals with health claims and nutrition claims • Permits claims is there is an “authoritative statement” from US government (sub G) for certain statements • Notice to FDA • Health claims require significant scientific agreement

48. General Labeling Requirements343(q) • Basic NLEA information (q)(1) (2) • Serving size, nutritional levels, etc. • Exceptions (q) (5) • Restaurants and retail sales • Small business • 343 (r)(5) includes other exceptions

49. Nutritional Labeling21 USC § 343 (r) • Characterization of food or nutrient value is misbranding unless exception applies • Special rules for cholesterol, fat, etc. • Multiple ways to make health claims • “authoritative statement” • Substantial Scientific Agreement • Pearson type claim • Dietary supplement

50. Nutritional Labeling21 USC § 343 (r)(2)(G) • Health related claims • authoritative statement by government entity • NAS • NIH • CDC • 120 day prior notification • Challenged by regulation, failure to comply with notification requirements, district court action • Relationship to DSHEA