Food and Drug Law September 20 , 2010

1. Food and Drug LawSeptember 20, 2010 Ralph F. Hall

2. Overview • Current events • Definitions • Labeling • Key definitional cases • Combination products • Food • Protected interests • Key concepts • Adulteration

3. Nutrilab713 F2d 335 (7th Cir. 1983) • Nutrilab manufactured a “starch blocker” • Starch blockers are made from raw kidney beans • Blocked digestive enzyme • 75 consumer complaints (relevant?) • Product used for weight loss • Nutrilab considered product a food • If a food, no premarket approval • FDA asserted it was a drug • If so, product was illegally marketed

4. Nutrilab713 F2d 335 (7th cir. 1983) • “Drug” definition includes multiple elements • Diagnosis, cure, treatment, etc. of disease • Articles (other than food) intended to affect structure • Components of drugs • Can article be both a food and drug based on intended use? • Definitions not mutually exclusive • What does that mean? Can it both at the same time? • If intended for drug use, regulated as such even if other intended uses not regulated

5. Nutrilab713 F2d 335 (7th cir. 1983) • Analytical process • Is it a drug? • Does the Subpart C exception for “food” apply • What is the definition of food • Which definition is being used • Something derived from “food” is not necessarily food • Interaction of types of definitions

6. Nutrilab713 F2d 335 (7th cir. 1983) • Definition of drug based on intended use • Objective intent • Based on manufacturer’s actions and statements • “Food” definition based on function, not source, composition, etc. • Definition broader than just usual usage • Nutritional value not required • Includes packaging

7. Nutrilab713 F2d 335 (7th cir. 1983) • Parenthetical reference to “food” in drug definition • Drug definition excludes common sense food • Starch blockers not food • Not ingested for taste, aroma or nutrition • From whose perspective? • Starch blockers are drugs • Affects structure or function of body • Not covered by exclusion in subpart C • Source not determinative

8. U.S. v. Technical Egg Products • Eggs not intended for food use • Industrial usage • Lack of intent to be used as food does not take “food” out of the regulation • Compare to drug definitional approach • Potential to be used for food is enough • Implications?

9. Intended Use • “Objective intent” of the manufacturer • Subjective intent irrelevant • National Nutritional Labs • Use labeling, promotion statements, advertising, etc. to determine objective intent • Consumer expectation • “Sudden Change” case • “the ignorant, the unthinking, and the credulous” • Is this “intent”? • Change the “intent”, change the classification

10. Intended Use • Intended use is to treat disease or affect structure or function • Changing definitions of “disease” or “function” • Obesity • Mental states • Does it have to work? • Non-functional articles • Adulterated/condemned products • Same article, different regulations • Caffeine • Does intended use result in illogical results

11. Intended Use • Pros • Covers consumer perception • Covers use decisions • Includes fraudulent products • Allows manufacturer control • Cons • Actual mode of action may be irrelevant • Difficulty in determining objective intended use • Not risk based classification • Foreseeable effect on the body does not establish an intended use

12. CosmeticsU.S. v. … Sudden Change (409 F.2d 734) • Product advertised as “face lift w/o surgery” • Reviewed intended use • Discounted “puffery” • “lift out puffs” • Examined label, promotional material and advertising • Affects structure test for a drug • Exception for “familiar exaggerations of cosmetic advertising” discounted as puffery

13. CosmeticsU.S. v. … Sudden Change (409 F.2d 734) • Intent based on objective (imputed) intent of manufacturer • How judged? • Level of understanding of the consumer deemed a key issue • Statute protects the “ignorant, the unthinking and the credulous” • The “virtually everyone” test for puffery • Why is this relevant?

14. This product is a liquid used to hydrate a person. It is a ____________.

15. Food

16. This product is a liquid intended to reconstitute a freeze-dried drug. It is a ____________.

17. Drug

18. This product is intended to cleanse wounds by physically washing away debris. It is a _______________.

19. Device

20. This product is a liquid used in an article to make you smell good. It is a ____________.

21. Cosmetic

22. Water • Is water “food” under 321 (f)? • SDWA governs drinking water • Water as a food component • Meets §321 (g) (3) definition • Bottled water regulated by FDA • §349 designed to promote consistency • Ice as a “food” • Water as a drug or drug component • Water as a manufacturing element in a device • Water as a cosmetic component • Steam therapy • Inhalants

23. Combination Products • Products can combine drugs and devices • Drug coated stent • Simultaneous mode of action • Cancer therapy delivery systems or insulin pumps • Sequential mode of action • Which regulatory system applies? • OCP • FDAMA provisions • Primary mode of action

25. Labeling • Label (321(k))– written or graphic matter on the immediate container of the article • Visible • Complete • Labeling (321(m)) – all labels and other written or graphic matters • Upon any article • Accompanying such article

26. Labeling • “Accompanying” is key concept • Kordel v. U.S. (1948) • Company shipped both product and literature • Some shipped separately • “Accompanying” not limited to physical proximity • Supplements or explains product • Advertising and labeling overlap (but not completely) • Is a press release about a new product labeling?

27. LabelingU.S. v. 24 Bottles ‘Sterling Vinegar & Honey’ • Sterling made a product combining honey and vinegar • Book described use of honey and vinegar • “Arthritis and Folk Medicine” • Mentioned Sterling • Third, unrelated company sold both products • No joint promotion • Key is use to which book is put • Sales of related products not ‘labeling’ • 250 Jars … Cal’s Tupelo Blossom … Honey • Combined usage

28. LabelingFirst Amendment Issues • Commercial speech protection • Central Hudson • Seizing books • Scientology • Is the E-meter a device? • Are the materials labeling? • Finding of misbranding as a statement re religion • When can religious materials be “labeling” or devices? • Lourdes?

29. Compliance Policy Guide 7153.13 • Where labeling other than books renders a product to be violative, and the labeling is closely associated with the product in question *(e.g. brand name, proximity at point of sale)* the agency will continue to recommend seizure of both the product and the labeling. • Where labeling is in the form of a book and the agency believes that the use of the book to promote the product creates a significant consumer deception, the agency will consider filing a complaint for forfeiture against the product and an injunction to halt, after a hearing, the misuse of the book.

30. Food The Original Regulatory Challenge

31. Do you want to eat? • Mold • Fungus • Partially decomposed food and • Microbial waste products

32. Protected Interests? • Food safety • Actual • Botulism • Perceived • Delaney Clause • Personal decisions • BST, etc. • Sensibility • The “ukk” factor • Cultural differences • Knowledge • Personal choice • Vegetarians • Personal health/medical issues • Sodium, allergens,

33. Protected Interests? • Economic interests • Quality • Non-safety related • Choice and economic protection • Contents • Quantity • Consumer protection • Producers • Oleomargarine • BST • Other?

34. Food Regulation • Food safety & purity • 10-30,000,000 cases of “food poisoning” each year • 300,000+ hospitalizations • 5-9,000 deaths per year • Personal requirements • Economic/consumer protection • Accuracy in labeling • Quality • Identity • Role of culture • Substances • Purity • Personal preferences • Defining what “food” is

35. Food - An Ongoing Challenge • Food based adverse events • Multiple foods/components consumed in 48 hours • Often multiple causes of adverse events • Cooking, storage, other pathogens • Adverse events often involve common symptoms • Internal production • Mass production • Speed • Imports • 13% of all food is imported • 35% of fruits, juices, etc. • 75% of fish/shellfish

36. Food Regulatory Overview • Jurisdiction • Adulteration control • Food pureness • Absence of contamination • Manufacturing and handling controls • Misbranding • Accuracy of labels • Mandatory label content • Economic fraud • Food standards • Import controls • Recall authority

37. Other Regulatory Systems • Raw agricultural products • Meat – USDA • Game meat - FDA • Poultry • USDA • Eggs – USDA • Alcohol – Treasury • Alcohol as an ingredient/component – FDA • 2% Rule • Restaurant food – local health officials

38. Food Categories • “Food” • Common food • Standards, tolerances, etc. • Food Additives • Dietary supplements • Infant formula • Medicinal food • Special dietary uses • Color Additives • Food and non-food uses

39. Possible Regulatory Approaches • Preset conditions or standards • Actual condition of article • Product • Labeling • Potential condition of the article • Consumer expectations • Effect or impact • Health & welfare • Economic

40. 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

41. Three Regulatory ApproachesFood Standards • Preset conditions (i.e. food standards) • Definitions of food • What is “chicken noodle soup” • Purity • Pros • Certainty • Awareness • Cons • Static • Gaps • Time and cost to develop

42. Food Purity • How pure is pure? • Standards • Levels of acceptable “contamination” • Tolerance levels • Defect action levels • Adulteration • Added components • Subtracted components • GMPs • Must be “wholesome”

43. Twin Concepts • Adulteration • Safety • Purity • Actual • Perceived • Economic expectations • Misbranding • Expectations • Anti-fraud • Evolved into safety (allergens, nutrition, etc) • Linkage to standards

44. Adulteration(§342) • Initially designed to address food safety • Not limited to safety • Adulteration = change from expected • Intentionally added materials • Accidentally added materials • Removed materials • Intent not required • Protects against potential, not just actual condition

45. Types of Adulteration • Unfit food • Poisonous • Filthy • Production processes or sources • Can cause undetected issues • Consumer expectations • Economic adulteration • Identify or constituents

46. Adulteration • Economic adulteration • §342 (b) • “valuable constituent” removal • Substitution • Concealment • Damage, inferiority, value • Reimportation

47. Adulteration§342 (a)-(h) • a) 1 • Contains poisonous substance • May render injurious • If not added, then must “ordinarily render it injurious to health” • Why the difference? • a) 2 • Contains any added poisonous or deleterious substance

48. Adulteration§342 (a)-(h) • a) 3 • Consists of filthy, putrid or decomposed substance • Otherwise unfit for food • Role of personal sensibilities • a) 4 • Insanitary conditions • Origins of GMPs and HACCP • A) 5 – No road kill • a) 6 • Container is composed of poisonous substance • Impact on actual food? • Jurisdiction?

49. Adulteration§342 (b) • b) • Omitted constituents • Substituted constituents • Concealment • Added bulk or weight • Make it appear better than it is • Who is the audience? • Reasonable consumer • “Credulous” consumer • FDA • Objective or subjective

50. Sources of Adulteration • Insanitary manufacturing • Actual contamination • Bacterial • Foreign matter • Failure to follow GMPs • Violation even if no actual harm • Designed to be preventive measures • If GMPs followed, then reduced risk of contamination • GMPs define manufacturing, processing and distribution methods and requirements • Can be very detailed • Risk mitigation • HACCP is special type of GMP