Food and Drug Law September 27-28, 2010

1. Food and Drug LawSeptember 27-28, 2010 Ralph F. Hall

2. Overview • Current events • Combination products • Food • Protected interests • Key concepts • Food standards • Adulteration • Misbranding

3. Food The Original Regulatory Challenge

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

5. 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,

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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Food StandardsThe Pineapple Story • 21 CFR §145 • Types of canned pineapple • Rings, chunks, spears, crushed • Types of medium • Water, light syrup, heavy syrup • Definitional specificity

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

15. 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

16. 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

17. 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

18. 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?

19. 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

20. 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

21. Other Types of Adulteration • Adulteration protects more than public health • Economic adulteration • Removal of “valuable” constituents • Failure to added listed ingredients • Quality substitution • “Corrective” actions or refurbishing • Mixing out of specification with in specification material to achieve compliance • If compliant, why do we care? • “Insanitary” but “fit for food” • Sanitary but “not fit for food”

22. Adulteration • U.S. v Cases of Center Cut Asparagus • Center cut is less desirable • Can be tough and “woody” • FDA condemned product as being unwholesome/unfit for food • Inspectors tried to eat a large can and found it tough and inedible • District Court reversed • Society needs less expensive foods • Not everyone can afford only asparagus tips

23. Economic AdulterationBireley’s Orange Beverage • Adulteration based on food type and label • Variation on misbranding? • Product not harmful • FDCA liberally construed • Congress used “brief test”, non-technical language” • Making food “appear better than it is” • Standard is the “reasonable person” • Compare to Sudden Change • Consider labeling, price, etc. to assess adulteration

24. Economic AdulterationBireley’s Orange Beverage • Low value foods not adulterated • If accurately described • Consumer expectations • What knowledge to impart to manufacturer • Any statutory basis for considering manufacturer knowledge? • Would a consumer confuse this with orange juice? • Active concealment of inferiority • Pop’nOil • Labeling may not be a defense • Doesn’t every manufacturer try to “improve” their product?

25. U.S. v. Tuente888 F. Supp. 1416 • Excessive drug residues in live hogs • Defendant was livestock dealer • Residues from producers, not Tuente • Prior issues and warnings • Are live hogs “food”? • Part of food chain • Deference to FDA • Introduction into interstate commerce • Producers first “introduced” hogs • Entire chain of distribution “introduces”

26. AdulterationDietary Supplements • Adulteration if • Intended uses present significant or unreasonable risk • Imminent hazard • New dietary ingredient for which there is inadequate information • Must satisfy current GMPs

27. Adulteration • § 342(a)(3) – food is adulterated “if it consists, in whole or in part, of any filthy, putrid or decomposed substance” • Is there a ‘de minimis” level for contamination • “We (FDA”) recognize that certain low levels of natural and unavoidable defects such as field insects may be present in certain foods even if handled in a sanitary manner.” FDA statement 1988 • Use of “tolerance levels”, Defect action levels and standards

28. 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”

29. Defect Action Levels • Curry Powder • Less than 100 insect fragments per 25 grams • Hops • Less than 2500 aphids per 10 grams • Coffee • Less than 10% moldy beans

30. Tolerance levels • “Even with modern technology, all defects in goods cannot be eliminated. …The defect levels (i.e. “tolerance levels”) set by … FDA represent a level below which the defect is both unavoidable under current technology and presents no health hazard” • 37 FR 6497 (3/30/72) • Do tolerance levels provide a defense if: • Insanitary conditions exist • Material deliberately added

31. Tolerance levelsU.S. v. 484 Bags of Green Coffee • Coffee damaged in hurricane • Initially condemned • Product refurbished • Company claimed not adulterated • Met NY Coffee Exchange standards • “level of contamination which would, with reasonable certainty, render the article unfit for food” • Export use only • Adulteration has two, independent, basis • “consists, in whole or in part, of any filthy, putrid or decomposed substance” • “otherwise unfit for food”

32. Tolerance levelsU.S. v. 484 Bags Green Coffee • Food can be condemned even if not “unfit for food” • Is the legal analysis correct? • Is this good policy? • Food can be “unfit for food” even if not filthy, putrid, etc. • Court can impose a stricter limit on food purity than FDA’s tolerance levels • Is there a “rule of reason” • Technical reading of statute

33. Tolerance levelsU.S. v. Capital City Foods • Imported butter • Contained some “foreign matter” • 3 “minuscule” particles per pound • No butter tolerance levels then existed • If no tolerance standard is the standard then zero foreign matter? • “Few foods contain no natural or unavoidable defects.” • Contamination of this level “trifle” and not a “matter of concern” to the law

34. Blend to Comply • Sugerman v. Forbragd • Can’t blend to satisfy defect action levels • Statutory support? • Why not (if the final product is safe and meets all requirements)? • Policy considerations

35. Anderson Seafood447 F. Supp 1151 • Mercury in fish • Some natural, some from pollution • Multiple sources of mercury • Is this an “added” substance • Note lower standard • FDA • Not inherent in food • Would include “natural” contaminants” • Policy arguments in favor • Industry • Added by act of man

36. Anderson Seafood447 F. Supp 1151 • Artificially introduced or attributable to the acts of man • “may render” injurious • Reasonable possibility, not certainty • Source of compound makes a difference • Natural v. introduced mercury • Policy reasons • Anti-backsliding provision • Highest standard denominator • Lack of precise knowledge • Scientific debate over numbers (MCEL) • 1.0 ppm level for adulteration

37. U.S. v. 1200 Cans … Pasteurized Whole Eggs • How scientific must the evidence of contamination, filth, decomposition, etc. be? • §342(a)(4) • Food prepared, packed, etc. under insanitary conditions in adulterated even if no evidence of decomposition, filth, etc. • GMP violations as per se adulteration • Role of “reasonably possible” contamination

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

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

40. 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

41. Misbranding • Statutory purpose • Financial elements • Economic protection • Anti fraud provision • Marketplace effects • Safety • Not original goal • Allergens • Dietary content • Sodium • Fat content

42. 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”

43. 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

44. 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?

45. 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?

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

47. 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

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

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

50. 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