1 / 79

Food and Drug Law September 20 , 2010

Food and Drug Law September 20 , 2010. Ralph F. Hall. Overview. Current events Definitions Labeling Key definitional cases Combination products Food Protected interests Key concepts Adulteration. Nutrilab 713 F2d 335 (7 th Cir. 1983). Nutrilab manufactured a “starch blocker”

latona
Download Presentation

Food and Drug Law September 20 , 2010

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

  24. 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

  25. 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?

  26. 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

  27. 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?

  28. 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.

  29. Food The Original Regulatory Challenge

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

  31. 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,

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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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”

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

  43. 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

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

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

  46. 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

  47. 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?

  48. 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

  49. 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

More Related