Adulteration and Misbranding

1. Adulteration and Misbranding Jurisdictional Prerequisites to the exercise of Federal Power in the area of foods

2. Adulteration and Misbranding • Jurisdictional prerequisites to exercise of federal power to seize, condemn, recall, or destroy nonconforming food products • Definitions have evolve since 1906 • Attempt to anticipate every situation where food may be injurious to health or misleading to consumer in any particular

3. What is Adulteration? • Simple definition: • Reducing the purity of an article by the addition of a foreign or inferior substance • Defines almost every situation where the quality of a food might by impaired to the point where it should be removed from interstate commerce • Statutory definition has been changed by court decisions (ad hoc) and by amendments.

4. Adulteration • Act of intentionally debasing the quality of food offered for sale either by admixture or substitution of inferior substances or by the removal of some valuable ingredient.

5. Adulteration • Defined by statute • 21 different criteria in FDCA • Statutes not interpreted by regulations • No regulations to explain law • Degree of contamination may determine if adulterated • Today, whether a food is adulterated or not is a question of fact which is decided by a court in an enforcement proceeding

8. Adulteration • Greeks and Romans acted to prevent wine makers from coloring and flavoring wine • Athens had “public wine inspector” • England proscribed “scanting weight” of bakery goods • Coffee, tea and cocoa placed under control of parliment

9. Adulteration • Edward the Confessor provided public punishment for brewers of “bad ale” • Pliny the Elder mentioned adulteration of bread • Addition of chalk to flour during WWII • Addition of sand to brown sugar and rice to make heavier • Addition of colors to disguise poor quality

10. Adulteration • Snails added to milk to make more “frothy” • Added water can be an adulterant • Addition of sand to brown sugar and brown rice

11. Adulteration • By middle 1800’s chemical and microbiological knowledge increases so food products could be analyzed • Food adulteration then could be studied from standpoint of consumer safety • Dr. Harvey Wiley’s poison squad

12. Intentional Adulteration • Salt and acid food preservatives • Food colors • Coal Tars in EU • Vegetable dyes in US • Pickles colored green with copper salts • Peas, wines, catsup • Food Flavors • Pear, banana essence in fruit juices

13. Intentional Adulteration • Milk adulterated with water and by removal of cream • Butter adulterated with lard and oleomargarine • Cheese made from skim milk or cottonseed oil • Filled Milk • Starch addition to sausages

14. Adulteration Criteria • Magic words: • Poisonous and deleterious • Added substances • May render injurious to health • Ordinarily injurious

15. Poisonous or Deleterious • Part of law since 1906 Act • Problem with P/D as adulteration criteria • Almost any substance can be shown to be P/D under some condition • Poisonous depends upon dose • “Everything that contains a poison is not poison” - Senate Chairman 1906

16. Poisonous and Deleterious • Poisonous = injurious effect or deadly effect as result of chemical reaction between substance and body • N2 gas in flour • Deleterious = broader term which includes mechanical, physical and bacterial agents • Shell fragments in Oysters

17. Added Substances • Substances intentionally added to foods are scrutinized more closely • Legal question is whether or not substance is considered “added” or a component of the food • Would now be considered “food additives”

18. US v. Coca Cola • Issue: Was caffeine an “added substance” in coca cola • Company argued caffeine even if added separately should NOT be considered an added substance b/c essential to identity of product. (Not coke w/o caffeine) • Court decided caffeine was an added substance on basis of protection consumer

19. May Render Injurious: • US v. Lexington Mills • Alsop process added N2 gas to flour • Presence of N2 caused flour to be adulterated • Court held: • Presence of a poison or deleterious substance must be such as may render the food article “injurious to health”

20. Ordinarily Injurious • Oyster shell fragments in canned oysters. • FDA alleged oysters adulterated b/c contained shell fragments • Court held presence of shell fragments not “ordinarily injurious to health” so product not adulterated. • Said: Is fish adulterated because it has bones?

21. Food Additives • Any substance which is intended to become a component of a food product or which affects a food product • Includes substances used for processing, manufacture, packaging, treating, etc. • Including irradiation • Excludes GRAS substances

22. Food Additives • Direct food additives • Substance intended for use in food • Serve a particular functional effect • Indirect food additives • Substances that become a part of food from processing, packaging or food contact surfaces reasonably expected to become part of food

23. Accidental Additives • Substances which accidentally get into foods are not considered food additives unless: • P/D or may render food injurious to health • Example: • Employee knocks box of cleaning solution into vat of food. Is food adulterated? • No, not unless P/D or injurious

24. Food vs. Food Additive • Food is broad term that includes food components, raw materials and food additives • No FDA premarket approval required for foods • Food becomes a food additive when used as a component in another food • Food additives require premarket approval

25. Example: • New single-cell protein manufactured by GM • If sold in pure form for direct ingestion? • Not adulterated because not ordinarily injurious • But, can it be used as a component of another food? • Not without FDA approval b/c _________?

26. Economic Adulteration • Food processed or manufactured in such a way as to make it appear to be better or of greater value than it is • Includes: • Appearance • Contents • Quantity (Slack fill) • Volume

27. Per Se Adulteration • P/D usually defined in relation to some measure of harm • May render injurious • Ordinarily renders injurious • Unsafe within meaning of…. • As necessary for public health • Poisonous without regard to quantity • Flourine or Monochloroacetic acid in beer • Quantity has no legal significance

28. Filthy/Putrid/Decomposed • Food is adulterated if consists in whole or in part of filthy, putrid or decomposed substances or if otherwise unfit for food • Products of diseased animals (died otherwise than by slaughter) • Protects aesthetics and sensitivities of consumers so contamination need not be visible

29. Defect Action Levels • All foods contains come filth so FDA sets tolerances for filth in foods called Defect Action Levels • Example: Corn (per 25g) • 1 or more whole insect • 25 insect fragments • 1 rodent hair • 1 rodent excreta per 50g

30. Other Adulteration Criteria: • De Minimis quantities • Quantity of contaminant too small • Otherwise unfit • Question of fact • Tough rubbery fish • Insanitary conditions • Packaged or held under insanitary conditions • Violation of a Good Manufacturing Practice, (GMPs)

31. Adulteration Summary • Adulteration is defined in terms of health, potential for harm and reduction in economic value • Standard is the measure of harm • May render injurious • Ordinarily injurious • Unsafe • Public health protection • Presence of unapproval food additive = adulteration?

32. Misbranding

33. Misbranding • Purpose of labeling: • Inform the consumer about the product • Induce the consumer to buy the product • Why regulate labeling: • Prevent fraud, deception or misleading statements • Require disclosure of information necessary for consumer to make “informed decision”

34. Misbranding • Regulation of labeling concerning the presence or absence of specific attributes of a food product has great potential impact on food market • Misbranding = presence or absence of information on label of a product which is false, deceptive or misleading

35. Label vs. Labeling • Label: • A display of written, printed or graphic matter upon the immediate container of any article • Labeling: • All labels and other written material upon any article or any of its containers or wrapper, or accompanying the product

36. Label vs. Labeling • Label: • A display of written, printed or graphic matter upon the immediate container of any article • Labeling: • All labels and other written material upon any article or any of its containers or wrapper, or accompanying the product

37. Misbranding • Label must not be “false or misleading in any particular” • Every aspect of label is considered in determining if false or misleading • FDA need not show consumer actually mislead • Test is effect of labeling on “ignorant, the unthinking and the credulous” consumer

38. Mandatory Labeling Requirement: • Product identity statement • Standards of Identity • Appropriately descriptive terms • Ingredient Line • List in descending order of predominance by weight of all ingredients • Statement of Net Content • Statement of contents in terms of weigh, measure or numerical count • Identity of Manufacturer Packer or Distributor

39. Standards of Identity • FDCA requires FDA to establish a “standard of identity” for any food • To promote “honesty and fair dealing” • 21 CFR 130 • Products Development • Choosing a name for a product • Must first consult standard of identity • Must use name set forth in standard if there is one • Appropriately descriptive name if no standard