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 Indirect 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: Why regulate 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: Labeling:
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: Labeling:
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