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

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

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.

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.

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

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

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

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

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

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

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

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

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

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

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”

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

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”

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?

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

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

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

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

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 _________?

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

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

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

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

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)

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?

Misbranding

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”

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

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

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

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

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

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