Presentation on theme: "Adulteration and Misbranding"— Presentation transcript:
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 productsDefinitions have evolve since 1906Attempt 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 substanceDefines almost every situation where the quality of a food might by impaired to the point where it should be removed from interstate commerceStatutory definition has been changed by court decisions (ad hoc) and by amendments.
4 AdulterationAct 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 FDCAStatutes not interpreted by regulationsNo regulations to explain lawDegree of contamination may determine if adulteratedToday, whether a food is adulterated or not is a question of fact which is decided by a court in an enforcement proceeding
8 AdulterationGreeks and Romans acted to prevent wine makers from coloring and flavoring wineAthens had “public wine inspector”England proscribed “scanting weight” of bakery goodsCoffee, tea and cocoa placed under control of parliment
9 AdulterationEdward the Confessor provided public punishment for brewers of “bad ale”Pliny the Elder mentioned adulteration of breadAddition of chalk to flour during WWIIAddition of sand to brown sugar and rice to make heavierAddition of colors to disguise poor quality
10 Adulteration Snails added to milk to make more “frothy” Added water can be an adulterantAddition of sand to brown sugar and brown rice
11 AdulterationBy middle 1800’s chemical and microbiological knowledge increases so food products could be analyzedFood adulteration then could be studied from standpoint of consumer safetyDr. Harvey Wiley’s poison squad
12 Intentional Adulteration Salt and acid food preservativesFood colorsCoal Tars in EUVegetable dyes in USPickles colored green with copper saltsPeas, wines, catsupFood FlavorsPear, banana essence in fruit juices
13 Intentional Adulteration Milk adulterated with water and by removal of creamButter adulterated with lard and oleomargarineCheese made from skim milk or cottonseed oilFilled MilkStarch addition to sausages
14 Adulteration Criteria Magic words:Poisonous and deleteriousAdded substancesMay render injurious to healthOrdinarily injurious
15 Poisonous or Deleterious Part of law since 1906 ActProblem with P/D as adulteration criteriaAlmost any substance can be shown to be P/D under some conditionPoisonous 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 bodyN2 gas in flourDeleterious = broader term which includes mechanical, physical and bacterial agentsShell fragments in Oysters
17 Added SubstancesSubstances intentionally added to foods are scrutinized more closelyLegal question is whether or not substance is considered “added” or a component of the foodWould 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 flourPresence of N2 caused flour to be adulteratedCourt 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 fragmentsCourt held presence of shell fragments not “ordinarily injurious to health” so product not adulterated.Said: Is fish adulterated because it has bones?
21 Food AdditivesAny substance which is intended to become a component of a food product or which affects a food productIncludes substances used for processing, manufacture, packaging, treating, etc.Including irradiationExcludes GRAS substances
22 Food Additives Direct food additives Indirect food additives Substance intended for use in foodServe a particular functional effectIndirect food additivesSubstances that become a part of food from processing, packaging or food contact surfaces reasonably expected to become part of food
23 Accidental AdditivesSubstances which accidentally get into foods are not considered food additives unless:P/D or may render food injurious to healthExample:Employee knocks box of cleaning solution into vat of food. Is food adulterated?No, not unless P/D or injurious
24 Food vs. Food AdditiveFood is broad term that includes food components, raw materials and food additivesNo FDA premarket approval required for foodsFood becomes a food additive when used as a component in another foodFood 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 injuriousBut, 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 isIncludes:AppearanceContentsQuantity (Slack fill)Volume
27 Per Se AdulterationP/D usually defined in relation to some measure of harmMay render injuriousOrdinarily renders injuriousUnsafe within meaning of….As necessary for public healthPoisonous without regard to quantityFlourine or Monochloroacetic acid in beerQuantity 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 foodProducts of diseased animals (died otherwise than by slaughter)Protects aesthetics and sensitivities of consumers so contamination need not be visible
29 Defect Action LevelsAll foods contains come filth so FDA sets tolerances for filth in foods called Defect Action LevelsExample: Corn (per 25g)1 or more whole insect25 insect fragments1 rodent hair1 rodent excreta per 50g
30 Other Adulteration Criteria: De Minimis quantitiesQuantity of contaminant too smallOtherwise unfitQuestion of factTough rubbery fishInsanitary conditionsPackaged or held under insanitary conditionsViolation of a Good Manufacturing Practice, (GMPs)
31 Adulteration SummaryAdulteration is defined in terms of health, potential for harm and reduction in economic valueStandard is the measure of harmMay render injuriousOrdinarily injuriousUnsafePublic health protectionPresence of unapproval food additive = adulteration?
33 Misbranding Purpose of labeling: Why regulate labeling: Inform the consumer about the productInduce the consumer to buy the productWhy regulate labeling:Prevent fraud, deception or misleading statementsRequire disclosure of information necessary for consumer to make “informed decision”
34 MisbrandingRegulation of labeling concerning the presence or absence of specific attributes of a food product has great potential impact on food marketMisbranding = 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 articleLabeling: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 articleLabeling: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 misleadingFDA need not show consumer actually misleadTest is effect of labeling on “ignorant, the unthinking and the credulous” consumer
38 Mandatory Labeling Requirement: Product identity statementStandards of IdentityAppropriately descriptive termsIngredient LineList in descending order of predominance by weight of all ingredientsStatement of Net ContentStatement of contents in terms of weigh, measure or numerical countIdentity of Manufacturer Packer or Distributor
39 Standards of IdentityFDCA requires FDA to establish a “standard of identity” for any foodTo promote “honesty and fair dealing”21 CFR 130Products DevelopmentChoosing a name for a productMust first consult standard of identityMust use name set forth in standard if there is oneAppropriately descriptive name if no standard