Presentation is loading. Please wait.

Presentation is loading. Please wait.

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

Similar presentations


Presentation on theme: "Adulteration and Misbranding Jurisdictional Prerequisites to the exercise of Federal Power in the area of foods."— 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 products Jurisdictional prerequisites to exercise of federal power to seize, condemn, recall, or destroy nonconforming food products Definitions have evolve since 1906 Definitions have evolve since 1906 Attempt to anticipate every situation where food may be injurious to health or misleading to consumer in any particular 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: Simple definition: Reducing the purity of an article by the addition of a foreign or inferior substance 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 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. 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. 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 Defined by statute 21 different criteria in FDCA 21 different criteria in FDCA Statutes not interpreted by regulations Statutes not interpreted by regulations No regulations to explain law No regulations to explain law Degree of contamination may determine if adulterated 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 Today, whether a food is adulterated or not is a question of fact which is decided by a court in an enforcement proceeding

6

7

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

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

10 Adulteration Snails added to milk to make more “frothy” Snails added to milk to make more “frothy” Added water can be an adulterant Added water can be an adulterant Addition of sand to brown sugar and brown rice 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 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 Food adulteration then could be studied from standpoint of consumer safety Dr. Harvey Wiley’s poison squad Dr. Harvey Wiley’s poison squad

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

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

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

15 Poisonous or Deleterious Part of law since 1906 Act Part of law since 1906 Act Problem with P/D as adulteration criteria Problem with P/D as adulteration criteria Almost any substance can be shown to be P/D under some condition Almost any substance can be shown to be P/D under some condition Poisonous depends upon dose Poisonous depends upon dose “Everything that contains a poison is not poison” - Senate Chairman 1906 “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 Poisonous = injurious effect or deadly effect as result of chemical reaction between substance and body N2 gas in flour N2 gas in flour Deleterious = broader term which includes mechanical, physical and bacterial agents Deleterious = broader term which includes mechanical, physical and bacterial agents Shell fragments in Oysters Shell fragments in Oysters

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

18 US v. Coca Cola Issue: Was caffeine an “added substance” in 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) 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 Court decided caffeine was an added substance on basis of protection consumer

19 May Render Injurious: US v. Lexington Mills US v. Lexington Mills Alsop process added N2 gas to flour Alsop process added N2 gas to flour Presence of N2 caused flour to be adulterated Presence of N2 caused flour to be adulterated Court held: Court held: Presence of a poison or deleterious substance must be such as may render the food article “injurious to health” 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. Oyster shell fragments in canned oysters. FDA alleged oysters adulterated b/c contained shell fragments FDA alleged oysters adulterated b/c contained shell fragments Court held presence of shell fragments not “ordinarily injurious to health” so product not adulterated. Court held presence of shell fragments not “ordinarily injurious to health” so product not adulterated. Said: Is fish adulterated because it has bones? 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 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. Includes substances used for processing, manufacture, packaging, treating, etc. Including irradiation Including irradiation Excludes GRAS substances Excludes GRAS substances

22 Food Additives Direct food additives Direct food additives Substance intended for use in food Substance intended for use in food Serve a particular functional effect Serve a particular functional effect Indirect food additives Indirect food additives Substances that become a part of food from processing, packaging or food contact surfaces reasonably expected to become part of food 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: Substances which accidentally get into foods are not considered food additives unless: P/D or may render food injurious to health P/D or may render food injurious to health Example: Example: Employee knocks box of cleaning solution into vat of food. Is food adulterated? Employee knocks box of cleaning solution into vat of food. Is food adulterated? No, not unless P/D or injurious 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 Food is broad term that includes food components, raw materials and food additives No FDA premarket approval required for foods No FDA premarket approval required for foods Food becomes a food additive when used as a component in another food Food becomes a food additive when used as a component in another food Food additives require premarket approval Food additives require premarket approval

25 Example: New single-cell protein manufactured by GM New single-cell protein manufactured by GM If sold in pure form for direct ingestion? If sold in pure form for direct ingestion? Not adulterated because not ordinarily injurious Not adulterated because not ordinarily injurious But, can it be used as a component of another food? But, can it be used as a component of another food? Not without FDA approval b/c _________? 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 Food processed or manufactured in such a way as to make it appear to be better or of greater value than it is Includes: Includes: Appearance Appearance Contents Contents Quantity (Slack fill) Quantity (Slack fill) Volume Volume

27 Per Se Adulteration P/D usually defined in relation to some measure of harm P/D usually defined in relation to some measure of harm May render injurious May render injurious Ordinarily renders injurious Ordinarily renders injurious Unsafe within meaning of…. Unsafe within meaning of…. As necessary for public health As necessary for public health Poisonous without regard to quantity Poisonous without regard to quantity Flourine or Monochloroacetic acid in beer Flourine or Monochloroacetic acid in beer Quantity has no legal significance 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 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) Products of diseased animals (died otherwise than by slaughter) Protects aesthetics and sensitivities of consumers so contamination need not be visible 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 All foods contains come filth so FDA sets tolerances for filth in foods called Defect Action Levels Example: Corn (per 25g) Example: Corn (per 25g) 1 or more whole insect 1 or more whole insect 25 insect fragments 25 insect fragments 1 rodent hair 1 rodent hair 1 rodent excreta per 50g 1 rodent excreta per 50g

30 Other Adulteration Criteria: De Minimis quantities De Minimis quantities Quantity of contaminant too small Quantity of contaminant too small Otherwise unfit Otherwise unfit Question of fact Question of fact Tough rubbery fish Tough rubbery fish Insanitary conditions Insanitary conditions Packaged or held under insanitary conditions Packaged or held under insanitary conditions Violation of a Good Manufacturing Practice, (GMPs) 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 Adulteration is defined in terms of health, potential for harm and reduction in economic value Standard is the measure of harm Standard is the measure of harm May render injurious May render injurious Ordinarily injurious Ordinarily injurious Unsafe Unsafe Public health protection Public health protection Presence of unapproval food additive = adulteration? Presence of unapproval food additive = adulteration?

32 Misbranding

33 Misbranding Purpose of labeling: Purpose of labeling: Inform the consumer about the product Inform the consumer about the product Induce the consumer to buy the product Induce the consumer to buy the product Why regulate labeling: Why regulate labeling: Prevent fraud, deception or misleading statements Prevent fraud, deception or misleading statements Require disclosure of information necessary for consumer to make “informed decision” 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 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 Misbranding = presence or absence of information on label of a product which is false, deceptive or misleading

35 Label vs. Labeling Label: Label: A display of written, printed or graphic matter upon the immediate container of any article A display of written, printed or graphic matter upon the immediate container of any article Labeling: Labeling: All labels and other written material upon any article or any of its containers or wrapper, or accompanying the product 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: Label: A display of written, printed or graphic matter upon the immediate container of any article A display of written, printed or graphic matter upon the immediate container of any article Labeling: Labeling: All labels and other written material upon any article or any of its containers or wrapper, or accompanying the product 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” Label must not be “false or misleading in any particular” Every aspect of label is considered in determining if false or misleading Every aspect of label is considered in determining if false or misleading FDA need not show consumer actually mislead FDA need not show consumer actually mislead Test is effect of labeling on “ignorant, the unthinking and the credulous” consumer Test is effect of labeling on “ignorant, the unthinking and the credulous” consumer

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

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

40


Download ppt "Adulteration and Misbranding Jurisdictional Prerequisites to the exercise of Federal Power in the area of foods."

Similar presentations


Ads by Google