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

Adulteration and Adulteration and MisbrandingMisbranding

Jurisdictional Prerequisites to the Jurisdictional Prerequisites to the exercise of Federal Power exercise of Federal Power

in the area of foodsin the area of foods

Adulteration and MisbrandingAdulteration and Misbranding

Jurisdictional prerequisitesJurisdictional prerequisites to to exercise of federal power to seize, exercise of federal power to seize, condemn, recall, or destroy condemn, recall, or destroy nonconforming food productsnonconforming food products

Definitions have evolve since 1906Definitions have evolve since 1906 Attempt to anticipate every situation Attempt to anticipate every situation

where food may be injurious to health where food may be injurious to health or misleading to consumer in any or misleading to consumer in any particularparticular

What is Adulteration?What is Adulteration?

Simple definition:Simple definition: Reducing the purity of an article by the Reducing the purity of an article by the

addition of a foreign or inferior substanceaddition of a foreign or inferior substance Defines almost every situation where the Defines almost every situation where the

quality of a food might by impaired to the quality of a food might by impaired to the point where it should be removed from point where it should be removed from interstate commerceinterstate commerce

Statutory definition has been changed by Statutory definition has been changed by court decisions (ad hoc) and by court decisions (ad hoc) and by amendments.amendments.

AdulterationAdulteration

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

Adulteration Adulteration

Defined by statute Defined by statute 21 different criteria in FDCA21 different criteria in FDCA

Statutes not interpreted by regulationsStatutes not interpreted by regulations No regulations to explain lawNo regulations to explain law

Degree of contamination may Degree of contamination may determine if adulterateddetermine if adulterated

Today, whether a food is adulterated Today, whether a food is adulterated or not is a or not is a question of factquestion of fact which is which is decided by a court in an enforcement decided by a court in an enforcement proceedingproceeding


Greeks and Romans acted to prevent Greeks and Romans acted to prevent wine makers from coloring and wine makers from coloring and flavoring wineflavoring wine

Athens had Athens had “public wine inspector”“public wine inspector” England proscribed “scanting England proscribed “scanting

weight” of bakery goodsweight” of bakery goods Coffee, tea and cocoa placed under Coffee, tea and cocoa placed under

control of parlimentcontrol of parliment


Edward the ConfessorEdward the Confessor provided public provided public punishment for brewers of “bad ale”punishment for brewers of “bad ale”

Pliny the ElderPliny the Elder mentioned adulteration mentioned adulteration of breadof bread

Addition of chalk to flour during WWII Addition of chalk to flour during WWII Addition of sand to brown sugar and rice Addition of sand to brown sugar and rice

to make heavierto make heavier Addition of colors to disguise poor Addition of colors to disguise poor

qualityquality


Snails added to milk to make more Snails added to milk to make more “frothy”“frothy”

Added water can be an adulterantAdded water can be an adulterant Addition of sand to brown sugar and Addition of sand to brown sugar and

brown ricebrown rice


By middle 1800’s chemical and By middle 1800’s chemical and microbiological knowledge increases microbiological knowledge increases so food products could be analyzedso food products could be analyzed

Food adulteration then could be Food adulteration then could be studied from standpoint of consumer studied from standpoint of consumer safetysafety

Dr. Harvey Wiley’s poison squadDr. Harvey Wiley’s poison squad

Intentional AdulterationIntentional Adulteration

Salt and acid food preservatives Salt and acid food preservatives Food colorsFood colors

Coal Tars in EUCoal Tars in EU Vegetable dyes in USVegetable dyes in US

Pickles colored green with copper Pickles colored green with copper saltssalts Peas, wines, catsupPeas, wines, catsup

Food FlavorsFood Flavors Pear, banana essence in fruit juicesPear, banana essence in fruit juices

Intentional AdulterationIntentional Adulteration

Milk adulterated with water and by Milk adulterated with water and by removal of creamremoval of cream

Butter adulterated with lard and Butter adulterated with lard and oleomargarineoleomargarine

Cheese made from skim milk or Cheese made from skim milk or cottonseed oilcottonseed oil Filled MilkFilled Milk

Starch addition to sausagesStarch addition to sausages

Adulteration CriteriaAdulteration Criteria

Magic wordsMagic words::Poisonous and deleteriousPoisonous and deleteriousAdded substancesAdded substancesMay render injurious to May render injurious to healthhealth

Ordinarily injuriousOrdinarily injurious

Poisonous or DeleteriousPoisonous or Deleterious

Part of law since 1906 ActPart of law since 1906 Act Problem with P/D as adulteration Problem with P/D as adulteration

criteriacriteria Almost any substance can be shown Almost any substance can be shown

to be P/D under some conditionto be P/D under some condition Poisonous depends upon dosePoisonous depends upon dose ““Everything that contains a poison is Everything that contains a poison is

not poison” - Senate Chairman 1906not poison” - Senate Chairman 1906

Poisonous and DeleteriousPoisonous and Deleterious

PoisonousPoisonous = injurious effect or = injurious effect or deadly effect as result of chemical deadly effect as result of chemical reaction between substance and bodyreaction between substance and body N2 gas in flourN2 gas in flour

DeleteriousDeleterious = broader term which = broader term which includes mechanical, physical and includes mechanical, physical and bacterial agentsbacterial agents Shell fragments in OystersShell fragments in Oysters

Added SubstancesAdded Substances

Substances intentionally added to Substances intentionally added to foods are scrutinized more closelyfoods are scrutinized more closely

Legal question is whether or not Legal question is whether or not substance is considered “added” or substance is considered “added” or a component of the fooda component of the food

Would now be considered “food Would now be considered “food additives”additives”

US v. Coca ColaUS v. Coca Cola

Issue: Was caffeine an “added Issue: Was caffeine an “added substance” in coca colasubstance” in coca cola

Company argued caffeine even if added Company argued caffeine even if added separately should NOT be considered an separately should NOT be considered an added substance b/c essential to identity added substance b/c essential to identity of product. of product. (Not coke w/o caffeine)(Not coke w/o caffeine)

Court decided caffeine was an added Court decided caffeine was an added substance on basis of protection substance on basis of protection consumerconsumer

May Render InjuriousMay Render Injurious::

US v. Lexington MillsUS v. Lexington Mills Alsop process added N2 gas to flourAlsop process added N2 gas to flour Presence of N2 caused flour to be Presence of N2 caused flour to be

adulteratedadulterated Court held:Court held:

Presence of a poison or deleterious Presence of a poison or deleterious substance must be such as may substance must be such as may render the food article render the food article ““injurious to injurious to healthhealth””

Ordinarily InjuriousOrdinarily Injurious

Oyster shell fragments in canned Oyster shell fragments in canned oysters.oysters.

FDA alleged oysters adulterated b/c FDA alleged oysters adulterated b/c contained shell fragmentscontained shell fragments

Court held presence of shell fragments Court held presence of shell fragments not not “ordinarily injurious to health”“ordinarily injurious to health” so so product not adulterated.product not adulterated.

Said: Is fish adulterated because it Said: Is fish adulterated because it has bones?has bones?

Food AdditivesFood Additives

Any substance which is intended to Any substance which is intended to become a component of a food become a component of a food product or which affects a food product or which affects a food product product

Includes substances used for Includes substances used for processing, manufacture, packaging, processing, manufacture, packaging, treating, etc.treating, etc.

Including irradiationIncluding irradiation Excludes GRAS substancesExcludes GRAS substances

Food AdditivesFood Additives

Direct food additivesDirect food additives Substance Substance intendedintended for use in food for use in food Serve a particular functional effectServe a particular functional effect

Indirect food additivesIndirect food additives Substances that become a part of food Substances that become a part of food

from processing, packaging or food from processing, packaging or food contact surfaces contact surfaces reasonably expectedreasonably expected to to become part of food become part of food

Accidental AdditivesAccidental Additives

Substances which accidentally get into Substances which accidentally get into foods are not considered food foods are not considered food additives unless: additives unless: P/D or may render food injurious to healthP/D or may render food injurious to health

Example:Example: Employee knocks box of cleaning solution Employee knocks box of cleaning solution

into vat of food. Is food adulterated? into vat of food. Is food adulterated? No, not unless P/D or injurious No, not unless P/D or injurious

Food vs. Food AdditiveFood vs. Food Additive

Food is broad term that includes food Food is broad term that includes food components, raw materials and food components, raw materials and food additivesadditives

No FDA No FDA premarket approvalpremarket approval required required for foodsfor foods

Food becomes a food additive when Food becomes a food additive when used as a component in another foodused as a component in another food

Food additives require premarket Food additives require premarket approvalapproval

ExampleExample:: New single-cell protein manufactured by New single-cell protein manufactured by

GMGM If sold in pure form for direct ingestion?If sold in pure form for direct ingestion? Not adulterated because not ordinarily Not adulterated because not ordinarily

injuriousinjurious But, can it be used as a component of But, can it be used as a component of

another food?another food? Not without FDA approval b/c _________?Not without FDA approval b/c _________?

Economic AdulterationEconomic Adulteration

Food processed or manufactured in Food processed or manufactured in such a way as to make it appear to such a way as to make it appear to be better or of greater value than be better or of greater value than it isit is

Includes:Includes: Appearance Appearance Contents Contents Quantity (Slack fill)Quantity (Slack fill) VolumeVolume

Per Se AdulterationPer Se Adulteration

P/D usually defined in relation to P/D usually defined in relation to some measure of harmsome measure of harm May render injuriousMay render injurious Ordinarily renders injuriousOrdinarily renders injurious Unsafe within meaning of….Unsafe within meaning of…. As necessary for public healthAs necessary for public health

Poisonous without regard to Poisonous without regard to quantityquantity Flourine or Monochloroacetic acid in beerFlourine or Monochloroacetic acid in beer Quantity has no legal significanceQuantity has no legal significance

Filthy/Putrid/DecomposedFilthy/Putrid/Decomposed

Food is adulterated if consists in Food is adulterated if consists in whole or in part of filthy, putrid or whole or in part of filthy, putrid or decomposed substances or if decomposed substances or if otherwise unfit for foodotherwise unfit for food

Products of diseased animals (died Products of diseased animals (died otherwise than by slaughter)otherwise than by slaughter)

Protects aesthetics and sensitivities Protects aesthetics and sensitivities of consumers so contamination need of consumers so contamination need not be visiblenot be visible

Defect Action LevelsDefect Action Levels

All foods contains come filth so FDA All foods contains come filth so FDA sets tolerances for filth in foods sets tolerances for filth in foods called called Defect Action LevelsDefect Action Levels

Example: Corn (per 25g)Example: Corn (per 25g) 1 or more whole insect1 or more whole insect 25 insect fragments25 insect fragments 1 rodent hair1 rodent hair 1 rodent excreta per 50g1 rodent excreta per 50g

Other Adulteration CriteriaOther Adulteration Criteria::

De Minimis quantitiesDe Minimis quantities Quantity of contaminant too smallQuantity of contaminant too small

Otherwise unfitOtherwise unfit Question of factQuestion of fact

Tough rubbery fishTough rubbery fish

Insanitary conditions Insanitary conditions Packaged or held under insanitary conditionsPackaged or held under insanitary conditions

Violation of a Violation of a Good Manufacturing Good Manufacturing PracticePractice, (GMPs), (GMPs)

Adulteration SummaryAdulteration Summary

Adulteration is defined in terms of Adulteration is defined in terms of health, potential for harm and health, potential for harm and reduction in economic valuereduction in economic value

Standard is the measure of harmStandard is the measure of harm May render injuriousMay render injurious Ordinarily injuriousOrdinarily injurious UnsafeUnsafe Public health protectionPublic health protection

Presence of unapproval food additive = Presence of unapproval food additive = adulteration? adulteration?

MisbrandingMisbranding


Purpose of labeling:Purpose of labeling: Inform the consumer about the productInform the consumer about the product Induce the consumer to buy the productInduce the consumer to buy the product

Why regulate labeling:Why regulate labeling: Prevent fraud, deception or misleading Prevent fraud, deception or misleading

statementsstatements Require disclosure of information Require disclosure of information

necessary for consumer to make necessary for consumer to make “informed decision”“informed decision”


Regulation of labeling concerning the Regulation of labeling concerning the presence or absence of specific presence or absence of specific attributes of a food product has great attributes of a food product has great potential impact on food marketpotential impact on food market

MisbrandingMisbranding = presence or absence = presence or absence of information on label of a product of information on label of a product which is false, deceptive or misleadingwhich is false, deceptive or misleading

Label vs. LabelingLabel vs. Labeling

Label:Label: A display of written, printed or graphic A display of written, printed or graphic

matter upon the matter upon the immediate containerimmediate container of of any articleany article

Labeling:Labeling: All labelsAll labels and other written material and other written material

upon any article or upon any article or anyany of its containers of its containers or wrapper, or accompanying the or wrapper, or accompanying the productproduct


Label must not be “false or misleading Label must not be “false or misleading in any particular”in any particular”

Every aspect of label is considered in Every aspect of label is considered in determining if false or misleadingdetermining if false or misleading

FDA need not show consumer actually FDA need not show consumer actually misleadmislead

Test is effect of labeling on “ignorant, Test is effect of labeling on “ignorant, the unthinking and the credulous” the unthinking and the credulous” consumerconsumer

Mandatory Labeling RequirementMandatory Labeling Requirement::

Product identity statementProduct identity statement Standards of IdentityStandards of Identity Appropriately descriptive termsAppropriately descriptive terms

Ingredient LineIngredient Line List in descending order of predominance by weight of List in descending order of predominance by weight of

all ingredientsall ingredients

Statement of Net ContentStatement of Net Content Statement of contents in terms of weigh, Statement of contents in terms of weigh,

measure or numerical countmeasure or numerical count Identity of Manufacturer Packer or Identity of Manufacturer Packer or

DistributorDistributor

Standards of IdentityStandards of Identity

FDCA requires FDA to establish a FDCA requires FDA to establish a “standard of identity”“standard of identity” for any food for any food

To promote “honesty and fair dealing”To promote “honesty and fair dealing” 21 CFR 13021 CFR 130

Products DevelopmentProducts Development Choosing a name for a productChoosing a name for a product

Must first consult standard of identityMust first consult standard of identity Must use name set forth in standard if there is Must use name set forth in standard if there is

oneone Appropriately descriptive name if no standardAppropriately descriptive name if no standard

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