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Adulteration andMisbranding
Jurisdictional Prerequisites to theexercise of Federal Power
in the area of foods
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What is Adulteration?
Simple definition:
Reducing the purity of an article by theaddition of a foreign or inferior substance
Defines almost every situation where the qualityof a food might by impaired to the point where itshould be removed from interstate commerce
Statutory definition has been changed by courtdecisions (ad hoc) and by amendments.
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Adulteration
Act of intentionally debasing thequality of food offered for sale either
by admixture or substitution ofinferior substances or by the removalof some valuable ingredient.
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Adulteration
Defined by statute 21 different criteria in FDCA
Statutes not interpreted by regulations No regulations to explain law
Degree of contamination may determine ifadulterated
Today, whether a food is adulterated ornot is a question of factwhich is decidedby a court in an enforcement proceeding
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Adulteration
Greeks and Romans acted to prevent winemakers from coloring and flavoring wine
Athens hadpublic wine inspector England proscribed scanting weight of
bakery goods
Coffee, tea and cocoa placed undercontrol of parliment
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Adulteration
Edward the Confessor provided publicpunishment for brewers of bad ale
Pliny the Elder mentioned adulteration ofbread
Addition of chalk to flour during WWII
Addition of sand to brown sugar and riceto make heavier
Addition of colors to disguise poor quality
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Adulteration
Snails added to milk to make morefrothy
Added water can be an adulterant
Addition of sand to brown sugar andbrown rice
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Adulteration
By middle 1800s chemical andmicrobiological knowledge increases so
food products could be analyzed Food adulteration then could be studied
from standpoint of consumer safety
Dr. Harvey Wileys poison squad
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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
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Intentional Adulteration
Milk adulterated with water and byremoval of cream
Butter adulterated with lard andoleomargarine
Cheese made from skim milk orcottonseed oil Filled Milk
Starch addition to sausages
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Adulteration Criteria
Magic words:
Poisonous and deleterious
Added substances
May render injurious to health
Ordinarily injurious
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Poisonous or Deleterious
Part of law since 1906 Act
Problem with P/D as adulteration criteria
Almost any substance can be shown to beP/D under some condition
Poisonous depends upon dose
Everything that contains a poison is notpoison - Senate Chairman 1906
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Poisonous and Deleterious
Poisonous = injurious effect or deadlyeffect as result of chemical reaction
between substance and body N2 gas in flour
Deleterious = broader term which
includes mechanical, physical andbacterial agents
Shell fragments in Oysters
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US v. Coca Cola
Issue: Was caffeine an added substancein coca cola
Company argued caffeine even if addedseparately should NOT be considered anadded substance b/c essential to identityof product. (Not coke w/o caffeine)
Court decided caffeine was an addedsubstance on basis of protection consumer
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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 deleterioussubstance must be such as may render
the food articleinjurious to health
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Ordinarily Injurious
Oyster shell fragments in canned oysters.
FDA alleged oysters adulterated b/ccontained shell fragments
Court held presence of shell fragments notordinarily injurious to healthso productnot adulterated.
Said: Is fish adulterated because it hasbones?
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Food Additives
Any substance which is intended tobecome a component of a food product orwhich affects a food product
Includes substances used for processing,manufacture, packaging, treating, etc.
Including irradiation
Excludes GRAS substances
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Food Additives
Direct food additives
Substance intendedfor use in food
Serve a particular functional effect Indirect food additives
Substances that become a part of food from
processing, packaging or food contactsurfaces reasonably expectedto become partof food
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Accidental Additives
Substances which accidentally get intofoods are not considered food additivesunless:
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
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Food vs. Food Additive
Food is broad term that includes foodcomponents, raw materials and foodadditives
No FDApremarket approval required forfoods
Food becomes a food additive when usedas a component in another food
Food additives require premarket approval
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Example:
New single-cell protein manufactured byGM
If sold in pure form for direct ingestion?
Not adulterated because not ordinarilyinjurious
But, can it be used as a component ofanother food?
Not without FDA approval b/c _________?
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Economic Adulteration
Food processed or manufactured insuch a way as to make it appear to bebetter or of greater value than it is
Includes:Appearance
Contents
Quantity (Slack fill) Volume
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Per Se Adulteration
P/D usually defined in relation to somemeasure 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
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Filthy/Putrid/Decomposed
Food is adulterated if consists in whole orin part of filthy, putrid or decomposedsubstances or ifotherwise unfit for food
Products of diseased animals (diedotherwise than by slaughter)
Protects aesthetics and sensitivities of
consumers so contamination need not bevisible
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Defect Action Levels
All foods contains come filth so FDA setstolerances 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
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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 ManufacturingPractice, (GMPs)
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Adulteration Summary
Adulteration is defined in terms ofhealth, potential for harm and reductionin economic value
Standard is the measure of harm May render injurious
Ordinarily injurious
Unsafe
Public health protection
Presence of unapproval food additive =adulteration?
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Misbranding
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Misbranding
Purpose of labeling:
Inform the consumer about the product
Induce the consumer to buy the product
Why regulate labeling:
Prevent fraud, deception or misleadingstatements
Require disclosure of information necessaryfor consumer to make informed decision
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Misbranding
Regulation of labeling concerning thepresence or absence of specificattributes of a food product has greatpotential impact on food market
Misbranding = presence or absence ofinformation on label of a product which
is false, deceptive or misleading
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Label vs. Labeling
Label:
A display of written, printed or graphic matterupon the immediate containerof any article
Labeling:
All labelsand other written material upon anyarticle or anyof its containers or wrapper, or
accompanying the product
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Label vs. Labeling
Label:
A display of written, printed or graphic matterupon the immediate containerof any article
Labeling:
All labelsand other written material upon anyarticle or anyof its containers or wrapper, or
accompanying the product
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Misbranding
Label must not be false or misleading inany particular
Every aspect of label is considered indetermining if false or misleading
FDA need not show consumer actuallymislead
Test is effect of labeling on ignorant, theunthinking and the credulous consumer
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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 ornumerical count
Identity of Manufacturer Packer or Distributor
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Standards of Identity
FDCA requires FDA to establish astandard of identityfor 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
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