Adulteration and
Misbranding
Jurisdictional Prerequisites to the
exercise of Federal Power
in the area of foods
Adulteration and Misbranding
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Jurisdictional prerequisites to
exercise of federal power to seize,
condemn, recall, or destroy
nonconforming food products
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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?
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Simple definition:
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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
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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
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Defined by statute
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Statutes not interpreted by regulations
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21 different criteria in FDCA
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
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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
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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
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Snails added to milk to make more
“frothy”
Added water can be an adulterant
Addition of sand to brown sugar and
brown rice
Adulteration
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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
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Salt and acid food preservatives
Food colors
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Pickles colored green with copper salts
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Coal Tars in EU
Vegetable dyes in US
Peas, wines, catsup
Food Flavors
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Pear, banana essence in fruit juices
Intentional Adulteration
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Milk adulterated with water and by
removal of cream
Butter adulterated with lard and
oleomargarine
Cheese made from skim milk or
cottonseed oil
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Filled Milk
Starch addition to sausages
Adulteration Criteria
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Magic words:
Poisonous and deleterious
 Added substances
 May render injurious to health
 Ordinarily injurious
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Poisonous or Deleterious
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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
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Poisonous = injurious effect or deadly
effect as result of chemical reaction
between substance and body
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N2 gas in flour
Deleterious = broader term which
includes mechanical, physical and
bacterial agents
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Shell fragments in Oysters
Added Substances
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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
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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:
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US v. Lexington Mills
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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
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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
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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
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Direct food additives
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Substance intended for use in food
Serve a particular functional effect
Indirect food additives
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Substances that become a part of food from
processing, packaging or food contact
surfaces reasonably expected to become part
of food
Accidental Additives
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Substances which accidentally get into
foods are not considered food additives
unless:
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P/D or may render food injurious to health
Example:
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Employee knocks box of cleaning solution into
vat of food. Is food adulterated?
No, not unless P/D or injurious
Food vs. Food Additive
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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:
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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
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Food processed or manufactured in
such a way as to make it appear to be
better or of greater value than it is
Includes:
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Appearance
Contents
Quantity (Slack fill)
Volume
Per Se Adulteration
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P/D usually defined in relation to some
measure of harm
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May render injurious
Ordinarily renders injurious
Unsafe within meaning of….
As necessary for public health
Poisonous without regard to quantity
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Flourine or Monochloroacetic acid in beer
Quantity has no legal significance
Filthy/Putrid/Decomposed
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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
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All foods contains come filth so FDA sets
tolerances for filth in foods called Defect
Action Levels
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Example: Corn (per 25g)
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1 or more whole insect
25 insect fragments
1 rodent hair
1 rodent excreta per 50g
Other Adulteration Criteria:
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De Minimis quantities
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Quantity of contaminant too small
Otherwise unfit
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Question of fact
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Insanitary conditions
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Tough rubbery fish
Packaged or held under insanitary conditions
Violation of a Good Manufacturing
Practice, (GMPs)
Adulteration Summary
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Adulteration is defined in terms of
health, potential for harm and reduction
in economic value
Standard is the measure of harm
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May render injurious
Ordinarily injurious
Unsafe
Public health protection
Presence of unapproval food additive =
adulteration?
Misbranding
Misbranding
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Purpose of labeling:
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Inform the consumer about the product
Induce the consumer to buy the product
Why regulate labeling:
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Prevent fraud, deception or misleading
statements
Require disclosure of information necessary
for consumer to make “informed decision”
Misbranding
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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
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Label:
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A display of written, printed or graphic matter
upon the immediate container of any article
Labeling:
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All labels and other written material upon any
article or any of its containers or wrapper, or
accompanying the product
Label vs. Labeling
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Label:
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A display of written, printed or graphic matter
upon the immediate container of any article
Labeling:
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All labels and other written material upon any
article or any of its containers or wrapper, or
accompanying the product
Misbranding
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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:
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Product identity statement
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Ingredient Line
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List in descending order of predominance by weight of all
ingredients
Statement of Net Content
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Standards of Identity
Appropriately descriptive terms
Statement of contents in terms of weigh, measure or
numerical count
Identity of Manufacturer Packer or Distributor
Standards of Identity
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FDCA requires FDA to establish a
“standard of identity” for any food
To promote “honesty and fair dealing”
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21 CFR 130
Products Development
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Choosing a name for a product
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Must first consult standard of identity
Must use name set forth in standard if there is one
Appropriately descriptive name if no standard