Adulteration and

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

Adulteration and Misbranding

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

Simple definition:

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

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

Defined by statute

Statutes not interpreted by regulations

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

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

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

Snails added to milk to make more

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

Adulteration

By middle 1800s chemical and

microbiological knowledge increases
so food products could be analyzed
Food adulteration then could be
studied from standpoint of consumer
safety
Dr. Harvey Wileys poison squad

Intentional Adulteration

Salt and acid food preservatives

Food colors

Pickles colored green with copper

salts

Coal Tars in EU
Vegetable dyes in US

Peas, wines, catsup

Food Flavors

Pear, banana essence in fruit juices

Intentional Adulteration

Milk adulterated with water and by

removal of cream
Butter adulterated with lard and
oleomargarine
Cheese made from skim milk or
cottonseed oil

Filled Milk

Starch addition to sausages

Adulteration Criteria

Magic words:
Poisonous

and deleterious
Added substances
May render injurious to
health
Ordinarily injurious

Poisonous or Deleterious

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

Poisonous = injurious effect or

deadly effect as result of chemical
reaction between substance and body

N2 gas in flour

Deleterious = broader term which

includes mechanical, physical and
bacterial agents

Shell fragments in Oysters

Added Substances

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

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:

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 deleterious

substance must be such as may
render the food article injurious to
health

Ordinarily Injurious

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

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

Direct food additives

Substance intended for use in food

Serve a particular functional effect

Indirect food additives

Substances that become a part of food

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

Accidental Additives

Substances which accidentally get into

foods are not considered food additives
unless:

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

Food vs. Food Additive

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:

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

Food processed or manufactured in

such a way as to make it appear to
be better or of greater value than it
is
Includes:

Appearance
Contents
Quantity (Slack fill)
Volume

Per Se Adulteration

P/D usually defined in relation to

some measure 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

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
Products of diseased animals (died
otherwise than by slaughter)
Protects aesthetics and sensitivities of
consumers so contamination need not
be visible

Defect Action Levels

All foods contains come filth so FDA

sets tolerances 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

Other Adulteration Criteria:

De Minimis quantities

Quantity of contaminant too small

Otherwise unfit

Question of fact

Insanitary conditions

Tough rubbery fish

Packaged or held under insanitary conditions

Violation of a Good Manufacturing

Practice, (GMPs)

Adulteration Summary

Adulteration is defined in terms of

health, potential for harm and
reduction in economic value
Standard is the measure of harm

May render injurious

Ordinarily injurious
Unsafe
Public health protection

Presence of unapproval food additive =

adulteration?

Misbranding

Misbranding

Purpose of labeling:

Inform the consumer about the product

Induce the consumer to buy the product

Why regulate labeling:

Prevent fraud, deception or misleading

statements
Require disclosure of information
necessary for consumer to make
informed decision

Misbranding

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

Label:

A display of written, printed or graphic

matter upon the immediate container of
any article

Labeling:

All labels and other written material

upon any article or any of its containers
or wrapper, or accompanying the
product

Label vs. Labeling

Label:

A display of written, printed or graphic

matter upon the immediate container of
any article

Labeling:

All labels and other written material

upon any article or any of its containers
or wrapper, or accompanying the
product

Misbranding

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:

Product identity statement

Ingredient Line

List in descending order of predominance by weight of all

ingredients

Statement of Net Content

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

FDCA requires FDA to establish a

standard of identity for 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