adulteration and misbranding

7/31/2019 Adulteration and Misbranding

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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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adulteration and misbranding

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