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Unit 5
Adulteration;
Food Standards
The Prevention of Food Adulteration Act;
Poisonous and deleterious substances;
Standards of Identity, Quality, Fill of
Container, and Infant Formulas; tampering,
aesthetic and economic adulteration
The Prevention of Food
Adulteration Act
•The Prevention of Food Adulteration Act of
1954 aims at making provisions for the
prevention of adulteration of food. It went into
effect on June 1,1955.
•The conditions that render a food adulterated
are described in FDCA Section 402 (21 U.S.C.
Section 342).
• Eggs are an example for reviewing
adulteration regulations
Adulteration defined
• Adulteration is the act of intentionally
debasing the quality of food offered for sale
either by the admixture or substitution of
inferior substances or by the removal of some
valuable ingredient.
• Examples: Color added to wine; dilution of
liquid food with water; manipulation of weight;
substitution with low quality ingredients.
Added Poisonous Substances
that are required for processing
• Food additives are allowed only if considered
safe by the FDA or, if unsafe, must be used in
the manner that is allowed in the regulations.
Any food with unsafe or illegally used additives
is adulterated
• New animal drugs must be approved by the FDA
before use, and properly labeled. Use of an
unapproved new animal drug renders the food
adulterated (FDCA S,ec. 512).
Adulteration and Misbranding in
Interstate Commerce
• The F,DCA prohibits adulteration and misbranding
randing of foods in interstate commerce (FDCA Sec.
301), while state laws go govern foods sold within
one State
• Interstate commerce r,efers to commerce between any
state or territory and any place outside it or commerce
within the District of Columbia or within any other
territory not organized with a legislative body.
• The Prohibited Acts section of the FDCA regullates
adulteration and misbranding of foods in all stages(21
U.S.C. Section 342; FDCA Section 402)
• Adulteration and misbranding of foods in all stages of in
terstate commerce are prohibited.
Investigation of Adulterated Foods
The FDCA prohibits actions that may
trigger the FDA's investigation of
adulterated or misbranded foods, e.g.,
refusal to permit access to records,
refusal to permit for inspection, remove
any official tag or mark authorized by the
FDCA, altering, mutilating, or removing labels
of foods that passed through interstate
commerce if they are for sale.
Additional Value of Food
Standards
• Food standards are important in
international trade as they provide basis
for negotiations
• In general, they are acceptable to the
American consumers and to the food
industry.
Food Standards
• There were no formal food standards prior to ,tlhe
passage of the FDCA of 1938.
• Food standards today include
- Standards of identity
- Standa rds of quality
- Standards of fill-of-container
- Standards for InfantFormulas
• Standardized foods that do not meet their standard are
considered misbranded.
• In absence of food standards, states may enact their
own standards
Standards of Identity
• These ensure that products have the characteristic,s expected
by the consumer.
• They prescribe the minimum amounts of certain ingredients;
maximum fat, water; methods of processing, cooking and
preparation.
• They permit certain optional safe ingredients.
• Foods th,at do not conform to these standards may be sold
under another non-standardized names.
FDA Standards of Identity are at: CFR title 21, 107, 130-189
USDA Standards of Identity are at: CFR title 9, 319 (meat and
poultry)
Standards of Identity
Initially, Standards of Identity defined:
1. The food product
2. Its name
3. The ingredients that must (mandatory) or may
(optional) be used in the manufacturing of the
food
These standards ensured that ,consumers knew
what they were getting and had control over
addition of food additi ves.
FSMA Final Rule for Mitigation Strategies to
Protect Food Against Intentional Adulteration
1. Rather than targeting specific foods or hazards, this
rule requires mitigation (risk-reducing) strategies for
processes in certain registered food facilities.
2. The proposed rule was issued in December 2013.
3. This rule is designed to primarily cover large
companies whose products reach many people,
exempting smaller companies.
4. Compliance date:
1.
2.
3.
Very Small Businesses: within five years after the publication of
the final rule.
Small Businesses: have to comply four years after the publication
of the final rule
Other Businesses: three years after the publication of the final
rule.