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Btech Notes 03
Btech Notes 03
CFR21
Reserved for rules of the Food and Drug Administration
FDA
Responsible for ensuring safety and proper labeling of all plant derived
foods and feeds, including those developed through genetic engineering
(or cell fusion techniques), except for meat and poultry products
Enforcement responsibilities under the Federal Food, Drug, and
Cosmetics Act
Include seizure and criminal prosecution
Authority for legal action against adulterated (Section 402) or misbranded
food (Section 403)
Adulterated- bears or contains poisonous substance
Misbranded- false or misleading label
Food Additives Amendment of 1958 (Section 409 of FFDCA)
Required pre-market approval for food additives: safety must be
demonstrated.
Additive
Not a normal constituent, or,
Level has been increased by human intervention
Includes preservative, emulsifier, antioxidants, artificial
flavors
Conditions for safe use are specified
FDA and GE foods
Any food additive, introduced by genetic engineering must receive FDA
approval before marketing.
Federal oversight of GE foods ensures public confidence in foods
produced by newer genetic techniques.
CFSAN
Department within FDA primarily responsible for safety of biotech foods.
Also enforces allowable reside levels of pesticides, including biotech
pesticidal substances that appear in food.
GRAS
Generally Recognized As Safe
Does not require pre-market approval. Marketed despite not being
formally reviewed by FDA.
Safety had been known based on long history of use in food. Ex: Salt,
vinegar, oil, spices and natural flavors
However, if the producer markets the ingredient as GRAS, and FDA
subsequently concludes the substance is not GRAS, the agency will stop
distribution of product on the ground that such foods contain an unlawful
food additive.
Dietary supplements
1997 Guidance