Federal Food, Drag and Cosmetic Act

The Food Additives Amendment to the Federal Food, Drag, and Cosmetic Act of 1938, which was adopted in 1958, requires that proof of safety of a new food additive be furnished by the manufacturer based on extensive scientific research. Since it is impossible to conclusively prove the safety of a new food additive through animal and clinical trials, manufacturers routinely conduct postmarketing surveillance and long-term follow-up studies to monitor adverse events. 

Across the globe, countries employ their own legislative controls for food ingredients, but there are two main regions that exert great influence upon world opinion on this issue the European system controlled by the European Parliament with designated E-numbers for permitted food additives, and the system used in the United States where at the federal level the Federal Food, Drag and Cosmetic Act (FFDCA) lays down the framework for food safety. 

Predicate regulations Federal Food, Drag, and Cosmetic Act, the Public Health Service Act, or any FDA Regulation, with the exception of 21 CFR Part 11. Predicate regulations address the research, production, and control of FDA regulated articles. 

The Federal Food, Drag, and Cosmetic Act of 1938 set np three categories ... 

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