Federal Food, Drug, and Cosmetics Act FFDCA

The Federal Food, Drug and Cosmetic Act (FFDCA) places the responsibility for establishing the safety and efficacy of human and veterinary drugs and devices and the safety of food and color additives on the sponsor of the regulated product. The Public Health Service Act requires that a sponsor... 

The Federal Food, Drug, and Cosmetic Act (FFDCA) deals mainly with pesticide tolerance. Pesticide tolerances are set by the EPA and enforced by the FDA or, in the case of meat, milk, poultry, and eggs, by USDA agencies. 

Anonymous (1997). The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Food, Drug, and Cosmetic Act (FFDCA) As Amended by the Food Quality Protection Act (FQPA) of August 3,1996, U.S. Environmental Protection Agency, Publication No. 730L97001,1997. 

Two acts are pertinent to any discussion regarding the regulation of food contact materials in the US. These are the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) and the National Environmental Policy Act (NEPA) of 1969. A brief discussion of the authority granted the Pood and Drug Administration (PDA) under each follows. 

In 1954, Congress enacted the Miller Amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA), which required that a maximum acceptable level (tolerance) be established for pesticide residues in foods and animal feed (for example, 10.0 ppm carbaryl in lettuce, or 1.0 ppm ethyl parathion on string beans). In 1958, congress enacted the Food Additives Amendment to FFDCA, which regulated pesticide residues in processed foods. 

The Eederal Eood Safety Program resides in part under the authority of the US Food and Drug Administration. The specific statutory authority is the Federal Food, Drug, and Cosmetic Act (FFDCA). The areas of responsibility include the consideration of the safety or risk of food and color additives, both direct and indirect, and food-borne contaminants, both natural and anthropogenic. The FFDCA proscribes somewhat different standards of safety/risk for intentional food additives that undergo pre-market assessment of safety, specifically, versus those dietary constituents that are found in food as contaminants because they occur naturally or because they arise from anthropogenic sources. 

Sponsors of FDA-regulated products are required by the Federal Food, Drug, and Cosmetic Act (FFDCA) and Public Flealth Service Act to submit evidence of their product s safety in research and/or marketing applications. These products include food and color additives, animal drugs, human drugs and biological products, human medical devices,... 

The Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938 of the United States of America was completed in 1958 by the Food Additives Amendment. This amendment established the requirement of safety , which led to a major change in the Food and Drug Administration s (FDA) approach to its activities. The US Congress applied the term safe as the criterion for action, thereby supplementing, but not replacing, the use of the term adulteration . The result was a shift in focus - from an approach which emphasised evaluation of the food in its entirety to one which emphasised evaluation of individual food components. 

Under Sections 408 and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) EPA establishes tolerances, or mtiximum pesticide residue limits, for food and feed commodities that are marketed in the United States. Before a pesticide can be registered under FIFRA for use on a food or feed crop, EPA must either establish a tolerance for that use, or grant an exemption from the tolerance requirement. Determination of tolerances involves carefiil review... 

Public outcry over thalidomide is credited for the 1962 amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA). 

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