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The United States Federal Food, Drug, and Cosmetic Act (FD&C) is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act was amended by the FDA Modernization Act of 1997. The introduction of this act was influenced by the death of more than 100 children. Elixir Sulfanilamide had been known to be a safe drug in powder and pill form. Its parent company dissolved it in diethylene glycol for sale in liquid form, but diethylene glycol (otherwise known as antifreeze) is highly toxic to the human body, resulting in death for those who took the new medication. Food coloring The FD&C is perhaps best known by the consumer because of its use in the naming of food coloring additives, such as "FD&C Yellow No. 6." The Act made the certification of food color additives mandatory. The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods in the United States, plus numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs or cosmetics. Color additives derived from natural sources, such as vegetables, minerals or animals, and man-made counterparts of natural derivatives, are exempt from certification. Both artificial and natural color additives are subject to rigorous standards of safety before their approval for use in foods. Certifiable colors: (name/common name) Food Additives The FFDCA act requires producers of food additives to demonstrate to a reasonable certainty that no harm will result from the intended use of an additive. If the FDA finds an additive to be safe the agency issues a regulation specifying the conditions under which the additive may be safely used. Definition of Food Additive The definition of "food additive" is "any substance, the intended use of which results directly or indirectly, in its becoming a component or otherwise affecting the characteristics of food". However, excluded from the definition of "food additive" are substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food before January 1, 1958, through either scientific procedures or through experience based on common use in food) to be safe under the conditions of their intended use. This is the so called '''g'''enerally '''r'''ecognized '''a'''s '''s'''afe (GRAS) exemption. GM foods are regarded as containing food additives These regulations apply to foods produced by genetic engineering and if the protein added to the food by the genetic engineering process is not "generally recognized as safe" then genetically modified food is regarded as containing a "food additive" and is subject to pre-market approval by the FDA . All GM foods sold in the USA have been subject to this FDA pre-market approval process. Cosmetics This Act defines cosmetics as products for "cleansing, beautifying, promoting attractiveness, or altering the appearance." In this sense the FDA can classify cosmetics without actually regulating them. This allows a manufacturer the ability to use ingredients or raw materials and market the final product without government approval. Questions are being raised about the potentially dangerous side effects of chemicals in everyday household products. Related legislation The Wheeler-Lea Act, also passed in 1938, granted the Federal Trade Commission the authority to oversee advertising of all products regulated by FDA, other than prescription drugs. Significant amendments to FDCA and other laws related to FDCA Amendments Other laws See also | |||||||
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