US Federal Food Drug and Cosmetic

The US Food and Drug Administration (FDA) is required by the US Federal Food, Drug, and Cosmetic Act to regulate drug products in the United States. Its role is to ensure that drugs are developed, manufactured, and marketed in accordance with regulatory requirements so that they are safe and effective. The FDA has four centers and a regulatory office ... 

The term food additive is used to cover any substance that is expected to become a component of human food. This covers substances intentionally added to food for their nutritional, chemical, or physical benefits (e.g., colorants and gelling agents) and substances used in the manufacture or packaging of foods (i.e., food contact substances, formerly known as indirect food additives ). The US Federal Food, Drug, and Cosmetic Act defines food additives as substances whose intended use results or may reasonably be expected to result, directly or indirectly, in its becoming a component of food or otherwise affecting the characteristics of food. ... 

US legislation on food additives consists of the Federal Food, Drug, and Cosmetic Act (FD C Act), the Fair Packaging and Labeling Act, and other applicable laws including the Public Health Security and Bioterrorism Preparedness and Response Act. The FD C Act states that foods are adulterated if they contain color additives that have not been approved as safe to the satisfaction of the Food Drug Administration (FDA) for a particular use. ... 

One major problem caused by Section 409 (c) (3) of the Federal Food, Drug and Cosmetic Act, commonly known as the Delaney Clause , which governed the registration of pesticides was the statement, No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal,... . Dr Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, in... 

US Food and Drug Administration, Federal Food, Drug and Cosmetic Act (Amended 1997). Also available on the World Wide Web http //www.fda.gov/opacoiii/laws/fdcact/fdctoc.htm. 

Under the terms of the US Food Regulations, flavourings fall under the definition of food additives. The respective definition was implemented in the Federal Food Drug and Cosmetic Act by the Food Additives Amendment of 1958. With this amendment, the general requirement of safety became the major topic for food additives. 

Colorants. In 1983 the US Congress passed the Federal Food, Drug, and Cosmetic Act popularly known as the FD C. This permits only seven food colorants to be used in the US, and these are as follows, with their European E number ... 

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. 

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. 

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. 

In its guidance document Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, the US Food and Drug Administration (US Department of Health and Human Services, FDA, 1998) describes the introduction of an effectiveness requirement according to a standard of "substantial evidence" in the Federal Food, Drug, and Cosmetic Act (the FDC Act) of 1962 ... 

Fluoropolymer resins are covered by Federal Food, Drug and Cosmetic Act, 21 CFR 177.1380 177.1550 in the United States and EC Directive 90/128 in the European Union. The US Food and Drug Administration has approved many fluoropolymers (e.g., PTFE, PFA, and FEP) for food contact. Additives such as pigments, stabilizers, antioxidants, and others must be approved under a food additive regulation if they do not have prior clearance. 

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