United States Federal Food, Drug and

US FFDCA 201 (s) = United States Federal Food Drug and Cos-metic Act (1938 enaction, as amended), section 201 Definitions . 

United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) Food Additive (21 C.F.R. 170, 171, and 172) GRAS (21 C.F.R. 182, 184, and 186) Food additive. Substances Generally Recognized as Safe (GRAS) Food Additive GRAS... 

In the United States antioxidant use is subject to regulation under the Federal Food, Drug, and Cosmetic Act.8 Antioxidants for food products are also regulated under the Meat Inspection Act, the Poultry Inspection Act, and various state laws. Antioxidants permitted for use in foods are divided into two groups ... 

The USP was combined as a compendium with the National Formulary (NF) in 1975. Currently, the USP gives information regarding substances considered as having active medicinal properties while pharmaceutically inactive necessities are described in NF. The combined United States Pharmacopeia and National Formulary (USP-NF) is legally recognized under the U.S. Federal Food, Drug and Cosmetic Act. 

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 FDA s Center for Biologies Evaluation and Research, CBER, is responsible for regulating vaccines in the United States. Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act. 

Franklin Delano Roosevelt, Democratic president of the United States from 1933 to 1945. Ranked by historians as one of the three greatest presidents, he presided over a major overhaul of U.S. law on prescription drugs with the 1938 Federal Food, Drug, and Cosmetic Act. Although it took several years to pass the law, Roosevelt supported the efforts of the FDA to modernize and improve the control of prescription drugs. 

The Federal Food, Drug, and Cosmetic Act and the Code of Federal Regulations contain the basic framework for the regulation of food additives in the United States. Section 409 (c)(3)(A) of the Act requires that food additives must be safe for their intended uses before they can be intentionally added to food. 21 CFR 170.3 (i) defines safe or safety as ... 

Hair Coloring Regulation Issues. In the United States the classification of color additives is complex. Under the Federal Food, Drug and Cosmetic Act, all cosmetic colors must be the subject of an approved color additive petition to the Food and Dmg Administration there is an exception for coal-tar colorants used to color hair. Based on the composition of these colorants, FDA can require a certification on each manufactured batch of colorant to assure conformance with the approved specifications. In the early 1990s FDA has required certification only for synthetically derived coal-tar type colors. Many of the approved color additives, both certified and noncertifled, are restricted in their potential use. These restrictions can be found in the color additive regulations in the Code of Federal Regulations at 21 CFR 73 and 74. 

The FDA is responsible for the review and market approval of new drugs, biologies, and medical devices in the United States under the authority of the Federal Food Drug and Cosmetic Act (the Act) and Section 351 of the Public Health Service Act (the PHS Act). The FDA defines premarket review as the examination of data and information in an application as described in Sections 505, 510(k), 513(f), 515, or 520(g) or 520(1) of the Act or Section 351 of the PHS Act. This refers to the premarket review of data and information contained in any Investigational New Drug application (IND), Investigational Device... 

C) in the case of a medical food, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical food for such disease or condition will be developed without assistance under subsection (a). Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under section 526 of the Federal Food, Drug, and Cosmetic Act is made ... 

The mission of the FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer s health, safety, and pocketbook.The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the United States. With numerous amendments, it is the... 

The regulation of Echinacea products in the United States would fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). In the United States, statutory 403 (a)(1) of the Federal Food, Drug, and Cosmetic Act prohibits labeling that is false or misleading. Under DSHEA, a structure/-function claim can be made, provided the claim meets the criteria set forth in statutory 403(r)(6). Structure/function claims are permissible if a specific disease is not targeted, unless reviewed by FDA. A structure/function claim such as supports the immune system would be acceptable whereas alleviates the common cold or flu would not be acceptable for Echinacea because the claim targets a specific disease state (i.e., cold or flu). 

Enzyme replacement therapy (ERT) is a therapeutic approach in which the specific enzyme that is absent or inactive in affected individuals is replaced with a functional enzyme molecule. Pancreatic enzyme preparations of porcine or bovine origin have been available in the United States for treatment of exocrine pancreatic insufficiency (EPI) in children and adults with cystic fibrosis and chronic pancreatitis since before the enactment of the Federal Food, Drug and Cosmetic Act of 1938 (ref FDA guidance on EIP April 2004). A... 

The Federal Food, Drug and Cosmetic Act prohibits the shipment of a new drug into interstate commerce unless there exists for that drug an approved NDA or an effective IND application. Unlike certain European countries, such as Germany and the United Kingdom, the existence of an IND is required regardless of the proposed phase of clinical trial. Thus, even phase 1 trials to be conducted in the United States on volunteer subjects require the prior submission of an IND before that trial may be undertaken. 

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