The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a comprehensive statute that provides the Food and Drug Administration (FDA) with authority to regulate the safety and efficacy of food, drugs, medical devices, and cosmetics. Key provisions of the FD&C Act include: - Prohibition of interstate commerce of adulterated or misbranded food, drugs, medical devices, and cosmetics (21 U.S.C. §331). - Requirements for new drugs to be proven safe and effective before marketing (21 U.S.C. §355). - Authority for the FDA to establish standards for food safety, including setting tolerances for pesticide residues (21 U.S.C. §§341-350). - Regulation of medical device safety and effectiveness, including a premarket approval process for certain devices (21 U.S.C. §§360c-360k). - Authority to regulate cosmetic safety and prohibit the marketing of adulterated or misbranded cosmetics (21 U.S.C. §§361-362). - Establishment of Good Manufacturing Practices (GMP) that manufacturers must follow to ensure the quality of their products (21 U.S.C. §351). - Enforcement powers, including inspections, seizures, injunctions, and criminal penalties for violations of the Act (21 U.S.C. §§332-334). The FD&C Act has been amended multiple times to address emerging health concerns and to give the FDA additional authorities, such as the authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act.
The Food Additives Amendment of 1958 requires manufacturers to provide evidence that food additives are safe for their intended use before they can be approved by the FDA. The amendment established the concept of 'Generally Recognized as Safe' (GRAS) for substances with a long history of safe use. It also introduced the Delaney Clause, which prohibits the approval of any food additive shown to induce cancer in humans or animals, regardless of the concentration of the additive.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements and sets forth a framework for their regulation. Under DSHEA, dietary supplements are treated as a category of food, not as drugs. Manufacturers are responsible for ensuring that their products are safe and that any claims made about them are substantiated by adequate evidence. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. DSHEA also provides for the establishment of Good Manufacturing Practices (GMP) specific to dietary supplements.
The Biologics Control Act of 1902 was the first federal law to regulate the quality of drugs and biologics. It was enacted in response to public health hazards from contaminated vaccines and serums. Although it has since been superseded by the FD&C Act and other statutes, it established the precedent for federal oversight of drug safety and efficacy. Today, biological products are regulated under the Public Health Service Act (PHSA) in conjunction with the FD&C Act, and the FDA's Center for Biologics Evaluation and Research (CBER) oversees these products.