Food and Drug Administration

Food and Drug Administration (FDA), agency of the United States Department of Health and Human Services. Part of the Public Health Service, the FDA administers the federal Food, Drug, and Cosmetic Act of 1938 and related laws to ensure that foods are pure and wholesome and produced under sanitary conditions; that drugs and therapeutic devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that labels and packaging of products are truthful, informative, and not deceptive. The FDA also enforces the federal Hazardous Substances Act to ensure proper labeling and safety of chemical products, toys, and other articles used in the home. In 1969 the FDA became responsible for promoting sanitation in public eating places and interstate travel facilities and for federal-state programs to ensure safety of milk and shellfish.

In 1971 the FDA was given responsibility for enforcing the Radiation Control for Health and Safety Act of 1968. This law was designed to prevent unnecessary human exposure to radiation from electronic equipment ranging from television receivers to dental X-ray machines. In 1972 the agency was assigned to regulate biologic drugs, including vaccines, antitoxins, and serums.

The federal Food, Drug, and Cosmetic Act prohibits interstate traffic in adulterated or misbranded products. Defective products may be voluntarily destroyed or recalled from distribution by shippers, or seized by U.S. marshals on court orders obtained by the FDA. Persons responsible may be prosecuted in the federal district courts or enjoined from further violations. All court proceedings are introduced by U.S. attorneys based on evidence supplied by the FDA.

Field operations are carried out at regional and district offices and at about 135 resident inspection posts in the United States and Puerto Rico. FDA inspectors periodically visit facilities and warehouses, and agency chemists analyze the samples that inspectors collect. Facts so determined are the basis of regulatory decisions.

Specific products must be approved for safety prior to sale or use. Manufacturers submit samples of production batches of antibiotic drugs, insulin, or color additives to FDA laboratories for testing. The agency must certify their purity, potency, and safety before they may be shipped. New drugs and their labeling must be approved for safety and effectiveness. Food additives must be generally recognized as safe or proven safe by scientific tests. Residues of pesticide chemicals in food commodities must not exceed safe tolerances, which are established by the Environmental Protection Agency and enforced by the FDA. Such premarketing clearances are based on scientific data provided by manufacturers, subject to review and acceptance by FDA scientists.

The FDA maintains extensive educational programs in order to promote compliance by industry with its regulations and to enable consumers to benefit from its work.