FDA

The U.S. Food and Drug Administration (FDA) is an agency of the Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of foods, drugs, biologics, medical devices, cosmetics, and radiological products. It regulates industry, conducts research, and enforces compliance.

The FDA has origins in the 1906 Pure Food and Drug Act and was reorganized in the 1920s. Its authority expanded under the 1938 Food, Drug, and Cosmetic Act, with later amendments addressing drug safety (1962 Kefauver-Harris) and devices (1988), among others. It now regulates a broad range of products, including dietary supplements and radiation-emitting devices.

The agency is organized into major centers and offices, including CDER (drugs), CBER (biologics), CDRH (devices), CFSAN (foods and dietary supplements), CVM (veterinary products), and ORA (field operations). These units conduct premarket reviews, safety testing, labeling, inspections, and enforcement.

Regulatory activities include premarket review of prescription and over-the-counter drugs, vaccines, and biologics; clearance or approval of medical devices; regulation of foods, dietary supplements, cosmetics, and radiation-emitting products; and postmarket surveillance, adverse event reporting, and recalls.

Enforcement relies on inspections, recalls, and safety communications. FDA funding comes from federal appropriations and industry user fees; it coordinates with state, national, and international partners to protect public health and oversee the global supply chain.