FD&C Act (aka FDCA) — Federal Food, Drug and Cosmetic Act

Signed by President Franklin D. Roosevelt on June 25, 1938, FDCA amended the Food and Drugs Act (FDA), which was signed into law by President Theodore Roosevelt on June 30, 1906.

Initially, FDCA assigned federal regulation to cosmetics and medical devices, and required drugs labeled with adequate directions for safe use. The Act also mandated pre-market approval of all new drugs—including proven safety results— and prohibited false therapeutic claims in marketing materials. FDCA also corrected abuses in food packaging and quality, mandated legally enforceable food standards and addressed tolerances for certain poisonous substances. Since its enactment in 1938, at least 30 amendments were added to the FDCA, including the Drug Quality and Security Act (DQSA) in 2013.