Federal Food, Drug, and Cosmetic Act (FDCA)

The Federal Food, Drug, and Cosmetic Act gives the United States Food and Drug Administration authority to oversee the safety of food, drugs, medical devices and cosmetics. President Franklin D. Roosevelt signed it into law on June 25, 1938, replacing the earlier Pure Food and Drug Act of 1906; Senator Royal S. Copeland was its principal author. Congress acted after the Elixir Sulfanilamide disaster of 1937, in which the toxic solvent diethylene glycol was used to dissolve a drug into liquid form with no prior animal testing, killing more than one hundred patients. The Act is codified at Title 21 of the United States Code, Chapter 9, beginning at Section 301, and has been amended many times since, most significantly by the 1962 Kefauver-Harris Amendment requiring proof of efficacy as well as safety.