On Jun. 25, 1938, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act with new provisions. President Roosevelt signed it into law which for the first time required manufacturers to show that a drug was safe before it could be marketed.

The 1938 act followed a therapeutic disaster when over 100 tragic deaths in 15 states, as far east as Virginia and as far west as California were associated with an untested medicine, Elixir Sulfanilamide, manufactured by S. E. Massengill Company in Bristol, Tennessee (now part of GlaxoSmithKline). The regulatory authorities granted by this law are still in effect today.