On Nov. 16, 1937, the U.S. Congress directed the Food and Drug Administration (FDA) to give a full accounting of the “Elixir Sulfanilamide” tragedy. The drug, manufactured by S.E. Massengill Co. in Bristol, Tenn. contained a poisonous solvent that killed more than 100 people, many of them children.

Because no pharmacological studies had been done on the sulfanilamide preparation, the company’s chief chemist and pharmacist failed to note one characteristic of the solution. Diethylene glycol, a chemical normally used as an antifreeze, is a deadly poison.

The incident spurred Congress to pass the Federal Food, Drug, and Cosmetic Act, which included stronger drug safety requirements.