Federal Food, Drug, and Cosmetic Act of 1938

Sulfanilamide, the first of the sulfa antimicrobial drugs, was still new in 1937, when a Tennessee drug company marketed it as a liquid, Elixir Sulfanilamide, using diethylene glycol as the solvent. The FDA's own history calls that solvent a highly toxic chemical analogue of antifreeze. No law required the company to test the product for toxicity before selling it.

More than 100 people died after taking it, many of them children. The emergency physician Paul Wax, reviewing the episode for Annals of Internal Medicine in 1995, counted 105 deaths from its therapeutic use. The Food and Drug Administration of the day worked mainly as a policing agency, seizing adulterated drugs once they were on the market.

A bill to replace the 1906 food and drug law had been stuck in Congress for five years. After the deaths it was strengthened and passed, and Franklin Roosevelt signed the Federal Food, Drug, and Cosmetic Act on 25 June 1938. Its central change was premarket approval: a manufacturer now had to prove to the FDA that a new drug was safe before it could be sold.

The act did more. It brought cosmetics and medical devices under federal control, required drug labels to carry adequate directions for safe use, prohibited false therapeutic claims for drugs, dealt with tolerances for certain poisonous substances in food and formally authorized factory inspections. Wax describes the result as a change in the FDA's work, away from confiscating adulterated drugs and toward overseeing the evaluation of new ones.