Elixir Sulfanilamide killed 107 people — and created the modern FDA

In September 1937, the S. E. Massengill Company of Bristol, Tennessee, marketed a new liquid formulation of the antibiotic sulfanilamide. The company's chief pharmacist, Harold Watkins, dissolved the drug in diethylene glycol (DEG) — a solvent chemically related to antifreeze — without any animal safety testing. The only testing was for appearance, flavour and fragrance. The product was labelled as an 'elixir' even though it contained no ethanol, a technicality that would later matter legally.

Within weeks, deaths were reported across the United States. The American Medical Association received reports of fatalities on 11 October 1937. By the time the FDA tracked down and recalled the entire supply — 240 gallons — 107 people had died, most of them children. The victims suffered agonising kidney failure from DEG poisoning. The company's owner, Samuel Massengill, issued a statement saying he could not have foreseen the results. Watkins, the chemist, died by suicide before the trial.

Under the 1906 Pure Food and Drugs Act, the FDA could only charge Massengill with misbranding — the law had no requirement for safety testing. The company paid a minimal fine. The public outrage was massive, and in 1938 Congress passed the Federal Food, Drug, and Cosmetic Act, which required manufacturers to prove drug safety before marketing. The disaster is widely considered the event that created the modern pharmaceutical regulatory system.