Tragic Lessons: The Elixir Sulfanilamide Incident and the Birth of Drug Safety Regulation

In 1937, the US-based Massengil pharmaceutical company’s chemists developed a new sulfonamide oral preparation named “Elixir Sulfanilamide.” At that time, there was no requirement for safety review before launching new drugs. Consequently, this untested drug went on sale in September of that year. In October, the American Medical Association received reports of fatalities caused by the medication. In November, the US Food and Drug Administration (FDA) intervened, recalling the drug. The investigation found that “ethylene glycol,” used as a solvent in the drug, was the main culprit of poisoning.

Ethylene glycol is highly toxic to mammals, with a minimum lethal dose (LD₅₀) of 786 mg/kg in humans. This issue, easily detectable through a simple animal experiment, resulted in over 100 deaths that fall, with 30% being children. The following year, under immense public pressure, the US Congress passed the landmark “Federal Food, Drug, and Cosmetic Act” (FFDCA), mandating safety reviews for all new drugs before market approval and granting the FDA regulatory oversight authority.