In 1937 a Tennessee drug company dissolved a medicine in a chemical cousin of antifreeze. More than a hundred people died, many of them children, and the only crime was mislabeling. The outrage broke a congressional deadlock and produced the 1938 Food, Drug, and Cosmetic Act, followed by mid-century amendments that built today's regulatory architecture.
The death toll is given as more than a hundred, with 107 most often cited. The Delaney Clause's strict zero-tolerance rule sits uneasily with modern trace-detection science, and the 1938 Act had been debated for years before the disaster broke the deadlock.



