Elixir sulfanilamide was an improperly prepared sulfonamide antibiotic that caused mass poisoning in the United States in 1937. It is believed to have killed at least 100 people, with some sources citing 107 deaths. The public outcry from this incident, along with other similar disasters, led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act, which significantly expanded the U.S. Food and Drug Administration's (FDA) authority to regulate drugs.
Background
In 1937, the S. E. Massengill Company, a pharmaceutical manufacturer based in Bristol, Tennessee, created an oral liquid preparation of sulfanilamide, a sulfonamide antibiotic that had been used successfully in tablet and powder form. The company dissolved the drug in diethylene glycol (DEG), a sweet-tasting but highly toxic solvent commonly used as an industrial chemical and antifreeze component, and added raspberry flavoring. The product was marketed as "Elixir Sulfanilamide."
Harold Watkins, the company's chief pharmacist and chemist, formulated the preparation. Although studies had been published in medical journals indicating that diethylene glycol could cause kidney damage or failure, its toxicity was not widely known at the time. No animal safety testing was performed, and none was required by law, as there were no federal regulations mandating premarket safety testing of drugs in the United States at that time.
The Poisoning
The company began distributing the medication in September 1937. By October 11, 1937, the American Medical Association had received reports of deaths linked to the drug. The FDA was notified and launched an extensive nationwide effort to recover the distributed medicine. At least 100 deaths were ultimately attributed to the product, with many victims being children. The toxic agent was identified as diethylene glycol, which caused acute kidney failure in those who ingested it.
Aftermath and Regulatory Impact
The incident generated significant public outrage. A mother whose daughter died after taking the medication wrote to President Franklin D. Roosevelt, describing her child's suffering and pleading for action to prevent similar tragedies.
Congress responded by passing the Federal Food, Drug, and Cosmetic Act of 1938. This legislation required drug manufacturers to perform animal safety tests on proposed new drugs and to submit the data to the FDA before marketing their products. It also prohibited the mislabeling of products, such as calling a preparation an "elixir" when it contained no ethanol.
The Massengill Company was fined under the provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling the preparation an "elixir" if it contained no alcohol. The company's owner, when pressed on responsibility, stated that the company had been supplying a legitimate professional demand and did not feel there was any responsibility on its part. Watkins, the chemist who formulated the product, died by suicide while awaiting trial.
Significance
The elixir sulfanilamide disaster is widely regarded as a pivotal event in the history of pharmaceutical regulation in the United States. It demonstrated the dangers of marketing drugs without adequate safety testing and directly contributed to the establishment of the modern drug approval framework administered by the FDA.
