05/23/2026
Why do we have government agencies charged with the protection of citizens? We need them because humans seldom admit they made a mistake.
By 1937 sulfanilamide was known to be an effective treatment for streptococcal infections (strep throat). But because sulfanilamide was extremely difficult to dissolve, the drug was only available in tablet or powdered form, and children resisted taking it.
In response to requests from salesmen and physicians, the S. E. Massengill Company, a pharmaceutical manufacturer in Bristol Tennessee, set about trying to create a kid-friendly liquid form of the drug. After Massengill chemist Harold Watkins discovered that it dissolved easily in diethylene glycol, he mixed raspberry flavoring into powdered sulfanilamide, dissolved it in diethylene glycol, and called his creation “Elixir Sulfanilamide.” In September 1937 Massengill shipped 633 bottles of the new product to salesmen across the country, who distributed it to physicians, who immediately began prescribing it to patients.
But Watkins had made a tragic mistake. There was no law requiring animal testing of the drug and none had been done. Diethylene glycol is a powerful solvent, used today as a component of, among other things, brake fluid, lubricants, antifreeze, and wallpaper stripper. Unbeknownst to Watkins at the time, diethylene glycol is toxic to humans.
Within a couple of weeks physicians in Tulsa Oklahoma began reporting the deaths of patients who had taken the drug. The president of the Tulsa Medical Society notified the American Medical Association, which in turn contacted Massengill demanding the chemical composition of the elixir. Claiming the composition was proprietary, Massengill released it to the AMA but only on the condition that it be kept confidential. The company admitted that there had been no toxicity testing of the product but insisted it was safe and that any adverse effects must have been from improper combinations with other drugs. To demonstrate his belief, Watkins took a dose of the drug himself, with no ill effects.
Watkins turned out to be among the approximately 75% of those who took the drug without suffering any adverse consequences. The other 25% would not be so lucky.
The AMA quickly determined that the diethylene glycol in the elixir was toxic and issued urgent warnings through radio and newspapers, while working frantically with the FDA and the company to try to track down the shipments. They were able to locate and destroy a little over 236 gallons of the 240 gallons that were manufactured and shipped. The remainder was consumed, killing 105 people, painfully and horrifically. Thirty-four of the victims were children.
Six-year-old Joan Niddifer became one of the public faces of the tragedy. After the little girl’s death from taking the drug, her mother sent a letter to President Franklin Roosevelt, enclosing a photo of her daughter, and pleading with the president to take action to prevent such tragedies in the future. “All that is left to us is the caring for her little grave,” the grieving mother wrote. “Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight...” The photo of Joan appeared in numerous newspaper stories, helping fuel public outrage and demand for action.
Massengill refused to acknowledge any responsibility for the tragedy. Samuel Massengill, the company’s owner, issued a statement that read: ““My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.” But Harold Watkins, the chemist who developed the formula, was overwhelmed with remorse. On January 17, 1939, he shot himself in the heart, taking his own life.
Under U.S. law at the time, pharmaceutical manufacturers were required to label their products accurately, but no safety testing was required. Finding that the word “elixir” implied that the solvent in its product was ethyl alcohol, Massengill was fined $16,800 for false labeling (about $450,000 in today’s money), the maximum fine permitted by law. For the failure to test the product, and for the deaths of those who died from it, the company was not held accountable. Only six civil lawsuits were brought against the company, and all were settled for between $300 and $3,000 (between $7,000 and $70,000 in today’s money).
In the aftermath of the disaster, Congress enacted the Federal Food Drugs and Cosmetics Act of 1938, which required that any new drug be tested for safety and that all results of the tests be reported to the FDA.