In 1937, a cough-syrup-style medicine killed over 100 people — and it was legal

Every prescription you pick up had to prove it was safe before it was allowed on the market. That wasn't always true, and the reason it changed is one of the worst drug disasters in American history.

A new wonder drug, in liquid form

In the 1930s, sulfanilamide was one of the first drugs that could actually cure bacterial infections like strep throat. It came as tablets and powder. Patients — especially kids — wanted something easier to swallow.

In 1937, the S. E. Massengill Company in Tennessee had its chief chemist, Harold Watkins, make a liquid version. He found that sulfanilamide dissolved in diethylene glycol, a sweet-tasting chemical related to antifreeze, added raspberry flavoring, and the company shipped it nationwide as "Elixir Sulfanilamide."

Nobody tested it on animals. Nobody tested it at all. No law required it.

The deaths

Diethylene glycol is poisonous. People who took the elixir developed kidney failure over days of agony. Many of them were children being treated for sore throats. More than 100 people died across several states.

The FDA, at the time a small agency, sent inspectors across the country to track down every bottle and every prescription — door to door, doctor's office to doctor's office.

Watkins died by suicide while awaiting trial.

The fine was for the label

Here's the part that shocked the country. Under the law at the time, a company could sell an untested drug that killed people. The only violation the government could charge was that the product was mislabeled: an "elixir" was supposed to contain alcohol, and this one didn't.

Massengill paid a fine for using the wrong word.

What changed

The public outrage pushed Congress to pass the Federal Food, Drug, and Cosmetic Act of 1938. For the first time, drugmakers had to show their products were safe — including animal testing — and submit that evidence to the FDA before selling them.

That law is the foundation of how drugs are approved in the U.S. today, including the generics you can get for a fraction of the price.

What this means for you

• The FDA approval process exists for a reason. "Natural" supplements don't go through it the same way — they don't need FDA approval before they're sold.
• Generic drugs go through it too. They have to match the brand's active ingredient and effect. Why generics are the same drug.
• Report bad reactions. Doctors and patients can report side effects directly to the FDA through MedWatch (fda.gov/medwatch). Those reports are how problems get caught.

Quick reference

• 1937: "Elixir Sulfanilamide," made with diethylene glycol, killed more than 100 people
• No safety testing was required by law at the time
• The company was fined only because "elixir" implied alcohol
• The 1938 Food, Drug, and Cosmetic Act required proof of safety before sale
• Supplements still don't need FDA approval before they're sold — prescription drugs do