Origin of U.S. Food, Drug, and Cosmetic Act


In 1937, S. E. Massengill Co., a small pharmaceutical manufacturer, began to sell a product it called Elixir Sulfanilamide.

Samuel Evans Massengill enrolled in medical school at the University of Nashville, Tennessee, but before he graduated he could see that making medicines for doctors would be more profitable than being a doctor. In 1898, he started up the S. E. Massengill Company with the goal of producing pharmaceuticals. He prospered.

An Untested Cure for Sore Throats

In the fall of 1937, the company put a new product on the market. Elixir Sulfanilamide was going to cure sore throats like never before. It was also promoted for use on a variety of other ailments.

The product contained sulfanilamide, diethylene glycol, a dash of red colouring, and a smidgen of raspberry flavour to help it go down. Unfortunately, Harold Cole Watkins, who created the medicine, didn’t know that diethylene glycol is poisonous; it’s otherwise known as anti-freeze.

Massengill shipped the magic potion all over the U.S. Writing in the June 1981 issue of the FDA Consumer magazine, Carol Ballentine reported that “The new formulation had not been tested for toxicity. At the time the food and drugs law did not require that safety studies be done on new drugs. Selling toxic drugs was, undoubtedly, bad for business and could damage a firm’s reputation, but it was not illegal.”

Deadly Effect of Drinking Anti-Freeze

Almost at once patients were suffering an “extremely painful, excruciating death.”

On October 11, 1937 Dr. Homer A. Ruprecht of the Springer Clinic in Tulsa, Oklahoma wrote a letter to the American Medical Association. In it he described what was happening to his patients.

“We have a list of ten patients who have received an elixir of sulfanilamide…Of these, ten patients, four are living, two of whom have definitely recovered, and the other two will probably die. Eight of these patients were children and the drug was given because of an upper respiratory infection. The other two patients were young men and the drug was used for a gonorrheal infection.

“The onset is usually with nausea, vomiting, malaise, sometimes diarrhea, and then complete anuria (inability to pass urine).”

By the time all the bottles were retrieved 107 people had succumbed.

Massengill Company Claims no Wrongdoing

S. E. Massengill Co. said it had done nothing wrong. The company chemist, Harold Watkins, thought otherwise; he took his own life, although some say his gun went off accidentally while he was cleaning it.

On October 17, 1938 Time Magazine reported that “Kin of the victims promptly started civil suits, to date have collected more than $150,000 damages (about $2.25 million in 2009 terms) from S. E. Massengill Co.” The government only pursued minor charges involving mislabelling the product and the company paid a fine of $16,800 (roughly $250,000 today).

The catastrophic event led to the passage in 1938 of the Federal Food, Drug, and Cosmetic Act. The public outcry caused by the Elixir Sulfanilamide issue not only reshaped the drug provisions of the new law to prevent such an event from happening again, it propelled the bill itself through Congress.