The Food, Drug, And Cosmetic Act Of 1938

A Terrible Mistake.

The press widely praised sulfanilamide as a miracle medicine. But in 1937 a terrible mistake was made. The chief chemist at a small pharmaceutical plant in Bristol, Tennessee, trying to create a liquid dosage form, found that the solvent diethylene glycol would dissolve sulfanilamide. With the solvent he created a liquid form of sulfanilamide called an elixir of sulfanilamide. The chemist tested the elixir for appearance, fragrance, and flavor but neglected to consult the scientific literature or make animal tests to determine the effect on the body. Nearly two thousand pints of the liquid were made, but not one named the solvent on the label. Its presence in the elixir was toxic. The Food and Drug Administration (FDA; created in 1906 with the passage of the Pure Food and Drug Act) began hearing a rumor that deaths were occurring from some sulfa compound. By the time the investigation was over, the "elixir,"...

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