Federal Food, Drug, and Cosmetic Act
The newly introduced sulfanilamide tablets had been found safe and effective for the treatment of streptococcal infections, and there was a call for a liquid. After trying a number of solvents, Harold Cole Watkins, chief chemist and pharmacist at S.E. Massengill Co., Bristol, Tennessee, found that he could dissolve the drug in diethylene glycol. Elixir Sulfanilamide, as it was called, looked good, and its raspberry flavor tasted fine. Shipped out countrywide in September 1937, it had never been tested for toxicity, which was not required by law.
Within weeks, the first deaths were reported, and before the drug shipments were recovered, 105 of 353 patients who had consumed it in fifteen states had died—many of them children treated for sore throats. The solvent diethylene glycol, used as antifreeze, was responsible for fatal kidney failure. The Food and Drug Administration seized some of the drug because it had been misbranded as an “elixir” (an alcoholic solution) when it did not contain alcohol.
Three consequences arose directly from this disaster: Massengill paid out $500,000 in injury claims; chemist Watkins died of a self-inflicted gunshot wound to his heart in January 1939; and, most significantly, the 1906 Pure Food and Drug Act, which had only prohibited the adulteration or misbranding of drugs, was thoroughly revised. With the sulfanilamide disaster fresh in mind, Congress enacted the 1938 Federal Food, Drug, and Cosmetic Act, which required that new drugs be tested for toxicity and approved by the Food and Drug Administration before they were marketed. (This protected the American public against the marketing of thalidomide in 1960.) Other provisions of the law required that drug containers provide adequate directions for use of the drug and differentiated between prescription drugs and those that could be sold over the counter. Laws now mandated that drugs be pure and safe, but proof of their effectiveness had to wait until 1962.
SEE ALSO Alcohol (c. 10,000 BCE), Pure Food and Drug Act (1906), Food and Drug Administration (1906), Sulfanilamide (1936), Thalidomide (1957), Kefauver-Harris Amendment (1962).
In the aftermath of the devastating Hurricane Katrina in October 2005, barrels of antifreeze (diethylene glycol) and synthetic oil were scattered over lawns and roadways in Venice, Louisiana. This same diethylene glycol was used in “Elixir Sulfanilamide.”