Sulfanilamide and the Food, Drug, and Cosmetic Act

In the fall of 1937, over 100 people died from consuming an antibiotic called “elixir of sulfanilamide”. This prompted a protracted scandal which would implicate drug manufacturers, pharmacists, and the federal government, eventually resulting in a fundamental shift in how drugs were regulated in the United States. 

Although it was discovered in 1908, sulfanilamide did not become commonly available until the late 1930s. During this decade, the popularity of sulfanilamide to treat minor infections exploded, particularly in Germany where it was invented. Since it was not patented, several American manufacturers began to produce and sell the substance in 1937. Most of these solutions were approved by the American Pharmaceutical Association, but this was mostly a formality and medicines could be sold without endorsement. The rapid expansion of sulfanilamide’s use coupled with a lack of research on the substance’s toxicity prompted concern from many medical professionals, and several articles warning against its potential dangers were published by major medical journals. These concerns prompted the FDA to investigate in the summer of 1937, and a general survey of sulfanilamide manufacturers was conducted. After this investigation, an outline for the regulation of sulfanilamide was drafted.

Unfortunately, this plan was not implemented  in time. In the fall of 1937, over 300 people would be hospitalized for poisoning related to “elixir of sulfanilamide”, a raspberry flavored solution produced by the pharmaceutical company S. E. Massengill. The culprit, however, was not sulfanilamide but rather diethylene glycol, a dilutant added to facilitate the dissolution of sulfanilamide. All told, 105 people across the United States would die from diethylene glycol poisoning, with the vast majority of these people being prescribed the elixir by a physician.

Several pharmaceutical trade magazines addressed the incident after its outbreak, with most of the articles deflecting blame onto either physicians or manufacturers. One article in American Druggist rebuts a claim made by Secretary of Agriculture Henry A. Wallace that “pharmacists prayed God’s forgiveness on a bended knee”, stating that it was a physician who prescribed the substance and not a pharmacist. Another article which appeared in The Apothecary in November of 1937 states there is “no excuse for the use of Drethylene Glycol [sic]” except to give the manufacturer a competitive advantage. The author then goes on to defend the use of unadulterated sulfanilamide, which he describes as “one of our great discoveries in medicine”. Despite the scale and publicity of the crisis, it did not seem to seriously affect the day-to-day operations of American pharmacies and the pharmaceutical publications which were directed at store managers generally made little mention of it.

On the other hand, the general press got into a heated back-and-forth with S. E. Massengill. Most notably, Time magazine published an article in November of 1937 which quoted a federal agent saying “they [S. E. Massengill] just throw drugs together, and if they don’t explode they are placed on sale”. They also implied that S. E. Massengill was primarily a veterinarian drug manufacturer rather than human drug manufacturer, and that diethylene glycol was never before used in medicine but was a common ingredient in antifreeze. In response, S. E. Massengill accused Time of spreading misinformation and claimed they had the best track record of any pharmaceutical company in America. They then go on to cite an unspecified “body of scientists” who hold the belief that “it is probable that no chemist or pharmacologist will ever be able to determine exactly what happened”. Finally, they denied that diethylene glycol was used in antifreeze, claiming that the author of the article must have been thinking of ethylene glycol.

After an investigation which lasted several months, the FDA seemed to agree that the fault lay mainly with the manufacturers. However, since drug laws were still enforced under the 1906 Pure Food and Drug Act, the most serious charge that could be pressed against S. E. Massengill was mislabelling. This spurred Congress–which had been considering passing food and drug legislation since Franklin Delano Roosevelt had been inaugurated–to pass the Food, Drug, and Cosmetic Act in 1938. This mandated that manufacturers prove the safety of their drugs before they go to market, and essentially set up the FDA as the gatekeeper of which drugs were and were not considered safe, dramatically changing the power dynamics of the pharmaceutical industry. Today, an amended version of the Food, Drug, and Cosmetic Act is still in effect.

By Leo Ryan
AIHP Intern

Bibliography:

Ballentine, Carol. “Sulfanilamide Disaster.” FDA Consumer Magazine, June, 1981. https://www.fda.gov/files/about%20fda/published/The-Sulfanilamide-Disaster.pdf.

Cooper, Dale E. “Adequate Controls for New Drugs: Good Manufacturing Practice and the 1938 Federal Food, Drug, and Cosmetic Act.” Pharmacy in History 44, no. 1 (2002): 12–23. http://www.jstor.org/stable/41112093.

“The Facts About Elixir Sulfanilamide.” Press statement released by S. E. Massengill, December, 1937. Accessed through the American Institute for the History of Pharmacy’s archives. 

Hutchinson, Herbert R. “Lethal Elixir.” The Apothecary, November, 1937, 52. Accessed through the American Institute for the History of Pharmacy’s archives.

“Lethal Remedy.” Time Magazine, November, 1937. https://time.com/archive/6820167/medicine-fatal-remedy/. 

“Not Guilty.” American Druggist 97, no. 1 (1938): 50. Accessed through the American Institute for the History of Pharmacy’s archives.

Wax, Paul M. “Elixirs, Diluents, and the Passage of the 1938 Federal Food, Drug and Cosmetic Act.” Annals of Internal Medicine 122, no. 6 (1995): 456-461.