1938 Food, Drug, & Cosmetic Act 

In the late 1930s, the S.E. Massengill Co. of Bristol, Tennessee responded to demand for their medicine Sulfanilamide in liquid form by releasing Elixir Sulfanilamide. However, within a month, reports of deaths related to the new drug surfaced, with 107 fatalities attributed to the elixir's solvent, diethylene glycol (DEG).

 

In response to public outcry, Congress passed the Food, Drug, & Cosmetic Act of 1938, significantly enhancing the Food and Drug Administration's (FDA) authority to regulate drugs in the United States. This incident exposed the lack of federal regulation over products marketed to the public prior to the tragedy.

 

The Food, Drug, & Cosmetic Act of 1938 mandated animal testing and data submission to the FDA before marketing any future product, addressing previous shortcomings. However, further reforms were needed, leading to the enactment of the Kefauver-Harris Amendments of 1962, which aimed to bolster drug regulation and enhance consumer safety.

 

These amendments, named after Senator Estes Kefauver and Representative Oren Harris, addressed various issues, including drug efficacy and advertising transparency. They required pharmaceutical companies to provide evidence of a drug's effectiveness before it could be marketed, aiming to prevent another tragedy like the Elixir Sulfanilamide incident. The Kefauver-Harris Amendments marked a significant step forward in ensuring the safety and efficacy of drugs marketed to the public.

 

Sources:

Office of the Commissioner. “Elixir Sulfanilamide Tragedy.” U.S. Food and Drug Administration, FDA, 31 Jan. 2018, https://www.fda.gov/about-fda/histories-product-regulation/sulfanilamide-disaster. (Broken Link)

​

Office of the Commissioner. “Part I: The 1906 Food and Drugs Act and Its Enforcement.” U.S. Food and Drug Administration, FDA, 24 Apr. 2019, https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-i-1906-food-and-drugs-act-and-its-enforcement. (Broken Link

​

Silverman, Steve. “Elixir of Death - Podcast #106.” Useless Information, 27 Feb. 2021, https://uselessinformation.org/elixir-of-death/. 

​

Thompson, Mike. “History of Drug Use and Drug Legislation Timeline.” Timetoast Timelines, https://www.timetoast.com/timelines/history-of-drug-use-and-drug-legislation-2310d80c-f20f-423d-b807-dd415b6b78f9. 

​

West, Julian G. “The Accidental Poison That Founded the Modern FDA.” The Atlantic, Atlantic Media Company, 16 Jan. 2018, https://www.theatlantic.com/technology/archive/2018/01/the-accidental-poison-that-founded-the-modern-fda/550574/.