Which event prompted the passage of the 1938 Food, Drug, and Cosmetic Act?

Which event prompted the passage of the 1938 Food, Drug, and Cosmetic Act?

• A. Thalidomide tragedy
• B. Diethylene glycol poisoning in a marketed drug
• C. OTC drugs found ineffective
• D. Patent medicines addicted

Answer: (B)

The event that prompted the 1938 Food, Drug, and Cosmetic Act was the diethylene glycol poisoning in a marketed drug—the Elixir Sulfanilamide disaster of 1937. This tragedy showed that safety testing wasn’t required before a drug could be sold under the existing law, leading to widespread deaths and public outcry. In response, the new act established that drugs must be proven safe before marketing, expanded FDA oversight, and mandated proper labeling. The thalidomide tragedy occurred later and led to different reforms in the 1960s; concerns about OTC drugs or patent medicines were addressed earlier and do not explain the 1938 act's passage.

The event that prompted the 1938 Food, Drug, and Cosmetic Act was the diethylene glycol poisoning in a marketed drug—the Elixir Sulfanilamide disaster of 1937. This tragedy showed that safety testing wasn’t required before a drug could be sold under the existing law, leading to widespread deaths and public outcry. In response, the new act established that drugs must be proven safe before marketing, expanded FDA oversight, and mandated proper labeling. The thalidomide tragedy occurred later and led to different reforms in the 1960s; concerns about OTC drugs or patent medicines were addressed earlier and do not explain the 1938 act's passage.