What triggered the enactment of the Federal Food, Drug, and Cosmetic Act of 1938?

• A. Discovery of counterfeit drugs in the black market
• B. An incident where patients died after taking medication with diethylene glycol
• C. A rise in counterfeit dietary supplements
• D. A significant decrease in drug safety awareness

Answer: (B)

The enactment of the Federal Food, Drug, and Cosmetic Act of 1938 was primarily triggered by a tragic incident involving the use of diethylene glycol in medications. In this case, patients suffered severe adverse effects and ultimately died after consuming a sulfanilamide elixir that contained this toxic substance. This horrifying event highlighted the urgent need for stricter regulations in the pharmaceutical industry to ensure the safety and efficacy of drugs before they reached the market.

The incidents surrounding this specific drug emphasized the lack of oversight and regulation that existed at the time, which allowed potentially dangerous products to be distributed to consumers without any requirement for safety testing or FDA approval. Consequently, the act was formulated to create a framework for ensuring that medications were safe for public consumption, which included requiring pre-market approval and proof of safety for new drugs.

By establishing these regulatory measures, the Federal Food, Drug, and Cosmetic Act aimed to protect consumers from the hazards of untested and potentially harmful medications, marking a significant turning point in the history of drug regulation in the United States.