The Federal Food, Drug, and Cosmetic Act was passed in response to which event?

• A. Some women who used thalidomide during pregnancy gave birth to children with phocomelia
• B. A pharmaceutical company marketed an antibiotic dissolved in the toxic solvent, diethylene glycol
• C. Some over-the-counter drugs were determined ineffective for their indicated use
• D. Individuals became addicted to patent medicines

Answer: (A)

The main idea here is why the FDA’s foundational act was created: to protect public health by ensuring drug safety, accurate labeling, and quality before products reach consumers. That protection came after a horrific incident in 1937, when a medication was contaminated with diethylene glycol, a toxic solvent, and hundreds of people died. This tragedy showed that drugs needed rigorous safety testing and clear labeling before they could be sold.

The thalidomide disaster, which caused birth defects, happened later and led to stricter rules about drug safety and efficacy in the 1960s, but it did not trigger the 1938 act. Among the events listed, the diethylene glycol poisoning best explains the motivation behind the FD&C Act. The other scenarios either refer to different issues or to regulations that came later.