The 1938 Food, Drug, and Cosmetic Act (FDCA) was enacted after the diethylene glycol sulfanilamide incident; what was its result?

• A. It repealed the Pure Food Act
• B. Why: ingestion of sulfanilamide (with diethylene glycol) = death; result: mandated safety standards for food, drugs, and cosmetics (+1951 amendment)
• C. It required labeling of cosmetics
• D. It mandated safety standards for devices and cosmetics

Answer: (B)

The incident showed that people could be harmed by unsafe medicines, so the 1938 Act was driven by a need to protect public health by ensuring products sold to the public were safe. It established federal safety standards for foods, drugs, and cosmetics and gave the FDA authority to enforce those standards, including rules about safety and labeling before products could be marketed. This was a broad expansion beyond earlier laws and laid the groundwork for stronger regulatory oversight. The later 1951 amendment refined these controls, adding specifics on labeling and the prescription versus over-the-counter distinction. These points together explain why the result was mandating safety standards for food, drugs, and cosmetics, rather than merely labeling cosmetics, regulating devices, or repealing the earlier act.