Which law increased labeling requirements and implemented the first drug safety requirements?

The Federal Food, Drug, and Cosmetic Act (FFDCA) was pivotal in reshaping the regulatory landscape for food and drug safety in the United States. Enacted in 1938, this law was a response to public health needs following incidents of harmful products, most notably the 1937 Elixir Sulfanilamide tragedy, which resulted in numerous fatalities due to toxic ingredients.

By establishing the first system of drug approval, the FFDCA required manufacturers to provide evidence of safety for new drugs before they could be marketed. This was the first legal mandate for pre-market safety assessments and contributed significantly to consumer protection. Additionally, the FFDCA laid the groundwork for stringent labeling requirements, ensuring that drug labels included critical information such as dosage instructions, potential side effects, and contraindications. These requirements aimed to enhance the safety and efficacy of pharmaceuticals available to the public.

While other laws mentioned play crucial roles in further refining drug regulations—such as the Durham-Humphrey Amendment, which distinguished prescription from over-the-counter drugs, and the Kefauver-Harris Amendment, which added efficacy requirements to pre-market approval—the FFDCA holds the distinction of being the foundational law that introduced drug safety requirements and comprehensive labeling standards. The Controlled Substances Act was