What was a significant outcome of the 1938 Federal Food, Drug, and Cosmetic Act?

The outcome that requires scientific proof of safety before marketing drugs was a monumental shift in the regulatory landscape brought about by the 1938 Federal Food, Drug, and Cosmetic Act. Prior to this act, there was limited regulatory oversight concerning the safety of drugs, leading to numerous hazards, including the infamous incident involving the toxic elixir sulfanilamide that resulted in multiple deaths. This disastrous episode highlighted the urgent need for reform.

The 1938 Act established that manufacturers must provide evidence of a drug's safety prior to its approval for marketing. This requirement was pivotal, as it introduced a system that mandated scientific validation of drug safety, which is a cornerstone of modern pharmaceutical regulation. By ensuring that drugs are tested and deemed safe before reaching consumers, the Act sought to protect public health and welfare, laying the foundation for the rigorous standards that exist today.

This regulatory approach also paved the way for subsequent legislation that would further refine drug approval processes, but the immediate impact of requiring proof of safety marked a significant evolution in how drugs were regulated, emphasizing the importance of safety over mere availability.