What does the 1938 Federal Food, Drug, and Cosmetic Act specifically require from drug manufacturers before a drug can be marketed?

The 1938 Federal Food, Drug, and Cosmetic Act was a significant piece of legislation that established the requirement for drug manufacturers to provide scientific proof of safety before a drug could be marketed to the public. This was a response to public health concerns, particularly following incidents such as the Elixir Sulfanilamide tragedy, where a toxic formulation led to numerous deaths. As a result, the Act mandated that manufacturers must demonstrate that their products are safe for consumption, meaning they must conduct appropriate testing to ensure that drugs do not pose significant risks to consumers when used as directed.

Labeling requirements, while important for informing consumers and healthcare providers about the drug's usage and potential side effects, are secondary to the primary necessity of proving that the drug itself is safe. Similarly, proof of advertising effectiveness and proof of therapeutic claims are also not required for a drug's initial approval; while these may have regulatory oversight, they do not serve as prerequisites for marketing the drug. Therefore, the emphasis of the 1938 Act is specifically on the scientific substantiation of a drug’s safety profile before it can be deemed suitable for the market.