What significant authority did the Federal Food, Drug, and Cosmetic Act of 1938 provide to the FDA?

The Federal Food, Drug, and Cosmetic Act of 1938 significantly enhanced the authority of the FDA by introducing requirements for adequate drug testing for safety before a drug could be marketed to the public. This legislation arose in response to public health crises, particularly those involving untested and potentially dangerous products.

By mandating that manufacturers provide evidence of a drug’s safety through appropriate testing protocols, the Act ensured that consumers would not be exposed to harmful substances without adequate information regarding their safety. This requirement not only aimed to protect public health but also established a formal process for evaluating the safety of new pharmaceuticals, which laid the groundwork for the modern regulatory framework governing drug approval.

While the FDA does have responsibilities concerning dietary supplements, the regulation of over-the-counter medications, and drug advertising, the establishment of safety testing requirements was a pivotal move that fundamentally shaped FDA's role in safeguarding consumer health. This focus on ensuring safety via testing was one of the key outcomes of the 1938 Act, setting a precedent for subsequent regulations and oversight.