What year was the Federal Food, Drug, and Cosmetic Act (FDCA) established?

The Federal Food, Drug, and Cosmetic Act (FDCA) was established in 1938, marking a significant milestone in the regulation of food and drugs in the United States. This law was enacted in response to increasing concerns about the safety of food and drug products, particularly after incidents like the Elixir Sulfanilamide tragedy, which resulted in numerous deaths due to a toxic formulation. The FDCA provided the framework for the FDA's authority to oversee the safety, efficacy, and labeling of food, drugs, and cosmetics, making it a cornerstone of public health legislation.

In contrast, subsequent years saw the introduction of amendments and other acts to address evolving issues in drug safety and efficacy. For instance, the 1951 Durham-Humphrey Amendment established the distinction between prescription and over-the-counter medications, while the 1962 Kefauver-Harris Amendments mandated that drug products be proven effective before they could be marketed. Each of these later developments built upon the foundational principles established by the FDCA.