What was the main reason for the creation of the Federal Food, Drug, and Cosmetic Act of 1938?

The Federal Food, Drug, and Cosmetic Act of 1938 was primarily established in response to the inadequacies of the Pure Food and Drug Act of 1906. The earlier legislation did not provide sufficiently stringent safety measures or rigorous standards for drug efficacy and quality. There were significant public health concerns highlighted by various incidents, including the tragic mass poisoning resulting from the unregulated use of sulfanilamide, a drug mixed with a toxic solvent. This event underscored the need for stronger regulatory oversight to ensure that drugs were not only safe but also effective.

The 1938 Act addressed these gaps by introducing more comprehensive regulations, requiring pre-market approval of new drugs, and establishing a framework for the FDA to oversee product safety and labeling. By emphasizing stricter regulations, the Act sought to protect the public from potentially harmful products and to enforce higher standards in the pharmaceutical industry. Thus, the creation of the Federal Food, Drug, and Cosmetic Act was fundamentally driven by the necessity for clearer and more effective regulatory measures than those provided by the earlier law.