What event prompted the implementation of the 1938 Federal Food, Drug, and Cosmetic Act?

The 1938 Federal Food, Drug, and Cosmetic Act was largely prompted by the Sulfanilamide disaster, which occurred in 1937. This event involved the use of a toxic solvent, diethylene glycol, in a liquid formulation of sulfanilamide, an antibiotic. Tragically, the product resulted in the deaths of over 100 individuals, including many children, who ingested the medication unaware of its dangers. This disaster drew significant public attention and raised serious concerns about the safety of pharmaceuticals.

In response to the outrage surrounding this crisis, lawmakers recognized the urgent need for more stringent regulations governing the approval and marketing of drugs. The 1938 Act established new requirements that mandated drug manufacturers to prove the safety of their products before they could be sold to consumers. This legislation was critical in shaping the modern regulatory framework of the FDA, aiming to protect public health by ensuring that drugs meet safety standards prior to being made available to the public.