Federal Food, Drug, and Cosmetic Act (FDCA, 1938)

1) Link to the Text of the Act
Read the statute (21 U.S.C. § 301 et seq.)

2) Why It Was Done
The FDCA was passed after a public health disaster involving a toxic drug (Elixir Sulfanilamide) killed over 100 people. It gave the Food and Drug Administration (FDA) authority to oversee food, drugs, and cosmetics for safety.

3) Pre-existing Law or Constitutional Rights
The Pure Food and Drug Act of 1906 provided some regulation but lacked teeth. It did not require pre-market safety approval for drugs. The FDCA created stronger standards.