Federal Food, Drug, and Cosmetic Act (FDCA)

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.

Healthcare Law Cases

FDA v. Alliance for Hippocratic Medicine

FDA v. Alliance for Hippocratic Medicine (2024)

1) Link to the Actual Opinion
Read the Supreme Court opinion (PDF)

2) Summary of the Opinion
Anti-abortion medical groups challenged the FDA’s approval and regulation of mifepristone, a medication used in medication abortions. The Supreme Court unanimously ruled that the challengers lacked standing, meaning they had no legal right to sue because they were not directly injured by the FDA’s actions.

3) Why It Mattered
The decision preserved access to mifepristone by dismissing the challenge on procedural grounds. It sidestepped broader questions about the FDA’s authority but underscored limits on who can bring cases in federal court.