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.

4) Overreach or Proper Role?
Supporters argue it established essential consumer protections. Critics say FDA authority has expanded too far, delaying innovation and restricting consumer choice.

5) Who or What It Controls

• Manufacturers of food, drugs, and cosmetics (must comply with safety and labeling requirements)
• FDA (gains power to approve new drugs and monitor safety)
• Consumers (gain assurance of regulated safety standards)

6) Key Sections / Citations

• 21 U.S.C. § 355: New drug approval requirements
• 21 U.S.C. § 342: Adulterated food provisions
• 21 U.S.C. § 352: Misbranded drugs and devices
• 21 U.S.C. § 374: FDA inspection authority

7) Recent Changes or Live Controversies

• Expanded through amendments (e.g., Kefauver–Harris Drug Amendments of 1962 requiring proof of efficacy)
• Continues to evolve with issues like e-cigarettes, dietary supplements, and gene therapies
• Ongoing debates over FDA speed vs. safety in approving drugs and vaccines

8) Official Sources

• U.S. Code – Title 21, Chapter 9
• FDA – Laws Enforced by FDA
• History of the FDCA

• Consumer Protection
• Public Health
• FDA
• Food Safety
• Drug Safety
• Cosmetics