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Federal Food, Drug, and Cosmetic Act (FDCA)

1938

21 U.S.C. § 301 et seq.

📌 Link to the Text of the Act

Read the statute (21 U.S.C. § 301 et seq.)

📌 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.

📌 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.

📌 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.

📌 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)
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    Consumers (gain assurance of regulated safety standards)

📌 Key Sections / Citations

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

📌 Recent Changes or Live Controversies

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

📌 Official Sources