Federal Food, Drug and Cosmetic Act (FDCA, FD&C)

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.[3] The act has been amended many times, most recently to add requirements about bioterrorism preparations.

The FDCA covers the regulations on the following:

  • Food coloring
  • Food additives
  • Homeopathic medications
  • Bottled water
  • Cosmetics
  • Medical devices

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