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U.S. Food and Drug Administration and Regulations

The U.S. Food and Drug Administration is a public health agency that is charged with protecting American consumers by enforcing the U.S. Federal Food, Drug, and Cosmetic Act and other related public health laws.

FDA regulates over US$1 trillion worth of products, which account for 25 cents of every dollar spent annually within the United States. These products include:

  • Food for human and animal consumption
  • Pharmaceuticals consisting of ethical, generic, and over-the counter drugs for human use as well as medicines for animals
  • Biological and related products including blood, vaccines, and biological therapeutics
  • Medical devices
  • Radiation-emitting devices such as microwaves
  • Cosmetics

FDA monitors the manufacture, import, transport, storage, and sale of these products by some 98,000 FDA-regulated businesses in the United States alone and by several thousand international organizations that conduct business in the United States.

Compliance with FDA regulations is a market requirement. In addition, products require FDA approval before they can be marketed or sold in the United States. Noncompliance with any of the laws enforced by FDA can be very costly in the form of recalls and legal sanctions, such as import detentions. When warranted, FDA seeks criminal penalties, including prison sentences, against manufacturers and distributors.

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