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FDA’s Regulation of Plant and Animal Biotechnology Products

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FDA relies on its authorities granted by the Federal Food, Drug, and Cosmetic (FD&C) Act and the Public Health Service (PHS) Act to regulate products, including biotechnology products. Under the National Environmental Policy Act, FDA also evaluates the environmental impacts of "major actions," such as product approvals. Under these statutes, FDA is charged, among other things, with helping ensure that:

  • Human and animal food is safe and properly labeled;
  • Human and animal drugs are safe and effective;
  • There is a reasonable assurance that medical devices intended for human use are safe and effective;
  • Cosmetics are safe and properly labeled; and,
  • Human biological products are safe, pure, and potent.

The FDA regulates plant and animal biotechnology products in coordination with the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA), consistent with the U.S. Coordinated Framework for the Regulation of Biotechnology.  Each of these regulatory agencies have developed regulations and guidance documents to implement its authority under existing laws to help ensure the safety and, where applicable, the effectiveness of biotechnology products.

As the landscape of biotechnology products evolves along with advances in molecular techniques, FDA is committed to protecting public and animal health and to working with stakeholders to increase the transparency, coordination, and predictability of the regulatory system so as to enhance public confidence in the regulatory system while also avoiding unnecessary barriers to innovation.

Plant and Animal Biotechnology Programs and Activities at FDA


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