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FDA’s Regulation of Plant and Animal Biotechnology Products

What's New

On December 19, 2022, the White House Office of Science and Technology Policy (OSTP) — in coordination with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) — announced a request for information related to the Coordinated Framework for the Regulation of Biotechnology. This action requests relevant data and information to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. The request for information seeks case studies and other data that relate to new and emerging biotechnology products.

Feed Your Mind Education and Outreach Initiative

 

 

 

 

Better understand genetically engineered foods (commonly called GMOs)

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 has 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, the 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 to enhance public confidence in the regulatory system while also avoiding unnecessary barriers to innovation.

Plant and Animal Biotechnology Programs and Activities at the FDA

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