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FDA’s Regulation of Plant and Animal Biotechnology Products

What's New

On February 22, 2024, the FDA issued a guidance for industry that describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants. The guidance reaffirms that the risk-based approach the FDA has taken for foods derived from new plant varieties also applies to foods from genome-edited plants. In addition, this guidance describes two processes through which they may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. These processes can help ease the pathway to market for foods from genome-edited plants, while keeping FDA safeguards in place. 

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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