The U.S. Food and Drug Administration (FDA) has issued a guidance for industry that describes how firms can voluntarily engage with FDA before marketing food from genome-edited plants.

FDA works with other U.S. government agencies to regulate products derived from biotechnology-derived plants, including products that have been developed using genetic engineering and genome editing.

The guidance reaffirms that the risk-based approach the agency has taken for foods derived from new plant varieties also applies to foods from genome-edited plants. In addition, the guidance describes two processes through which manufacturers 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.    

The recommended pathway for engagement is based on a food’s risk-based characteristics. The voluntary premarket meeting pathway is recommended for developers to inform the agency of their foods when a voluntary premarket consultation is not warranted based on the food’s risk-based characteristics. The agency expects this voluntary premarket meeting pathway to take less time than a voluntary premarket consultation, because the meeting pathway is recommended for foods that are less likely to raise safety questions. FDA continues to suggest voluntary premarket consultations for foods that have certain risk-based characteristics, as described in the guidance.

FDA’s voluntary premarket Plant Biotechnology Consultation Program enables developers to engage with the agency to determine the appropriate oversight pathways to bring safe, innovative, plant-based products to market. Foods from genome-edited plants must meet the same food safety requirements as foods derived from traditionally bred plants.  

The guidance helps to improve the efficiency of the regulatory processes for biotechnology products, as directed by Executive Order 14081, “Advancing Biomanufacturing and Biotechnology Innovation for a Sustainable, Safe, and Secure Bioeconomy.” The guidance is also consistent with the principles in the 1992 Statement of Policy: “Foods Derived from New Plant Varieties” (NPV policy).

Comments about the guidance can be submitted electronically to www.regulations.gov. Written comments can be submitted to the Dockets Management Staff (HFA-305), U.S. Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2019-D-4658 and with the title of the guidance.

Update, December 19, 2024: FDA has published a list of voluntary premarket meetings that have been held between the agency and developers of foods from new genome-edited plant varieties.