In February 2024, the U.S. Food and Drug Administration (FDA) clarified the regulatory pathway for foods produced from genome-edited plants in a final guidance titled Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry.¹ The Guidance addresses the regulatory approach for both human and animal foods produced from genome-edited plants. Toward this end, FDA introduces a streamlined, premarket meeting option for lower-risk plants. In this sense, the Guidance is consistent with the 2017 update to the Coordinated Framework for the Regulation of Biotechnology,² as well as the Biden Administration's 2022 Executive Order on Advancing Biotechnology and Biomanufacturing Innovation,³ which included a promise to clarify—and potentially simplify—regulatory pathways for products of biotechnology.

The Guidance is timely as genome editing is now the dominant tool for targeted modification of plants to produce desired traits and novel proteins for both human and animal use. Moreover, the Guidance may have significance in providing an up-to-date list of FDA's key safety concerns regarding novel ingredients that may be useful not only in developing foods from genome-edited plants, but also in considering the use of genome editing in microorganisms. Additionally, it will be worth monitoring FDA to see whether the agency takes steps to introduce a similarly streamlined path to market for other, lower-risk, novel foods.