FDA Issues Guidance for Industry on Foods Derived from Plants Produced Using Genome Editing

The U.S. Food and Drug Administration (FDA) has posted a February 2024 guidance entitled “Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry.” According to FDA, one purpose of the guidance is to clarify how its 1992 policy statement “Statement of Policy: Foods Derived from New Plant Varieties” (NPV policy) (57 Fed. Reg. 22984) applies to foods derived from NPVs produced using genome editing. The NPV policy provides scientific and regulatory guidance on foods from NPVs, laying out broad, risk-based principles for ensuring the safety of foods from NPVs. FDA states that these principles “are sufficiently flexible to accommodate foods from new plant varieties developed using a wide range of techniques.” The guidance explains that the principles outlined in the NPV policy apply to foods from genome-edited plant varieties and reminds developers of NPVs of their obligations under Section 403(w) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was enacted after FDA issued the NPV policy. FDA notes that the guidance describes two processes through which developers may voluntarily inform FDA of steps taken to ensure the safety of foods from their new genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. The voluntary process FDA recommends for a new food “is based on the objective characteristics of the new food, especially those related to food safety.”