FDA’s New Guidance on Food from Gene-Edited Plants
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EmailThe FDA's new guidance provides a simplified process for products less likely to raise safety issues.
The Food and Drug Administration (FDA) released new guidance: Food Derived from Plants Produced Using Genome Editing, which provides a simplified process, a premarket meeting, for products less likely to raise safety issues.
The guidance emphasizes product assessment of the food’s characteristics and builds on the FDA’s 1992 Statement of Policy - Foods Derived from New Plant Varieties. This risk-based approach is flexible and accommodates food derived from new plant varieties using a wide range of techniques.
A voluntary premarket meeting is different from an FDA premarket consultation. A premarket meeting is appropriate for foods *without* any of the characteristics described in the guidance, such as a modification that creates significant homology to a known allergen, a modification that causes an increase in levels of potentially harmful components, including toxins, allergens, and anti-nutrients, or a non-negligible change in the nutritional value (level or bioavailability of a nutrient) of the food. When foods produced from new genome-edited varieties have characteristics that may raise food safety questions or regulatory considerations, such as those described above and in the FDA’s Genome Editing Guidance, an FDA premarket consultation is expected.
Mandatory FDA Review and Approval
Remember, when a food contains an unapproved food additive or color additive, developers must obtain premarket approval from the FDA (see sections 409 and 721 of the Food, Drug, and Cosmetic Act). Developers of biotechnology-derived new plant varieties voluntarily consult the FDA before marketing because this helps developers ensure that foods are safe and legal before marketing. A food with an unapproved food or color additive is deemed adulterated even if it is safe.
Learn more with MSU's online graduate courses, particularly:
- Food Laws and Regulations in the United States (fall and spring semesters)
MSU's Institute for Food Laws and Regulations offers online graduate courses to food industry professionals. Most IFLR students work full time for food companies or regulators, and take one online course at a time to further their professional development. Students may take as few or as many courses as they desire, and may earn a Certificate in International or United States food law after completing twelve qualifying credits (usually four courses).
