i- On February 22, 2024, the U.S. Food and Drug Administration (FDA) issued a guidance for industry that addresses how firms should voluntarily engage with the Agency before marketing food produced from genome-edited plant varieties. The guidance reaffirms that the risk-based approach FDA has taken for foods derived from genetically engineered plans under the new plant variety policy also applies to the newer foods from genome-edited plants.
- FDA identifies and describes two processes by which firms may voluntarily inform FDA of steps they have taken to ensure food safety: (1) voluntary premarket consultations and (2) voluntary premarket meetings. The voluntary premarket meeting 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. Voluntary premarket consultations are advised for products that are more likely to raise safety questions.
- FDA’s Plant Biotechnology Consultation Program intends for developers to engage with the agency to determine 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.
- FDA is currently accepting public comments on the draft guidance.
FDA Issues Guidance on Voluntary Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing
Friday, February 23, 2024
