• 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  • FDA is currently accepting public comments on the draft guidance.  Keller and Heckman will continue to monitor and relay any developments in this area and can assist with any comment submissions.