Biotech Updates

FDA Releases Guidance on Voluntary Premarket Engagement for Foods from Plants Produced Using Genome Editing

February 5, 2025

The U.S. Food and Drug Administration (FDA) released a new inventory of voluntary premarket meetings held between the FDA and developers of foods from new genome-edited plant varieties.

Voluntary premarket meetings are one of the processes that the FDA outlined in its guidance for industry describing how developers can voluntarily engage with the agency before marketing food from genome-edited plants depending on the food's risk-based characteristics.

Voluntary premarket meetings are different from voluntary premarket consultations, and the agency continues to encourage consultations for foods that may be more likely to raise safety or regulatory considerations because they have one or more of the characteristics described in the guidance. Foods from genome-edited plants must meet the same food safety requirements as other foods. The FDA anticipates that the inventory is on an ongoing basis as the agency holds more meetings.

For more details, read the news release from the FDA.


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