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

plants

The U.S. Food and Drug Administration (FDA) released a new inventory of voluntary premarket meetings that have been held between the FDA and developers of foods from new genome-edited plant varieties. Voluntary premarket meetings are one of the processes the FDA outlined in its guidance for industry that describes how developers can voluntarily engage with the FDA 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 adding to the inventory on an ongoing basis as the agency holds more meetings. 

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