WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) issued a guidance for industry that describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants.
The guidance reaffirms that the risk-based approach the FDA has taken for foods derived from new plant varieties also applies to foods from genome-edited plants. In addition, it describes two processes through which developers may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. These processes can help ease the pathway to market for foods from genome-edited plants while keeping FDA safeguards in place, said FDA.
Read the full guidance here.
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