/>i- On December 16, 2024, FDA released a new inventory of voluntary premarket meetings that the Agency has held with developers of foods from new genome-edited plant varieties. FDA holds voluntary premarket meetings to ensure the safety and lawfulness of foods from genome-edited plant varieties when a voluntary premarket consultation is not warranted based on the food’s risk-based characteristics.
- The inventory of premarket meetings will list all voluntary premarket meetings between FDA and genome-edited plant variety developers. FDA intends to add to the inventory on an ongoing basis as the agency holds more meetings.
- Voluntary premarket meetings are one process outlined in FDA’s Guidance for Industry on Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing, which we discussed previously on this blog. Voluntary premarket meetings are not intended to represent an FDA evaluation of a developer’s food safety assessment. Voluntary premarket consultations are advised for products that are more likely to raise safety questions. Foods from genome-edited plants must meet the same food safety requirements as other foods.
FDA Updates Guidance on Premarket Engagement for Genome-Edited Plant Varieties
Tuesday, December 17, 2024
Current Public Notices
Published: 17 December, 2024
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