Premarket Meetings for Food from Genome-Edited Plants
The Inventory of Premarket Meetings for Food from Genome-Edited Plants includes voluntary premarket meetings that have been held between the FDA and developers of new genome-edited plant varieties that do not warrant a full premarket consultation based on the food safety characteristics described in the FDA’s Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing (Genome Editing Guidance). The purpose of these meetings is to enable developers to share with the FDA the steps they have taken before marketing to ensure the safety and lawfulness of foods from genome-edited plant varieties.
A voluntary premarket meeting is different from an FDA evaluation conducted as part of a voluntary premarket consultation. Also, a voluntary premarket meeting does not substitute for a voluntary premarket consultation when foods produced from new genome-edited varieties have characteristics that may raise food safety questions or regulatory considerations, such as those described in the FDA’s Genome Editing Guidance. If safety or regulatory questions arise based on information shared by the developer, the FDA will discuss those with the developer during the premarket meeting or through follow-up communications.
The Inventory of Premarket Meetings for Food from Genome-Edited Plants provides the following information:
- Number that the FDA has assigned to the voluntary premarket meeting
- Date of the meeting
- Name of the plant species
- Designation of the plant variety
- Trait(s) of the plant variety discussed at the meeting
- Name of the developer
- Intended use of the plant variety