Premarket Meetings Regarding Food from Genome Edited Plants

This page lists voluntary premarket meetings (VPM) between FDA and the developer of certain new genome edited plant varieties. The voluntary premarket meetings listed here are described in FDA’s Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry. The goal of the meetings is to enable developers to share with FDA prior to marketing the steps they have taken to ensure the safety and lawfulness of foods from certain genome edited plant varieties. A voluntary premarket meeting is not intended to represent an FDA evaluation of a developer’s food safety assessment similar to the evaluation we conduct as part of a completed voluntary premarket consultation. Likewise, voluntary premarket meetings are not intended to substitute for a voluntary premarket consultation when foods have characteristics, such as those described in FDA’s Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry, that may raise food safety questions and/or regulatory considerations not amenable to resolution during a simple meeting. If safety and/or regulatory questions arise based on information presented during the developer’s narrative, we will discuss those with the developer during the meeting or through follow-up communications.

Foods, including foods from certain genome edited plant varieties, that have been the subject of a voluntary premarket consultation with FDA are listed at: New Plant Variety Consultations.

We intend to update this inventory within approximately one month after a meeting.