FDA Issues Guidance on Foods Made from Genome-Edited Plants in Newest Update to Its ‘Plant-Based Cookbook’

Lexology July 31, 2024
Morgan, Lewis & Bockius LLP

The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for evaluating the safety of foods derived from genome-edited plant varieties. The Genome-Edited Plants Guidance also describes two voluntary processes for developers to inform and engage with FDA regarding the steps taken to ensure the safety of foods from their genome-edited plant varieties.

Then: FDA’s Historical Regulatory Approach to Foods from New Plant Varieties

In 1992, FDA published Statement of Policy: Foods Derived from New Plant Varieties (NPV Policy), which described risk-based principles for ensuring the safety of foods from new plant varieties under the Federal Food, Drug, and Cosmetic Act (FDCA). In the...

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