New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

New Plants, Old Frameworks: Fda’s 1992 Policy Applies To Foods Derived From Genome Edited Plants

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

On February 22, 2024, FDA released a final guidance[1] detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers.

The new guidance applies FDA’s 1992 policy regarding Foods Derived from New Plant Varieties (“NPV policy”) to foods derived from GE plants, consistent with the approach taken in FDA’s 1997 guidance describing the NPV policy’s associated consultation procedures. Overall, FDA concluded that “the risk-based principles laid out in the NPV policy” are sufficiently flexible to accommodate foods derived from modern genome-edited plants.

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Stacy Cline Amin
Partner

Stacy Cline Amin leads the FDA + Healthcare Regulatory and Compliance practice within the firm’s Global Life Sciences + Healthcare Group and provides strategic regulatory and business advice to companies in the life sciences, healthcare, and technology industries. Stacy previously served as Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), and

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Brigid DeCoursey Bondoc
Partner

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

As a member of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics,

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Liz Freeman Rosenzweig Ph.D.
Associate

Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech; algae; environmental incentives such as carbon credits; crop science; gene editing; genetics; GM/GE plants; molecular biology; plant breeders’ rights/plant variety protection; plant breeding; plant IP; and soil technologies.

Prior to joining the firm as an associate, Dr. Freeman Rosenzweig

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Owen Grayson Hosseinzadeh
Associate

Owen focuses his practice on intellectual property litigation and regulatory counseling for clients in the agriculture, food, life sciences, and healthcare industries. He is a frequent contributor to the MoFo LifeSciences blog, where he writes about intellectual property strategy, biotechnology regulations, and novel foods.

Owen earned his J.D. from Harvard Law School, where he edited the Harvard Journal of Law & Public Policy, served as a research assistant to Professor Molly

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