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In 2017, the United States Food and Drug Administration proposed to regulate a specific subset of these variations as drugs: in particular, those introduced into animal genomes using modern molecular techniques like gene editing. A drug is “an article (other than food) intended to affect the structure or any function of the body of animals” according to the Federal Food, Drug, and Cosmetic Act, which was first signed into law by President Franklin D. Roosevelt in 1938.

I am a geneticist who specializes in how genetics can be used to improve the efficiency of livestock production. While I agree that DNA variation undoubtedly affects “the structure and function of the body of animals,” it is unclear to me why intentional DNA alterations introduced via gene editing in food animals should uniquely be considered a drug. This seems inconsistent given that the United States Department of Agriculture has no plans to treat such alterations in gene-edited plants as drugs because genetic variations are part of conventionally bred varieties. Ultimately this ruling may hinder the use of gene editing to introduce useful attributes – like disease resistance – into U.S. livestock populations.

…continue reading ‘Is a Gene-Edited Animal a Drug?’

Image via STAT –  Alison Van Eenennaam/ University of California, DavisCC BY-NC-SA

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