Why Basement Biohackers Might Need to Start Fearing the FDA
December 4, 2017
(Gizmodo) – After the initial warning, Gizmodo reached out to the FDA for clarity on how it might affect the biohacking community. For one, the agency, made clear, it’s not just CRISPR: “Gene editing in humans by any method would be considered gene therapy regulated by FDA,” a spokesperson said, noting that it only mentioned CRISPR because it’s such a buzzy word. And the selling of kits, it seems, would be considered illegal because, in broad terms, the agency would consider it the sale of any unapproved “gene therapy product” akin to the sale of an unapproved drug. If someone wants to test an unapproved drug in humans, they must first clear a clinical investigation with the FDA.