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The FDA Is Not Cool With Selling DIY Gene Therapies

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The Food and Drug Agency has issued a stern warning to anyone who might be crazy enough to undertake gene therapy in the do-it-yourself fashion. Definitely don’t do this at home, a statement released on Tuesday implies. And if you do, we’ll throw every law we can at you.

The FDA’s deterrent comes on the heels of a brazen DIY gene therapy experiment, in which a 27-year-old software engineer injected himself with an unproven gene therapy for HIV designed by three biohacker friends. The first injection was streamed live on Facebook in October, and went viral after it was covered by Gizmodo. 


“You can’t stop it, you can’t regulate these things,” patient zero, Tristan Roberts, told Gizmodo at the time.

Apparently the FDA begs to differ.

“FDA is aware that gene therapy products intended for self-administration and ‘do it yourself’ kits to produce gene therapies for self-administration are being made available to the public. The sale of these products is against the law. FDA is concerned about the safety risks involved,” the agency said in its brief statement.


“Consumers are cautioned to make sure that any gene therapy they are considering has either been approved by FDA or is being studied under appropriate regulatory oversight,” it concluded.

It was not the first time a hacker type has injected themselves with something designed to alter their body genetically. Over the past few years, the advent of simpler genetic engineer technologies and services that allow you to design and order DNA on the internet has spurred a burgeoning movement of biohackers that aim to edit the genes of bacteria, plants, animals and even people outside of fancy labs and without the prerequisite degrees.


On a few occasions, the FDA has intervened, such as when the agency questioned whether a green fluorescent jellyfish protein being sold to make glowing beer might be classified as a color additive for food that hasn’t yet been FDA approved. Typically, though, the Food and Drug Administration does not choose to intervene when individuals carry out experiments on themselves, though it does typically strongly discourage such self-experimentation.

The October experiment, though, may have moved the agency to make a statement for a few reasons. While Roberts actually injected the vaccine himself, its development was paid for by a company, Ascendence Biomedical, a mysterious biotech firm with transhumanist leanings. The company plans to sell the “research compounds” used to make the vaccine online and to fund “transparent” clinical trials, beginning next year in places like South Africa, that would skirt typical regulatory oversight by having people like Roberts deliver their own treatment. Self-experimentation is not against the law. So the FDA is instead cracking down on the selling of the supplies that could enable it.


The experiment also raised concerns because, while it involved a gene that research has suggested may one day lead to a highly effective HIV vaccine, there has been no human clinical trials of such a vaccine to date.

It’s unclear from the FDA’s statement exactly which laws the selling of DIY gene therapy supplies may be violating, or how the agency will enforce those laws. Gizmodo reached out to the FDA for comment, but did not receive a response before publication.


The agency singles out CRISPR in particular as a subject of concern, noting that it “considers any use of CRISPR/Cas9 gene editing in humans to be gene therapy.” It does not, however, mention other gene editing systems, though the October experiment relied on a different method. Clinical trials or sale of any gene therapy product already requires approval by the FDA. The clarification here seems to be that the FDA considers any human CRISPR application to be gene therapy.

It’s also uncertain how this could impact businesses like the aforementioned glowing-beer-kit company, The Odin, which sells biohacking supplies including those to modify genes. What does seem certain is that the FDA is drawing a battle line—and signaling to biohackers, beware.


Update 5:40pm ET: The headline of this article has been updated.