In Oakland, The Odin company will happily sell any customer a surprisingly affordable DIY CRISPR kit. Their kits are designed to help a non-scientist use CRISPR to mutate bacteria. The Odin originally offered a similar kit to mutate human DNA, but that human kit is no longer available, thank goodness.

Think this is science fiction? It’s not. It’s non-fiction. Whether you like it or not, this brave new genome world is upon us.

DIY biology regulation?

The world of DIY gene editing has been, for the most part, an unregulated space. If you’re not running clinical trials and putting patient lives at risk – there is quite a bit of wiggle room with genome tinkering…

To that point, in 2017, the CEO of The Odin, a bio-hacker named Josiah Zayner, attempted to modify his own genome in front of a live audience. While drinking scotch, Josiah injected his muscle cells with a CRISPR plasmid that should mutate a gene called myostatin. In theory, this could increase the size of the affected muscle tissue. As far as I know, this public stunt did not succeed in boosting muscle mass.

It should also be noted that, in early 2018, Josiah publicly expressed regret over the stunt. He is now concerned his DIY CRISPR demonstration could lead to other folks hurting themselves while performing similar actions.

I’ll admit when I did it, it was very provocative. It was very, very, very provocative—kind of on purpose, kind of on accident. I wanted people to recognize what was [possible] with this technology. I wasn’t trying to give myself bigger muscles. I wasn’t trying necessarily to genetically modify myself…. There’s no doubt in my mind that somebody is going to end up hurt eventually.

This brings up an interesting regulatory question.

Is it legal to self-experiment on your own genome? It seems this is a bit of a grey area with federal regulators. Conducting clinical trials while seeking FDA approval of a new drug is both very expensive and very regulated. However, according to Brian Hanley, self-experimentation with gene therapy is legal. Brian Hanley is the founder of a small DIY company called Butterfly Sciences. Butterfly researches gene therapies for anti-aging and other pursuits.

Hanley says he did not secure the approval of the FDA before carrying out his experiment either. The agency requires companies to seek an authorization called an investigational new drug application, or IND, before administering any novel drug or gene therapy to people. “They said ‘You need an IND’ and I said, ‘No, I don’t,’” recalls Hanley, who traded e-mails with officials at the federal agency. Reference.

New developments regarding the legality of self experimentation

Nov. 2017: In response to a few widely publicized accounts of self experimentation, the FDA just issued a statement clarifying that it is not legal to sell gene editing kits to the public.

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 FDA also clarified that researching human therapies with CRISPR or other gene editing techniques is regulated by the FDA.

Gene therapy products are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). Clinical studies of gene therapy in humans require the submission of an investigational new drug application (IND) prior to their initiation in the United States, and marketing of a gene therapy product requires submission and approval of a biologics license application (BLA).

Clearly the FDA is well aware of the DIY biohacker world and is scrambling to catch up and regulate.

You can read more about this FDA statement here.

Ok, so the FDA does not approve, but what about laws? Are there any laws regulating DIY gene editing in humans? As of July 30, 2019 – the answer is YES, a state law.

2019 update: On July 30, 2019, the first American law was passed that regulates the use of CRISPR. Republican state senator, Ling Ling Chang, wrote this bill for California state law that prevents companies from selling CRISPR kits designed to modify human DNA. This bill was obviously written as a direct challenge to Josiah Zayner, the California operating The Odin. As mentioned above, Josiah’s company sells genetic-engineering supplies but he no longer sells the kits that modify human cells. Clearly, California meant this state law to serve as a warning shot to discourage anyone else from peddling human CRISPR kits.

What about modifying the DNA of animals, such as dogs or farm animals.

Is this legal? Well, it’s another grey area. The FDA is in the process of creating new regulations to address these pursuits. David Ishee, a dog breeder and biohacker from Mississippi, is on the forefront of this world. David is attempting to fix a genetic problem with pure bred Dalmations. In January of 2017, the FDA let David know they are not thrilled with his Dalmatian project. The FDA now regards gene therapy on a commercially sold animal to be a ‘veterinary drug’ and, therefore, subject to fees and regulations.

Related note on the FDA: The FDA is also in charge of regulating CBD, the non-psychoactive chemical from cannabis. Here is my recent article updating the public on the FDA regulatory landscape of CBD.