Free Enterprise - The FindLaw Small Business Law Blog

Is It Legal to Sell Biohacking Tech or DIY Gene Therapies?

You've probably heard of a wide variety of DIY projects before -- home renovations, car mechanics, furniture builds, and the like. But what about more scientific DIY projects? Can you experiment with DNA and DIY gene therapies? Is it legal to sell these and other biohacking tech? With biohacking gaining popularity, the FDA is attempting to crackdown on the sale of these products, but many enthusiasts argue there is no law against what they're doing.

Biohacking and Gene Therapies Gain Notoriety

Biohacking has been around for a few years, but it's recently gained more fame with certain experiments that went viral. Where normal scientific experiments take place at a university or a traditional laboratory, biohacking occurs mostly in smaller community labs by people without as many degrees. Some even conduct experiments on themselves, injecting gene therapies or playing around with DNA.

Late last year, biohacker Josiah Zaynor, a biotech CEO, injected himself with the gene-editing tool CRISPR on video during a biohacker conference in California. Another man injected himself with an untested HIV treatment on Facebook Live. And these are just two videos that went viral. Imagine all of the experiments taking place that aren't recorded.

FDA Says Sale of Biohacking Tech and DIY Gene Therapies Illegal

The Food and Drug Administration (FDA) is not OK with certain aspects of the amateur biology movement. Almost immediately after these biohacking experiments went viral, the FDA issued a warning against DIY gene therapy and the like saying, "The sale of [gene therapy products intended for self-administration and 'do it yourself' kits to produce gene therapies for self-administration] is against the law. FDA is concerned about the safety risks involved."

While the FDA can't really stop people from experimenting on themselves, they can require approval for the sale of food and drugs, including genetically modified ones. So, if an amateur scientist tries to sell products created with genetic engineering, the FDA might have something to say about it.

Biohackers Not Deterred by FDA Warning

Two biohacking companies, The Odin and Ascendance Biomedical, say that despite the FDA warnings, they plan to continue selling their biohacking tech and gene therapies to whoever wants to buy them. Zaynor, the biohacker who injected himself, is also the CEO of The Odin. He argues that selling biohacking tech (such as CRISPR) is legal, and that they warn people against direct use on humans. He also adds that it's not up to him how people use the supplies.

Aaron Traywick, the CEO of Ascendance Biomedical, argues that what they're doing is also legal. He argues that while the FDA thinks his company is "providing a compound and marketing a compound for a specific health purpose and providing it for sale," they really just sell the therapy for research purposes only.

Many biohackers simply want to learn more about how DNA works, while others want to push the envelope on experimentation and the sale of biohacking tech and gene therapies. If you're unsure about the legality of your activities, speak with an experienced attorney who can advise you going forward.

Related Resources: