The problem is the literature around these genes and causality with certain diseases is murky. From reading geneticists comments elsewhere, it sounds like the best science today has a relatively incomplete picture on how all these genetics fit together with regards to the causation or predisposition of diseases. In otherwords, making the claim that such a gene predisposes you for some medical condition may be inaccurate or based on an evolving understanding that may or will change.

I believe we have a right to know our genetics. If 23andme were somehow giving me the raw data, or sticking with more understood interpretations (ie “you are of sub-Saharan African descent”), then I would disagree with the FDA. Because 23andme provides interpretation beyond what has medically been established, I agree with the FDA.

The FDA isn’t withholding from us the right to know ourselves. They withholding the right for 23andme to tell me what it means unless it can prove it knows what it means.

… but the FDA rightly draws lines preventing companies from claiming health benefits that aren’t really proven in the literature.

Telling a client “by my analysis you have a 5% lifetime probability of developing galloping halitosis” is not a “health benefit”. It is an opinion.

Anybody with a robe and a crystal ball can legally tell you his opinion about your life for a fee, without interference by the FDA. 23andMe is doing nothing more unlawful than that.

The FDA is trying its nanny best to expand its remit to regulate mere opinion. If they succeed here, where will they stop? Ban discussion of genes and health except by the properly licensed?

If we were talking about an acupuncture clinic claiming that it could determine a patient’s potential to develop 260 conditions ranging from preeclampsia to ADHD, lots of folks would be (rightly) going bananas. Yet, from the FDA’s perspective, the 23andMe and the hypothetical acupuncture clinic are the same, because, for the majority of those 260 conditions claimed by 23andMe, 23andMe does not have sufficient scientific evidence to satisfy FDA requirements applicable to drugs and medical devices.

Alex Tabarrok seems to have missed a crucial distinction: the FDA isn’t complaining about the service per se, they’re complaining about the wildly outsized marketing claims. Requiring clinical validity isn’t a “death-knell” for these services, it’s a death-knell for these services making unsupportable claims, as it should be. The service can operate, but it can’t make scientifically unsupportable claims about the results. Spend some time on their site, and try reading about it as someone with modest knowledge of genetics — do you get any sense of just how weak some of these claimed correlations are? Or does it look like 23andMe can identify the (non-existent) ADHD gene? If they spent a little more time being scientifically honest and a little less time marketing, they wouldn’t have a problem.

I’m a big fan of services like 23andMe, and I think consumers should have ample access to these types of services, but the FDA rightly draws lines preventing companies from claiming health benefits that aren’t really proven in the literature. Just because 23andMe does a lot of things right and because they have prominent backing doesn’t mean they’re exempt from those rules.

Ditto for paying for it wrapped up in/as something else; e.g.free DNA analysis with your magazine subscription, we email the results to you (Not valid for US residents, ha ha, there we said it, we’re covered.)