In my opinion, the answer is clearly yes.
That's although 23andMe has, I think, not marketed its services in any unethical way. Their website and their most recent TV ad avoid raising fears. This is in welcome contrast to many adverts by established pharmaceutical companies I see in the United States.
My point is that 23andMe's test should not be treated any differently than other diagnostic tests.
But is 23andMe a diagnostic test? On its website, the company lists the traits and diseases it returns information on. Whilst some of them, like ancestry or odour sensitivity, are harmless, others are specifically designed to inform on the risk for diseases including Alzheimer's, breast cancer, Parkinson's, and many more.
To claim that all 23andMe does is return information about variant-gene associations is disingenuous. By extension, there shouldn't be regulation of any diagnostic test, because all they do is return information on some marker-disease association. This may be a valid point of view, and if you hold it, you need to argue for the deregulation of the diagnostics market as a whole, and not just against the regulation of 23andMe.
A few weeks ago, I bought a test from 23andMe myself, but I haven't received the results yet. Does this make me a hypocrite? I don't think so.
Firstly, I strongly advocate that people have free access to their genetic information, and to their medical data in general. That does not mean that the quality of disease-relevant genetic tests should not have to meet the same requirements than other diagnostic tests.
Secondly, I feel that because I am working in the field, I have a good grasp of how reliable genotyping data as that provided by 23andMe is and what it can tell me. If my test returned anything that was of serious concern to me, I wouldn't dream of taking drastic action without further testing to confirm the results. I believe that this distinguishes me from some other people, including the least educated and vulnerable ones.
Some people may feel that the FDA has an anti-genomics agenda. I don't know whether that's true, but I don't see the letter it sent to 23andMe as any evidence for it. If genetic testing that fulfils regulatory requirements for $99 is not possible, that's unfortunate, but why should an exception be made in this case?
The opinions I express on this blog are not necessarily those of my employers or my funding body.