I think that this is actually a very complex issue, and the part that more informed people are finding problematic isn't that people are regulating 23andme at all. There are lots of genetic laboratories in the US where you can send in a sample of DNA and they'll tell you things like that you've got the G:A or A:A variant of Rs601338. A laboratory that does stuff like that is covered under CLIA[1], administered by CLS which like the FDA is part of the DHHS.

The FDA's theory here, though, is that since 23andme goes beyond just saying "You have the G:A variant of Rs601338" to "You are probably as susceptible to norovirus infection as a typical person" they're not just a medical laboratory but also a medical device manufacturer, and therefore come under the FDA's purview with much stricter tests for what they can market and what sort of tests their product undergoes.

To me, that sounds pretty ridiculous since you can easily just go on SNPedia to look up the associated information yourself[2].

[1]http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA... [2]http://snpedia.com/index.php/Rs601338