You think diagnostic services sold to doctors aren't a concern for the FDA? Virtually every medical product or service the FDA regulates is marketed primarily to doctors.

Anyways, my comment was a response to the commenter who claimed 23AM was marketed as "entertainment". Horseshit.

No, they need to prove to the FDA that their tests do each of those things. If they say the test lets you find out "if your children are at risk for inherited conditions", should the FDA just trust them about that? I mean, that's a pretty serious thing to be testing for.