This Forbes article is worth reading...
23andStupid: Is 23andMe Self-Destructing? - Forbes
for starters... the rest of the article gives details...
23andStupid: Is 23andMe Self-Destructing? - Forbes
Really? In six months, a company choosing to work in a business in which it knows the FDA believes it has jurisdiction decided not to respond to the agency for six months? At a time when 23andMe was going to be launching an advertising campaign to try to sign up a million people to its service? At a moment when Anne Wojcicki, the company’s chief executive, was going to be on the cover of FastCompany talking how 23andMe is revolutionizing health care? And 23andMe thought the FDA was just going to, I don’t know, not notice?
Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration.
for starters... the rest of the article gives details...