> I wonder if there was a bit of 'tech' clash with old school 'medicine' clash. Basically tech folks take the position of move forward and fix things that break

> I wonder if there was a bit of 'tech' clash with old school 'medicine' clash. Basically tech folks take the position of move forward and fix things that break, rather than wait until you are 99.999% nothing will break and then move forward. If that were the case, I could imagine a product manager getting incentivised to get the kits out the door and testing ramped up in spite of FDA reservations because 'hey it isn't like its something people take or anything.' Replace "product manager" with "marketing exec", and I think you have it right here. The FDA's problem with 23AndMe isn't with the tech, it's with the marketing. The FDA has asked for studies proving that 23AndMe's marketing is correct, and so far, 23AndMe has not produced the results of the studies. This isn't anything new, too. Here's what the FDA said to General Mills about their Cherrios advertising in 2009: http://en.wikipedia.org/wiki/Cheerios#2009_Drug_Claim http://en.wikipedia.org/wiki/Cheerios#2009_Drug_Claim