Completely understandable and it's a fair point people might undergo unnecessary surgery as a result of a false positive (like having breast tissue removed preemptively after false positives for chances of contracting breast cancer). 23andMe is a nice idea, but you can't beat an old fashioned regular trip to the doctor and blood test to check for these things.
Think about the opposite, though -- most people don't get tested for anything, especially weird/uncommon conditions. Tests like 23andme aren't something your local doctor does every checkup.
For $100, people who otherwise would have been clueless know if there's something they should ask their doctor about. In this case, I think some false positives are better than ignorance.
Worst case, you think "oh no, I'm predisposed to ___!" for a few days until you make it to a doctor who can tell you for sure.
It's fair to say 23andme has saved far more lives than it's hurt.
We could write something untruthful or harmful in the newspaper (maybe about acai berry weight loss).
So why not let the government go through a process, investigate whether what we write is conducive to the public good, and once approved it can be safely published.
The idea that someone is going to get their breast tissue removed based on 23andMe alone strikes me as unbelievable. A doctor would be consulted, who would likely order more appropriate diagnostic tests first. I would imagine any doctor that jumped straight into surgery based off of a 23andMe print out would eventually be sued for negligence.
Just as there will be people who get surgery due to false positives (which happen with regulated testing too), there are lots of people who otherwise have no preferred means of testing if it's regulated away.
The FDA doesn't appear to be trying to shut down 23andMe, just trying to force them to file the appropriate documentation and follow the same rules as everyone else regarding how they advertise their services.
