> Even the FDA isn't arguing that 23andMe should not offer it's service, just that it shouldn't market it.
They aren't even really arguing that either; they are more arguing that if they are going to market it, then they need to provide studies supporting the accuracy and take other steps to get it approved to be marketed for the particular uses it is being marketed.
They are saying in the Warning Letter that 23andMe must stop marketing the product because 23andMe has abandoned the approval process (and apparently was not preventing 23andMe from marketing the product as long as they were working through the approval process), not because the product is inherently unmarketable.
They aren't even really arguing that either; they are more arguing that if they are going to market it, then they need to provide studies supporting the accuracy and take other steps to get it approved to be marketed for the particular uses it is being marketed.
They are saying in the Warning Letter that 23andMe must stop marketing the product because 23andMe has abandoned the approval process (and apparently was not preventing 23andMe from marketing the product as long as they were working through the approval process), not because the product is inherently unmarketable.