23andMe has not proved that the information it provides is sufficiently accurate. It makes claims about an individual's susceptibility to various diseases, and

23andMe has not proved that the information it provides is sufficiently accurate. It makes claims about an individual's susceptibility to various diseases, and furthermore it markets itself as a reliable source of information (which the FDA takes to mean, a tool for making decisions). The FDA's mandate is if someone makes that claim, consumers should be able to rely on it. That has not been satisfied.