In late November 2013, FDA sent a warning letter to 23andMe, the company that has provided direct-to-consumer genetic test results with an interpretation of the results. FDA stated in its letter that the “Saliva Collection Kit and Personal Genome Service” was being marketed by the company without marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).
The company has stated that “we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.”
23andMe also states on its website, “We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.”
The FDA action and 23andMe response have stimulated much online discussion, with some criticizing the FDA action for the potential to deprive them of genetic information and others criticizing 23andMe for their product and for their response to FDA. Those in the latter group cite concerns about the reliability and utility of the information provided by 23andMe. The public debate about direct-to-consumer access to genetic information and FDA regulatory efforts will likely continue, both in connection with the 23andMe action and otherwise.