23andMe and the FDA.

n engl j med 370;11 nejm.org march 13, 2014 985 of things about your health,” including that you “might have an increased risk of heart disease, arthritis, gallstones, [or] hemochromatosis” (www.ispot.tv/ad/7qoF/ 23-and-me). It was the centerpiece of the company’s campaign to sign up 1 million consumers. On November 22, the Food and Drug Administration (FDA) sent 23andMe a warning letter ordering it to “immediately discontinue marketing the PGS [Saliva Collection Kit and Personal Genome Service] until such time as it receives FDA marketing authorization for the device.” On December 5, the company announced that it was complying with the FDA’s demands and discontinued running the commercial, noting on its website, “At this time, we have suspended our health-related genetic tests to comply immediately with the [FDA] directive to discontinue new consumer access during our regulatory review process.” 23andMe’s services relied on single-nucleotide polymorphism (SNP) technology to identify genetic markers associated with 254 specific diseases and conditions (the list has grown over time), which, the company said, could inform people about their health and how to take steps to improve it. In the words of 23andMe’s TV commercial, “Change what you can, manage what you can’t.” In its warning letter, the FDA said it was concerned that 23andMe failed to supply any indication that it had “analytically or clinically validated the PGS for its intended uses.” The agency was also concerned about how consumers might use information concerning breast-cancer mutations and warfarin-related genotype results. The company and the FDA had been in continuous negotiations since July 2009, but in May 2013, the company stopped communicating with the agency. The company’s failure to attempt to resolve the issues identified by the FDA, while it continued marketing the product, led to the warning letter. The FDA has not yet developed specific rules for direct-to-consumer (DTC) genetic testing, and whether government regulation or private litigation will determine the future contours of DTC genomic sequencing will probably depend on the extent to which consumers and physicians support government regulation.1,2 23andMe had previously framed DTC genetic testing as consumer 23andMe and the FDA