23andMe and the FDA

In August 2013, the genetic-testing company 23andMe began running a compelling national television commercial, in which attractive young people said that for $99 you could learn “hundreds 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)...