Calif.-Based 23andMe Temporarily Halts Health-Related Genetic Reports During FDA Review
On Thursday, California-based 23andMe announced that it has stopped providing consumers with personalized health analyses during a federal regulatory review process of the company's personalized DNA kits. The action comes after FDA sent 23andMe a warning on Nov. 22 saying that the company was advertising the kits "without market clearance or approval in violation of the Federal Food, Drug and Cosmetic Act."
- "Bowing Again to the FDA, 23andMe Stops Issuing Health-Related Genetic Reports" (Fung, "The Switch," Washington Post, 12/6).