FDA Sends Warning Letter To 23andMe
FDA Sends Warning Letter To 23andMe: The Food and Drug Administration is ordering 23andMe to stop selling its saliva collection kits for its personal genome service.
23andMe is a health and ancestry DNA startup, founded by Anne Wojcicki in 2006. For $99, you receive a spit kit, provide 23andMe with a saliva sample, and send in your results.
Within a few weeks, you receive a bunch of information about what your DNA says about you.
But now the FDA is accusing 23andMe of violating the Federal Food, Drug, and Cosmetic Act, it recently stated in a warning letter addressed to 23andMe CEO Anne Wojcicki. In the letter, the FDA claims that 23andMe marketed its saliva collection kit and personal genome service without clearance or approval.