Today, the Food and Drug Administration published a letter giving the company two weeks to discontinue marketing the kit, which the agency classifies as a medical diagnostic device in need of approval.Welcome to today's hyper-regulatory environment. How does this product relate to either food or drugs? They are simply providing a service by educating people with genetic information about themselves. Why would that need to be approved? 23andMe has not yet responded.This is yet another example of government overreaching because it can.
According to the letter, the FDA has been seeking information needed to approve the test for a while, "including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications"
Monday, November 25, 2013
More Government Overreach: 23andMe Ordered To Cease and Desist
The FDA has ordered the company 23andMe to stop providing its genetic overview and genealogy results package, which the agency describes as a "medical diagnostic device in need of approval." From the story in Popular Science: