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:

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.

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"

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. 

23 And Me

For her birthday, the husband of one of my friends here at the library gave her a complete genetic profile from the company 23 And Me. Among the findings: she is 2.7 % Neandertal.  There's nothing like being able to trace your ancestry back 70 to 80 thousand years. 

She is going to check to see if there are any genes linking her to the Denisovan group.  They may or may not have included that information.