(Image via Shutterstock)
(Image via Shutterstock)

Citing concerns “about the public health consequences of inaccurate results” from 23andMe’s Personal Genome Service, the FDA on Friday told CEO Anne Wojcicki in a stern warning letter that her company must “immediately discontinue marketing” the service “until such time as it receives FDA marketing authorization for the device.”
Alberto Gutierrez, a director in the FDA’s Center for Devices and Radiological Health, wrote that Wojcicki is “marketing the 23andMe Saliva Collection Kit and Personal Genome Service without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act” and that the uses for the kit, as advertised by 23andMe, “require premarket approval or de novo classification, as the FDA has explained to you on numerous occasions.”
Though consumers of 23andMe services do not use or interact directly with a diagnostic device—they merely spit in a tube and put it in the mail—the FDA has said the service “is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.”
Gutierrez called some of the intended uses of the kit, which has been available directly to consumers since November 2007, “particularly concerning.” For instance, he wrote that “serious concerns are raised if test results”—in particular tests of genetic risk for breast and ovarian cancer and drug responses—”are not adequately understood by patients or if incorrect test results are reported.”
23andMe responded this afternoon by posting a brief statement on its Facebook page:

“We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”


The FDA claimed that, despite “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications,” the agency still has no “assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions.”
The announcement was met mostly by outrage in the Twittersphere, and fanned the flames of an ongoing debate about consumers’ rights, access to information, and medical establishment paternalism. Among the ticked-off Tweets:

@betzsteve: Has the government just ruled that I don’t have a right to my own genetic information? #23andme

@health2.0seattle: FDA halts #23andMe from selling product because of what people might do with the results?

@rongalloway: The FDA has lost its mind. @23andMe kit predicted my glaucoma and potentially saved my eyesight. #23andme #insanebureaucrats

@alecmuffett: FDA decides that you’re not allowed to know your own genome without regulation, slaps down #23andme 

@wester: Big Medicine (Goliath) vs. Google-backed 23andMe (David) .. Fingers crossed for an upset… #23andme #FDA

@johnrobb: FDA moves to shut down #23andMe Looks like gov’t corruption via health industry. Wish opt out was an option. 

But a Scientific American blogger was among a few who argued that the FDA’s order was reasonable. Christine Gorman called “getting raw data about your genome worse than useless,” and wrote that:

“Cheap sequence data from 23andMe and other gene testing companies has much greater potential to harm without the proper interpretation of the results, which is still quite difficult and expensive in most cases.”


The FDA gave 23andMe 15 working days to notify the agency of specific actions taken to address all of the issues noted in the letter.
No news yet on what this means for consumers whose DNA is already in the 23andMe pipeline, or if kits purchased as 2013 holiday gifts will be refunded. But as of 4:30 pm Monday, 23andMe was still accepting online orders for its $99 spit kit.
See the FDA’s complete Warning Letter to Wojcicki.