FDA to 23andMe: Stop Marketing Kits

The US Food and Drug Administration blocks the marketing of unapproved genetic tests.  

By | November 26, 2013

WIKIMEDIA, APERS0N23andMe, a California company at the forefront of personalized genetic testing and no stranger to controversy, is in hot water with the U.S. Food and Drug Administration (FDA). The agency put an end to the company’s marketing of its $99 Personal Genome Service (PGS) because the tests were not given regulatory clearance. “Hope you weren’t planning to give your relatives the gift of genetic insight through 23andMe this holiday season,” writes Kashmir Hill at Forbes.

The kits offer genetic information for consumers on 254 different diseases and conditions. In a warning letter to 23andMe CEO Anne Wojcicki, the FDA explains that the company submitted applications for some of these indications, but that “23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it.” The letter goes on to say that the agency has worked with the company since 2009 to help it comply with regulations, but “we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses.”

The company has had little by way of response, although the San Francisco Chronicle posted a tweet from 23andMe co-founder Linda Avey, who said: “So much for patient empowerment,” and linked to the FDA’s warning letter.

According to the New York Times, about a half million people have used the service to date. The FDA’s biggest concern is that consumers might use it to self-manage any health risks that come to light as a result of the testing, and that a poor understanding of the results or inaccurate testing could lead to people inappropriately taking drastic measures. Timothy Lee at the Washington Post disagrees with the move. “Patients have a right to make dumb decisions if they want to,” he writes. “We don’t ban patients from reading medical textbooks or WebMD, even though doing so undoubtedly leads to some harmful self-diagnoses.”

Christine Gorman at Scientific American’s Observations blog backs the FDA, however. “Cheap sequence data from 23andMe and other gene testing companies has much greater potential to harm without the proper interpretation of the results,” she writes, something that is “still quite difficult and expensive in most cases.”

The FDA gave 23andMe 15 days to respond with a description of how it’s addressing the agency’s concerns.

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Avatar of: blumberg


Posts: 32

November 27, 2013

Love it.  Conservatively, half the literature is not reproducible.  23andMe uses the literature to inform customers about their genetic predispositions.  Anything with legitimate validation likely already has an FDA/CLIA approved test.  Kudos to the FDA for stopping 23andMe from selling snake oil.

Avatar of: BW012375


Posts: 6

November 29, 2013

On the one hand, it's distressing that a company could get away with this for any amount of time. On the other, I'm glad to see the FDA actually being on top of it.

Avatar of: HChapman


Posts: 9

November 29, 2013

Unfortunately, there are more than a handful of misguided drugs out there that for one reason or another (likely industry corruption), are still on the market.

Seeing as this isn't even INGESTIBLE. I have to question the priorities here.

Avatar of: ProfessorK


Posts: 11

November 29, 2013

It's political. People who do the right thing in small instances just to show that we can do the right thing. And I'm positive that the FDA is really concerned about people self-managing health risks. That's what big pharma is for. And of course the FDA is for big pharma.

Avatar of: CBerrien


Posts: 8

November 29, 2013

Part of me doesn't believe we could do the right thing, even if it were directly in front of us. It's not so much related to the people doing these things, but in my belief is more institutional. I'd suggest simply looking at the way that journalists and scientists work together - which to my understanding is very poorly.

Regardless, it's a huge part of the reason for this disconnect between what we read and what's happening. A good read here regarding this:


Although, as one of my friends once put it, "If you are getting your science news from journalists, you are doing something wrong."

Avatar of: THenry02


Posts: 12

November 29, 2013

I wish the FDA would stop a lot of other people from smelling snake oil. This type of thing should be the least of our worries when unforeseen side effects are taking the lives of our fellow citizens.

Avatar of: JenniferHill02


Posts: 7

November 30, 2013

I think this has blown up so unnecessarily...partially on the part of 23&me turning this into a media/political stunt to boost their media showing. The FDA's agenda is more likely to be about an unregulated, unverified, genetic test that would potentially make the majority of the population who is under-educated about its real limitiations jump into hysteria when some fo their tests all of a sudden come back positive for something...

Avatar of: BW012375


Posts: 6

Replied to a comment from JenniferHill02 made on November 30, 2013

November 30, 2013

I agree. Turned a straighforward thing that couldve been resolved with simple compliancy and turned it into a media stunt. You'd think that people would recognize this or that even 23&me would see this as not really validating their medical science standpoint's status.

Avatar of: HChapman


Posts: 9

Replied to a comment from ProfessorK made on November 29, 2013

November 30, 2013

I agree. If this was a matter of simply being 'unregulated', I'm sure the FDA wouldve chimed in much earlier with less opposition to the product itself to ensure the product was simply complient as opposed to being 'off the market'.

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