FDA orders 23andMe to stop selling DNA tests

23andMe in violation of federal regulations with its genetic testing service

The Food and Drug Administration has ordered Mountain View-based 23andMe to immediately stop marketing its DNA sequencing kits directly to consumers.

The FDA warned 23andMe CEO Ann Wojcicki that the company is marketing its "Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act," it stated in a letter dated Nov. 22.

The letter was signed by Alberto Gutierrez, director of the Office of Invitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health. Elaborating on his concerns, Gutierrez explained that he remained skeptical of the company's service.

While the Personal Genome Service is marketed as a tool to empower consumers -- by informing them of certain genetic risks and providing them with knowledge that would help them make better treatment choices -- Gutierrez wrote, "We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses. ... Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."

In a brief response to the FDA's letter, posted on 23andMe's website, the company wrote, "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."


Like this comment
Posted by anne
a resident of Green Acres
on Nov 26, 2013 at 4:44 pm

The program on Forum this morning dealt with this topic. Having used the service, I'm guessing there's an insurer or competitor behind what happened. Since they are not a lab, and the accuracy of the work seems not in dispute, the problem seems to be allowing patients access to their own information. I think it's the height of ridiculousness that we are not able to have the information about our own genes, especially given how carefully 23 and me gives out the information. They indicate not only risk, but relative confidence in how well that risk is known based on the genetic information. They also put up barriers and caveats before people are allowed to get results for tests with serious implications, you can't accidentally stumble on results you don't want to see.

I think the insurance industry sees it as nonessential and is worried about being hit with the expense of paying for genetic testing.

I have been really happy to have the information they provide and believe they present it in such a responsible way, I feel this ruling is like outlawing ladders because no matter what you do, there are boneheaded people who will use ladders unsafely. It's not even a great analogy, because these tests are nowhere near as dangerous as a ladder. And actually, 23andme doesn't even make it that easy for people to get their actual genome information (the only thing I am personally unhappy about, I'd like it to be easier to just download the genetic code).

Like this comment
Posted by Interested reader
a resident of Duveneck/St. Francis
on Nov 27, 2013 at 10:28 am

I think the headline is in error -- I believe 23andme can still SELL the kits, just can't MARKET them… there's a difference.

Like this comment
Posted by musical
a resident of Palo Verde
on Nov 27, 2013 at 11:29 am

Selling vs Marketing -- sounds like the rules for cigarettes.

Like this comment
Posted by Rich W.
a resident of Another Palo Alto neighborhood
on Nov 27, 2013 at 11:39 am

Rich W. is a registered user.

I went to the 23andMe web site just now, and it still appears to be possible to buy a testing kit -- I didn't see any "temporarily unavailable" notices anywhere.

Like this comment
Posted by bick
a resident of University South
on Nov 27, 2013 at 5:43 pm

On the bright side, I think this action by the FDA is the best advertising 23andMe could have hoped for. Now word of their service is really in the public domain. Can't buy this kind of advertising.

Shame on you Alberto Gutierrez. Government out of control.

Like this comment
Posted by maguro_01
a resident of Mountain View
on Nov 27, 2013 at 5:45 pm

Of course 23andMe will have to conform to medical device or other requirements. But the disturbing thing about the published FDA letter was its view that consumers should not have access to their genetic information. That is reminiscent of the practice that real psychiatric patients cannot access their own records. Medicine is evidently headed to more individualized treatment based on individual genetics so Web searches will not be as useful for us then as now. The FDA's position seems to be that the less consumers know, the better.

We know that insurance companies have the view that if we have such access and they don't, it might someday break their business model. But ACA makes the pools bigger and would prevent them anyway from trying to cherry pick buyers based on their genomes. There is a good chance that the FDA's desire to cut off consumers is a result of industry lobbying. In the coming years ignorance is unlikely to be bliss for us but is bound to make a lot of money for the industry.

We will get to see who our representatives work for.......

Like this comment
Posted by jared harwell
a resident of Community Center
on Nov 29, 2013 at 3:56 pm

personalized genomics are way to primitive to be used clinically like this. The FDA did this because it's unfair to claim an medical validity when to contribution of these certain genes that are being sequenced could still be minuscule. Personalized genomics is not ready for things like this other than as a novelty

Like this comment
Posted by wondering
a resident of Palo Alto High School
on Nov 29, 2013 at 6:41 pm

Anyone with an M.D. degree at this company, or was it a hobby for someone's wife?

Like this comment
Posted by Alan
a resident of Charleston Meadows
on Dec 2, 2013 at 11:04 pm

I got tested with 23andme about 2 years ago and just love their product. It confirmed some things that I already knew, -mother is genetically predisposed for rheumatoid arthritis, and learned some things that I would not have known without this test.

The most interesting part about it is the ancestry knowledge you learn. My grandfather's parents disappeared when he was 16 years old (during the great depression) and all that remained of his family was a picture of his dad and his memories of the family. I'm trying now with the help of 23andme to reconstruct his family history by finding distant relatives from his side of the family.

Since then I've convinced my mom to take the test and have several cousins that took it on their own. My grandmother is old and might take the test if I give it as a gift at Christmas.

I really do think some competitor that feels threatened by people having this knowledge is behind this. 23andme's tests seem accurate as far as I can tell, and how people use knowledge about themselves should be the business of the government.

Like this comment
Posted by Alan
a resident of Charleston Meadows
on Dec 2, 2013 at 11:06 pm

Well I need to correct the last sentence of my previous post. It should read.

...and how people use knowledge about themselves should NOT be the business of the government.

Sorry, but further commenting on this topic has been closed.

Burger chain Shake Shack to open in Palo Alto
By Elena Kadvany | 15 comments | 4,112 views

The Cost of Service
By Aldis Petriceks | 1 comment | 942 views

One-on-one time
By Cheryl Bac | 0 comments | 363 views

Couples: When Wrong Admit It; When Right; Shut Up
By Chandrama Anderson | 0 comments | 347 views

This time we're not lying. HONEST! No, really!
By Douglas Moran | 1 comment | 261 views