FDA Orders 23andMe to Discontinue Testing

23andme logo

Never, ever, mess with the big guns.

The FDA has issued a cease and desist letter to 23andMe and ordered the firm to stop selling their DNA tests based on concerns of accuracy, failure to comply with FDA requirements and the fact that they are providing “specific health recommendations” to their clients.

Here is the actual letter.

“The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act.

Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”

Normally, the DTC (direct to consumer) test concerns voiced are about people misinterpreting their results, or being frightened by them, without the involvement of a physician.  In other words, the move until now has been to force you to visit a doctor to obtain a prescription for this type of test.  Of course, the underlying assumption is that the physician will then be available and have expertise in all of the areas that the test covers.  That, of course, would mean another follow-up visit, and if all you really wanted was the genealogically relevant results, this would in effect kill that part of their business.  In fact, it would probably kill the business entirely, at least under the current marketing model.

The FDA says that the product that 23andMe sells is a medical device, especially since it involves important medical information such as the detection of the BRCA-related breast cancer gene and sensitivity to the blood-thinner, warfarin.

Again from the FDA to 23andMe letter:

“Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these.”

The FDA wants 23andMe to show that these tests are accurate.  They are concerned, for example, that the BRCA test provided by 23andMe might provide either a false positive or, even worse, a false negative.  A false positive would, of course, provide an individual with a great deal of angst, but they would certainly immediately visit a physician who would prescribe industry-standard follow-up testing where the “false positive” would be caught.  A false negative, on the other hand, might mask a deadly situation, delaying detection until too late.

The FDA states that they have been working with 23and Me who has failed to provide the necessary proof.  From the looks of this letter, and understanding there are two sides to every story, it looks like 23and Me has not taken the FDA seriously.

“As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.

However, even after these many interactions with 23andMe, we still do not have any 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. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests.  You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.”

I do believe the FDA has their undivided attention now.

“Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”

23andMe has 15 days to reply and if they don’t, it could get even uglier.

“Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific actions you have taken to address all issues noted above. Include documentation of the corrective actions you have taken. If your actions will occur over time, please include a timetable for implementation of those actions. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the actions will be completed. Failure to take adequate corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”

Yep, never mess with the big guns.

In 2010, five different companies, including 23andMe, were served with warning letters when Pathway Genomics announced it would sell its DNA testing product at Walgreen, a plan that never came to fruition after the warning letter.  However, this is the first letter of this type to be served on a genomics testing company.

What’s next?  We just don’t know.  23andMe has yet to comment, but it looks from this letter like they have limited choices at the moment.

Stay tuned for the next episode of the Wild West in DTC Testing.



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52 thoughts on “FDA Orders 23andMe to Discontinue Testing

  1. This is amazing although not shocking. If 23andMe are providing accurate results, they could put the medal field in danger. I’m suspicious of the medical field anyway- not every doctor is a healer. By letting people take control of their own health, it gives them a lot of power.

    On the other hand, the tests can seem alarmist and can cause panic. They shouldn’t be used without a professional. Either way, thanks for sharing this letter!

    • The way the government is acting in this and other regards, we SHOULD be alarmed, not at the test results, but at the thought of the feds gaining intimate access to our personal DNA data.

    • I have only hemochromatosis to think about and I just mainly wanted to be tested to see if anyone is related to my family. I swear, I just feel like not giving out anymore information to anybody. The Goobermint is in everything.

  2. “A false negative, on the other hand, might mask a deadly situation, delaying detection until too late.”

    Which means what? That we might have done a “real” DNA test?

    Well, in order to do an approved DNA test, your doctor would need to order it and you would need to pay for it and it would only cover one disease/condition.

    • One thing that I find confusing about this is the FDA commentary about accuracy. Are these not the same tests and protocols that the “one off” tests are utilizing, or are these somehow different? Is it the underlying technology they need to “prove” is equivalent to the standard medical “one by one” DNA tests? And why has 23andMe not been able to do this?

  3. Too bad that the medi ak community doesn’t have tests for alnost all of the test that 23andme privides. People should be gouged by the medical testing community and be milked dry by them instead.

  4. It’s infuriating to think that the FDA should believe (or pretend to believe) that other testing labs are better than 23andme. This is all about power and control, and that’s so transparent. Maybe 23andme should operate from another country.

  5. Thank you for this update. I wonder what this means for people like myself whose kits are currently being tested. My results are scheduled to appear anytime between now and two weeks. I’ll let you know when (if?) I receive my test results.

    • As Tim Janzen pointed out on another list, the actual letter says they have to stop marketing the tests, which of course means they won’t have any to test in the future…so in essence it stops testing as well. But having said that, it would appear that they can continue to process anything still in the pipeline. Plus, they have 15 days to do something about this, and I’m betting they are very busy right now trying to resolve this situation.

      • They ignored FDA since 2010.

        23andme is at fault. They oversell the results in ways they need to be addressed.

  6. I just bought two kits a couple weeks ago. My husband’s was just received by the lab last week and I have yet to use the second kit. It is a little frustrating to think that I just spent money for kits that might not be possessed. I am definitely staying tuned.

  7. 23andMe, on their Facebook page posted this about half an hour ago.

    Hi everyone, Many of you have seen and been asking about this morning’s news.

    Here’s the statement we’ve issued to the media: “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.”

    We’ll continue to keep you updated here as we know more. Thanks for all the messages of support!


  8. As an Investor in Bio-Research, i have gotten to know the FDA extremely well, they are very careful about what is sent into the public domain, frustrating as they may be, there is a very long list of drugs and medical devices that may have been foisted onto the general public that may well have created more harm than good had the companies involved been able to by-pass the FDA.
    Imagine if you will a company that has invested up to $500,000,000 in their research over as many as 10 years learning that their drug or device was useless or even dangerous, would you trust them to shelve that product if they never had to go through the processes of the FDA, or do you think they would be more interested in selling that dangerous product to recover their investment, i think i know the answer to that !
    I will put my trust in the FDA every single time.

    • I couldn’t agree with you more Leigh. The letter to 23andMe only hints at the issues, I can assure you. I understand there are a lot of tea-party-types writing today on this, and I suspect some of them either wouldn’t be around or have as many cousins to track down were it not for the FDA. Frankly, I wish the FDA would extend their review to supplements as studies show many are fraudulent, made with unlabeled ingredients. But I guess some people will nevertheless maintain that they have the right to poison themselves or buy phony drugs.

      • Mark, your comment is way out of line. Your definition of “tea party” is straight out left field, if you know what I mean. Tea Party is not a party, but a movement similar to the one that put Ronald Reagan into the White House. Grassroots in origin and nature, people in the libertarian-conservative movement have run out of patience with the federal government (and some states, too) meddling in our private affairs. The FDA is doing that in this case. The reason you read so many comments from libertarian-conservatives is, we are not going to go down again, I promise you! We will definitely Remember in November!!

  9. I am very upset that the FDA may be interfering with what I perceive as my right to get DNA testing from any company I want. If I want to get further information from my doctors about any test results that I receive, I am certainly free to do so and I have done so. If I worry about any false positives or false negatives that I may potentially receive from any DNA testing company, that is my problem, not the FDA’s. I am responsible for my life and I think that the 23 and Me testing provides me with useful information in deciding what alternatives are best for me. If I choose to base a decision about what medications may or may not be suitable for me in my life situation on what DNA results show my potential reaction to various medications may be, I should have the right to get that information. The 23 and Me tests provide me with valuable potentially life saving or at least life enhancing information to help me make the best decision on medications that I can. 23 and Me testing may or may not be perfectly accurate. I have to evaluate my DNA testing results in contest with other factors. The FDA has certainly approved a lot of medicines which have caused great harm to many people. Vioxx and Trasylol come to mind but there are many others. Since I fear that the FDA is more concerned with the financial welfare of big pharmaceutical companies than with the health and well being of consumers/patients, I do not have any confidence in what they may be doing to regulate DNA testing companies. I would certainly like to make sure that 23 and Me test results are always complete and accurate, but in life we can’t get guarantees that anything is always complete and accurate. If 23 and Me can and will prove the validity of their test results in response to the FDA letter, good. If not, I still want to be able to order test kits and get the results because I have a lot more faith in 23 and Me than I do in the FDA. I am willing to pay my money for the tests and take my chances as to their accuracy or to my ability to check other factors out and determine whether the 23 and Me results are helpful to me.

    • I agree totally with Aleda. Well said! I find the issue hypocritical as well. Since when does the medical profession not make errors! I have gotten more false positives with xrays, mammograms, sonagrams, and blood tests than I’ve ever gotten valid information!! I’ve had friends die from medical errors. And the FDA is fussing about our being alerted that we might have a bad reaction to a drug or that we might be at higher than average risk for heart disease. We need to take responsibility for ourselves and stop blindly trusting “the doctor.”

  10. There will be some in the medical community who would prefer people to have to no say in their own health, out of fear for their own career future. If they are successful in shutting 23andme down, you would have to imagine the next thing which would be taken away would be the right to download and analyse your own DNA. Health outcomes can be inferred from the raw DNA plus for those who have been fearful of ‘designer babies’, people could try to ‘design’ a child. The sad part about the debate around designer children is genetic counselors, who advise on the probabilities of genetic risk, advise purely around ‘probabilities’. There are very few health outcomes, or traits such as IQ, and even eye color which are single genes and therefore easy to assess/’design’. 23andme didn’t appear, nor seemed to have the intention, from an outside perspective of allowing you to bring two sets of genetic results together for comparison to assess the probabilities of genetic risk for the next generation. For those of us who have benefited from DNA testing, and enjoy being able to assess individual SNPs for ancestry and health purposes, we should all be very worried about the outcome from the FDA.

  11. Very concerned with this over-reaching from the FDA. It is a ‘service, not a ‘device’, for one thing. Then again, I’m confused about anyone ordering their tests for Ethnicity with the medical information, and them ‘expecting’ 23andMe to ‘advise’ or ‘instruct’, them or… So, apparently, the FDA wants that portion to be ordered only by a physician and to be ‘on record’, i.e., your medical file.

    This now removes you, the requestor, from having the info for your own confidential information. And like all the comments posted, I don’t trust doctors and outside pathology labs with testing like I have trusted the process of the DNA testing and results. So why isn’t this from the AMA instead of the FDA, if it is ‘medical’. Staying tuned!

  12. It is likely to be about the usual and customary….MONEY! Under ACA, medical devices will be taxed at the first of the year. .. I.e. power and control……

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  14. Most likely, FDA will lose this battle. For every test that 23andMe provide ‘result’ for is backed by a peer reviewed published article. If FDA has to say that 23andMe is selling stuff that is not true or ‘intended as diagnosis test’ then I think they are twisting words to interpret way more than 23andMe wants them (or users) to interpret.

    From the letter, I am still not very clear what is the problem that FDA has. I feel, there is a lot of stuff between the lines and the problem is not what is stated in the letter.

  15. People might be surprised that that tongue depressors and bed pans are considered “medical devices” by the FDA and subject to regulatory oversight. Then it isn’t much of a stretch to think that saliva kits and personal genome services might also come under their oversight. As a country, we have long recognized the need to protect our citizens from unsafe or dangerous foods and drugs. The FDA was signed into law by Theodore Roosevelt in 1906. Its predecessor, the Division of Chemistry was established in 1862. I’m sure the smart people at 23andMe will figure out how to comply with the FDA’s requests in the next 15 days. It does make you wonder what business strategy they are following, though.

  16. I’ve ordered a kit myself and hope that I get it and can get the results tested.

    I’ve read a lot of the comments above and I just shake my head at the ignorance that spreads throughout these United States. Several comments above about not understanding what the FDA letters states is very very sad. If you cannot understand English, then you shouldn’t post comments about how the government is meddling in your life.

    It’s a shame that as Americans, we do not look back in history to understand why we have these government agencies that oversee private enterprises. However, I’m not going to sit here and rant and try to school anyone over what is not an overreach of government, but government working for us.

    I hope that 23andme can get their act together and comply with FDA guidelines. Otherwise, I’m gonna be pissed being ripped off for a $100.

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