23andMe Statement Regarding FDA Warning Letter

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.






  • Kevin C

    Are you still in business as usual, or is the FDA shutting you down? I want to buy a kit today, can I?

  • William Stevenson Weston V

    If this does go in effect I hope we will at least be able to get results in raw data for samples already received. I don’t like this government bullying. They allow too many negative food additives and drugs, but want to stop a testing process?!

  • bcamarda

    I know there’s a tendency to think of federal regulators as speedbumps to race over on your way to the future. But count me as one potential customer who wants to see FDA’s concerns fully and thoroughly addressed.

  • http://www.biocompta.com/ Christopher Goodman

    As a physician, and a son of a physician, who help develop clinical pharmaceuticals, I am quite surprised at the marketing behavior of 23andMe with regard to their genetic test. You should provide better scientific and clinical information for patient’s benefit and to relevant physicians.

  • Melissa Miko

    I don’t see what role the FDA has in a company helping us chemically decode OUR SELVES. We own ourselves; if we were blind, would they write a letter for having a seeing person tell us what color hair we had?!?

    • Fully472

      No. Wrong. The FDA knows you own yourself and your information, what they want to stop is a large corporation marketing a test as a health indication when it has a huge error rate due to the cheapness of the test when showing propensity towards gentically carried diseases. They also want to protect the fact that you own yourself by pressuring 23 and Me to destroy any record/DNA material of tests done if the consumer wishes the record/DNA material destroyed. They’re right to do so. I hope they prevail. I hope 23 and Me starts offering reasonable privacy and reasonable accuracy, I’ll participate too if they will.

      • Melissa Miko

        LOL Yes, Right. What the FDA wants to do is make sure their cronies profit.

  • Briskette

    In my country, it’s horribly difficult to get such tests done, not to mention extremely expensive. I’m grateful to 23andme for the information which I hope to receive soon. Meantime, 23andme should simply move all its operation to a more accommodating country. Kudos 23andme for the brilliant work, please move location and continue the service!

    Would 23andme please build an online petition/website for those of us who are not American or do not live in the US in addition to the American petitions already circulating? And regroup all of the petitions on a dedicated page available even to those who have not yet submitted tests? Thanks a zillion times :)

  • Andrew Lonie

    Having just sent back my kit for assessment, my take is that the FDA letter was extremely important and the 23andMe response above is not at all commensurate or appropriate to the situation. My opinion of the company has plummeted. This is serious.

  • Laura Henze Russell

    Using 23andMe to have a conversation with your doctors is a great and very cost-effective way to finally identify and then work to correct some of the causes of chronic disease that are very costly to patients, their families, and our health care and long term care systems.

    Why ban 23andMe? Everyone has a right to their genetic information. Many serious chronic diseases are the combined result of genetic susceptibility and environmental exposures, which cause inflammation in people not well equipped to clear these substances, setting up
    a downward spiral.

    We all pay for this in higher health care costs for costly consultations with specialists who do not think to look into environmental causes, for lifelong use of prescription drugs to manage
    symptoms rather than treat disease, for “chronic disease management” rather than reversing and curing these conditions, and for hospitalization and long term care as serious chronic diseases progress.

    President Obama and Congress need to do a serious house cleaning at the FDA, and set its priorities straight. We need immediate action to keep companies that generate low cost, health promoting solutions in business, and ban the toxins – starting with dental amalgam that causes mercury poisoning and triggers a host of chronic diseases in genetically susceptible individuals – if we are to have a prayer of lowering health care costs in the U.S.

  • esh13

    he FDA’s action shows whose interest it has in mind. Knowledge is power. People have the right to make decisions about their body. Information can be taken to a physician who can chart a course of action based on what the DNA test shows. Some people may have issues dealing with some of the findings I’m sure. But knowledge is power and humans deserve power over their bodies. My healthcare advisor has discouraged me from taking the DNA test, but another hospital chain has encouraged me to get another opinion. Why do health insurance companies not pay for this? Preventative health care could make a dent in their profits.
    I think this is one of the most important issues facing people. I wish you all the best and thank you for establishing this service.

    Elke

  • dave

    Why not start taking Bitcoins? My thought is that they can stop you from selling the service for dollars but not for something that is unregulated…

    • Peter Reilly

      If you do business in the US and sell, advertise that business you have to comply with the Law. The FDA is not trying to stop 23andME, but 23andMe.s non-response was not only stupid its suspicious. What company cannot and as not prepared to answer its questions. Is that a company that be trusted with medical material (DNA), to not only oversee its testing in a safe and secure method, but to also properly assure that your DNA IS your DNA not someone else’s. Imagine basing your medical decisions on such an error, or misunderstanding the results. Bitcoins or not we still live in a community of laws.

  • Raymond Yee

    I suggest posting a message linking to 23andme’s response to the FDA that shows up to customers when they login.

  • Chris_8304

    I looked in the mirror this morning and saw a suspicious spot on my face. I am going to see my dermatologist about it. So, now I am waiting to get a cease and desist order from the FDA for using an unregulated mirror as a medical device.

    • Chad

      You may be disingenuous, but I’m going to answer as if you’re serious. The FDA doesn’t regulate you. As far as the FDA is concerned, you can do anything you want until you market something as a tool for diagnosing or manipulating health. The FDA’s job is to keep claims of health tools well-defined and safe.

      The mirror isn’t sold as a health tool and labled “brown spots are cancer 20% of the time”, or the mirror manufacturer would be in trouble too.

      • brendan

        Both homeopathy and anti-vaccine groups advertise as health tools. 23 and me is a far more responsible healthcare business than any homeopathic website/manufacturor. It has no negative health impacts the way that anti-vaccine groups have. Why not go after the real enemies of public health?

      • Paul Lundbohm

        The FDA allows hundreds of medicines to be marketed that kills thousands of people each year. Big Phama pays a fine and consider’s it cost of doing business. Almond and cherry growers can not advertize the scientifically proven health benefits of their natural products. So much for safe.

  • Rolf Linder

    It seems to me that 23andMe should have a more complete and thoughtful response to the FDA’s actions. What you have posted is boilerplate but does not fully explain your views or intentions from this point forward. If your company disagrees (which presumably you do), you should state your case for all to read and consider.

    • nunyabidnessfoo

      I’m sure their lawyers told them what to say and what not to say.

  • UnfrozenCavemanMD

    As a physician, and a son of a physician, and a 23andMe customer, I find that 23andMe provides what would otherwise be many thousands of dollars worth of genetic testing and supporting information for $99. They are careful to delineate the limitations of what their SNP chip technology can determine. They adhere to the very highest ethical standards in their informed consent process. They go above and beyond by offering free testing for family members if a major health risk is identified. 23andMe are the good guys here. The FDA, not so much.

  • Chad

    FDA makes sure, among other things, that health claims are backed up by science. 23&M neglected the safeguards the FDA insists on. That’s not to say that 23&M is doing anything bad, just that for many months when the FDA came knocking for information, 23&M plugged their ears until the FDA went away.

    • Cowboydroid

      23andMe doesn’t make any health claims. There is nothing to “safeguard” against with their product. Their product is information. How the customer chooses to use that information is entirely up to the customer, and anything the results indicate would first have to be verified and corroborated by any physician before that physician would take action on that person’s particular risks.

      If the FDA is just harassing, and can’t prove anyone is actually being harmed by the product 23andMe is selling, then 23andMe has no obligation to pay any attention to them.

    • Laura Henze Russell

      The FDA insists on no safeguards for some real medical devices that are proven toxic, such as dental amalgam, which is 50 percent mercury, and causes grave harm to genetically susceptible children and adults. It ignored advice of its own Scientific Advisory Panels on amalgam which asked for restrictions and informed consent. The FDA doesn’t even require health warnings on amalgam’s risks to patients, only from manufacturers to dentists. Read them, they are very scary. 23andMe is not. What is wrong with this picture?

      • Melissa Miko

        So true, Laura! Right on.

  • Cowboydroid

    That’s just it. The FDA doesn’t believe that you own yourself.

  • mkoutlaw

    Please explain if you will be continuing to process tests already purchased. We have 3 tests recently purchased. We have not sent in the samples yet. Will the be processed if we submit the samples? Or will we receive a refund if we return unused?

  • achill88

    Like others commenting here, I’m very disheartened by the recent news about 23andMe. I was about to purchase a kit for myself and my whole family, and now I worry that the company isn’t allowed to maintain operations, so my order will be canceled or something. I really hope this is just a quick blip in business, and if not, I really hope it can move operations to more sensible places.

    While I don’t have anything wrong with the FDA in principle, I think these objections are ludicrous, and current FDA policies and principles are largely as well. The FDA allows chemicals, additives, hormones, medications, and pesticides to be added to our food chain that are linked with cancers and chronic disease and are banned in most other countries in the world. It stands by without a problem while the nation is so addicted to fat and sugar that we don’t have the energy to do anything other than watch TV and stuff our faces even more, all the while considering pot of all things a dangerous substance. All pot ever did was make people obnoxious idiots. There’s a real monetary value that we as a society lose every day in terms of productivity loss due to our obesity and ill health.

    Besides, all tests have error rates, and consumers know that. And if consumers are too stupid to know that, doctors aren’t. You can’t just go do some dramatic procedure just because you think you need it. Even in the event of a false positive, a doctor will require additional testing before lopping off your breasts.

    Makes me mad, but I’m not surprised. Hope you guys can bounce back soon. Let us know what we can do to help!

    • http://blogs.forbes.com/danmunro/ Dan Munro

      The FDA is not (as of today) halting sales – it’s just saying their application (to market it as a clinical device) is denied. They will need to start over (assuming they wish to continue marketing the kit as … ” … knowing your DNA, you can take steps toward living a healthier life.”

      The unknown here is the accuracy of that “knowing” because the company doesn’t wish (at least to this point) to comply with the FDA process for assuring clinical accuracy. The way the test is today – there is no way to know that 2 separate tests from you – will return the same result. That make the science behind all this very questionable.

      There is already a case of one person using the service and getting a “false positive” on a rare condition/disease. That’s *really* troubling – because the anxiety and stress of that should not be allowed to happen. You can read the story here: http://hc4.us/1c74YkZ – and decide for yourself if you think this is a novelty product – or real science.

      Either way – I’m sure you’re order is safe – and you will get your “test” results. At this point the FDA has not started legal action (with penalties and fines).

      I also wrote about this in more depth here: http://onforb.es/1emcJ61

      I’m all in favor of innovative healthcare solutions, but until we see the science validated in a rigorous way – at least for me – it’s 23andNotMe.

    • datcv

      You should be against the FDA, or at least how the FDA acts today. They constantly prevent medication that could save lives from going to market because it doesn’t align with their very narrow definition of what should be allowed. For example, pharma companies have found certain drugs to be very effective in fighting cancer for certain groups of individuals with a specific genetic profile — this is the genetic/personalized medicine that we keep hearing about, but the FDA will ban the drug because it isn’t effective in the general population. In this respect, the FDA has blood on its hands.

      The problem is that if they approve a drug and someone dies or has a negative effect from it, the FDA will receive the blame. But we never get the body count of people that could have been saved by drugs the FDA refused to give approval to, even in humanitarian use cases where the patient is going to die any ways.

      • Scott23H

        DATCV, We’re trying very hard to work with the FDA. As our CEO expressed, regulating at DTC genetic testing company is new for both the agency and 23andMe. We believe ultimately we can get through this process and make it work.

        • datcv

          Good luck!

  • CommentsFrom92649

    23andme should immediately call upon the congress to sponsor legislation modifying the Food Drug and Cosmetic Act to permit for a novel category: non-diagnostic genetic testing. This situation is analogous to the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA wisely permitted dietary supplement manufacturers and distributors to make certain approved claims. Furthermore, those claims must be disclaimed by adding the following disclosure. “This information has not been reviewed by the FDA, this product should not be used to cure, prevent or mitigate disease.” Finally, dietary supplements products have to specify that they are indeed DIETARY SUPPLEMENTs rather than approved drugs, by disclosing that name on the label. People aren’t stupid. The testing and resulting information is useful but not diagnostic, therefore as long as the testing is reasonably distinguishable from validated genetic testing services, and properly disclaimed, FDA should permit the services to continue. FDA always seems to start from the point-of-view that consumers are too dumb to live. For that I fault them, but 23andme appears to have blown off FDA’s attempts to help them define a new “non-diagnostic” genetic testing category. As a company, they may not live to regret that decision. FDA will immediately seek a consent decree if 23andme does not voluntarily shut down.

    • Melissa Miko

      Nice workaround idea!

      What if 23andMe split into two separate companies: one to process and provide the raw data, and another headed by “doctors” or FDA-ok’ed people to interpret the data and send you the personalized report?

  • mimi

    sometimes the same people that order the product misuse and abuse it to find some type of wrong to define their own truth. I found 23 and me to be extremely important to me and my concerns I also found my results to be quite interesting.

  • http://www.kathryncramer.com Kathryn Cramer

     #FDAoutofMyDNA I should be allowed to use @23andMe to read my DNA without insurance companies reading over my shoulder! #overruletheFDA

  • Jason

    I read the story, and I don’t see the big deal. 23andMe does not provide diagnosis. They don’t test for specific diseases. They tell you if your genes compared with other genes put you at a higher risk for other diseases and such. 23andMe should be used as a reference and educational tool for the users. NOT AS ANYTHING MEDICAL. Anyone who uses the service to self-diagnosis is just being stupid. The person in the story, had they not discovered the “bug” in the website code, would have likely gone to see a doctor for follow-up, and to test further for the condition. MANY MANY medical tests have false positives. Blood tests, even certain cancer screenings, can indicate false positives. And when a positive result is found, typically the correct course of action is to do a second test to verify, many times using different means. And sometimes even medical tests can indicate false negatives. I could give you a sob story about that too. About how when I went to the doctor with a sore throat, fever, and fatigue, but the strep throat culture came back negative, I was sent on my way. However, a few days later I was back, covered in red splotches, tongue was white, fever was uncontrollably high, and I was sicker than ever before. It turns out, I really did have strep throat, and it went untreated, due to that false negative, and developed into scarlet fever. I was sick for weeks, unable to eat, barely able to move, unable to go to work, etc. And THAT REALLY happened. The story you posted, the guy didn’t REALLY have any health problem. And if he did, he would have gone to the doctor, who would have confirmed or provided other medical advice about the condition. NO HARM was done. Other than perhaps a few tense days. The FDA’s claims that people are going to go rush out and get surgeries and chemotherapy treatments due to possibly false positive results in the 23andMe reports is just ludicrous. They would need a doctor to do anything. And the doctor would do their own independent tests to confirm or deny anything that the user thought may be a health issue. And then the doctor would provide advice about what to do to remain healthy. People aren’t going to go do surgeries and chemotherapy in a vacuum without any other medical intervention.

    However, all that being said, I too am severely disappointed in the 23andMe response. First, they owe their users a fuller explanation. I was going to buy a bunch of kits as Christmas gifts for family members. Should I now not? Is the company’s future ability to provide the service certain? Also, there is no excuse in 23andMe not providing the FDA with the documentation they requested in order to get whatever regulatory approvals they needed. So, I for one, say shame on both sides. As is typical, the consumer is the one who potentially loses out because of this.

  • Milonguero139

    FDA’s decision seems to be based on the pretense that some customers are not bright enough to understand the DNA test findings and will take the wrong decision (although any action they would take would have to be implemented through a medical practitioner who, in theory, must have the patient’s interest at heart). 23andMe will have to keep trying to bring FDA onboard, although it might be frustrating to answer the repetitive and dumb question that they probably receive from them. Please try hard, folks, and do not fail your customers!

  • lswaters

    If a doctor orders a genetic test from a laboratory, is every such test fully compliant with FDA regulations? I don’t think so, in fact it appears that very few are. Why is 23andMe in trouble and they aren’t?

  • herveg

    This looks like populism ! Sure, Knowledge is power, but it is knowledge … I don’t know how I would call what’s happening here !

  • Stevet

    I purchased 4 kits over a year ago and have not used them (or opened them) … Are they refundable????

  • L Armstrong

    I understand that this is part of “big government”, but your company is in this country, and your people are electing your representatives and president (as well as likely donating to campaign funds), and have a multimillion dollar business. Therefore, I do not understand why “23″ did not respond sufficiently to government (ie the FDA) demands for information in the years they were demanding it. Okay, maybe you are protesting “big brother”, which I doubt, but you did know that you would suffer the consequences if you did not. Why not respond? We have to hire a tax person to do our taxes, even if we hate giving such a large chunk of our income to Uncle Sam. So, uh, why not give our “Uncle” the info? You give us fairly detailed descriptions of our results and work hard to get our “study” responses (which I think are used by pharma and other companies) and you work hard to market your product. So what’s the big deal?

    This is what I simply do not understand…Yep, I’m one of your customers. I hope you respond in a clear way.

  • Miri

    so will i be getting my money back? i JUST sent in my kit 2 weeks ago and I’m so mad about this. I wasted $200!!!! 23andme better give me my money back!!!!!!!!!

  • neve

    what if i bought kits for my parents and these were received by the lab weeks ago?

  • Scott23H

    Miri, All customers who ordered kits as of the 22nd of November, the date we received the FDA letter, can ask for a refund. You should be getting an email directly from 23andMe. We were not able to answer your question until we got clarification from the FDA today.

  • Scott23H

    Sorry for the delayed response. If you ordered your kit before November 22nd you will still have access to both health and ancestry information. See our update regarding the FDA that was posted today.

  • Scott23H

    Kevin, We are still in business and we are still able to provide customers access to their genetic ancestry results as well as their raw data.

  • Layne

    Scott23H, I’m afraid that the blog post and your answer to the questions about whether customers will receive the data they expected is confusing. From what I understand, you are saying that all customers who purchased the kits ON OR AFTER November 22, 2013 will receive only ancestry information and raw data. Customers who purchased kits UP TO AND INCLUDING November 21, 2013 will receive the information and interpretation that 23andMe previously provided. Is that correct? (The wording “as of” is actually unclear.)

    • ScottH

      Layne, Customers who purchased before November 22nd, the date of the FDA warning letter, will have access to both ancestry and health reports. Those who purchased on November 22nd and later will only receive ancestry results.

  • Scott23H

    Hannah, Yes. We are committed to this process with the FDA and believe we will ultimately be offering customers access to their health reports. That said we can’t promise that because we don’t have approval to do that now. You would not have to get retested.

    • Hannah Skiles

      Behind you 100% :)

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