An Update Regarding The FDA’s Letter to 23andMe

23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives.23andMe_Logo_blogIt is absolutely critical that our consumers get high quality genetic data that they can trust.    We have worked extensively with our lab partner to make sure that the results we return are accurate.  We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to healthier lives — a goal that all of us share.We will provide updates as they become available.
  • CommentsFrom92649

    Call upon the Congress to sponsor legislation modifying the Food Drug and Cosmetic Act to permit for non-diagnostic genetic testing. Your 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 health claims if they meet the criteria: “a consensus of scientific fact.” or are structure function claims. Furthermore, these limited health 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, you may not live to regret that, as FDA is an extremely aggressive regulatory agency who will no doubt seek out a consent judgement degree in order to avoid prosecution.

  • R Stewart

    You could start by not giving people percentages. Too many are relying on those percentages as fact when 23andme knows it only the percentages based on the relatively few genes you test. All the other factors, especially those other genes you did not test, can easily spike those percentages a lot higher. The commercials and some of the stuff on the site are promising a lot more than you can deliver, both on health and ancestry.

    You could also hire customer service staff and other employees who are willing to respond to customers.

    • Faith

      As far as I can tell, the percentages and stuff shared comes directly from studies published on those genes (so in essence a database of already accepted information)…and that information is already publically available. However, I agree…stopping posting the percentages might appease them and is worth considering imho. While it is a fun tool to read, the browse raw data is more helpful…and that comes with no analysis…and is also useful to doctors who work with us.

    • Angela Hey

      The answer is to educate the general public in what percentages mean!

    • Laura Henze Russell

      It is elementary that we are a product of genes and environment, nature and nurture, exposures and events. We need to focus far more attention on the exposures we get in the U.S. if we are to address skyrocketing chronic disease rates, which are impacting people at younger and younger ages. 23andMe gives us a fighting chance to begin to learn how our genes impact our ability to clear various toxins, and to incent the medical profession to go “back to school” and learn about genomics and toxicology. These should be the top topics in medical school these days. Sadly, they are not. Our medical-pharma complex shines on diagnosing conditions, expensive new drugs, new surgical techniques and inserted medical devices, and chronic disease management, not on diagnosing CAUSES and addressing them to remove inflammation and restore health.

  • Lucy Clemence Potts

    Please can you provide any updates on people who are already in process or have recently purchased kits?

  • Karen Glammeyer Medcoff

    please don’t tell us that the FDA will make you turn over dna samples to the govt

    • SpamJay

      That better not happen, but I also would not be surprised!

  • Extreme_One

    Keep up the good work. We are counting on you!

  • mjustin88 .

    Do those who have already submitted samples still get their results?

  • Dawn

    My test shows that on 11/15 it started to be analyzed. Will it be finished? What happens to tests in progress? If halted do we get a refund? That is what we want to know.

  • Lea Ann Roach

    Hang in there – Git ‘er Done!!

  • Piret

    So, you “must officially respond by Dec. 13.” What happens if you don’t respond…ever?

  • Tammy Jay Jay Wilson

    I am taken back by the government trying to stop this, this sight is for people that want to learn about themselves and understand what is going on with themselves. I see no need for the FDA to interfere with others taking their lives into their own hands, and trying to make it better. I think they need to go back to where they belong, start taking care of what is wrong with the food people eat, the water they drink, and the air they breath, not a place where someone can find out what is wrong with them, (unless they are the ones that have caused it). I say FDA STAY THE HELL OUT OF PERSONAL BUSINESS AND TAKE CARE OF WHAT YOU ARE REALLY PAID FOR. IT IS CALLED FREE ACT. I am sorry, but I love what I have learned, and I hope I can continue to learn more about my GENES.

    • Cheryl Whittle

      I agree totally with you…We have every right to use the sites and tools we desire to learn about our genome, DNA, health, ancestry and such. Government, specifically FDA, needs to stay out of our business. I too have enjoyed learning about the human genome, my health risks, my ancestry, and getting to know those that match me. I want to continue to search for possible matches that may lead me to my biological father. Government needs to stay out of this, they are always trying to fix things that don’t need to be fixed, and when they get into those things, they mess them up much worse than they had been….just look at health care now days! What a huge mess, that has done nothing but hurt the citizens of the USA. I am a retired Registered Nurse, and I am thankful for the information I glean from 23andMe, as well as the many diseases they continue to research to find answers and cures…

  • Kaitlin F

    thank you Anne for your response and for taking the time to advocate for your customers. I love this service and think 23andMe is a pioneer in biotechnology and personalized medicine. The FDA will have to consider the future when approving such technologies and I applaud you for starting the conversation.

  • Hal Jennings

    What would be helpful is to understand what the FDA ruling means to 23andMe current operations. Are you not allowed to sell new kits? Are you not allowed to receive kits? Are you not allowed to process kits you’ve received? Are test results provided on the web affected in any way?

  • 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 genetic and 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.

    How can we help? We can ask the Administration and Congress to order the FDA to cease and desist on the warning letter, and we can tell our stories to the media, the public, and our friends and families. The FDA bans helpful personal gene information as a medical device. Yet for decades it takes no action on real medical devices with serious health risks, such as dental amalgam, whose mercury toxicity is a grave danger to genetically susceptible children and adults. The FDA doesn’t require health risk warnings to dental patients for this medical devices as it does for all prescription drugs, it only requires health warnings from amalgam manufacturers to dentists. Ask to read them, they are very scary.

    A few years ago, the FDA banned a supplement developed by a renowned chemist that helps neutralize mercury amalgam’s toxic effects when still present in the teeth, and raided medical and dental offices to confiscate it. They deemed the supplement a drug because it was so effective. He is about to begin clinical trials testing in Sweden, one of a growing number of countries that have banned amalgam outright. Its availability to help people in the U.S. is years away. The irony is unconscionable, and the consequences tragic.

    • Chris Rogers

      Well said!

  • Kate

    You started talking in 2008 and it took you four years to submit an application! It sounds like the FDA has every reason to be asking you to stop overselling your unverified test.

    • jimkress

      It takes almost 20 years and $2 billion to get one new drug approved. 4 years is nothing compare to that.

    • JD

      I don’t understand why all of these people who show no sign of previous interest in 23andMe are showing up and posting in the blog comments. They’re welcome to their opinion, of course, but it’s not easy to see why they would bother to tell us.

  • Caroline Susan Chapman

    I think the FDA has lost their minds. They cannot seriously believe that someone who gets a “BRCA-related risk assessment for breast or ovarian cancer” will rush out and “undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions”. In order to get any of these treatments the patient has to see a physician. The first thing that physician will do is a repeat test. Then the physician and patient will decide on how to proceed, within a medical environment.

    23andMe is the leader in genetic testing and this knowledge is empowering everyday people. This is an opportunity for the public to take control of their health. The public will take their findings to their physicians – and that is the medical environment that will ensure that treatments are legitimate, safe and within FDA guidelines.

    The warfarin example is a perfect example of the FDA making unsubstantiated claims – “warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect.” While this statement may have merit, what evidence does the FDA have that patients are using 23andMe data to make these sorts of decisions? Does the FDA plan to ban the entire internet. Patients make all sorts of decisions everyday, based on discussions with their doctors, internet research, magazine articles, news reports. There is simply no evidence that having a report from 23andMe is going to adversely affect patient health to any degree greater than any other source of information that patients currently have access to.

    In the FDA’s own words the solution is already in place: ‘These risks are typically mitigated by INR management under a physician’s care.” 23andMe is not suggesting to any customer that they should alter their treatment without first consulting their doctor.

    The FDA appears to be seriously behind the curve on genetic testing. The public are demanding genetic testing. The consumer can purchase tests from multiple sources, both within and outside the USA. No-one is forcing individuals to take these tests. The risks of genetic testing are spelled out. This is a commercial transaction to provide patients with information. It is not a treatment plan, it is not a medical diagnosis of disease, only information of disease potential, which patients can then take to their physicians. Many physicians are recommending 23andMe to their patients as means to empower their patients and are encouraging their patients to bring their results in to discuss them.

    The FDA appears to be asking 23andMe to redo all the research that has already been done on sequencing and the false positive and negative rates obtained when sequencing and clinically measure the results of the testing. This is ridiculous. The technology is well tested. Information on the genome and diseases continues to evolve. 400,000 people and counting have trusted their data to 23andMe. I am one of them. I discuss my results with my physician regularly. I don’t have any relationship to 23andMe other than as a customer. It seems very wrong that the FDA is attempting to control my access to my own information under the guise of ‘marketing clearance’.

    • jimkress

      What other behavior would you expect from the panoply of FDA bureaucrats who panic at the thought a new idea or technology might actually be promulgated without their blessing? After all, in their own minds they are the fountain of knowledge about everything. Control Freaks doesn’t begin to describe how the clueless people in the Federal Bureaucracy behave.

      • Golrokh Kiani

        Exactly!

    • Jillian Jordan

      Right. Would their doctor NOT be involved? I can’t walk into a surgeon’s office and demand a mastectomy and chemotherapy because of the test. There is a lot more to it.

      • SpamJay

        Yes, the FDA is in the business of funneling money to the American Medical Association’s members. That’s my firm belief.

        They will want to regulate clairvoyance next, since people might use those findings for medical purposes… Ridiculous!

    • Donald Yates

      I actually know a woman who did have a masectomy after finding out from a genetic testing company she “had” the BRCA. This was in 2010. The woman was/is highly intelligent and well informed, in fact a professor.

      • leondb

        Was her name Angelina Jolie?

      • Rich Smith

        I’m sure the professor you speak of would have obtained confirmation that her risk was indeed elevated, either by having a family history of breast cancer in addition to the genetic test or a confirming genetic test. Even if she didn’t seek confirmation and was willing to undergo this drastic, irreversible step it was up to her surgeon to ensure she was properly informed before taking this action.

      • emjayay

        The whole story no doubt is that the testing alerted her, a cancer doctor repeated the tests and found out that she did indeed have all the genes, a genetic counselor advised her that she had a 90%+ chance of getting breast cancer and most of the women in her family had died of breast cancer.

      • TerryDarc

        Not 23andMe apparently. Didn’t she have a backup testing? One DNA test doesn’t sound like enough to me.

      • Jenean Livesey

        And I am sure a qualified MD did further tests on her and explained all the pros and cons, did appropriate tests confirming the BRCA. A qualified Surgeon did the surgery. She was not at any greater risk than doing nothing, knowing she had the BRCA gene

      • Yes, and there are people who choose that route – generally based on other risk factors as well – like family history, general health etc. But that’s besides the point because what surgeon would perform a mastectomy based on 23andme data alone? NOT ONE.

      • Faith

        You may not realize this, but the breast cancer/ovarian cancer genes have been patented by a company. Only they can do the test of the specific genes (per the patent) and it costs $3,000 last I heard. Upon positive result, the standard of care that doctors practice and advice is pre-emptive surgical removal. Likewise, she did not independently, in her own home, by herself remove her body parts…a doctor did that for her because the DOCTOR (not her) found it medically warranted given the current standard of care for those defects. Numerous women have undergone that. Numerous women still need to undergo that but cannot because they cannot afford the $3,000 test that is NOT covered by insurance (because that is discretion of the companies to not-have to deal with insurance companies…so they don’t). So that I can understand you, are you saying she acted poorly because she keep her eye on the money?

        • R Stewart

          That patent was overturned by the Supreme Court. It never should have been granted, but that is a separate issue. It is very easy to find a doctor who would accept the results from 23andme and not independently verify the results and perform whatever procedure or prescribe meds the patient wanted. I worked in the mental health field and saw it in both the mental health and general medicine field. If their doctor will not do it, then they go doctor shopping.

          The problem is 23andme’s marketing is over the top. They need to re-work the marketing and be more realistic in what they can do AND to be honest about what SNPs are tested compared to the known SNPs for the condition.

          They need to make it very clear the percentages and risk factors are only based on SNPs tested and can be seriously off. It needs to be on the Health Overview page and any sub-pages. Telling me that I have a 1 in 9 chance of developing a fatal condition is irresponsible because they are ignoring 5+ other SNPs known to affect the probability in a major way and they are not taking into account environment, other hereditary factors, choices made by the individual.

      • John Granacki

        Many highly intelligent professors are out of their minds. Unless she is planning an extended expedition to somewhere without hospitals she should have monitored her breasts, not removed them. The best regulation would be requiring doctors to observe their Hippocratic oaths.

      • PJGU

        Then, her doctor and surgeon clearly agreed with her decision and the information it was based upon , so again, the FDA is wrong. Or, are you saying she cut off her own breasts?

      • zar kers

        Yep. After getting tested, and most likely retested (most medical tests are prone to false-positives), discussing the genetic risks & family history with a physician, and after discussion with a surgeon. The fact that a well educated person after much deliberation did this also shows that the FDAs argument is silly – an intelligent person should take this information and put it to use by discuss it with medical doctors, getting retested, and then make an informed decision thereafter. Knowledge is power. To choose ignorance is to choose stupidity.

      • Laura Henze Russell

        I suspect it was after a full diagnostic genetic test, not only 23andMe. No surgeon could or would do a mastectomy without that or they could lose their license.

      • Angelina Jolie paid $3000 to myriad for the brca1 test. She had a mastectomy too. While we may or may not agree with preventative surgery there remains a basic principle to be preserved.

        The problem isn’t the collection and disclosure of information, the problem is what people do with it. Don’t restrict the provision of information because a few people decide to take extreme measures.

      • Laura Henze Russell

        I’m sure it was a diagnostic BRCA test, or her doctor could lose their license.

      • Dana

        Yes, but she had to clear it with her doctor first. You can’t just go out in the backyard with an ax and lop your boobs off.

        Well… OK… I suppose you could… but that would entirely be on you.

    • Greg31415

      23andme is being stupid by not instructing the FDA. The FDA has literally 1700 classifications for medical devices and NONE of then can deal with Genomics …or… DNA Sequencing …or… Personal Genome Service. 23andme has the OPPORTUNITY to help write NEW classifications. But they have been ignoring their regulator pretending that the issue will just go away. If 23andme doesn’t stop dragging its feet, then the FDA will LEGITIMATELY CLOSE this company DOWN. But Wojcicki’s recent email shows that she (erroneously) believes that this is all about test-kit-quality. She’s wrong.

      • JD

        I’m more inclined to think that an enterprising person like Anne Wojcicki would long ago have satisfied the FDA if it were feasible to do so. But who can control whether the FDA is satisfied except the FDA? From the letter, it seems they want to be petitioned for approval when new SNPs are added to the chip and when new research findings are incorporated into our reports. To the proud antiques at the FDA, each reported connection between a SNP and a disease risk warrants a new, expensive, FDA-glorifying petition for approval.

    • Bob

      I agree with Caroline Chapman. No one could have any of those procedures without consulting a physician and most likely a specialist, none of whom would be likely to accept a website’s diagnosis without further testing. I took my 23andMe list of the chances of various medical problems to my physician. I must say that none of them surprised me (all fell well within my family history), and none surprised my physician, although he’d never seen such a printout before.

      The only danger I see is that someone might take a 23andMe piece of information and begin to self-medicate rather than see a licensed physician. But people do that all the time, and FDA does not regulate the many supplements and treatments available. I have a physician in my family who has horror stories of people who were given a physician’s diagnosis and recommendation for treatment, but preferred to use herbs or meditation or whatever and who, of course, died because they chose to ignore science. There is no way that the FDA can prevent people from doing loony things. 23andMe does NOT point anyone to such loony practices, and the FDA needs to recognize that, in fact, 23andMe is very conscientious in its advice.

    • Joyce Richards

      Do you know if Angelina Jolie used 23andMe? You know she had a radical double mastectomy because she learned that she carried the gene from both parents.

      • Laura Henze Russell

        Any doctor would run the diagnostic version of the BRAC test before surgery, or they would lose their license.

    • Ryan Conlon

      Very well written. My thoughts exactly, but a lot more eloquent than I could write. Thank you!

    • Brin

      Remember that FDA receives a lot of money from the Pharma industry. So preventive medicine is something that will not constitute a benefit for the drugs companies in the long run.

    • Sue Bennett

      They haven’t lost their minds – they are testing the waters to see how much of our basic freedom of choice they can take away. This was the deal brokered by both the Republicans and Democrats with the powerful pharmaceutical and medical organizations in approving socialized medicine (Obamacare) in exchange driving the alternative medicine and health community out of business and making it so that only that large corporations can afford to produce supplements due to the FDA creating huge amounts of red tape and legal requirements only large corporations can afford to comply with. The big losers are the average person who would be healthier and spend less on health care if they were allowed to receive information about how supplements and natural products can help them – with out the FDA censoring this. They shut down POM, the pomegranate juice manufacturer for making claims about their juice having anti-oxidant properties – well, duh, it does – and POM had to spend a lot of time and money as a result. The FDA has decided to violate the freedom of speech of people who make or sell supplements and natural food products by telling them they can’t say what their products do even if there is solid university research to back this up. The FDA has to say it’s OK and it costs companies millions of dollars to get health claims approved by the FDA – it’s a mafia style protection racket. Most of the people who are in charge at the FDA have ties to pharmaceutical or the chemical industry – lots of hidden bribery and corruption. Based upon the FDA’s narrow definition of what is a drug vs a supplement – all the natural foods we eat are drugs because most foods have beneficial health properties that can contributed to preventing, treating and curing disease. In their never-ending quest to kill the alternative health/supplement industry they are conversely allowing pharmaceutical companies to patent ingredients that naturally occur in nature, such as a form of Vitamin D in fish, so that a pharmaceutical company has a patent on a natural ingredient and can make big bucks over it. Both political parties are owned and operated by powerful lobby groups at this point. I suggest anyone with ambition and ethics run for office and try to unseat the pretty uniformly corrupt congressman and senators in both parties who don’t even bother to raise money from average people because they get all their money to run for office from lobby groups.

      • Dana

        You are so full of it. The military has had socialized medicine for decades and they haven’t gotten up to this nonsense.

        Don’t conflate people getting easier access to health care with people being told what to do. If anyone needed to be micromanaged it’d be the men and women in uniform defending this country but as long as I didn’t do anything that hurt myself, I led the way on my own health management when I was in.

        Heck, I had friends while in the Army who willingly got their deviated septa fixed just so some young officer MD could get the practice. That would be unheard of in the civilian population.

        • Sue Bennett

          Evidently the military didn’t teach you manners. I don’t know what your service in the military has to do with this conversation. That aside, I know many vets who have major health problems/mysterious debilitating health illnesses that leave them in a semi-invalid state. In addition the highest rates of children with autism and also with birth defects are the children of people in the military. I would say that this may have something to do in part with the military immunization schedule and exposure to toxins. I rather suspect you are someone who is getting paid to post comments like this by a private organization, lobby group in order to derail and de-legitimize a intelligent discussion by being provocative and trying to encourage a conversation to devolve into a foul-mouthed diatribe. I’m not going to stoop to the name-calling level.

    • Socrates

      It’s not about marketing or protection; that’s a Trojan horse. It’s about control and money, period. History shows control and money wear a “for your protection” mask.

    • Dana

      And, if some doctor out there is putting their patient’s health at risk based on 23andMe test results, take it up with the doctor. 23andMe provides no medical treatment whatsoever.

  • Jerry Garrison

    I believe that 23andMe has a serious approach to an area that is needed. I have participated in World Community Grid massive computing, and one of the current projects is “Mapping Cancer’s Markers. One of the main pushes in the medical industry at this point is looking for genetic markers which can be followed to alert individuals to their predisposition to a condition. One of the good things that 23andMe does in their results, is they point out that some conditions seem to be more genetically disposed, some more environmentally; there are multiple vectors in most cases, and awareness to your genetic disposition can alert you to modify behaviors, or monitor developments.

  • kenofken

    The question I have not seen addressed anywhere is what happens in this 15 day window? Will kits that have been ordered be shipped and processed? If FDA takes some enforcement action on day 16, are we out the money if our samples are still somewhere in the processing pipe but before a report is generated? I’d love to go ahead and get mine done, but would I be gambling $99?

    • Suzanne Thielmann

      Thank you kenofken. This is not being addressed anywhere. I have three kits that I plan to give as Christmas gifts to my sons at our family gift exchange on December 14.

      There must be thousands of us out here with unused kits or who have recently sent in kits for processing. What should we do? FDA seems to have stopped sales, but I already made my purchase. Can the work I have paid for still be done?

      • Cheryl Whittle

        I have a kit here on my desk as well…I wonder if it will be processed if I send it in…Please address this issue 23andMe!

    • Ashley J.

      I’m wondering about this as well. Does this business with the FDA mean the company is frozen at all levels? I purchased a kit as a gift and read about this literally the morning after. I was not allowed to cancel my order, and it has now shipped. My hope is that since 23andMe was willing to take my money, that it means processing shall happen as normal, under the terms by which I made the purchase. I believe the FDA is wrong for trying to shut the company down…but I also think it’s wrong to process someone’s credit card for a service you have no means of delivering. Very anxious to see whether customers are kept well informed. I’m trying to stay positive, but the lack of any substantive answers have me worried.

    • Laura Henze Russell

      They don’t yet know how this will play out. They will let you know when they know.

    • Carl

      You should gamble your $99. I trust 23andme to honour their commitments, if the FDA allows them to. I would take the gamble, if I hadn’t already ordered.
      Losing $99 isn’t important. Losing our basic rights to access our own DNA is the important issue.
      If it’s still possible to order a 23andme DNA test, and you haven’t already, I strongly recommend you do so now. It is much better than waiting until the FDA stops them and it is too late. An opportunity like this will never happen again if the FDA has its way. The cost would have to go up to (literally) about $10000 to meet the FDA’s stupid requirements, and the quality would go way down. So get in now while you still can afford it.

  • kstoneman

    Let me know how I can help. The data you have me was actualy dead on with the diagnosis I have already received from doctors. I think this is a great service. I was adopted and until 23 and me I had no idea what my medical history was or what i should be more concerned with. Your results Are not in any way diagnoses, I don’t think anyone would take them that way. The service you provide is my information that is already mine, you are just comparing it to your database and giving results. My dna is mine, not the FDA’ S! If i had some my test results earlier it would have saved me and my insurance company the money to find the health problems that i have, which are very minor. (A gallstone and low iron levels)

  • Nine Inch Nail

    /sarcasm
    Send the FDA a box of Buckyballs and tell them to go play with the Nannystate CPSC.

  • Martin Lewitt

    This attempt to control individual access to information is a threat to the progress of science itself. I make lifestyle and medical decisions including drug prescription decisions even to the point of stopping drugs I’ve been prescribed, based upon reading the peer review literature. Does that make peer review journals a medical device? 23amMe should reclassify itself as a press organization, providing a personal news service based upon well sourced and cautiously disclosed state of the art investigative reporting, and seek 1st amendment protection.

    • Klaus Metzeler

      Martin, you are making decisions you are not qualified to make (unless you are an MD) – but you do so at your own risk. 23andMe need to prove that their test gives correct results, so that IF people like you decide to act on their information, at least they do not act on the basis of wrong data. I strongly believe the FDA should ensure proper quality control precedures and documentation for such tests. Seems to be reasonable to me.

      • Laura Henze Russell

        How many times have you been misdiagnosed by a doctor? How many times has the FDA changed its mind – took 20 years on trans fats. They still haven’t come around to restrict or ban dental amalgam. We need to apply quality control on the FDA, or transfer medical devices to EPA, which at least understands toxins.

      • Martin Lewitt

        I follow the literature and frequently update my MDs on research relevant to my conditions, for instance the nephroprotective effects of ACE inhibitors and subsequently ARBs, and the anti-oxident properties of melatonin, the different side effect profiles and hypothesized mechanisms of those different profiles for ED drugs, the latest age specific “normal” ranges for free and bound testosterone levels from specific tests, the neurotoxicity of the metabolites of selegiline vs. rasagiline, etc. In each of these cases the MDs were months to years behind the literature. For the truly informed patient, no MD or government is qualified to substitute its judgement and values for those of the patient.

  • Catherine Trahan Yost Bottomle

    Sounds fishy to me. Gov is worried that we will have knowledge of our true heritage. We are a melting pot. Gov wants to separate us using heritage. When we have information who we really are they have no leverage to pit one against the other. When we know we are all related on some level we may break down the barriers that separate us. Of course if you really want to be conspiratorial . . . Gov doesn’t want us to find out that there may be some very unusual genetic markers . . . extraterrestrial . . . LOL . . . you never know we all may be Martian after all!

  • CJN

    Just being cynical here, but: if you provided an additional service that was extremely expensive, only accessible by doctors and provided them medical data dumbed down for which they could bill insurance companies even more money… the AMA and the FDA will feel more cozy and the entire healthcare system can remain dysfunctional.

    • Debbie Doud

      Very well stated. My feelings exactly.

    • zar kers

      Nailed it.

    • Your cynisism may not be so far from the mark. Myriad have patented the brca1 and brca2 genes and tests for these specific genes cost $3,000. The FDA should be fighting against the patenting of genes that occur in nature, instead they target a company that reveals millions of genes for $99. I wonder who is in who’s pocket?

  • Valerie Smith-Griffin

    I assume that 23&Me has hired attorneys and while at it, hire customer service reps to RESPOND to our emails/phone calls. Unless this issue can be quickly resolved – those of us that submitted samples/paid money for our kit need IMMEDIATE reimbursement. This blog is not sufficient. It’s obvious to me that the FDA wants a piece of 23&Me’s pie – and a big piece at that, let’s not see 23&Me doing the same with their customers.

    • camilos007

      So your main concern is not the fact that the FDA and the billion dollar health care industry is trying to shut down 23andMe, its the fact that you may (and that is a huge assumption) lose 99$?

      If the 99$ is that important to your lively hood, why are you wasting it on 23andMe.

  • Cliffa Gaddis

    First off I would like to say that I do agree with R Stewart as far as Customer Service Reps are needed. If nothing more than to explain test results or to answer what may be simple questions to 23andme, but are confusing to others. I would also like to say to Kate, for some of us who have had loved ones pass from long drawn out illnesses, this could be life changing in e decisions we make later on down the road. My mother passed away in April after suffering from Alzheimer’s Disease for 12 years. It was the saddest, most pathetic thing I’ve ever seen. I refuse to put my own family through what my father has gone though. You don’t believe in the tests? Then don’t spend your money!! Personally, I want to know if I’m carrying the gene or I’m at high risk (which sadly I’m pretty sure I am carrying the gene)! Lastly for 23andme, what does this mean for a person like myself who sent her sample in within the last 2 weeks? Will I still get my results???????????????????????

    • encierro

      Food for thought. Search “coconut oil and Alzheimer’s disease. Interesting material. You decide. And the FDA has no role in this product….yet!

    • Faith

      My understanding is that they cannot explain the test results to you, only a doctor (which is what the FDA is arguing) can do that. However, at the doctor’s office, a doctor can browse your raw data and tell you right away. Hope that helps

    • MP Follett

      I found their customer service to be EXCELLENT before this controversy obviously catalyzed the predictable onslaught of questions.

  • Clarence

    The 23andMe service is neither a food nor a drug. It is an informational service, albeit partially medical. Are the FDA (Food and Drug Administration) overstepping their mandate? If 23andMe falls within the FDA’s purview, does the statistical nature of the information provided provide too complex a system for the average person to navigate and comprehend, and if so, does the FDA have the authority to effectively limit the information, thus protecting the collective us from our lesser selves? These are important questions.

    • anneymarie

      I think you’re taking things a little too literally. The FDA also covers hip replacements, which are technically neither food nor drug.

      • Laura Henze Russell

        They cover medical devices. This is not a medical device. Dental amalgam is, and a very dangerous one for genetically susceptible people. FDA does not restrict it or warn patients about it, against the recommendations of its own Scientific Advisory Panels.

  • I received an email from 23andme around a week ago confirming that you received my sample. Will I still receive its results? Also, my 19-year old son hopes to send you his sample on Friday. Will he be able to receive results? If not, can we expect a refund?

    • Jonathan

      I would also like to know this.

      • Mary Johnson

        +1

      • Jenean Livesey

        Ditto.

    • tyrelh

      The FDA’s letter just said that they have to stop MARKETING the kit. I’m sure if you already have one and send it in that you will get your results.

    • Marybeth Hart Janerich

      I’m in the same position and wondering the same thing.

    • zar kers

      It takes a bit of time to do the analysis. Be patient.

      • Ofelia

        More than 3 months? They should have disclosed that in the website.

    • madiphco

      I am a fan and customer. I appreciate the letter and update in this regard especially since I heard that there were FDA issues with 23&ME on the morning news. I’m invested! I paid! Will I get results back or not. If not then what are next steps. My families samples were sent in over 3 weeks ago. Will someone one from 23andME please reply!
      Good luck and thanks for your time.

      • Ofelia

        I sent my samples back on early September and I have NOT gotten my results yet. I which they had a working Customer Service Department. I have no idea how to contact them and know what to expect.

    • Anniemac_98

      I also would like to know this!

    • Janice Stern

      Me too. I sent in my test a few months ago. I got the health results, but not the genealogical data. I had to resubmit because I was told there was not enough DNA. I mailed the new sample about a week ago. Also my brother is waiting for his test results.

    • tstusr

      Me too. Should I still order?

    • txannie1955

      In my case it took about 3 weeks after the results were received, my daughters (mailed at same time) took about 6 weeks and hers showed received a week before mine.
      I had received an email about the FDA before our results were even received so I doubt it will effect getting results. They are working with FDA and have been since 2012, unless contacted that the FDA has suspended testing (which hasn’t happened yet) it just takes time. Time worth waiting.

    • Will.kelly.86@gmail.com

      I am in the same boat. I have received my kit and will be sending it in a few days. Is it possible that the FDA would block health related results while still allowing ancestry related information to be given?

  • Donna

    Is it possible that the good old FDA who seems to be totally owned by the drug companies, might be getting pressure by them? DNA testing for health might give the consumer a heads up on some areas to work on before they have to buy expensive meds, thus cutting into the drug company profits.

  • What is your objection to the 23andMe service, specifically? In what sense is the test “unverified”? How do you know? I’m a customer. The test accurately identified a lot of my health aspects, as well as those of my father, whom I also had tested. I do not use the service primarily for health results. I was looking for genetic relatives, which I have found. In many cases, my 23andMe cousins and I are able to find our common ancestor within the last four or five generations. This service has been helping me piece together some puzzles of my past. I had plans to get more of my family members tested by the end of the year. I’m disappointed that they will have to wait. Is the FDA ban the result of an insurance industry hissy fit? That’s what it sounds like.

    • zar kers

      Yep, and 23andme correctly identified a serious inherited problem that has been plaguing my family.

    • Mrtjbv

      Like you and many others here, the test identified a number of my health concerns, as well as my right-handedness, brown eyes, and ability to differentiate between “bitter” and “sour.” It verified I have 2.6% Neanderthal DNA–that’s so awesome–and that my ancestors were almost all East Europeans–which I knew, but only for the last 5 generations. It revealed that I am 1.5% Ashkenazi Jew, which I did not know but was delighted to discover.

      My most recent astrological chart did much the same regarding my personality traits–so much so and with even greater accuracy than I could have thought–and gave a nearly-cinematic account of the last 5 years of my life. I was astonished.

      A Meyers-Briggs test a few years ago identified me as an INFP, a judgment with which I must concur, especially as it coincides precisely with the findings of 23 & Me AND the horoscope. (As well as what little or much self-knowledge I have accumulated over the years.)

      These tests, including 23 & Me, are entertainments. I enjoy them. They’re about ME, of course. “I” is always the most compelling subject matter of our lives. Is it meaningful? Yes.

      Is it accurate? Not particularly–most people are right-handed, brown-eyed and can report distinctions between “bitter” and “sour” as well as “salty” and “bland,” etc. Who cares, unless it severely deviates from the norm or reflects a pathology?

      I could go to a seance or consult a tarot reader and learn about as much. Either activity could be fun and worth the price. But my argument remains that 23 & Me did not apply for FDA certification for nearly 5 years and yet it made health claims of exceptional importance to each of us. How they got away with it for so long is beyond me.

      What will be their excuse? “We didn’t know”? “We didn’t care”? “We decided to wing it and see what would happen”? Any way I look at it, it suggests 23 & Me has some things it wants to keep secret, and that’s why I wrote here at all.

      • Laura Henze Russell

        Do your homework on the FDA, there is some sorry regulatory history there, and this is a new area. I contend it is not a medical device. Dental amalgam is, and they require no warnings to patients or restrictions on its use, even for genetically susceptible children and adults.

  • Catherine Coste

    On the one hand, this interesting 23andMe
    case: should medical information (data) be kept by specialists or is it
    up to the patient to learn how to decode his own data/information? MOOCs
    in genomics will give the tools to patients if they want to do their own (genomic) risk management, instead of trusting blindly — which can be the biggest risk of all…
    On the other hand, remember it took 24 years to the FDA to approve HIV
    tests outside of hospital. How many avoidable and unnecessary HIV
    infections during those 24 years?…

  • Cosmicsmith

    I am awaiting results from my sample. While I think the FDA is being heavy handed, to claim we fell behind is a disingenuous excuse at best. You don’t fall behind on such things especially while saying they are valued in your organization. What’s the real story?

    • Laura Henze Russell

      Do your homework on how the FDA handled dental amalgam and won’t restrict it, while shutting down promising companies and therapies, forcing them to more to Europe for testing and marketing, or shut down.

  • Jason Lacoss-Arnold

    My doctor used your findings as a jumping off spot for performing some other tests that she wouldn’t have done otherwise. I don’t believe you’re trying to replace a doctor’s role – you’re enhancing it.

    • TerryDarc

      Precisely and my Warfarin result would be something I would bring up with my physician if it became necessary. We are not idiots although the FDA seems to think we must be.

    • MsLibertarian

      I think you have the answer here… insurance does not want to pay for tests unless the dr. has a good documented reason. Follow the money.

    • SpamJay

      Same here. It took 23andme results to finally force them to test my wife for some problems. And wouldn’t you know it, their tests returned the same results 23andme had, but cost a lot more.

  • Toni Coleman

    Can’t you just put the standard medical disclaimer that supplement companies use “this is not intended to diagnose or treat” blah blah blah?

    • caroltheartist

      They have disclaimers like this all over the site. I did the test so i
      could see if i had marker for Alzheimer’s and the whole disclaimer was
      repeated again so that I’d see before I opened up that file that even if
      i have the marker, it doesn’t mean I’d get it — or if i didn’t have
      the marker, there is no guarantee I won’t get it. As it was, i didn’t,
      which is great, but they made everything abundantly clear. And i know
      that things can vary from the results, because i am listed with a low
      incidence of asthma but i do have it and have since childhood. Nothing
      is perfect. God knows, Doctors and Hospitals are certainly not, either.
      And sure as hell the FDA isn’t.

    • Faith

      Indeed, it may just be that that is all that is needed.

    • Laura Henze Russell

      They already do that…

  • Toni Coleman

    I agree that it seems like a long time… however the wheels of corporations and government move slowly, and I am going to “go” with the notion that this is not all one party’s fault.

  • Toni Coleman

    Or the other option is having people sign a waiver before processing their test, like what is already required for some tests, like ALS.

    • Faith

      Another really great idea.

  • Katie

    Wow! My sister informed me of this FDA intervention since she subscribes to the WSJ. I sent my sample a few weeks ago and anxiously await the results. I think those of us who are fans should market it through word of mouth. The FDA is an overblown bureaucratic bunch of idiots, the same people who approved aspartame.

  • Katie

    I don’t believe they are putting a stop to the service. I think it’s just the MARKETING of it.

  • hdavis

    Is there a legal loophole here? Could you just send us the genetic information you determine and then we look up those values on an independent website?

  • JMZ

    This is a ludicrous action on the part of the FDA. First, it does not
    meet the definition of a device. It ain’t a device just because the FDA
    wants it to be and so it can have control of everything biologic. The
    FDA does not own people’s DNA and does not (should not) have the ability
    to decide whether an individual should have access to their DNA info or
    only get it through their physician. In fact, I dare say most people
    who have this test do not want it to be part of their medical records
    because of how it could be used for insurance purposes (health, life,
    disability, etc.), employment possibilities, etc. It is private info
    that an individual should be able to decide whether it should be shared.
    To state that someone would have a medical procedure performed based
    on this test alone demonstrates extreme ignorance on the part of the FDA
    and an affront to physicians who the FDA imply would perform a
    procedure based on this test alone.

    The FDA has enough problems handling food contaminations, compounding
    pharmacies (oh look, the horse is out of the barn!), and the everyday
    assessment of new drug applications (so slowwww), that to make up
    another problem (just because they want control of it) is plain stupid!
    They are not helping people here, only helping themselves. I suspect
    there is a personal reason here that has to do with someone within the
    FDA or a very influential outsider. This has nothing to do with
    medicine or science.

    • zar kers

      Here here

  • M Shumway

    Exactly.

  • Carol Wells-Smith

    Before I knew of the existence of 23 and Me I had BRCA testing before having breast reduction surgery. Everyone has the right to know what is going on inside their bodies. Had I had the BRCA gene, it would have been my decision on how to proceed with surgery, not the FDA. I am having trouble understanding a lot of other things on 23 and Me, I am only given “risk factors” and from what I can gather, that information is gotten through surveys, not what actually pertains to me or what I may or may not have. The information given could have been given to me without me having to provide a genetic sample including my ancestry. American Indian is in my ancestry, but not found on this testing, how could that be? I have more questions now than I did before. I also received no information on my paternal history, which is what I was most interested in since my grandfather was adopted. I am really questioning the validity of the testing and whether or not it is accurate and I hope if the FDA does anything, it will discover what is going on for us as consumers and the quality of the information we are given, not whether or not we have the right to know.

    • Jane Osborne

      Only those with a “Y” chromosome can get information on paternal ancestry. Since most women are “XX,” they would need to have a close male relative have the testing performed.

    • Ashley Brown

      You clearly don’t understand how 23 and me works. The surveys assist in genetic research to help identify which gene correspond to certain conditions. If you share DNA with someone who has been diagnosed with a disease, than obviously that puts you at greater risk. As for as the Native American ancestry, if you look at that section it says that NA ancestry usually goes back 5 or more generations so little DNA evidence exists. I don’t think it will identify you has NA unless you have a significant % because there isn’t enough data. Maybe with time this will change. Also, if you read the results you would understand that that the maternal and paternal ancestry is traced based on the X chromosome if you are a woman and Y if you are a man. Therefore you will not get any paternal information unless you have a male relative like a brother or your father’s nephew do the testing too.

      • Carl

        Actually maternal ancestry is traced on the MITOCHONDRIA, not the X chromosome. Everyone (men and women) have hundreds of mitochondria inside each cell, and those mitochondria have a small circle of their own completely separate DNA (containing only about 15 genes). Your mitochondria always come from the egg, never the sperm, so even though everyone has mitochondria you only get mitochondrial DNA from your mother.

        The X chromosome has a confusing inheritance pattern, so it is only used sometimes. Girls inherit their X chromosomes from bother parents, but boys inherit their X chromosome only from their mother. So if you are a man your X chromosome has DNA from your mother’s mother and your mother’s father, but not from your mother’s father’s father. The mitochondrial DNA is a lot less confusing and more useful.

        They can detect ancestry even if it is as little as 0.1%. But only if you inherited some DNA from them, and it’s possible to randomly not inherit DNA from some of your ancestors (it’s actually not exactly 25% from each grandparent).

    • DobieOwn

      It clearly states on their website that they CAN NOT do Paternal history on FEMALES. You might try reading the information again and perhaps again, since you seem to be so confused by the results you were given. They have not done anything wrong regarding your results it doesn’t seem. However, you might want to research their site some more and get educated with what you are supposed to see. As far as not finding American Indian in your Ancestry, I am certain that you are not by yourself in this finding. Most Americans like to say they have American Indian Ancestors, yet it has never been proven to them that they indeed do. So, they go through life and they just think they have American Indian Ancestors. Suddenly, when the truth is revealed, they want to say the test is inaccurate, yet they never had any concrete proof to begin with. I mean seriously? If you’re going to question everything that you know absolutely nothing about then why bother doing the test? It defeats the purpose really.

    • Carl

      There are a few reasons why your American Indian ancestry might not show up…

      1. They made a mistake in the lab and mixed up your results with somebody else’s. This is very unlikely but has happened before. Check if your BRCA testing matches what 23andme says.

      2. You are wrong and you don’t have American Indian ancestry at all. I think this is the most likely. It’s very easy to make a mistake in your family history.

      3. You didn’t click on the (+) button to change to Regional Resolution. American Indians descended from East Asians in ancient times, so American Indian ancestry is in the Asian category. It might even be shown as “Nonspecific Asian” if they weren’t able to tell whether it was Asian or American Indian.

      4. You inherit exactly 50% of your genes from your mother and 50% from your father. BUT you don’t inherit exactly 25% from each grandparent! Sometimes you might only get 10% from one grandparent’s DNA and 40% from the other. So it’s possible that you didn’t get any DNA from one of your great grandparents, or that you got a small part of their DNA that isn’t distinctively American Indian.

      Actually… you did receive some information about your paternal ancestry because part of your normal DNA came from your paternal ancestors. But it’s all mixed together with DNA from your other ancestors so it’s impossible to tell which bit of DNA came from which ancestor.

      The only part of DNA from your paternal ancestors that is not mixed is the Y Chromosome. But only men have Y chromosomes! Women have two X chromosomes instead. Y Chromosomes are passed down unchanged from father to son.

      To find your paternal ancestry you need to ask one of these people (who do have the right Y chromosome) to also have their DNA tested: Your father, your father’s father, your brother, your brother’s son, your brother’s grandson, your father’s brother, your father’s brother’s son, or your father’s brother’s grandson.

      They tell you your chance of getting each disease, based on your DNA. My chance of getting each disease will be very different from yours. It is not just gotten through surveys. The chance is usually not 100%, because many diseases can be prevented if you have the right lifestyle or are lucky.

  • Rock Phone

    “We are from the government and we are here to protect you”. Hey FDA = BACKOFF, its just information.

    FDA is controlled and made of former drug company execs so no way we as individuals will get to continue to benefit from this great service. Good for everyone who already has results because the gov at the push of big pharma will end this low-cost, direct-to-consumer DNA information. No Pelosi, no Obamacare, no big pharma, no insurance scams=no chance to exist.

    Big Pharma will not allow this non-diagnostic genetic testing for $99. With billion$$$ going to drug companies. Thousand$$$ on each BRCA test alone. Don’t kid yourself, money controls any government agency.

    FDA is happy for you to treat just the symptoms and take Vicodin, OxyContin, Percocet etc but oh no if you want information to address the actual cause of a disease. What a joke the FDA is.

    • zar kers

      Yep, just keep on suppressing the symptoms and you will be fine. Why would the FDA want us to know the cause of disease. Then you might find the right treatment. Then you will need less drugs & medical care. Not in their interests.

  • Sandra Watkins

    I trust you guys much more than the FDA. Carry on.

  • Laurie QuadrosTamez

    Ill tell you what, 23andme correctly showed a gene mutation for my husband’s
    sensitivity to Warfarin, and only a month later ended up in the hospital after
    and accident, and almost died, having a conversation with the icu doctor about the odd
    sensitivity to the prescribed medication, and told the doc about the 23andme
    results, and sure enough, using that confirming information lowered the
    medication, and hit the correct levels much sooner, aiding in recovery.
    Knowledge is good. Soon the icu doc and pulmonologist were asking for the 23andme website address.
    Folks who ask for the 23andme products are knowledgeable enough to take personal responsibility for their personal information, its usage, and decisions and choices regarding its use, much like any other personal decsion making process in life.
    FDA, I appreciate your concern, but we don’t need you to dictate how we use our own personal information. I believe we already have HIPPAA laws in place regarding this.

    • zar kers

      Exactly. It is obvious to anyone with a shred of intellect that this knowledge is beneficial. And certainly the benefits outweigh the spurious possible negative outcomes that probably never happen.

  • blueoysterjoe

    I am a big fan of your service and hope this all gets sorted out. The only thing that bugs me about what you have done is apparently you have decided, like Big Banks and other corporations, that you can just ignore the law because … you’re special? You are smarter than everyone else? You have a great house? Unsure. All the little people in the US have to follow the law, and so should you. You don’t just get to break it because you live in Silicon Valley and have a ton of lawyers at your disposal.
    Frankly, I think people should be able to get the information you provide and do what they want with it. If they want to do stupid stuff, that’s their right. But you can’t just ignore the law because you think you’re special.

    • Laura Henze Russell

      Do your homework on this and you’ll learn things that will make your hair stand on end about the FDA.

    • Carl

      They ARE special… they aren’t a food or a drug… or even a medical test, procedure, or device. They are a new kind of information service, and the FDA doesn’t know any better than 23andme how it should be regulated or what the law really says about the issue.

  • Larry Popelka

    I hope you fight the FDA to the bitter end on this. They have no right to tell us what information we can and cannot have. All you are doing is providing information. In my mind this is effectively censorship. The only people threatened by this are in the established medical community, which unfortunately, controls the FDA. You need to start enlisting politicians to over-rule the FDA bureaucrats – that’s how Uber and AirBnB are doing it.

  • Mrtjbv

    23 & Me started in 2007 and only applied for FDA clearance in 2012?

    Huh?

    Perhaps Ms. Wojcicki might want to address that 5-year absence from protocol….

    • Ryan Conlon

      Why should this even be under FDA’s purview? It is true that quality information is very important, but the FDA doesn’t have all that good of a record on that front either. Think of all the delays they cause. More people having this data is a good thing.

      Of course, if we want to act on it, we all must get medical professionals involved.

      FDA doesn’t belong in this area at all.

    • Timothy Jon Early

      Why would anyone think to get clearance from a group not believed to have purview or authority to regulate.

    • Laura Henze Russell

      There is a much longer story here, do your homework, and look at the FDA’s sad track record in a number of areas.

  • Gavin McLelland

    So your telling us that the FDA has an issue with The People having direct access to their personal health data, yet they seem to be perfectly ok with Genetically Engineered Foods?

    I fully support the 23andme service, as well as The Peoples free right to personal genetic data.

    I wonder if this FDA pressure has anything to do with Obamacare’ and its Genetic Testing coverage under the Affordable Care Act?… We’ll, If worse comes to worse, you can always move the 23andme HQ to Canada.

  • Timothy Jon Early

    Anne…Keep up the good work. The FDA are absolute idiots! Again an absolute waste of taxpayers money. I hope they are sequestered and have to get real jobs

  • Carol Stimmel

    I’ve been a member of 23andMe since nearly the beginning. I paid an inordinate amount for my kit (~1000), because I was adopted and wanted the information. 23andMe should be allowed to offer this service, but we should also realize that interpretation is far from perfect. The ancestry tool was so bad for awhile that it was pulled and as time passes I’m always getting different results. I’ve done my own research using different models and the 23andMe ancestry painting is certainly not comprehensive, and who knows if it’s accurate. I just ignore it, since somehow I went from being Basque to Scandinavian in just a few years. Maybe I should just send a picture?

    As far as the health information, 23andMe could do much better with providing context. People in general don’t understand statistics and “Higher Risk” may not be meaningful at all. Double the risk of a condition when your baseline is next to nothing just is nothing to get excited about.

    Finally, I am not impressed with the way 23andMe has handled this issue. I find transparency rather than political gamesmanship to be a better way (flushing out the FDA by not responding to their initial inquires in the summer of 2013). Anyway, I am glad 23andMe exists, though it has evolved very slowly and given what I know now, I might have gone with a different service.

    Good luck.

  • Akeya Barre

    thanks to Obama care

    • anneymarie

      I logged in just to say, “What?”

      Since when does the FDA have anything to do with the ACA? I hope you’re kidding because otherwise I’m scared.

    • emmy2

      Sadly, you do indeed support the FDA’s contention that some 23andMe users aren’t capable of correctly interpreting complex data and drawing valid conclusions from it.

    • concerned citizen

      What is the best forum to lodge a complaint to/about FDA wasting government resources?
      I can’t find a place to file a complaint about FDA so I’m tempted to lodge said complaint in the form of a medical testing device complaint about the ineffective function of the FDA.
      There must be a better address…to the director of FDA? congressman? president?…

      • Laura Henze Russell

        Congress and the President. Time to update our regulatory system to safeguard patient health, not medico-pharma-device industries. Put toxicology and genomics at the top of the health pyramid.

  • Mary Johnson

    I and 20 million others worldwide (1 million in the US alone) suffer from the life-taking illness known as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Despite our vast numbers, the CDC, NIH, and various other government agencies has chosen to dismiss our cause. With less than $4 million per year in US government research funding (MS gets over $140 million with half the numbers, male pattern balding receives $16 million), it now falls on us, the patients and a small dedicated group of physicians to crowdsource treatments and a cure.

    I personally, tried getting genetic testing done through a top national research hospital, but was turned down due to “insufficient need.” Without companies like 23 and Me, what chance do we have of getting to the bottom of our illness? Please do not take away our rights to understand what ails us!

  • bob Ashell

    I have limited experience with FDA, but my understanding is that the FDA only says, “you will do what you said you did.” It just means a whole lot of paperwork to say everything is the same. There might be a safety concerns. Its just a test, and its safe to the client. So the issues being raised may come from medical precisioners that feel like this undermines them. I just want to say I 100% support companies like 23andme that provide me information my doctor can’t or won’t. The medical system has failed to address a couple of my health problems that have come up in my years. And after years, they were addressed. Its scary having health problems and not having answers. If you have problems with me as a patient having more information, you don’t need to be my doctor or anyone’s doctor. 23andme hasn’t given me answers, but it has given me motivation. 1) to learn more about it. 2) to take better care of my health. I hope the FDA looks out for my best interests as an individual, instead of medical and pharmaceutical ones. Good luck

  • Jantima

    We are expecting our first child and we used 23andme mainly to determine whether we were facing any serious risks to watch for, by conceiving as a couple.

    We are very happy of the service and, so far, I feel that the information can only be helpful for us to make sure we keep healthy habits and watch for things we might be more at risk than normal.

    We cannot wait until our first child is born to have his sample collected and get interesting results about how much he inherited from each one of us. We really hope the service will continue and we are confident the FDA will make only reasonable and necessary regulations.

    Thanks and keep up the great work!

  • taryl

    always have and always will support 23andme. anything serious i would review with my doctor, and the other information was fun and informative. good luck with the fda. i think there are a lot of doctors who would like to see you put out of business in order to make money for themselves.

  • Phyllis Kasper

    The “reasoning” used by the FDA is absurd. Any difficult decision about surgery or having children will not be made on the basis of this testing alone. The test has proven to be extremely helpful to me personally & to my sister. I’m 74 & have fibromyalgia, osteoarthritis & chemical sensitivities. Having the data allows me to understand the difficulty my liver has in removing toxins from my system. Hopefully it will lead to a way to get around my deficiency of lacking an enzyme. I also expect it to get my body into a less inflammatory state in general & my sore knees in particular. In the long run, being able to lower the inflammation will lower the probability of heart attacks, strokes & dementia. Why would I not want to have this information & be able to get updates as research progresses????

  • Jane

    Since the Government is doing so well with health care insurance, they think they will try their hand at this genetic mapping? FDA, stay out of this. Your only motivation would be to try and keep us on drugs that aren’t really working to keep the drug companies in $$. Let free enterprise decide what will succeed. The public is not dumb, they will fail this if it is not true and accurate.

  • Richard Bailey

    I’d think that any concerns could be addressed by strongly worded disclaimers on the proven accuracy, reliability, or certification of the testing and medical correlations. Users should be warned to always consult medical professionals. Some of the reporting on this has been ridiculous. The idea that someone will see they have a risk of breast cancer and take drastic measures? And what exactly are they going to do “drastically” without consulting a medical professional? I had tinnitus start 2 years ago and found no hope in an endless offering of cures and reliefs. Where is the FDA on the claims by these providers and products? I have felt 23AndMe has done a good job of explaining the processes and uncertainties. Thank you for the honesty.

  • john verdon

    I heard about the FDA decision last week. My first reaction and continued belief is that the FDA is wrong to do this. It is important that all consumers feel confident in the safety of products they buy, the safety of the food we eat, and the basic soundness of the information we as consumers are given by all sorts of information providers (from medical to market information).

    However, the FDA’s decision is like saying book publishers can no longer publish medical books for anyone but health professionals in case consumers misinterpret and/or misapply what they read. The same would go if the FDA were to ban all health/medical, legal, self-repair information related web sites.

    I have been a consumer of 23andMe’s genetic analysis and was/am thrilled at the information that was provided. Every individual is responsible to consult their doctors before any form of self-medication. Yet people remain free to do with their body and health as they wish.

    Thank you 23andMe – please work with the industry to illuminate the error of the FDA’s ways.

  • V Johnson

    It is about doctors protecting their interest and power. Everyday I use information to manage my health; from scales, to blood pressure, to calorie counts on food. It is my body and my life. Years ago patients couldn’t even get access to their own medical records. Knowledge is power and power can be used for both good and evill. My body, my knowledge and not through some gatekeeper Dr have to pay.

  • Peter Vogel

    Best of luck to you. Personally, I’ve viewed my own results as presented, there is a higher or lower than average risk of particular diseases. I don’t go running off to the doctor saying “HEY DOC! I HAVE THIS!”. That would just be dumb.

    I’m intentionally disclosing these facts from my report. The average fisk for Type 2 Diabetes is 25.7%. My risk is 38.9%. Great, so instead of 1 in 4, I have 1 in 3 chance of having Type 2 Diabetes. That doesn’t tell me (or anyone) to go rush off to the doctor and demand meds. The only thing it tells me is that I should have some concern relating to it. Neither one is a 0% chance. So far, I do *not* have Diabetes in either form.

    The report also says for Gallstones, my risk is 6.2%, where average is 7.0%. I had my gallbladder removed about a year ago, due to golfball size gallstones. Yup, reduced risk, even at a low percentage, doesn’t make anyone immune. There was no indication that it was diet related. It fell into the “well, there’s a chance” department.

    Honestly, I consider the disease section on here a curiosity. I joined up for ancestry purposes. I want to know about my ancestors. Where am I from? Where are my ancestors from? Now it’s conclusive, I’m an average European mutt, just like genealogy shows.

  • Sterling Hill

    oh yes, the FDA – those wonderful people pushing the genetically altered frankenfish, those great folks who approved the use of 30 million pounds of antibiotics for feed lot animals last year, those splendid FDA people (in bed with Monsanto) who say Americans don’t need no stinking GMO labels… do I give a non-GMO fig for what they think? NO!!

  • Carl Badgley

    so many of you have no issue with a company that has willfully resisted a basic request for over 5 years, has changed, pulled, then changed again its stance on ancestry reporting; is offering little to any solid information as to what is actually happening internally; and provides no positive response to customer service complaints and requests concerning these issues?

    but you have a problem with a federal regulatory group using its investigatory powers to determine if the company is even providing scientifically verifiable data?

  • Q Wilkinson

    Thanks for the updates and we know you are doing your best for us.

  • MK Faria

    I work in the regulatory affairs department of a biopharmaceutical company. Regardless of whether you agree with the policies of the FDA (and most people really don’t have an idea of how FDA works), the need to respond to FDA inquiries is always clearly outlined in their communiques. I’m really surprised that 23andMe chose to ignore FDA attempts to gather information for so long. According to FDA, 23andMe has not communicated with the Agency since May. I’m actually surprised that the Agency did not take action sooner. 23andMe has had plenty of time to provide any information needed.
    The Agency is correct in asking for proof of validation of the tests and procedures 23andMe uses. This is simply a means of verifying that 23andMe is providing correct, verifiable, substantiated results. 23andMe surely knew, when it embarked in the business (and began advertising health benefits) that is was operating in a regulated area. If I were a stockholder, I’d be pretty upset with the lack of foresight the company has shown, and what can only appear to be –whether or not it is true– a cavalier attitude toward FDA’s requests.

  • emjayay

    If the FDA thinks you have been dragging your feet way too much, I’m thinking that is true, and as other comments here have said, your public relations press release leaves a lot of questions. So, why? What’s the point? What about Dana Ullman’s questions? What about everyone’s questions?

    I can’t even find a contact email address on the 23andme website, much less a customer service phone number.

    What is the problem with providing enough information, references to existing information on specific gene markers, references to genetic counselors, etc. etc. And if the problem is that your information looks a little like a diagnosis, it should contain lots of disclaimers. It would seem like cooperating with the FDA would be a lot better corporate decision than blowing them off and stonewalling and dragging your feet until they lost their patience.

  • Maggie Pax

    Any medical device, diagnostic or drug needs to demonstrate that it is both safe and effective. That means demonstrating that the test results — in the hands of non-clinicians in this case — are not likely to give people misleading information. This is true for glucose tests where patients could mis-dose insulin (with potentially fatal results), and it’s true of 23andme data where people could make medical or lifestyle decisions.

    There are relatively few DTC (direct to consumer) medical devices and diagnostics, and it is important that consideration be given to HOW consumers may interpret and use the data, as well as ensuring that the information has been verified, by substantial testing, to provide accurate

    I recently submitted my 23andme test and hope to see the results. But I understand why caution is required — this type of complex information is very hard to interpret correctly as to real risk levels.

    Of potentially greater concern is the fact that 23andme is not making their pool of data available to researchers for the ‘greater good’. They are keeping the pooled data proprietary to 23andme. What a missed opportunity to enable genetic researchers access to this vital pool of data!

  • Jeri Burtchell

    I JUST sent my kit in last Friday and then this hits the news yesterday? What is going to become of my sample or did I just spit into the wind?

    Honestly, if the FDA started this conversation with you almost six years ago, why have none of the issues been addressed? You can’t ignore a letter from the FDA as if it were junk mail and toss it aside thinking they’ll just go away.

    Whether you agree with their interest in seeing data that proves the accuracy of your testing or not, they are the ones you have to answer to and this delay of addressing the matter for nearly six years leaves me less than confident in your company.

    I have multiple sclerosis and I am getting by on a very limited income. Making the decision to invest hard earned money in your genetic testing wasn’t done on the spur of the moment. Lord knows I could have used that money for any number of other expenses… and no doubt I would have, had this letter hit the news a mere week earlier.

    Color me skeptical but I’ll be delighted and surprised if I get my money’s worth.

  • askalice

    I’m guessing it all goes back to Big Pharma who is in bed with the
    FDA. Think of the prescriptions that won’t be sold because they are
    harmful or aren’t appropriate or necessary. If people become more in
    control of their health the doctors and Big Pharma stand to lose money.

    Look at what they are doing with statin drugs right now. They just reset the
    recommendations so it appears everyone should be on Lipitor.

    My husband and I were just getting ready to submit for these 23 & Me tests. Just great!

  • Calken54

    I have more of a suggestion. Produce a web page so you can print your DNA in full. I’m glad I did this it was worth the $99.00. It said I was a high risk of getting Gout and I would haveBlue Eyes.

  • Jeff Baker

    I’ve watched the FDA routinely mishandle its core mission as well as attempt to unduly enlarge its sphere of influence for over 25 years. While defining the role of services like 23andme, and their place in providing health awareness has its place, the idea that informed consumers are likely to make dangerous choices based on that information is greatly overblown.

    The FDA’s Mr. Gutierrez avows that “it’s well-chronicled that patients can push their
    doctors into authorizing unnecessary procedures.” This is highly unlikely to involve tests or procedures of notable risk. I’d like to hear about how many double mastectomies were casually done based on data like that provided by 23andme. This is another example of federal bureaucracy over reach. Nonetheless, the FDA et. al. have the ultimate power to shut down any health information or service provider, so it makes sense to stay in the game and hammer out an understanding that protects the availability of this and similar services in years to come.

  • Matt L

    Direct to consumer genetic testing has the potential to massively affect the flow of money in the health system. Any disruptive technology will cause loud screams from those who stand to lose. You can guarantee they will run straight to the FDA Sheriff.

  • Patricia Simms Williamson

    Is this all of 23 and me or just the health portion? Are you still offering the other genetics?

  • Barbara Ellison

    I just got a call from a cousin today about this, so it’s the first I heard of it…I think it is ridiculous that FDA is threatening you guys..Medical Device? What? We have the right to know about our DNA..You guys are not suggesting much less dispensing drugs OR “medical devices”…What medical device?? The kit for collecting saliva?? Really?? Jeez.. I wonder if it’s really about people learning about their mixed heritage…Maybe some don’t like finding that out and are grumbling in the ears of the FDA about “health” issues rather than the REAL issue with them..just to get 23andme to go away…23andme is potentially getting rid of racism by showing people their actual heritages…How can one remain a white racist after learning they have African ancestry? Seems that would be a very difficult thing to do, IMO..
    You all stick to your guns on this.. FDA needs to be concerned with GMOs and cancer treatments that are killing people instead of allowing treatments that have been proven to at least HELP people gain more time..This is all beyond stupid…

  • Darcy Moncada Linsdell

    I agree that the FDA is likely being pressured by doctors and pharmaceutical companies. They would like to require that a doctor orders the test. Therefore they get paid. Typical American Style health care. I have used 23andme and I really think it is amazing and affordable. The ancestry information was important to me since I have never been able to trace my heritage back more than 3 generations. There is no danger to anyone using these kits. The website clearly indictates that it is not diagnostic. All results are linked to peer reviewed scientific journals. Clearly, the medical association would like to profit from this and does not want people having access to affordable information. The only negative thing about the results is that the amount of information about each condition/trait is very abundant and may be difficult for some to understand. Those with a basic science background shouldn’t have any problem understanding the results. And of course any positive results should and can be discussed with a doctor and investigated further. 23andme needs to stay open to the general public!

  • Buffalo Bill

    Thank-you for your excellent service. I have found the ancestry information entertaining
    and your description of traits and health information has been spot on. For example, it was suggested that I “may” be at higher risk of contracting norovirus and it was suggested that
    oysters “may” be problematic. Guess what, 25 years ago I quit eating oysters because I became very ill on two separate occasions. Another example, you suggested I don’t have one of the markers for melanoma….interesting, but you went on to suggest what would be proper precautions for anyone spending time in the sun. At no time did I believe that any information
    was an “absolute”. I did not subscribe to your service expecting to be diagnosed or prevent disease. I absolutely knew that we were in the infancy of genetics and wanted to support
    the expansion into all facets of life. Wouldn’t it be great after having 10-25 million people tested
    that we have information at our fingertips about relative risks.

    My daughter-in-law is weeks away from dying of Triple Negative Breast Cancer……wouldn’t it be nice in future generations after testing millions we began to see correlates with diet, etc. We all understand that most disease is multifactoral so I personally am not looking for absolutes but information that “might” lead to better decisions. Life has no guarantees.

    If there is not a “spirit” of reasonableness by the FDA after earnestly working with them
    please move to another country and continue your excellent work…..pioneering is always fraught with enormous challenges!

  • Robert Blum

    I am troubled by the ex loco parentis position that the FDA seems to be taking. One of the reasons that the cost of medical care is so high in the US is due to this type of regulation. The only way to get the test is to spend even more money by requiring the involvement of a physician.
    Why does the FDA refuse to treat us as adults who are capable of making this type of decision? Shame!!

    Robert Blum

  • caroltheartist

    I am a big believer in 23 and me, and it should be accessed by more doctors.

    I got my 88 year old Dad to take the test so I
    could get his sample to fill out my history. When his came back there
    was an interesting note – his genome type has a problem with Coumadin, a
    common blood thinner. It’s not used by their body as it is with others.

    Well three years ago he started getting coumadin after heart
    surgery and he’s never ever done well with it – he easily overdoses from
    it and it knocks him out, even small doses. His doctors finally – after
    three years – changed him to a different blood thinner but i think that
    his time with coumadin did significant damage to him in his recovery.

    Ifthey had seen the DNA results, perhaps they would have chosen a better
    solution immediately. It thoroughly pisses me off that this information
    would we be withheld from us if the FDA gets their way. That community
    seems happiest when we wallow in ignorance so they can be the ones to
    lord over us.

  • Andrew McIntyre

    Its a website. The information can be hosted anywhere in the world and the lab processes are transferable. P4 medicine is a done deal and the regulators have been working on it for years. Whats with the trolling stunt to raise awareness for the 23andme brand in the existing customer base. What is the true broader strategy here? Good governance and quality controls is the FDAs mission and this is a marketing stunt. I ask how does any of this conversation create value for the 23andMe community

    • Laura Henze Russell

      FDA does a poor job at quality control but is good at industry protectionism for Monsanto, amalgam manufacturers, etc. There are a lot of sorry FDA stories against promoting patient health, and for promoting certain industries. Commissioner Hamburg sat on the board of a dental amalgam manufacturer before heading the FDA, and a website warning they had finally posted in 2009 was removed in 2010, when they decided to finally classify it as Class II medical device, with no warnings to patients – only dentists. They overruled their own Scientific Advisory Panels, which twice called for restrictions and Class III. It’s been banned in Scandinavia, which has the highest rates of Alzheimers, and the most people with susceptible gene types who don’t clear mercury and heavy metals well.

  • Aalap Sharma

    I think FDA has no business in deciding for peoples’ own health decision. I feel insulted that the FDA think I am that stupid.

  • Hail the Resistance

    I can make my own decisions, thank you very much. FDA busybodies, leave us alone!

  • Jean-Louis Thuotte, Sr

    Jean-Louis
    I have seen parts of the FDA’s letter and do not concur with their thinking or lack thereof. All of the results are clearly marked and identified for educational NOT diagnostic use; there is also an advice to contact your health care professional i.e. doctor. I guess they are like the rest of this government’s current admiration, can’t read or tell the truth.

  • Michelle Hurtado

    I really wish we could express to the FDA how unhelpful their decision is. I believe 23andme has been completely empowering and informative. What can we do to help?

  • Charles Poncelet

    I have trouble trusting the FDA for several reasons and have less concerns with 23 and me… They must have ulterior motives that might benefit their corporate keepers. Sorry to here they are on you. Keep your head up and eyes open.

  • Patricia Ayers

    I have never considered 23 and me as the be all, end all. I would think people who are intelligent
    enough to order 23 and me are intelligent enough to ask their doctors what certain results mean before doing something drastic. I had one gene that could be passed on to my son but only if his father had it too. We checked and nothing to worry about. I agree with Carolyn Chapman, you have to be responsible. That’s more than you can say for the FDA, how many drugs and procedures have they put on the market because someone had enough money to push it through? I will continue to use 23 and me until the gov’t takes over that part of my life as well.

  • Steven Callister

    And there goes free enterprise down the drain. You don’t like 23 and me? Then don’t use them FDA. Wow! This is really about the FDA asserting its importance to the world and not about 23 and me.

  • Brian Pridham

    Thank you for sending this letter out to all of your clients.

    I
    believe that the risks the FDA cited are risks that we clients have
    chosen to take after reading 23andMe’s terms of agreement. Further, I
    understand that the FDA’s concerns are not relative to the analysis but
    rather to the clinical explanations based on those analyses and I
    believe that by getting accurate test results, I am also getting full
    (or almost full) return on my investment. If I choose to entrust the
    clinical interpretation of my results to a third party/parties, then I
    can do so.

    In short, I believe that the FDA’s action has no bearing on
    the agreement I have with 23andMe and I hope that the company will be
    able to follow through with their business paradigm. Thanks for hanging
    in there – you have my full support.

    Sincerely,
    Brian P

  • Paul

    will I still get my results Will they arrive by mail or email

  • $83483765

    As somebody who, for the most part, hates government, I think that the FDA should have no say on whether 23andMe sells these tests, regardless of how accurate/predictive are. Astrologers are not prevented from “predicting” all kinds of issues even though the so called “science” behind astrology is completely bogus.

    That said, the reason I have not ordered a 23andMe test and I am unlikely to ask for one in the future is because the information 23andMe collects is too private. If 23andMe were to offer its product anonymously, as say the Home Access tests are offered, I would be intrigued to know what the heck a DNA test can say about me. Those of us who didn’t trust collectors of private data like Google and Facebook for fear that our private data might be compromised were mocked until the disclosures of the NSA activities. Big data is great, but we should all pause for a second and ask ourselves whether we want to give 23andMe or any other company, access to our most treasured data, and that would include the behavioral data that Google collects from us to sell ads.

  • Liddy M

    You have my full support and best wishes
    for a successful outcome to this sad development.
    You provide an invaluable service from which so
    many of us have benefited on several levels.

    Thanks, again, and go get ’em!

  • Joyce Richards

    I support 23andMe and hope they continue to provide consumer genetic testing. I, too, have not received my results yet, but have received an email saying that they have my sample.

  • Frank S

    What 23andMe offers is vital for anyone who wants to be more proactive in living well. The education and insight that this service offers is phenomenal and is much appreciated. The FDA……I don’t want to even get into the political, subjective, preferential treatment, palm greasing, back scrubbing, hipocritical, etc etc shortcomings of the FDA…. Thank you 23andMe and keep trying to educate the FDA

  • Robert Burns

    I am taking in stride what I read in my newspaper about this controversy. If the issue is how to handle and disseminate medical information, reasonable people should resolve all miscommunication and any deficiency. I am, however, concerned about accuracy of test results medical and genealogical–I am here only for genealogy–as I have already come across two blatant instances of presumptive falsity: (a) being told I am of only 20% U.K. & Irish stock though my father traces 3 lines entirely to Ireland and my mother is at least 25-50% Scotch, Irish, and English and (b) I have the same or much greater genetic sharing with “cousins” than does my mother even though there is no chance that my father had any.

  • Jim Sea

    I can only guess that the FDA investigation was initiated by someone in Congress getting campaign contributions by the medical industry. I always say follow the money trail and you will find out who is behind what. The US government is as authoritarian as any when it comes to freedom of information. This is the Information Age – Misinformation and Disinformation, and Collection of Information on everything we do and say. We vote them in to represent us, sure we do…

  • Faith

    Well I just wanted to say, as one of your consumers, that I found it to be accurate and exceedingly helpful. From the genetic results, my doctor was able to order more relevant lab work (to see what was truly being affected by the defects) than most doctors typically can or do. From those labs we found that I wasn’t making taurine, the supplementing of which has gone a LONG way to restoring my health. No doctor would ever, or could ever, have guessed that without the genetic results. This has proven to be one of the most effectively accurate ways my doctor has had to quickly assess what was going on within me, and I cannot thank you enough for providing this tool. If there is anything I can do to help please don’t hesitate to ask.

  • JerryEMP

    I have my response to the FDA letter of November 22 on my web site at:

    http://www.futurescience.com/fda.html

    I know that the management of 23andMe has to play nice with the FDA, but I do not. I have spent most of my 65 years doing everything possible to avoid FDA tyranny. The DNA tests that I obtained from both 23andMe and DeCodeMe, along with information from SNPedia, have literally saved my life. I would be in a nursing home by now, on my way to an early death, without these services that so offend the FDA.

    I have nothing but the utmost contempt for the FDA. I hope that 23andMe prevails in their legal battles against these horrific tyrants in every respect.

    Jerry Emanuelson

  • Paula fedewa

    I have a kit that arrived the same day as the FDA shut 23&Me down. Anyone know if they will be allowed to process the kits already paid for by and sent to consumers? If not, will they refund money if the unopened ( and
    now useless) kit is returned to this company?
    What a mess!

  • Faith

    Some thoughts…please consider some of the advice posters are sharing in that you should probably lawyer up. All the issue may be is over adding disclaimer language; adding a waiver that people can electronically sign; and if that is not enough maybe taking down the percents…or more clearly linking to the pert. study…as well as disclaiming, “according to this study” and somekind of statement that the study’s views are its own and not the views of this site. Lawyers can help you with that as well as the wording. Having it down regardless of the FDA is probably a good idea…as well, if they escalate matters, having those there may be what wins your case. As well, please consider the possibility that these are the first steps being taken by other genetic testers (like the cancer gene test company) in order to win against you. The FDA is in truth a company insulator or protection (if they say it is safe, it becomes very hard for consumers to sue for damages…for example, vaccine injuries)…so who are they protecting here? That said, your letter sounds like you are coooperating and willing to do what it takes…as well as sounds like you are keeping your head. Realize that other companies are out there interpreting your data (and giving medical advice)…so that you don’t nessarily need to combine the test results and the interpretation on this site. In other words, maybe seperating the two services??

  • A Amit Sharma

    Well a lot of us global citizens are benefiting from a service that happens to be under the purview of FDA (whatever that is). I think your DNA analyzed for $100+ is just fabulous. however i think these FDA people are right from a perspective of :

    a. 23andme should have taken requisite approvals prior to launch
    b. they should have taken this FDA agency more seriously prior to continual matketing to people aroubd the world!

    I would put this in the category of administrative and legal oversight.

    23andme, please sort this out, government bodies and bureaucracy are a necessary systemic evil, deal with it. Make it quick please. 5 years!! Wow

  • 4mothernature2

    Over-reach.

  • Bruce Pountney

    Wishing all our support from Switzerland. I hope this FDA nonsense will be only a tiny blip in your quest to provide this brilliant service to the masses. Keep up the good work!

  • Paul Gill

    Get into Ydna Full Genome Sequencing.

    Don’t let FDA get away with this nonesense.

  • xceedsaid

    I wholeheartedly agree with all the comments in support of 23andme, it is a great service to the entire world that need to be expanded and supported not curtailed.
    I for one from North Africa, I found out so much info from the test 23andme provided, very useful not just to me but for an entire community.
    Please don’t sit on the fence – write to your representative or whoever can leverage some power over the FDA to support 23andMe.
    23andME, we are all behind you – you are doing great job, stand your ground.

  • Carole Burrowbridge

    My biggest concern is that currently using 23and me I control my genetic information. If it becomes controlled by the doctors and insurance, be it private or government, they will control my genetic information. When I pay out of pocket for 23andme as a direct to consumer service, I can choose when and how to share it. If it is treated as a medical service controlled by doctors and insurance, it becomes like every other medical record. As someone who has repeatedly had to print out the law and state statute and assert my Patient Rights to Medical Records in order to get copies of my medical records, I can see how doctors would make it very difficult for me to access my genetic information and they and the insurance or government would own it and control it, not me.

  • MP Follett

    23 & me test results indicated I have the “Diet Response’ rs101282 marker. I immediately started the Mediterranean Diet and have lost 50 lbs easily! I had been gaining weight around my waist despite diet efforts, headed toward diabetes and high cholesterol medication: not good for someone approaching 60 yrs old. I feel 10 yrs younger now! Amazing results acting on scientific data. THANKS! KM

  • Doug

    I believe the 23andMe test is an excellent screening test. Having worked in the medical field for many years I know that screening tests are designed to identify possible conditions to be further evaluated. Doctors usually look at multiple factors and often repeat tests before deciding on a plan of action. I have confidence that 23andMe can meet the expectations of the vast majority of reasonable people.

  • Chris Rogers

    FDA…let’s see Food and Drug Administration. How is this company even required to file reports or receive approval from the FDA? In our world of GMO (genetically modified foods) and amalgam fillings in our teeth leaching mercury daily into our systems, they want to waste my tax dollars shutting down this greatly beneficial service provided to anyone with health concerns? I am not even sure what country I live in anymore!

  • rollincrichmond

    I heartily agree with Ms. Chapman. Doesn’t the FDA have better things to do with their time and our money?

  • David Sarney

    I read the article in the WSJ recently and thought they presented the
    problem pretty well. I have enjoyed and used my 23andme account for
    both family ancestry and health. I received the account and kit from my
    daughter Beth as a Christmas gift almost 2 years ago. I had done some
    family research on my own but hesitated to spend too much time and money
    going through the ancestry businesses on the Internet. 23and me allows
    me to do some research efficiently and points to other places that may
    be helpful either free or at a cost. I especially have found the
    ability to check for possible relatives helpful and even got what looks
    like a hit on a 5th to 7th cousin recently that has allowed me to grow
    and fix a few errors in my family tree. Moreover, I found a new friend
    that I can chat with over the Internet. Medically,,I took advantage of
    going over my DNA results in all areas but Alzheimer’s and Parkinson’s
    (I’m 69 and at this point would rather not worry, just my personal
    opinion–there are good points both ways but I know myself well enough
    to choose not to get it–I’m not a terrible worrier but those might
    bother me too much). I’m sure that’s the kind of rational, personal
    decision almost all of us using 23andme would make. Of course, being on
    the cutting edge always presents new problems that must be worked
    through and there’ll always be some mistakes made, but again most of us
    here can “live” with that. I’m hoping that the FDA and 23andme can work
    closely together to come to a balanced decision on the best way to move
    forward. All in all, in most cases the rewards for all our futures are
    worth some risk and mistakes and help make our lives and the future
    generation’s lives better ones. Happy Thanksgiving to everyone.

    • Carl

      THERE ARE NO GOOD POINTS FOR NOT GETTING YOUR ALZHEIMER’S STATUS!
      Alzheimer’s is believed to be preventable and treatable if you catch it early. Don’t foolishly reject health information. The prevention may be as simple as exercising, drinking coffee, taking vitamins, and losing weight. So there’s no reason not to check if you need to take steps to prevent it.
      I’m heterozygous for APOE4, and I’m glad to know that in advance so I can look after my health and talk to my doctor.

  • Kevin Norton

    Welcome to regulation nation! It is all about the government sticking their nose in everything. Geez

  • vowels

    What’s remarkable to me is that neither the email sent to 23andme customers nor the two 23andme blog entries referred to in the email actually state what the FDA warning is. As such, these blog entries and the email come across as exercises in damage control. It would have been so much simpler to provide a link to the FDA letter or an article in an outside news source, and to provide a straightforward summary of the letter and an explanation how the problems with the FDA might affect current and future customers. Instead we have what appears as double talk from 23andme.

    • Laura Henze Russell

      Just Google and you’ll pull it right up. The FDA has a poor track record on a number of products and actions, by the way, enabling dental amalgam, and shutting down some promising companies and therapies that then offshore to Europe and beyond.

  • Yogi108

    I believe folks who navigate to this site will have a strong bias (as do I) to support 23andme, which is borne out by the comments. Salient points:
    1) 23andme needs to let folks know if their kits will be processed in a timely manner, or if that has been suspended;
    2) 23andme should have been more on the ball with responding to FDA letters;
    3) Textbook case of government intrusion into our lives, ostensibly to ‘protect us’;
    4) FDA is only authorized to act in US; 23andme could conceivably relocate to offshore location and provide same services with no FDA intrusion;
    5) (redundancy alert) Biggest lie of the past century: “I am from the government, and I am here to help.”

    • Laura Henze Russell

      I expect 23andMe doesn’t yet know how it will play out re #1, and will let us know when they do.

    • Yogi108

      On the plus side, there is no such thing as bad publicity. This was widely covered by the press, so I imagine that once the green light is lit once again, 23&me will have a plethora of new orders….

  • encierro

    Please sign the petition below directed to the FDA and let them know of your concerns. Support is critically needed in this matter.

    https://www.change.org/petitions/fda-administrator-margaret-hamburg-don-t-ban-home-genomics-kits

  • Phil Jones

    My cousin died earlier this year because she had a bacterial infection that the doctors couldn’t treat because they couldn’t identify it.

    It’s trivially easy to identify bacterial infections. We do it all the time at my work. You use DNA-based methods such as PCR or a DNA microarray. Or you can just sequence all the DNA. It’s fast, cheap, and accurate.

    Almost no one does that in American hospitals, and tens of thousands of people die every year in America, because the FDA will not approve general DNA diagnostics, because their approval system assumes that every test must be validated for every specific pathogen it can detect. So instead we use expensive immunological tests that take days, cost hundreds of dollars each, each test for only one pathogen, and are completely unreliable. They are strictly inferior on every measure, but we’re stuck with them by the FDA. No one will ever put general pathogen PCR testing through FDA approval because it would cost, literally, trillions of dollars, and yet the resulting test cannot be patented.

    A fellow came to my workplace a while ago and gave a presentation on a new microfluidics-based PCR system that can do nearly-instantaneous pathogen identification in the field. They’re making them for crops, for farm animals, and for use in Africa, but have no plans to ever make it available to humans in America, because of the FDA.

    I’ve had several medical conditions that are considered untreatable in America humans, but for which my doctor told me about a treatment available in Europe, or for dogs or horses, but not for humans in America because of the FDA. I have several times had to buy black-market drugs from Mexico and administer them to myself because the effective, proven treatments had never been approved by the FDA.

    The FDA kills many more people than it saves. It’s good to have a government agency that evaluates drugs and devices, but there is no need for them to have the authority to ban either. Any American should have the freedom to use any medical drug or device they choose, after being informed of the risks.

  • GG SanDiego

    Editorial appearing in the San Diego Union Tribune, Nov. 28, 2013

    FDA halts wealth of info on ‘me’

    Intrigued by the thought of getting some cutting-edge genetic information about me for only $99, I signed up for a 23andMe genetic test kit (“FDA orders company to stop sale of DNA test kits,” Nov. 26).

    Within a few weeks my kit arrived, and I mailed it back. My genetic information arrived electronically. Using my unique name and password, I read a wealth of fascinating data about me. It wasn’t about lab rats, or a controlled study of select subjects. It was about me, down to the natural color of my hair and eyes.

    Genetics is a fascinating new frontier, and I was excited to be receiving genetic information about me. Could I have handled bad news? Sure. It would give me time to plan accordingly. Would I have gone to my doctor for a second opinion if the results were troublesome? Of course.

    The information I received about me was far superior to anything I could find on the Internet. Self-diagnosing via the Internet is rampant, and I haven’t heard a peep from the FDA on that front. FDA, lighten up. Don’t kill this innovative company. People are adults. If they can’t handle knowing specific and accurate information about their genetic makeup they won’t get their genes tested.

    subscriber
    San Diego

  • Odog55

    What I don’t understand is why Ms. Wojcicki has chosen to “dodge and weave” with the FDA and the public? This is a business and like most business, it falls under government regulation. If they can address the FDA’s request for information, then do so. If they feel they don’t need to then say so. It seems they simply chose not to respond to the FDA at all. If they think the laws the FDA are enforcing governing this testing are antiquated, then get congress to change them. It seems this will likely be litigated, if so say so and mover forward. The evasive “answer” in this blog is non-responsive.

  • tonobungay

    There has got to be some proper bureaucratese disclaimer that makes the difference between a medical claim and what this is: a really cheap you-get-what-you-pay-for test for a variety of genes coupled with some over-simplified explanation of what the medical literature says about that gene. It’s more accurate than that other diagnostic tool where my doctor asks me about my ethnicity and which relatives got which disease. Apart for some suggestions about my diet, which he might have made anyway, my doctor took no action based on my report other than ordering one for himself.

    However, any public health policy based on the superiority of ignorance over imprecise information is seriously flawed.

  • Tim Mahoney

    I would think the FDA would better serve its mandate by applying its limited resources to investigating and regulating foreign fish farms that routinely maintain aquaculture with massive dosages of veterinary antibiotics and export the product to every major grocery store chain in the US without so much as a warning label as opposed to regulating scientists trying to bring additionL knowledge about the human genome from voluntary participation of citizens.

  • Glenn Barres, Jr.

    I am not worried and I am still pleased with teh service and results I got from 23andme. Just do what you need to do

  • Autumn Foghamar

    Frankly, I think the FDA is acting in a hysterical manner and I trust that you will move forward to resolve this with them. My brother and his wife have sent off for kits, I had my daughter tested, and a number of my friends are waiting for their kits. I approve of the fact you give people the best possible information based on the existing technology.

  • Autumn Foghamar

    I will add that there have been so many hits that had I known this information 10 years ago I could have been spared many problems or have been able to address them differently. I’ve had so many “hits” on problems that developed long before I took this test. The information is remarkable and I appreciate the continuing rollout of data.

    Honestly, I have to agree that the FDA has lost their everlovin’ minds. This is my DNA and I have the right to know what potential problems I have – and what has missed me. It doesn’t change my relationship with my doctor at all.

  • Liz Schroeder

    23andMe has affected me and my family in more ways than I think the FDA realizes. I am a graduate student in genetics at Yale, and probably like most grad students I’ve struggled with how to relate what I do every day to my family. 23andMe has given me the invaluable opportunity to share modern genetic research with my family on a level that is immediately relevant to them. The information we gather from ANY genetic test (FDA approved, patented, or not) is only as valuable as a patients’ ability to understand that data and its relevance to his or her disease risks. I think that by making genetic information accessible and understandable, 23andMe provides an invaluable service that moves the population closer to being able to interpret and apply genetic information. The moments that I spend discussing 23andMe results and quizzes with my family gives me hope that one day the entire U.S. population will learn and benefit from the type of information that you provide. I stand by your mission as a customer and student.

    Sincerely,

    Liz S.

  • Brin

    I think is outrageous that FDA would consider a saliva kit as a Class III device or De Novo. Why FDA would not have the same requirements for Quest Diagnostics. Double standards? Funding agencies as well as regulatory agencies have been failing us by blocking innovation and only authorizing studies that fit their paradigm of interest.

  • So… The BIG question in MY mind is:

    Will testing still continue?

    I’m awaiting my results and would LOVE to know!

  • Gaby

    I received my confirmed shipment email the DAY before the news broke. It was my Christmas gift! I would really love a response to the debate of ‘processing’ vs. ‘ordering.’
    If kits are still floating around, will the work be carried out? Will I get a refund?

  • Sue Bennett

    The FDA has once again overstepped their bounds and is violating basic constitutional rights, such as freedom of speech and information. Why shouldn’t we have the basic right to obtain information about our genes. This isn’t a medical procedure and it isn’t a drug. We need a major revision to our laws on supplements which are based upon a lie – that natural supplements don’t treat, prevent or cure diseases – there is too much solid research now to the contrary. Obviously broccoli and cruciferous vegetables can reduce risk of cancer but the FDA prevents food companies and supplement manufacturers from saying so. I think they should limit their activities to shutting down products proven unsafe or harmful – but wait. . . .this would put most pharmaceutical companies out of business. . . Statistically the amount of people harmed by prescription drugs and by additives the FDA allows in foods far outstrips any harm (if any) done by supplements and natural foods.

  • Gayle

    I am curious what those two letters from the FDA questioned. It’s surprising that 23andme did not or could not respond in a timely manner. Was this yet another get-rich-quick scheme? My daughter has spent in excess of $2000 purchasing these as gifts for family and friends, We should have realized there was something wrong when the initial price of $299 suddenly did a nosedive down to $99. It’s quite likely 23andme realizes they are in trouble — the reason for hastily sending emails to all.

  • SpamJay

    Considering that many of the people who advise/work for the FDA and/or the
    CDC are also board members for the various companies they are supposed to
    protect consumers from, I no longer believe any word that comes out of either
    agency. In addition, I believe that their main aim is not to protect or even
    inform consumers about harmful additives, chemicals, drugs, etc. but to funnel
    as much money to the medical and chemical establishments as possible.

    Consider this for example: if the FDA truly had the consumers’ back, they
    would mandate labeling of transgenic foods, as well as what types of chemicals
    that food was treated with before it ended up on our tables. None of that is
    happening in the U.S. the way it does in Europe. Not saying Europe is better in
    everything, but U.S. infant mortality is double that of most European nations,
    so you do the math.

    If anyone is dumb enough to use a 23andme report as the only means of
    diagnosis, then that is their problem. But for the FDA to want to stick their
    nose into a privately run company’s business is inadequate in this case. They
    need to go regulate the “weight loss” and supplement sector first
    because it is ripping people of and causing much more harm than genetic testing ever will. Both my wife and I had our 23andme testing done and the results were spot on and allowed us to finally conceive after we found out what the problem was (MTHFR, Factor V, etc.). So FDA-approved testing or not, I could care less. We received much more information for a measly $99/person than we ever did with testing done through the medical establishment (who was milking our insurance to the tune of thousands for a couple of FDA-approved tests, some of which even turned out to be giving false results).

    I’m so sick of this money-grubbing!!!

  • W.c. Varones

    Screw the overreaching FDA. This is a clear First Amendment case. Send those government goons back to the Soviet Union!

  • PC Tactical Wargamer

    ok so my test results came back for my family. It indicates I have the worst Alzheimer genes possible yikes! But good to know…. What further testing should I have at this stage (44 years of age) to confirm my risk assessment? The genes I have indicate a distinct possibly of an early onset of Alzheimer’s.

    • Alpentrudel Alpi

      Any relatives like sisters, parents, grand-parents, aunts or uncles who have or had Alzheimer disease?

  • shawn

    I had a kit for my dad still out ,it is being processed and was expecting it in a week or so but i’m not sure now:/ it also appears that they are still selling kits?! I was planning on getting one more for another family member but think ill wait to try after this thing gets resolved…I know my medical results were pretty spot on with what I already know.. I hope they can still offer this service at such a good price. I dont know of any other dna company that also gives you ydna and mtdna along with ancestry and everthing else ,that is huge.

  • shawn

    I had some trouble getting my comments to show up so if this duplicates appologies….I still have a kit out that Iorder for my dad ,was expecting the results in a week or so but not sure now. it also appears that they are still selling kits?? I was planning on getting one more for another family member but think i’ll wait till this is resolved . I know that the medical on mine was spot on with what i know, i hope that they can still offer this service at such a good price.This is the only dna company i am aware of that give y-dna and mtdna results with the ancestry and everything else,this is huge.

    • Carl

      Don’t wait. Order while you still can. You may not get another chance if the FDA gets their way.

  • I do wonder why the FDA is so concerned about the accuracy of 23andme’s $99 genetic lab work. The FDA have approved countless medical screening tests that they and the medical profession know are of dubious quality, but are very cheap. Cheap screening followed up with more accurate lab work to confirm a positive result is the mainstay of medical practice. No doctor worth his salt would grab a scalpel and start cutting off body parts on the basis of a $99 test he didn’t order, clearly the patients concerns will either be confirmed or otherwise by additional tests and examination.

  • 23blog

    Shawn, Could you direct your questions to our Customer Care team. Go to this link to find the form to email questions to the Customer Care team – https://customercare.23andme.com/anonymous_requests/new?reference=via_search_box.

  • 23blog

    You should talk with your doctor. Remember even having the higher risk mutation does not mean that you are going to get Alzheimer’s.

    • PC Tactical Wargamer

      Thanks…..wondering if I should test again with another company just to ensure the results are accurate. Can anyone suggest further type of genetic tests?
      My Alzheimer genes seem to indicate early onset. From Canada so seeing a doctor with rationed health care – well they have no idea about genetic testing. He mentioned – oh hey too bad maybe take Vit D. Pathetic huh?

  • 23blog

    The email to customers and post were an attempt to address the issues we felt we could address. As our CEO said there are many questions to our customers have that we do not have the answers to. We will answer them when we can.

  • 23blog

    Faith, 23andMe does not diagnose illness. We look at genetic markers that are associated with risks. Using those markers we can give you a genetic risk for certain conditions and traits.

    • Faith

      Yes, thank you, I do understand that. However, no matter how right that may seem to you or I or everyone else, the finite-ness of the law may be trickier than this (why I suggest that you at least consult a lawyer, because I very much want 23andMe to continue). While I am unsure of the un-authorized practice of medicine law…and it seems a bit liberal as nurses are writing prescrips now and physician’s assistants are indeed practicing medicine with what appears to be no-oversight…the laws on the unauthorized practice of law are clearly defined. The case that decided what was the unauthorized practice of law had to do with a paralegal (an attorney’s assistant to compare to physician’s assistant), when a client was filling out divorce papers accidently checked the wrong box, the paralegal pointed out that they may want to re-look at that…and that was deemed the unauthorized practice of law. My guess is that even providing those connections (which you appear to be pulling from all the known studies, and I have no problem with) may very well fall into that gray area. Lawyers can help find you the legal arguements and protections to keep your site up and even possibly get the FDA’s blessing. I have much appreciation and gratitude for your service…it has greatly helped my doctors help me and my health is doing much better today as a result…so thank you, thank you, thank you…and keep up the good work.

  • 23blog

    Jeri, As our CEO stated we are working with the FDA and we are committed to the process.

    • Jeri Burtchell

      That is an extremely frustrating answer on two counts. 1: it’s a little late to be committed to the process. If that had come from the start you wouldn’t be behind the eight ball like you are. 2: you didn’t answer the question that many of us have posed about whether or not kits purchased will be processed.

      There are many “be patient” comments from other consumers, but did I miss the one from 23andme addressing this legitimate concern?

  • 23blog

    Emjayay, We have a Help page. There are answers to frequently asked questions there. If those do not address you question, you can then contact Customer Care directly. Here is the link: https://customercare.23andme.com/home. As our CEO said in her statement there are still questions for which we do not have the answers. We’ll address those when we do.

  • William Johnston

    i love my DNA, and i enjoyed seeing my 23andme results. i have encouraged my local legislator to pass a law that makes it a CIVIL RIGHT for a person to have DNA and medical information.

  • Amber

    Why is 23andme still selling kits if the FDA has ordered them not to? I’d really like to buy some for Christmas, but I’m afraid to spend the money just to find I can’t get the results back. Clarification please, 23andme!

  • Paula Fedash

    Me also!

  • Gear Mentation

    The FDA seems to be a struggling both to fulfill its mission to keep us safe, and also struggling badly to keep up with changing technology. One can only hope that it gets its act together, because genetics is now an information technology, and our capacities with genetics will therefore grow exponentially, as they have the past decade. If the FDA doesn’t allow safe and effective access to this technology, that will not mean that people go to their doctors. It will mean that we create our own tests, which will have NO quality control. If the FDA wants to keep us safe, it should authorize public access rather than create an opportunity for completely uncontrolled home-brewed genetic testing.

  • Valerie Olague

    So is there anything we as users of 23andme can do with respect to FDA? I work in the embedded business and understand all of the issues associated with FDA approval of medical devices. Stringency is great when it keeps people from being killed. But it is stunning that the FDA is calling 23andme a medical device — they are severely stretching the definition and clearly are mischaracterizing what a ‘medical device’ is for a consumer-used service that provides genetic information. There is no life or death implications for using this service, it is information only and is marketed as such.
    If 23andme is interested in getting any kinds of petitions or user input for whatever reason, I’m here to provide it for sure.

    • Laura Henze Russell

      Call your Congressional delegation and the White House, sign the White House and Change.org petitions, contact your news media to tell your story, etc.

      We need a clear definition of a medical devices as things installed in the body or that pass through the body (like an xray, CT scan or MRI).

      Then two levels of testing: diagnostic, and educational/informative, with the former highly regulated.

      We also need actual real medical devices to have similar requirements for prescription drugs – inserts to patient on materials composition, potential health impacts and mode of action, potential side effects and % reported in tests, where to report adverse events. We also need specific informed consent for all medical devices.

      FDA should be stripped of its ability to regulate medical devices and transferred to the EPA, or a new Toxics Control Agency (Human Healthland Security Agency?) until they ban dental amalgam, as mercury off-gases over time with heat and abrasion, causing needless chronic diseases in genetically susceptible children and adults.

  • Ken Willette

    I agree with zar kers post on Wednesday 11/27/13/@ 11:41 PM. Intelligent people should take this information and put it to use by discuss it with medical doctors, getting retested, and then make an informed decision thereafter. Knowledge is power. To choose ignorance is to choose stupidity.

  • patriot (oops the IRS will cal

    interesting they are told to quit marketing at the same time the FDA approves genetic testing by Illumina from

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htm

    FDA Clears Illumina’s ‘Next-Gen Sequencing,’ Cystic Fibrosis Dx

    San Diego-based Illumina will begin filling
    orders for its high-throughput gene sequencing tests and two other
    diagnostics by the end of the year, following FDA 510(k) clearance of
    all four devices.

    The agency called the clearances a major
    advance for personalized medicine. Used together, the Illumina MiSeqDx
    instrument platform and Illumina Universal Kit reagents will allow
    laboratories to sequence and validate any part of a patient’s DNA to
    look for abnormalities. They were cleared through the de novo process
    for novel devices that do not pose a high risk to patients, based on
    safety and efficacy performance “across numerous genomic segments
    spanning 19 human chromosomes,”
    the agency said.

    CDRH Director Jeffrey Shuren called the
    clearance a win for personalized medicine and regulatory science.
    “Knowing the potential of next-generation sequencing to advance
    personalized medicine, FDA researched next-generation sequencers to
    understand how they work and their likely limitations,” he said. “By the
    time Illumina … walked in the door, FDA had the expertise and tools
    needed to timely review the submissions for the next-generation
    sequencers.”

    The company’s two cystic fibrosis detection
    tools also garnered 510(k) clearance. The Illumina MiSeqDx Cystic
    Fibrosis 139-Variant Assay checks a patient’s gene sequence to determine
    what variant of cystic fibrosis he or she may have, while the Illumina
    MiSeqDx Cystic Fibrosis Clinical Sequencing Assay examines a large chunk
    of the patient’s cystic fibrosis gene to understand how it differs from
    a reference gene. To obtain clearance, Illumina submitted data on both
    diagnostics compared
    with human reference genomes.

    • Laura Henze Russell

      What is the cost of that test? I’m sure its great, just beyond the reach of many. It is “relatively” “easy” to get approval for tests for one condition and its markers, but for the whole ball of wax, would be prohibitive, expect we’d all be broke and/or expired before completed.

  • Therese Tomlinson Hostetter

    So can we still purchase the kits or no?

  • 6161940

    I was thirty before I found out that the man my mother was married to was not my father. Even though I know, she refuses to tell me anything about my father. This has gone on for 40 years and even though I have asked her to just tell me his nationality, she still refuses. When I heard about this test, I thought my prayers had been answered. It was received and analysis began on 11/22/13. If the FDA stops this, I don’t know what I will do. 40 years of wondering and now with just a few weeks to go, it could all be stopped. FDA, mind your own business.

  • Kernos

    I would be as interested in your comments concerning the article in Scientific American: http://www.scientificamerican.com/article.cfm?id=23andme-is-terrifying-but-not-for-reasons-fda

    Further, by charging for this test are you not leaving out a big chunk of human data–that from those cursed with poverty?

    • Laura Henze Russell

      Call Congress and ask them to include full gene sequencing in Health Care, and see what reaction you get. Medicare and Medicaid should cover it, it will save them billions. Employers should cover it, it will save them billions on health care insurance, and on time lost to chronic conditions and long-term care for relatives with needless chronic disease. 23andMe has made the test available at incredibly low cost. Read comments on Forbes’ posts on this if you want some interesting comments from diverse stakeholders.

  • Carl

    23andme is more trusted and reliable than the FDA. I’m not even in America, so the FDA should stop interfering with my right to learn about my own body. The FDA has a strong reputation for holding back medical research, drug development, and new treatments.
    This is a completely safe and non-invasive test, it is more accurate than most medical tests, and it doesn’t try to diagnose or treat any disease. There are no possible safety issues or risks. And there are huge benefits for many customers’ health because it encourages them to take better care of themselves. There are also huge potential benefits for the medical research process itself.
    When it comes to things the FDA actually should ban, the FDA allows all kinds of outrageous anti-science health fraud and quackery, such as homeopathy, chiropractic, osteopathy, scientology, falun gong, reiki, etc. And nonsense health claims like “natural”, “gmo free”, etc.

  • gogo

    What is the official response directly from 23andme regarding whether pending test results will be delivered as ordered? I can’t find it anywhere. I’ve seen the PR response, but no definitive response on what status of pending orders is at this time. If I don’t get the full results panel, then I will definitely want a refund and will go with another company.

  • rkamai

    It is easy to imagine strong arguments on both sides of the 23andme v. the CDC issue. The big question here is why 23andme isn’t more transparent with its users and the general public about what they are doing and intending to do. The rampant speculation fostered by blogs and the media would be best dampered by real and candid information from 23andme. This company is ostensibly about allowing us all to be better informed… why not expand that to include this issue?

  • David W Edsall

    as a physician who has been recommending 23&me to my patients,I am very concerned about this issue. 23&me had better be careful to have no hint of scamming or hyping like the food supplement industry.
    At the same time I think the FDA is corrupt political and subject to bribes. Look at the droperidol and Sugamadex events. looks like bribes to me No sense to ban drugs that safe 1000’s of lives or complications because of an issue that might harm an infinitesimal few.

  • Dilanka Wettewa

    Personally, I think it’s a FANTASTIC idea to have some 3rd party entity have oversight into the accuracy of 23andme’s testing process. How many of you KNOW for sure that the $99 test results you received is in fact ACCURATE? What if it’s not? Are you seriously going to base life altering decisions based on those results?

    I believe 23andme has the best intentions — but, I am not smart enough to know if their testing process (and results) are in fact accurate.

    Having a 3rd party to monitor/audit 23andme’s testing/lab protocol is GREAT….But, the FDA (..or anything else starting with the word “Federal”..) might not be the best entity to carry out the task.

  • Donna Pryor

    I wisht the email 23andme had sent out had been more informative. This update didn’t tell me anything and now I am wondering if I will ever get my test results. I think the FDA is wrong for holding this company back from testing our samples and giving us complete reports. However, 23andme needs to be specific about what is the actual complaint(s), what they are SPECIFICALLY doing to resolve them, give their customers an estimated time line or the opportunity to request a refund. I am very disappointed in how they are handling this issue with their customers and I am angry that the are not telling us anything that is helpful.

  • Brian Hickory

    Why not just move off shore? The Feds want to block progress, let them leave US behind. I also suggest everyone start learning Chinese.

  • Beavis71cox

    @AnneW……it seems to me, that the FDA is concerned with how your website s worded, such as “your risk” and others……it would be possible to change the wording of your website and still provide the same information without being diagnostic…….for example, I can download my raw data at FTDNA, go to GedCom, and run it through their SNP analysis program. I can then take the results and reference to free public SNP databases and find the same studies and results you give. So maybe if you sell your genealogy part for $99 to everyone, then offer the health part as a free upgrade…..you are no longer selling a medical device, but providing free info…….as far as wordings go, instead of listing “risks”, you could just list the diseases. Instead of increased risk, list them as “studies more important to you” and “studies east important to you”. And then on each disease page, instead of listing “you risk”, say something like “your SNP was found in such and such study, and it was found that the people in the group had an (increased or decreased) percentage for risk of the disease.

    In this way, you would no longer be offering diagnostic information, but instead referencing all results to known public studies, and you would be doing it as part of the free health upgrade……..just a thought, but I think it could work

  • Carl

    You couldn’t be more wrong. There is no possible way of meeting the FDA’s insane requirements. It would cost billions of dollars and take 20 years. Not just once but for every update.
    The only thing 23andme can do is keep explaining to the FDA why what they are demanding is insane, and why the FDA is acting outside it’s authority. And keep stalling until they have enough public support and it is a fait accompli.
    Or they can relocate to a free democratic country outside the reach of FDA tyrants.

  • Rick

    I personally, have found the results to be valuable and so far, accurate. I have supplied my results to my doctor also.

    I am concerned about this report and hope to find 23andMe vindicated. I have two people that wanted to do this and I was going to gift but now am waiting to find the true underlying story.

  • Scott23H

    Paul, We do not mail people results. We do let you know when your results are ready. You log in to your account to see your results. You can also download your raw data from your account.

  • Scott23H

    Maggie,
    We actually have a research portal that allows outside researchers to access our data. We’ve also entered into several cooperative research projects with other researchers. (https://www.23andme.com/researchportal/)

  • Kathryn Wolf

    Let’s just expedite the results, people.

  • Larry Popelka

    Check out my Bloomberg Businessweek article on why government regulators are shutting down start-ups like 23andme – its all about protectionism for old-school companies, and it’s hurting us all.
    http://www.businessweek.com/articles/2013-12-02/what-do-government-agencies-have-against-23andme-uber-and-airbnb?

  • jimkress

    You already have the right to know. The government has no Constitutional authority to keep you from knowing. If Congress is going to do anything, it should restrain the FDA from these types of Unconstitutional power grabs.

  • AnonymousArizonan

    It isn’t socialized medicine, it’s an insurance scheme lyingly made out to be socialist medicine so Communists/socialists/corporatists will back it.

    • eric braun

      so, with “capitalized medicine” if you don’t have money you can just go die, right? how is survival of the fittest supposed to work if the poor can’t get fit?

      and, as if ayn rand didn’t take SS after she got cancer (which, as a right-wing lunatic she blamed on liberals rather than her smoking)…PFFT!!

  • AnonymousArizonan

    Wrong. Those patents are bye-bye. It was ruled they can’t own other people’s genes to prevent them from seeking second opinions, other test sources, or other doctors.

  • Jiri Dluhos

    Please keep fighting, don’t allow bureaucrats to stop you! I mostly consider FDA pretty sane, but this case seems to be an exception. 🙂 Your work is extremely useful, not only for the data it provides, but also that it shows that crowd knowledge can advance our knowledge! This is, I believe, crucially important. Good luck 23andme, we are with you! (Or at least I am.)

  • AnonymousArizonan

    DNA testing/genome mapping is not medical, and is not comparable to medical things.
    Laws on food, drugs, and cosmetics can’t touch 23andMe, and would have no business discussing such businesses at all.
    Such businesses need their own laws, designed to protect people from their DNA being used without their consent, let alone patented, or profited off.
    I think the FDA is trying to get the DNA from 23andMe for it’s true owners to do exactly those unethical actions with it.
    There is a dire need for a law to be written, passed, and put into affect stating that only those carrying a gene legally own it, and that they must all give consent for it to be used for profit, cloning, or insertion into GMOs (that must be specified to include “designer babies”). And, this law must be not only nationally enforced, without exception, and with the highest possible punishments for breaking this law (execution would be best – scientific rape, and kidnapping deserve to be considered among the most horrific things a scientist could ever do), but arrangements must be made with other countries to make their scientists also adhere to this law concerning citizens of countries with such laws.

  • WotAWarld

    I don’t know about US English, but in Canadian English and English English reporting on a risk of something happening is not saying that it has actually happened, does not prevent it happening and does not fixing up the results of it happening.

    So that stating there is an increased risk of something does not cure, mitigate, treat, prevent or diagnose anything.

    Next thing the FDA will outlaw people telling each other, “You’re fair skinned, you should use a strong sunscreen.”

    “And any kit intended to cure, mitigate, treat, prevent, or diagnose a disease is, according to federal law, a “medical device” that needs to be deemed safe and effective by the FDA.”

  • WotAWarld

    Kernos, there is nothing stopping you from doing charity yourself and donating testing kits to poor people.

    Charity is primarily something we should do ourselves, not something we should tell other people to do (unless they are enormously wealthy, Steve Jobs was).

    But if you mean scientifically, I think more human data is left out by which geographic regions of the world it is marketed in, but that is relieved by various governments, drug companies and universities doing studies around the world.

  • WotAWarld

    The thing is that those are narrow tests looking for just a few things related to cystic fibrosis.

    A test that looks for a few things is comparatively trivial to validate.

    If Illumina wants to market another test, say for MS, the FDA will make them get another round of FDA approvals.

    This would be fine if each FDA approval was relatively streamlined, but it apparently is not.

    Say $300,000 (and it is probably much much more) multiplied by the thousands of disease risks computes out to something even big pharma could not afford, over $300 billion.

  • WotAWarld

    I view 23andMe test results as (a) suggesting questions to ask my doctor about and (b) suggestions of topics to read up on on my own.

    I have never viewed 23andMe test results as being diagnostic. It says right there in the text on the results pages that results are not to be used for diagnosis.

    Certainly the fonts used to make assertions and cautions about the tests not being definitive for diagnosis are big and clear enough on the 23andMe website. IF the FDA wants them in more places or in plainer language, then fine that is reasonable.

    “And any kit intended to cure, mitigate, treat, prevent, or diagnose a disease is, according to federal law, a “medical device” that needs to be deemed safe and effective by the FDA.”

    And on its own, no diagnostic test of any kind marketed by anyone anywhere at any time is ever curative or preventative. So what in the world if the FDA on about?

    If they are not merely want changes to the placement of existing cautions, and maybe simplified language, then I could only guess bureaucratic empire building or maybe protecting big pharma.

  • Alexa

    As a long-time scientist in the pharmaceutical industry, 23andMe’s battle with the FDA frustrates me. The knee-jerk reactions to the FDA’s legitimate concerns in this blog sadden me. True, the FDA’s published comments about possible needless mastectomies were unduly alarming, but I believe they reflect the agency’s frustration with Anne Wojcicki’s “damn the torpedoes, full speed ahead” attitude, which endangers the entire field of easily available genetic testing. It shows a reckless disregard of her obligations to her employees and investors. The FDA-drug industry conspiracy folks fail to realize that 23andMe is a FOR-PROFIT company. They pushed out and widely marketed a test that was not fully validated (fully tested for accuracy, etc.) BECAUSE THEY NEEDED TO MAKE SOME MONEY. You can’t run a company with high research costs without some cash flow (money coming in). They antagonized the FDA with their blatant disregard for generally accepted scientific standards, which makes the folks at the FDA dig in their heels. The FDA has made some huge mistakes in its history, but in general, it is made up of good people trying to do a very difficult job. Anne, genetic testing can’t be done in an HP garage. Grow up.

    • ChristyPeck

      As a long-time pharmaceutical industry scientist you are no doubt aware that pharmaceutical companies are also FOR-PROFIT. The difference being that 23andMe is smaller, newer, and less politically established than most pharmaceuticals who have been working with the FDA over the years. With healthcare costs what they are in these times there is an urgent need for preventive approaches to health care. The availability of genetic tests are simply one means to that end. Please don’t underestimate the public’s intelligence and ability to understand the limitations of usefulness of the results of 23andMe’s tests.

      • Alexa

        ChristyPeck, All of my pharmaceutical industry experience has been with “smaller, newer, and less politically established” startup companies. I completely agree with the need for preventative approaches to health care. The biggest roadblock to affordable preventative care has not been the FDA, but the fact that Medicare and private insurance companies have resisted paying for such care and testing. The problem I have with 23andMe is that much of information (linkage of the presence of certain genes or SNPs to the propensity for various diseases) has not been fully vetted by the general scientific community outside the FDA. The general public unfortunately may not be able to understand this limitation on the results, a fact I blame partly on the shameful deterioration of scientific education in our secondary schools. That being said, I stand by my point that 23andMe’s recklessness may put up unnecessary walls for the rest of the more responsible genetic testing industry. Being new on the scene is no excuse for being politically stupid.

  • Ramin

    It would be good if you give an update on the FDA situation, especially regarding the samples which you received and were already paid for. I haven’t seen anything since the 26/11!!

    Thank you.

  • Brill Pappin

    Does the FDA claptrap effect customers from other countries (like Canada) on only US sales?

  • Corey Chambers

    23andme simply needs to adhere its marketing verbiage to comply with the FDA requirements. I see no words in 23andme’s marketing that specify or imply that the tests “diagnose”, “treat” or “prevent” disease. 23andme is therefore currently in compliance.

    Alberto Gutierrez is in charge of the FDA’s complaint against 23andme:Office of In Vitro Diagnostics and Radiological HealthDirector: Alberto Gutierrez, Ph.D.301-796-5453

    While the FDA often seems to error in saying that everything is a medical device, the FDA will likely come to agreement regarding the personal, non-medical nature of 23andme’s personal genome service.

    Corey Chambers, PrivateGene.org

  • Valerie Olague

    Unfortunately we don’t get to decide what is and is not a medical device. Although I’m astounded that the FDA would consider this service a device, when you read the regulation and it’s description it is clear that they have defined a device to be much broader than a physical thing that can be inserted into a body. Insulin pumps are medical devices and there a lots of things like MRI systems that are not inserted but are clearly medical devices. They have also left it open for non-hardware kinds of things.
    Someone else has mentioned that the issue here is 23andMe marketing, not the service. And the FDA letter does specific that it is how 23andMe is marketing the rest results that makes it a medical device.
    Have the marketing leads for the company considered changing the marketing statements to include wording such as another replier recommended is being used to market dietary supplements?
    I will of course petition, but we need to be real that the FDA is out for power and money. Ignoring them is not an option, nor is telling them that as defined today 23andMe is not a medical device.

  • kelly

    stop hiding under your desk and communicate with your customers!

  • Rodney Wilder

    I sent in my kit a month or so back and received first results late last week, and my family information today. All is fine, I just don’t think they are currently allowed to sell the kit in the USA for now until the fda issue is cleared up

  • Chi

    Howt does the FDA involvement, impact Privacy? Will my data be kept private, or does the FDA believe it has a right to access my data?

  • Chi

    I was told the Government refuses to allow any but Registered Native Americans to access definitive DNA tests that can identify tribe and %. Isn’t that discriminatory?
    HOW can we access having THOSE DNA tests done?

  • Chi

    Exactly! What people choose to do, with their Doc’s advice into the equation, is THEIR business, NOT the FDA’s!
    If someone wants to have prophylactic surgery to preempt breast cancer, fine.
    If someone wants to ignore strong evidence, and wait it out, fine.
    It’s between the person and their Doctor[s], based on science, data, & personal circumstances.
    I am REALLY TIRED of Government [Read: Industries] Micro-managing our lives. Industries are terrified people will stop allowing them to run our lives.
    Follow the money. Monsanto runs the FDA, et al.

  • Chi

    Yep–I knew it! Follow the money. Every time.
    It’s Industries, buying legislator’s votes, micromanaging our lives to pieces.

  • BlahBlahBlah

    This comes from the same FDA that says Walnuts when eaten are a drug.
    http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm

  • amy

    I received my kit just after the FDA announcement. I wanted to make sure I would either 1) get a full refund or 2) get my results if I sent it in. Your customer service is nonexistent. You replied to my inquiry with an email saying the CEO sent an email to all existing customers. False. You will not reply to my questions. If you can’t handle obvious customer services in the face of this type of “crisis” why should we trust you with our DNA?

  • IrateCustomer

    Minutes ago they changed the home page to include the following:

    “Welcome to 23andMe.

    At this time, we have suspended our health-related genetic tests to comply
    immediately with the U.S. Food and Drug Administration’s directive to
    discontinue new consumer access during our regulatory review process.

    We are continuing to provide you with both ancestry-related genetic tests
    and raw genetic data, without 23andMe’s interpretation.

    If you are an existing customer please click the link below and then go to
    the health page for additional information. If you are a customer that
    purchased before 11/22/13, you will still have access to your health-related
    results.

    We remain firmly committed to fulfilling our long-term mission to help
    people everywhere have access to their own genetic data and have the ability to
    use that information to improve their lives.

    Upon entering the site, please confirm you understand the new changes in our
    services.

    I understand that 23andMe only sells ancestry reports and raw
    genetic data at this time. I understand 23andMe will not provide health-related
    reports. However, 23andMe may provide health-related results in the future,
    dependent upon FDA marketing authorization.”

    When I signed up on November 28, 2013, I was led to believe that the service would include medical information. Cancellation will cost me $25 per kit plus shipping costs (the rest will be refunded). Who do I need to contact for a full refund? I am not getting the service I was promised, and may have to do a credit card chargeback. Alternately, give me the information I was promised.

  • Scott23H

    Please see the post from our CEO that went up today. We were unable to answer the questions regarding refunds and access to health results until our conversation with the FDA.

  • Scott23H

    Ofelia,
    You can check the status of your sample by logging on to your account. You can also contact the customer care team directly if there is a problem accessing your data. Got to our help page enter your questions. If there isn’t an answer for your question we have a link to email the customer care team directly.

    • Ofelia

      I received my results the next morning after my comment. I was very excited to get them. Thanks!

  • Scott23H

    Gogo, Please take a look at the latest update regarding the FDA and our customers. We are also emailing customers directly with details about how this will impact our service. We were unable to answer those questions until today’s meeting with the FDA.

  • Scott23H

    We are complying with the FDA order. Please see our update regarding the FDA that was put up today. Thanks.

  • Scott23H

    Gaby, If you purchased your kit before November 22nd you will still have access to health and ancestry reports. Please take a look at our updated response to the FDA.

  • Scott23H

    Kathy, Please take a look at the updated statement regarding the FDA order that was posted today.

  • Scott23H

    Yes your sample will still be processed.

  • Scott23H

    Lucy, Please take a look at the update posted today. We were unable to answer many of these questions until we received clarification from the FDA which didn’t occur until today.

  • Scott23H

    Michael, I’ve been told that the email to customers will be sent shortly.

  • Scott23H

    We don’t offer sequencing at this time. We are a genotyping service (although we have done some limited sequencing for research). You can download your raw data and use it however you wish.

  • eric braun

    Have
    you all considered a “we the people” petition to the whitehouse? how
    many customers do you have who you could email? i am sure most of your
    customers are as happy with your service as i have been and are ready to
    get fighting mad!

    this is supposed to be a free country! it’s my dollar and my DNA!!!

  • Dana

    I don’t know if Brin’s right about the FDA getting money from Big Pharma–I don’t see how that would work, precisely, since FDA officials are not elected and hence do not have to run campaigns. However, there *is* a revolving door between Monsanto and the FDA. Someone who cared enough to do the research might Google around and see if there are similar revolving doors involving the pharmaceutical companies as well. It’s not like the federal government polices any of this very closely.

    And if you’re about to say “this is outrageous”, you’re absolutely right. So why is it legal?

  • Laura Henze Russell

    I’ve just launched a Tweet Race: @POTUS @FLOTUS @VP @DrBiden @23andMe: #Free23andMe! #FDAisClass3! Health=Truth #23andMe #FDAhttp://www.facebook.com/hiddenriver pic.twitter.com/H7zPLvdlVp Pick up your whistle & spread the song!