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_blog

It 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

      • http://shooshee.tumblr.com/ sheeshoo

        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.

      • http://jpwhitehome.wordpress.com JP White

        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.

    • http://jpwhitehome.wordpress.com JP White

      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.

  • http://www.homeopathic.com/ Dana Ullman

    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.

  • http://cli.gs/XRyhSm jillelswick

    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.

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