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.


  • 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!

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