23andMe Provides An Update Regarding FDA’s Review

By Anne WojcickiAfter discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review 23andMe_Logo_blogprocesses.23andMe has been giving consumers access to health information for six years and is committed to finding the right regulatory path for our customers.  I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future.  Our goal is to work cooperatively with the FDA to provide that opportunity.We also want to make clear that we stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 – known as CLIA. These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data.As we work with the FDA to get clearance, there will be some significant changes to the site.  Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had.This is clearly a much different service than in the past, so we are offering customers who purchased kits on or after November 22, 2013 a full refund if they wish. Those customers will get an email from 23andMe with details on the refund policy. Eligible customers who do not receive an email are encouraged to check their spam email folders for the email with their personalized instructions or contact our Customer Care Team.Research is and will continue to be a significant priority for the company.  The 500,000+ customers we have today have given us more than 250 million survey data points.  You, our customer, have powered an incredibly important crowd-sourced research database that I believe can have a significant impact on the pace of discoveries and cures. We will continue our Parkinson’s, sarcoma, MPN and African American research projects and plan to launch more communities in 2014.23andMe will also continue educational efforts to consumers, physicians and other health providers as we believe genetics will be an increasingly important part of all of our lives.Finally, I want to say thank you to our customers for your support and your stories.  Many of you have written in about how 23andMe has changed your life.  It is rewarding for me and all the employees at 23andMe to serve our customers.  I am committed to 23andMe and committed to being a pioneer in the genetics revolution.
  • Jim E

    We purchased a kit before Nov 22nd but have not yet sent it in. Will the original medical results be available for that kit or not?

    Hope you can eventually get this all worked out!

    JE

    • ScottH

      Jim,
      No, if you bought on or after November 22nd, you will not get health results at this time. You can ask for a full refund however.

  • Holger Kraus

    I have ordered the kit just yesterday – which means I am affected by this policy change.
    In case I decide to go ahead and send in my DNA sample – will this mean it only gets tested for my ancestry markers or will it still receive the full set of testing but this information will simply (and hopefully temporarily) not be available to me for now?
    In case it receives the full testing: Is there any rough estimate on when the FDA’s terms will be met so I can get access to my health information? (Are we talking days? Weeks? Months? Years?)

    My sole intention of getting genetic testing from 23andMe was getting my health information. I see little point in going ahead with my order (which is still within the 24h cancellation period and I assume as well eligible for a refund)

    I am looking forward to your reply so I know whether or not to cancel my order and how to proceed in general.

    Thanks,
    Holger

    • ScottH

      Holger, We don’t have a firm timeline as to when we might be able to again offer health reports to customers. I wish I could give you a specific answer but I don’t have one. Your decision about whether to go forward or not is a tough one. We are offering full refunds for customers, who like you bought with the intent of getting health results. Also just to clarify something in your comment. We are still processing samples and you can download all of your raw data.

  • I appreciate your honesty and open communication, and I continue to believe in your work. I feel terrible about the disappointment and frustration you and your colleagues must feel. Keep the faith! 🙂

    • ScottH

      Clinton, Thanks for your comments.

  • Nancy

    This saddens me, I do hope for a change back in the near future. I sent a kit in today and have other one I’ve not used yet. I purchased both of these kits several months ago. Will I still be able to get health reports on the one I sent today and the one I’ve not used yet?

    • ScottH

      Nancy, If you purchased the kits before November 22nd then yes you will get both your health and ancestry results. We do hope that we can quickly move through the FDA process.

  • Margaret

    Typical of the federal government. They think that the way to help people is to limit their choices and access to information. I hope the FDA backs off and treats us like adults capable of making decisions based on the best information available.

  • John Stover

    Why did you wait until the FDA cut you off before you thought you might need to show some progress on this? You had enough time to make the rounds on the talk show circuit but you couldn’t find the time to comply with the FDA? Thousands of companies comply with the FDA every single day. Did you think they were just kidding around for the past 6 years? It’s time for the leadership of this company to get it together; you’re doing important work so please stop screwing it up.

  • Are this new rules only for US customers?
    Or also international?

    I haven’t received refund email yet.

    • Scott23H

      Mike, It’s for all of our customers. If you haven’t received an email please contact our customer care. There’s a link in the post.

    • Carl

      Don’t get a refund. 23andMe still lets you download all your raw DNA data, so just use a 3rd party program like Promethease to analyse the raw data and generate a health report for you.

  • Camoleft

    Over the past few years, I have discussed and shared info from my 23andME with my doctor. Last visit, I noticed that there is a sign in his office offering genetic testing with just a simple swab. I guess the doctor thought it was a good idea, especially since his patients were already doing it on their own. However, there is no way that the information 23andMe provides would lead me to self diagnose or self treat a condition I may experience. I would ALWAYS need the guidance and assistance of trained professionals. It’s not like if I had that breast cancer gene, I could just schedule a mastectomy. DUH FDA!

  • Ronald Herring

    Kudos for you, the FDA could surely better direct their efforts to protecting Americans in so many more ways than the actions that they have taken. Your efforts to collect data cannot be minimized, they should instead be embraced. I originally bought the product to expand my genealogical research and I will continue to promote your product to others as I am sure MOST of your customers will do. I look forward to continue completing health related surveys as they become available again in the future.
    Best Wishes to a continued successful venture and we’re here to help you weather the storm.
    Ron Herring

  • Scott23H

    You won’t get health reports that include estimated genetic risks for certain health conditions as well as carrier status and traits. We hope to add those features back into the service with FDA approval. The ancestry level data looks at your Ancestry Composition, connects you to DNA relatives – close relatives and distant cousins – and it allows you to compare genomes. Your raw data is essentially all of SNP reads – your genotype for each of those markers. You can download that data explore it on your own.

  • Scott23H

    Ian, The change is tied to the purchase date not the date that the kit is returned.

  • Scott23H

    Joanne, If you haven’t received an email, first take a look in your spam folder to make sure it wasn’t automatically routed there. If you still don’t find it, go to the link that we’ve put up on the post and that will walk your through the process for a refund.
    Thanks.

    • Joanne Jourdain

      Hi Scott, please reread my message. I don’t want a refund as I am delighted with 23andMe. Thank you for your concern. Happy holidays!

  • Susan Friel-Williams

    I stand by 23andMe. Question however, since you are suspending Health Data an concentrating on genetic data, does that mean that you can now ship to states such as New York and Maryland that you could not previously? If so, let’s target NY for a sale!

    • Scott23H

      Susan,
      Your questions are on point, but at the moment I can’t answer your question. We’ll look into and let you know.
      Thanks.

      • jane snyder

        Scott and Susan – I live in Maryland, and would love to order a test legally. I’ll be watching for the answer eagerly. Thanks.

  • James lizotte

    I ordered mine on Nov. 25th and already sent it in. I mainly did it for the health results, so whats the odds this gets resolved in a couple weeks and I can see my health risk results?

    • Scott23H

      James,
      Because you ordered after the November 22nd FDA letter we cannot give you your health results. This isn’t an issue that will be resolves in a couple of weeks. We are deep into the process but it is hard to predict how long it will take to get through the FDA process.

      • aGuyWithOpinions

        Hey, Scott. I purchased my kit on Nov. 17th and mailed my sample on the 25th (the day the news broke about the letter). What am I going to get?

        • Scott23H

          The controlling issue is the date of purchase. You purchased before November 22nd, so you will get both your health and ancestry results.

          • aGuyWithOpinions

            Great! Thank you for answering questions here, Scott. ( https://www.23andme.com/health/ which gives an unequivocal statement to the same effect; I didn’t find that until after posting my question here.)

  • Mill Stone

    @ Carl… what you wrotte means i can still have the same result as before NOV 22 if i do it myslef once i get the result back? We ahave to go to those 3rd parties website and we will have the same information as before nov 22? just curious and confused. I bought 4 test 2 days ago! sucks1

  • James lizotte

    Great thanks! I guess I won’t get a refund then.

  • joshua kit

    How generous of you to “comply” with the FDA directive.

    • cs30109

      The FDA is totally wrong, and should be ashamed of their inexcusable waste of public resources pursuing this.

  • Marilyn Collins

    I recently bought 3 tests. I understand that I will not get my health results on these tests now. If the matter with the FDA is resolved in the future, will health results of tests done between 11/22/13 and the FDA compliance date in the future then be released?, or will we have to redo the tests post-compliance to receive health information?

    • Scott23H

      Marilyn, You would not have to retest under that scenario.

  • David D

    Can you explain why you are extending this restriction to your health
    report service to international customers? Does the FDA have the
    authority to prevent you from offering this service internationally and
    have they requested that you stop offering it worldwide? Apart from the
    rather high international shipping rates (why so high?!) I am sure there
    are many, like me, who would like to continue to receive all of the
    health information you previously provide.

    I would like to back
    Carl’s comment – there is a lot of information out there already for
    those that are restricted, and I would like to add http://opensnp.org to
    the list of useful sites (it allows you to upload your 23andme data
    too). I have yet to personally use 23andme (I planned to use it in the
    New Year), but i use these third party sites almost daily in my
    research, and find them invaluable.

    PS. Any thought about setting up in Europe?

    • Scott23H

      David, You make some valid points but it boils down to the fact that we are operating in the US and wish to engage in this process with the FDA in good faith. We believe ultimately we’ll be able to work through this process and again return health results to customers.

      • Jennifer Carole

        Okay – if I read between the lines here, if we have bought the test and turned it in but fall in this hideous window, you’ll still process everything you just won’t “release the data” until issues are resolved. Right? So you’ll have it we just have to wait for the g’ment once again, to add value (really means a ton of lawyers to write a ton of words to basically say it’s all on us – which we already know).

        • Scott23H

          Jennifer, We won’t be offering health reports at this time, but customers can still download their raw data.

  • Munna2002

    Is there a timeline on when the issue between FDA and 23andme might be resolved? If it will be resolved, will 23andme provide health analysis to customers who were restricted from seeing such info post-November 22nd?

    • Scott23H

      Munna, I wish we could tell you. All we can say right now is that we are committed to working through this and are already deep into the process. When we can be more specific we will.

  • Carl

    Will people who ordered after the 22nd of Nov, still be getting the “Traits” page (eye colour, hair colour, etc.), since that’s not related to health or disease?

    • Scott23H

      Carl, No we’ve removed all health results including traits and carrier status.

  • Carl

    It’s still worth getting the test because you can download the raw 23andMe data and run 3rd party programs on it (like Promethease) to generate a health report. It might not be as convenient or quite as good quality, but you can still get a good idea of your genetic health risks and traits. It would just be analysed by a different company, not 23andMe.

  • Robyn

    For those who have not yet received their results yet ordered their kits before November 22nd, is everything currently on hold? My kit was delivered back to the lab on the 22nd and it has yet to be marked as received.

    • Scott23H

      Robyn, No everything is not on hold. We are still busy processing kits.

  • Scott23H

    Daniel,
    Thanks for the note. The price isn’t going to change. Although you are correct that we are now giving less information back to customers, the cost of processing the sample is the same and we are reporting back the same amount of raw data. We understand that for some customers this just isn’t going to work, hence the refund policy.

  • Scott23H

    Mike, My answer to Marilyn was that you would not have to be retested under the scenario she described.

  • Richard Gao

    I ordered one kit on Nov. 25. What can I do to get health results? Help!

  • Allen

    My letter to Alberto Gutierrez at the FDA (author of the “Warning Letter” to 23andMe):

    Dear Mr. Gutierrez –

    In spite of the following, I generally appreciate most of the
    services the FDA provides for US citizens.

    However, even considering the agency’s well-known polygamist,
    common law marriage to big pharma and the AMA, I think your highly imaginative
    recent warning letter to the president of 23andMe, Inc. represents a trip far
    beyond common sense regulatory guideline enforcement and clearly into the realm
    of hit-man hired by those two jealous spouses.

    For example, I’m sure it would’ve been in the news if, for any
    reason, someone tried to perform surgery on themselves–that is, without a
    doctor’s involvement–for either breast or ovarian cancer, not to mention–as you
    did–any post-op chemo or radiation therapy. Are you serious?

    Having read through your letter, as many others now have, I would
    agree with the best comparative analogy I’ve read about it so far; that if you
    and the assumptive applications of FDA guidelines set forth in your letter are
    to be taken seriously, I would fully expect you to send a similar warning
    letter to every manufacturer of oral thermometers so all of us idiots will stop
    making wild assumptions and perhaps performing surgeries (and post-op
    therapies) on ourselves based solely on information about our body temperature.

    This kind of over-kill is just another demonstration that the FDA
    is at least, if not more interested in protecting the sacred turf
    of big pharma and the AMA from upstart “outsiders,” as it is in protecting the
    health of the public.

    I also think that more in-depth information is the best
    preventative medicine we can get, whether it comes from beyond your agency’s
    cartel members or not; although most likely if not. Towards that end, I
    hope 23andMe, Inc. is able to reword all of their accompanying product
    information in such a way as to escape the predatory tentacles of that cartel,
    via your agency, and provide us with basic information which we have every
    right to obtain. Admittedly, I’m not holding my breath until that happens.

    With all due respect Mr. Gutierrez, I know who’s paying your
    salary, but in this particular case whose best interests do you
    really think you’re working for? I don’t need a reply; that’s just for you to
    ponder.

    Sincerely –

  • Allen

    Ok. Now I see.

  • Vincent

    I purchased kits in December, and I’m from Canada. Why does this FDA ruling should apply to my tests? We have Health Canada here, and they’ve been silent about these things.

  • SocialMicrobe

    If the FDA is so worried about people self treating then they need to shut down WebMD because that is were all the crazy self diagnosed and treaters go…

  • Matthieu Heimer

    This sucks, it kills the primary reason I wanted to use your service.

  • Scott23H

    Anna, Yes you’ll still be able to see your health results.

  • Scott23H

    Rose, You don’t have to do anything to allow for your sample to continue to be processed. You’ve purchased and sent in your sample, if you don’t ask for a refund we will simply proceed with processing it. We typically let people know when their sample is received by the lab and let them know when your results are ready. We appreciate your business, but we cannot offer the health results at this time. Part of the reason we are offering a full refund is for people like you who purchased with the understanding that they would get both health and ancestry information. We apologize that we cannot continue to do that at this time, but that decision was not in our hands.

  • Scott23H

    Jonathan, I’m sorry to say that individuals who ordered on or after Nov. 22nd, the day we received the FDA letter, will not get health results. We are offering full refunds (including shipping) if you would like.

  • Scott23H

    Yes Aaron, If you purchased before the 22nd you will get health and ancestry reports.

  • Scott23H

    John, You’re sending this message to the blog. You need talk to our customer care team. Go here: https://customercare.23andme.com/anonymous_requests/new?reference=via_search_box

  • Scott23H

    Jenny, We won’t be able to do updates until we get approval from the FDA for each individual report.

    • Cotay

      Scott, I’m very confused by all of this. I ordered my kit on November 8th and it was returned and received on November 18th. It is now at the lab as of December 4th. From the email I received, I was led to believe that I would still have access to all health-related information that was available prior to the FDA letter. Is that not the case?

      • Scott23H

        Cotay, You purchased before Nov. 22nd so you will have access to both health and ancestry reports. It may take a few weeks for the lab to process your sample.

  • Scott23H

    Mike, Yes the refund includes postage. You can biobank your sample but not if you get a refund. What we do is offer biobanking as part of the service. This is so that if we develop a new chip that you want to be sampled on you do not have to resubmit a sample. Your questions about Promethease I can’t answer. Obviously many of our customers have taken their raw data and done their own research using other services. Part of what we offered with our health reports were curated review of the scientific literature. We have criteria to reporting back risk that ensured that anything we reported back had to meet a certain threshold. I’m not sure what criteria Prometheus or others offer.

  • Scott23H

    Mike, The date in question is Nov. 22nd. We will continue to process samples in the same way. We will biobank samples if customers request it. The difference is that customers who purchased on or after November 22nd will not be getting health reports.

  • Scott23H

    Jonathan, No. If your ordered on or after Nov. 22nd you will not get health reports. Because many individuals ordered at that time expecting to get both ancestry and health information, we are offering those individuals a full refund.

  • Scott23H

    Inder,
    If you purchased before Nov. 22nd you will still receive health information.

  • Scott23H

    Frak,
    If you purchased before Nov. 22nd you will still get your health results. The purchase date is what is important.

  • Scott23H

    Darcy, You are not the first person to make this point, but we are based in the US. We are trying to work with the FDA because we ultimately believe it’s the best course of action.

  • Scott23H

    M.L. Harsens,
    At this time we are working with FDA and through their process. We believe they do have a role to play here. This is not the outcome we’d hoped for, but we’re optimistic that we can get through this process and offer our customers health reports again.

  • Scott23H

    Briylaln,
    If you ordered on or after Nov. 22nd and ask for a refund you will get a full refund including postage.

  • Scott23H

    Mark,
    We will continue with our research mission. We are involved in several specific research areas and will will continue to publish based on those studies.

  • Scott23H

    Deb,
    No. We take customer privacy very seriously. Your data is not going to be turned over to the FDA.

  • Scott23H

    Rose, The issue isn’t going to be resolved by Christmas. I don’t imagine that we would open up the refund policy so that you would get results and then wait around a few months to see what happens and still be able to get a refund after that time. That said, if you want a specific answer to that question it would be best to contact customer care. (You should have gotten that contact information in an email regarding the refund offer.)

  • Scott23H

    Andreas,
    We won’t be able to update health results until we get approval from the FDA for those results. We will continue our research.

  • Scott23H

    Maris, Yes. If you purchased before Nov. 22nd, even if you haven’t sent the sample in yet, you will still get both health and ancestry results.

  • Scott23H

    Matt, We don’t have a timeline at the moment. We expect to complete what we need to submit soon, but there will likely be a back and forth after that.

  • Scott23H

    Filbo, Thanks for the suggestions and we wish we could make that offer, but the decision was made as part of discussions with the FDA. We cannot make that offer for people who purchased on or after the date of the warning letter from the FDA.

  • Scott23H

    You can contact our customer care by going to the help page. Here’s a link to email them directly: https://customercare.23andme.com/anonymous_requests/new?reference=via_search_box

  • Scott23H

    The 22nd is the date of the FDA letter, which includes the order to stop offering health reports to customers.

  • Scott23H

    Christine, Our apologies if this hasn’t happened fast enough. We are working hard to complete these refunds as soon as possible.

  • Scott23H

    Kenofken,
    Yes we will give individuals all their raw data.

  • Scott23H

    Richard, Individuals can opt out of DNA relatives. You do not have to share your information with anyone you don’t want to. Here is the link to privacy settings: https://customercare.23andme.com/entries/21243132-DNA-Relatives-Privacy-Settings

  • Scott23H

    Savannah,
    No they are not on hold. We had a very large volume of orders that increased the processing time. We were also in the process of validating a new lab to handle orders. That process also slowed things down a bit, but ultimately it will help us process samples more quickly.

  • Scott23H

    Mike,
    Thanks for your thoughtful comments. Several customers have asked about what they can do. As a company we are not making recommendations one way or the other, but we do believe that anything people can do to encourage thoughtful debate is helpful. Thanks.

  • Scott23H

    AnnaC,
    Because the kits were purchased before Nov. 22nd you will still get both health and ancestry results.

  • Scott23H

    Guest,
    I think the answer to your question about future partial refunds, is no. I don’t think what you are suggesting is really feasible, but we appreciate that customers are now put into a tough position if they came in expecting to get health results. We hoped that by offering full refunds for those who came in with that expectation would suffice.

  • Scott23H

    Paul,
    That’s a question I can’t answer. You’ll have to talk to Customer Care directly. You can create a ticket and they’ll contact you by going here:
    https://customercare.23andme.com/anonymous_requests/new?reference=via_search_box

  • Scott23H

    I don’t know if data from the new chip will be compatible with third party products. And yes, you will know whether you are on v4 or v3.

  • Scott23H

    If the kit was purchased before Nov. 22 you will get both health and ancestry information.

  • Scott23H

    Thanks Jason. Just want to add that we had to wait until we got clarification from the FDA before we could answer the questions we were getting. The day we had follow up from the FDA is the day we sent out detailed responses to customers.

  • Scott23H

    Melissa, We haven’t set a deadline at the moment. The request should be made before the sample is processed by the lab however.

  • Scott23H

    WC,
    We can’t return new health data even on upgrades.

  • Scott23H

    There isn’t a set deadline at the moment, but if your sample has been processed and your results have been returned then it would be too late to request a refund. If you want a refund you should request it as soon as possible.

  • Scott23H

    PJ,
    You should have received an email with details on how to obtain a refund in full. If you ordered before Nov. 22nd you will get your both your health and ancestry information. If not we cannot give you your health information at this time, so you may want to request an refund.

  • Scott23H

    We are working hard to get everything in as soon as possible, but this is going to take some time.

  • Scott23H

    Thank you Neil

  • Scott23H

    It means you will not get health results. You would get all your ancestry results and you’d be able to download your raw data. If that doesn’t work for you, you can get a full refund.

  • Scott23H

    Laura, You are mistaken. We are not selling below cost. At the same time the cost of the service, even with just ancestry is very competitive with other services.

  • Scott23H

    Paul,
    What happens is that once you fill out that email form. You create a ticket. It gets assigned to a customer care team member and then they contact you directly. The automated response is to acknowledge that we got your message and we’ll get back in touch. We don’t have a call center to take phone calls, but we can arrange for phone support if that is necessary.
    So that automated response was to tell you that they got your message and they’ll get back to you directly as soon as they can. Thanks.

  • Scott23H

    ML,
    Right now we’re trying to work through the FDA process. We see value in doing that. As to the basis of the action, I think the FDA has outlined their stance fairly clearly. They are regulating us as a medical device.

    • M. L Harsens Is.

      A taxable medical device….

  • Scott23H

    You should be able to change that in our profile settings. Your settings also control how you are identified in the community and how much you share with the community. Here is a link to more information about privacy settings in your profile:
    https://customercare.23andme.com/entries/21243132-DNA-Relatives-Privacy-Settings#options

  • Womyn2me

    I think any organization that provides information that impacts the health of a human should welcome a visitation from the FDA. If they found something that made them blink, then that is good and 23andme will improve.

    It HAS always bothered me that I could not print a copy of the medical portion of my results. I showed them to my provider during visits, but she would like to read the accompanying information from 23andme, just NOT during my visit, of course.

    I would propose that there be a way to take the medical information more easily to a provider might help them with their recent FDA issues. Has anyone read the FDA report itself? I wonder what they got pinged on?

  • anonyman99

    Excellent point. The government can’t regulate information. 23andme should register in Barbados or somewhere. Reminds me of the pirate ship radio stations that broadcast off the coast of Britain to thwart the BBC.

  • Scott23H

    Nancy, We are still processing samples so yes you can still send in your sample. If you purchased before Nov. 22nd you will get both health and ancestry results. If you purchased on or after Nov. 22nd you will get just your ancestry results.

  • Scott23H

    Harold,
    We are phasing out v3. I’m not sure if we’ve already shifted over entirely to testing on v4. There isn’t an option to request to be tested on v3 instead of v4. As for the amount of information, as we said v4 is designed to be backward compatible so that we are able to give customers the same reports that we were able to using v3. We also were able to select all the SNPs on v4, which gives our researchers more imputing power in the future.

  • Scott23H

    Henrik, So the new information will just be on the ancestry side. That means you’ll have access to all the ancestry tools and reports. This gives you your Ancestry Composition, matches on DNA Relatives, Neantherthal percentage and Gene Comparison.
    We do expect to be reporting back health data in the future. At first we expect the number of reports will be limited, but as we go through the FDA process we hope to keep adding to those reports as we get approval.

  • Scott23H

    I don’t have a specific deadline to give you. I would expect this is not indefinite. I was also letting you know that if you sent your kit in to be processed and you waited until after your results were returned to you to ask for a refund that that would probably be too late. If you hold onto your kit that buys you more time, but I don’t yet know when the refund would sunset.

  • zar kers

    Oh wow, Carl, you are awesome. Thanks brother!

  • Ashley J.

    Glad to see such a lively, educated dialogue from other customers! For those of you who have decided to get the refund, a question:
    Anyone else having trouble getting their refund? I followed the instructions in the first email but never received a confirmation email. 2 days later I received a second email that said there may have been some technical issues with my refund attempt. I followed the new link provided in that one. Still, no confirmation email and no pending refund on my credit card. It’s been 3 business days. I realize they get 2 more before i get to be officially upset, but as someone who needs that $100 back to buy a different xmas present I’m honestly still pretty irked about the whole thing. Customer service has not responded to me in 4 days. Not having heard or seen any movement, I’m starting to wonder if I should just try having my credit card company retract the money from their end. Thoughts? Any company reps out there able to put my mind at ease?

    • Scott23H

      Ashley,
      I will forward you comments to our Customer Care folks. I know they are trying to respond as quickly as they can to the refund requests. There also a glitch with a batch of emails that went out early. They are clearing that up. Apologies for the back and forth. You will get your refund.

      • Ashley J.

        Thank you for such a prompt response. I wish the Customer Care dept demonstrated the same courtesy. Last time they replied to my customer service thread was Dec. 7., and the company phone number my bank was able to track down has been disconnected. While i understand the customer care reps are likely quite busy, none of that makes the operation look very trustworthy. Tomorrow marks the 5th business day from my refund request. I will be watching to see whether the refund comes through, as promised. Fingers crossed.

        • Scott23H

          Ashley,
          I spoke briefly with Customer Care. They are going to be getting refunds back to folks within three to five days. There were some initial glitches with the email and follow up emails. You can confirm that your request for refund went through by going to the page and it should indicate whether you’ve put in for a refund or not. Again, my apologies for the delay in getting the refund. You should be getting it soon.

          • Ashley J.

            Well, no refund today either. Today is the 5th business day since I requested to have my money back, so unless it comes through in the next few hours, the company will have failed to make good on what it is telling its customers. I checked the page you suggested. The bottom of my refund page says my request has been”received”, but if there were known technical problems with both the initial email AND the follow up emails, I question whether my request actually went through properly. My page said the same “received” message after each submission on 12/6 and 12/8. If my request HAD gone through properly, wouldn’t the refund have been issued by now? No responses from customer care in 5 days, and thus no way to confirm whether my request suffered a glitch or actually got through.

          • Scott23H

            Refunds are starting to go out today Ashley. Whether you get the refund today or not I’m not sure. All I can say is that they are starting to go out. If you’ve gone to the page and it’s informing you that you’ve submitted the request then they got it. My apologies for the delay.

  • Drew65

    Anne,

    I hope you will continue to market the value of medical research your data still has. Even though health results aren’t displayed, it appears you can still collect data and customers can still answers surveys. I’m sure there’s a segment of the population who are willing to donate their spit, so to speak, if they know it could benefit Parkinson’s research or some other important discoveries.

  • shivabeach

    This angers me to no end. I am not angry with 23 and me at all. The reason I did this was for my health information. The govt is simply pulling a fast one. Considering all the garbage they allow in our foods, they never should have had a thing to say about this

  • Carolyn

    Does all of the trait information also count as health – like eye colour, earwax, cilantro taste? I’m not sure what harm the FDA thinks that could cause, if someone realises that they might be a carrier for blue eyes. However, I can’t see anything on the 23 and me site saying that they still provide this information. Is that correct?

    • Scott23H

      Traits are also part of the health information. You’re point is well taken and we too believe that this should not be a problem with the FDA, but at the moment it is part of the health information that is being reviewed in the FDA process.

  • Scott23H

    Alexandros,
    My apologies for the delayed response. The answer is we can’t actually separate out the order. The recommendation is that you ask for a refund for that purchase and then reorder the two kits you want. Just throw away the kits. They don’t have to be sent back. Sorry that is clunky but it’s how they recommend handling it. Thanks.

  • Scott23H

    Alexandros, Yes you should still cancel if you want the refund. You want to do that before they begin processing the samples. Hope that helps.

  • hsfrey

    Anne:

    I am outraged at FDA’s action, and at your rush to submit.

    There is nothing on your site or the information you send to users which is inconsistent with published scientific data.

    This is a First Amendment issue, and you should vigorously fight back against this gag order.

    Meanwhile,
    the con-men promoting total quackery like homeopathy, chiropractic,
    naturopathy, aromatherapy etc. carry on their public ad campaigns and
    actually Treat patients, unaffected by FDA constraints.

    And, the vast majority of doctors that FDA says people should consult with are far less knowledgeable about the genetics literature than your people who do this full-time.

    Does
    the FDA restrict Science magazine from selling subscriptions to people
    who may be unable to adequately evaluate the information presented
    therein? Why are they exempt from the restrictions imposed on you?

    PLEASE do not be so passive! Take this absurd FDA decision to court!

    That said, I agree that your presentation of risk data could be improved –
    in particular by making Absolute probabilities far more salient than
    relative probabilities. EG: instead of just saying that I am 3x more
    likely to get disease X, say that my probability is .03% instead of the
    population average of .01%.

  • Scott23H

    Eddie,
    If you’d like your money back, please follow the link that we have posted in the blog. You should also have received an email that has directions on how to get a refund.

  • Scott23H

    Paul, We don’t have the ability to immediately call people back. We also are a bit backlogged with refund requests. In your case, you will have to request that your refund is in the form of a check. You do that by submitting a customer care form. They will then send you the refund by check. Here is the link:
    Here is the link: https://customercare.23andme.com/anonymous_requests/new?reference=via_search_box

    • Paul

      Scott,

      I received a confirmation today that a credit has been issued to the pre-paid VISA that I had used. I need to wait several days to see if it goes through on this card.
      Thanks for the link in case I need it.

  • Scott23H

    Eddie, If you purchased your kit on Nov. 22nd or after you can get a refund. You just need to ask. If you purchased before Nov. 22nd and your sample hasn’t been processed you can also get a refund. In addition if you purchased before Nov. 22nd you will still get the same health and ancestry information that customers have always received. I don’t get your idea calling this a scam.

  • Kate Lindekugel

    Keep fighting, Wojcicki. You have a good product, an excellent service, and you are in the right.

  • Eddie

    The FDA does not agree with you, nor do I. Any legit business would refund money in good faith after misrepresenting their services

    • Scott23H

      I don’t understand Eddie, we are refunding people their money. What’s the issue for you?

  • Eddie

    I sent in money before Nov 22 so you say too bad no refunds? Then it comes out the FDA does not approve. We would never have been involved had you been upfront. The spin goes on!!!

    • Scott23H

      You are implying that we knew that the FDA would issue their warning letter. We did not know that. If you submitted before Nov. 22nd then you should still get all of your health and ancestry results. I still don’t understand how that’s somehow not being upfront, as you said. If there is some other issue you have please contact our Customer Care team at this link: https://customercare.23andme.com/anonymous_requests/new?reference=via_search_box

  • Sherry Sander

    i have repeatedly found that when I occasionally go to the doctor, I know more about my health than they do. (they shrug their shoulders a lot, and then start trying to give me drugs,not very impressive) So…I go to the doctor for tests and diagnosis and then go to my Natural Healing Books and find a solution. Then when the problem resolves, I go for my follow up. They always say “How did you do that?”
    I will continue to monitor my own (Known History) but I wanted to use 23andme to go beyond what I know from my family. I deeply resent The FDA interfering with my 40+ year pursuit of My Personal Health. To me, it looks like the Fox trying to guard the Hen house. They should Butt Out and go monitor some of the Dangerous Drugs they keep approving.

  • James C

    I signed up with 23andMe on October and took the time to fill in all of the questionnaires first. I ordered my kit November the 25th but considered myself a registered 23andMe customer the day I signed up on their web site. I agreed to share my results for research and was looking forward to seeing my results. I am an adopted individual and as such have no way other than genetic testing to know anything about my medical family history. The FDA says i might not be able to handle the truth. They say I need to be protected? They say I might be the victim of misleading advertising. They say the spit container is an unregistered medical device. Does any of this have any bearing on my results? I waited until genetic testing was affordable and reliable. According to the FDA I waited four days too long. Well, I paid for both ancestral and health related results the day I paid my money. That is what was advertised on the 25th. I refused the offer to get my money back because I want my results. The minute my tests are complete and according to the FDA’s allegations are the results of “medical” tests. Results of all my medical tests are part of my “medical record”. HIPAA says I have the right to my medical records, the right to correct them, and the right to know who has seen them. Under the HIPAA “right to access” laws I request the full set of my genetic testing results, including my health data. Please comply with the HIPAA act, the FDA, and with the Office of Civil Rights and deliver my full results. Not having any family history immediately puts me in all the high risk categories and makes correct medical diagnosis more difficult. I have no expectations other than a look at my past. A view that can not be gained by any other means except for being raised with your biological family. I don’t qualify for that type of knowledge and now the FDA prevents me from knowing what everyone else knows. Why again was that? Stop the madness and let science continue while you figure things out. Columbus was not stopped from sailing because he might prove the earth round and the people “might not be able to handle the truth”. No one said after he left the port that he over sold expectations and shouldn’t have been given funding. If my results are medical then I am entitled to the results under HIPAA. If my results are not medical then I am entitled to my results because I paid for them. Either way I look at this I see that both ancestral and health results should be delivered to all that have asked for them. Please don’t let the FDA (government) strong arm private corporations.

  • Nexus Creative Labs

    Thanks to the Economist’s article covering your battle with the FDA, you have a new customer (me) once you reach a resolution. Thanks for the publicity FDA 😛

  • Ted Schober

    I propose an alternative to 23 and Me providing health reports. Just as you provide access to members to the database of their genetic makeup, provide similar access to a separate database of the genetic markers for various diseases and the coefficients for analysis of multiple markers. Access to the databases would be available on a challenge response basis to assure that only members could access their data and the global information database.
    A third database could be made available for genealogical research.
    23 and me could then release to the public an open source client program which accesses these databases and provides for secure communication between the client and the databases using member identification entered into the client by the member.
    Since the client program would be open source, members and others would be free to modify and enhance the program as they see fit. The open source community that would be developed among the users would provide the resources to assure that the information. 23 and me would not be providing health advise, only access to the member’s genetic data and to the best peer reviewed research concerning health genetics and genealogical genetics.
    23 and me would be out of the business of providing anything that could be considered medical advice, while still allowing the members to access the best data available on their family history and results of research on genetically related health considerations.
    By dividing the service between provision of data, and an open source client (owned in common) any possible jurisdiction of the FDA would be removed.

  • Scott23H

    Eddie, No spin related to refunds. Although we did not get them done as quickly as we wanted, you should have gotten your refund by now.

  • It’s another example of what some refer to as the “Nanny State.” You know, that, “We want to protect you from yourself, and nanny knows best!” attitude? This is actually preventing access to useful health information, which we own because it’s a part of our body; hence the 4th amendment protects this as a civil right.

    I have MS and other health issues. I exist on TONS of meds and I want to cut that number down and prepare my body for stem cell treatments in the future. The meds are killing me, quite literally. If I could refine my meds to what is best for me as an individual, and someone prevents me from doing so, that seems to me to be “Preventing safe access to medication.” (see safe access org)

    The violations of civil liberty are abundantly clear imo!

    This is marketing Bullshit! I hope the companies providing this service have a game plan!

  • Scott23H

    Daniel, If you purchased before November 22nd you will get health and ancestry results. I believe this was the answer we gave you previously so I’m not sure if there was something else you are asking.

  • Joan Dolores Robinson

    The only thing the FDA is “protecting” are the outrageous profits that doctors and DNA testing companies have enjoyed until 23andMe came upon the scene with their affordable pricing.
    I hope 23andMe is in the process of hiring or finding pro-bono attorney help (think of the beneficial publicity for these lawyers), and has already contacted the ACLU regarding the usurping of individual’s rights to their own genome results. The FDA has approved many medicines and devices that later proved to be extremely harmful or fatal to the public. (They won’t ban cigarettes altogether because big tobacco pays them to keep that industry alive.) People, rise up and demand the release of 23andMe from imprisonment. Let’s send a blizzard of letters to: Division of Dockets & Management (HFA-305), Food & Drug Administration, 5630 Fishers Lane, Room 1061,Rockville, MD 20852. . Also, hit the FDA Administration at 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, or phone 1-888-463-6332 for general information. Maybe we can get some individual names, which is always more fruitful. Let’s not let the FDA get away with this one.
    .

  • Scott23H

    Jim,
    Thanks for your note. Right now we are attempting to work with the FDA through this process. We will keep you up to date and let our customers know of any new developments.

  • Lightboy

    I am sorry for US citizens and companies that have to deal with the FDA. I have a question, I was about to purchase 2 kits when I saw what happened, and not having access to health results and only getting ancestors raw data… well, that’s not what I was looking for. As I am an European Citizen living in Europe and purchasing the kit from Europe, is there any option for me to have the results without those restrictions imposed by the FDA?

  • Valerie Olague

    I just want to share that this must be part of the broader effort the FDA is making to try to make Electronic Health Record software fall under the category of “medical device”. It is just nonsensical. Read how some healthcare providers and lawmakers are fighting back.
    http://www.bostonglobe.com/news/politics/2014/02/25/health-data-industry-fights-fda-oversight/TyVGBPuuP9pltTx7HTYBjO/story.html

  • misterfunpants

    It takes a very special person to write a sarcastic letter to a politician.

  • Surprised no one has asked if there is a solution outside of the US we can gain the same answers from that 23andme use to be able to deliver.

  • Scott23H

    Traits are also part of the review so the results do not currently include traits.

  • Scott23H

    No we would not be able to do that. We hope to be able to again offer health results when we complete the FDA process, but at the moment we do not offer health results for new customers.

  • NN

    Move to another country. The FDA will not let you in peace here

  • healingnavigator

    no they would not. many patients are told that no one else has had
    a sensitivity to that particular drug. The patient needs to take control and decide which drugs he is willing to take and be told of all problems these drugs cause. If you look at most drugs they all cause damage to kidneys and liver, two most important organs in our body. But don’t worry after the drugs damage these organs you can get on the list for transplant…

  • healingnavigator

    Look at stats. 2012 29.1 mil have diabetes. It was around 18 mil in 2010. The cost for this is 245 billion dollars a year…The diabetic educators are still counting calories and have not changed their info on teaching. However, only the ADA can teach diabetics. iF you have diabetes it can damage every organ in your body. I don’t know where you live but if you are a health professional you cannot miss these stats.

  • Tonie

    a little sad about not finding out medical history but still very excited! I have looked for my dad for a very long time & finally found his family, he died in 1997 but I still have 3 half brothers…one brother & I are going to take the test to make sure we are a match & that will tell me if he really was my dad. I still cant believe this happening! Thank you!

    • 23blog

      We’re happy that you were able to connect with your half brothers.

  • Natashacbk

    I am a little unsure of how a genetic test falls under FDA jurisdiction. This is an information product, not a drug or a form of therapy. I’m just not seeing the connection here.

  • lauklejs

    I whole-heartedly agree that the FDA is wrong here. OTOH this is one of the VERY VERY VERY Few true examples of nanny state–maybe the only 1 IMO. In particular for those with selective amnesia, I would like to remind everyone that America had the fewest thalidomide babies of any western nation because of the FDA doing its job.