23andMe Provides An Update Regarding FDA’s Review

By Anne Wojcicki

After 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.


  • 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 :P

  • 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.

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