Dear All, The letter doesn't say that 23andMe must discontinue testing or selling its product. In any case, the way I interpret this 23andMe will not be able to advertize on the internet, on TV, on radio, or in printed media until they have this situation resolved. Exactly what they will be able to say to promote their product on their web site remains to be seen. In any case, I would be very surprised if the FDA forces 23andMe to stop selling its kits. This situation will have a negative impact on autosomal DNA used for genetic genealogy purposes. Many of my matches at 23andMe tested initially for the health side of things and then got interested in the genealogical side after they had been tested. I think that this will also result in fewer transfers from 23andMe into the FTDNA Family Finder database, which is also not a good thing. Sincerely, Tim Janzen -----Original Message----- From: autosomal-dna-bounces@rootsweb.com [mailto:autosomal-dna-bounces@rootsweb.com] On Behalf Of Roberta Estes Sent: Monday, November 25, 2013 9:35 AM To: autosomal-dna@rootsweb.com Subject: Re: [AUTOSOMAL-DNA] 2013 > 23andMe, Inc. 11/22/13 warning letter from the Feds In 2010 the FDA sent warning letters. 23andMe has failed to comply. http://dna-explained.com/2013/11/25/fda-orders-23andme-to-discontinue-testin g/

Marketing can mean two things. It can mean advertising and selling or it can mean just advertising. It appears to be the first, although I hope not. There is absolutely nothing good about this for the genetic genealogy community. It will hurt FTDNA profits as well due to the lack of transfers. CeCe Sent from my BlackBerry 10 smartphone. From: Tim Janzen Sent: Monday, November 25, 2013 10:19 AM To: autosomal-dna@rootsweb.com Reply To: autosomal-dna@rootsweb.com Subject: Re: [AUTOSOMAL-DNA] 2013 > 23andMe, Inc. 11/22/13 warning letter from the Feds Dear All, The letter doesn't say that 23andMe must discontinue testing or selling its product. In any case, the way I interpret this 23andMe will not be able to advertize on the internet, on TV, on radio, or in printed media until they have this situation resolved. Exactly what they will be able to say to promote their product on their web site remains to be seen. In any case, I would be very surprised if the FDA forces 23andMe to stop selling its kits. This situation will have a negative impact on autosomal DNA used for genetic genealogy purposes. Many of my matches at 23andMe tested initially for the health side of things and then got interested in the genealogical side after they had been tested. I think that this will also result in fewer transfers from 23andMe into the FTDNA Family Finder database, which is also not a good thing. Sincerely, Tim Janzen -----Original Message----- From: autosomal-dna-bounces@rootsweb.com [mailto:autosomal-dna-bounces@rootsweb.com] On Behalf Of Roberta Estes Sent: Monday, November 25, 2013 9:35 AM To: autosomal-dna@rootsweb.com Subject: Re: [AUTOSOMAL-DNA] 2013 > 23andMe, Inc. 11/22/13 warning letter from the Feds In 2010 the FDA sent warning letters. 23andMe has failed to comply. http://dna-explained.com/2013/11/25/fda-orders-23andme-to-discontinue-testin g/ ______________________________ For answers to Frequently Asked Questions about mailing lists, please see: http://dgmweb.net/MailingListFAQs.html ------------------------------- To unsubscribe from the list, please send an email to AUTOSOMAL-DNA-request@rootsweb.com with the word 'unsubscribe' without the quotes in the subject and the body of the message

Hi Tim, I looked back at some of the press releases, and in June, Andy Page was added as their new President. This wasn't too long after 23andMe announced their drive to sell 1 million kits by the end of 2013, so his focus has probably been there. It kind of sounds like the FDA compliance issue might have gotten pushed aside and neglected in light of their new focus. http://www.forbes.com/sites/matthewherper/2013/06/13/expect-to-see-23andme-a ds-as-the-company-tries-to-take-genetic-tests-mainstream/ But maybe this is a good thing in that it will force 23andMe to finish jumping through those hoops and then it will be done. Roberta -----Original Message----- From: autosomal-dna-bounces@rootsweb.com [mailto:autosomal-dna-bounces@rootsweb.com] On Behalf Of Tim Janzen Sent: Monday, November 25, 2013 1:19 PM To: autosomal-dna@rootsweb.com Subject: Re: [AUTOSOMAL-DNA] 2013 > 23andMe, Inc. 11/22/13 warning letter from the Feds Dear All, The letter doesn't say that 23andMe must discontinue testing or selling its product. In any case, the way I interpret this 23andMe will not be able to advertize on the internet, on TV, on radio, or in printed media until they have this situation resolved. Exactly what they will be able to say to promote their product on their web site remains to be seen. In any case, I would be very surprised if the FDA forces 23andMe to stop selling its kits. This situation will have a negative impact on autosomal DNA used for genetic genealogy purposes. Many of my matches at 23andMe tested initially for the health side of things and then got interested in the genealogical side after they had been tested. I think that this will also result in fewer transfers from 23andMe into the FTDNA Family Finder database, which is also not a good thing. Sincerely, Tim Janzen -----Original Message----- From: autosomal-dna-bounces@rootsweb.com [mailto:autosomal-dna-bounces@rootsweb.com] On Behalf Of Roberta Estes Sent: Monday, November 25, 2013 9:35 AM To: autosomal-dna@rootsweb.com Subject: Re: [AUTOSOMAL-DNA] 2013 > 23andMe, Inc. 11/22/13 warning letter from the Feds In 2010 the FDA sent warning letters. 23andMe has failed to comply. http://dna-explained.com/2013/11/25/fda-orders-23andme-to-discontinue-testin g/ ______________________________ For answers to Frequently Asked Questions about mailing lists, please see: http://dgmweb.net/MailingListFAQs.html ------------------------------- To unsubscribe from the list, please send an email to AUTOSOMAL-DNA-request@rootsweb.com with the word 'unsubscribe' without the quotes in the subject and the body of the message

Full disclosure - I work for LabCorp, (parent company of NGI, CLIA approved lab, who I believe provides the 23 raw data) - as a Quality Manager and past Compliance Officer and am a medical technologist. Not speaking for LCA, of course, but personally, I see this in the same light as the situation with patients being able to access their own lab test results. For many years, CMS required that lab results only be given to authorized providers - physicians who order the tests. Some states passed state laws and became "right to know" states. In the past decade, CMS decreed that all states were "right to know" so now we provide lab results directly to patients including through patient portals such as the Beacon system. Also, beginning about 15 years ago, reference labs were faced with "internet testing." Clients would set up accounts with unsuspecting reference labs and websites where anyone could go to the website, choose tests, place them in their cart, pay by credit card and have a requisition printed to take to a local draw station. Reference labs spent years working through this federal compliance maze and finally it is pretty much settled with the internet companies having CLIA approved lab directors. So, the real argument is whether this is a medical device OR simply allowing people to order and access their own results which is already occurring in the situations I mention. Based on the open access for test results now available, the FDA will be hard pressed to make the medical device argument stick. Just my two cents worth, Ruth Cottrell -----Original Message----- From: autosomal-dna-bounces@rootsweb.com [mailto:autosomal-dna-bounces@rootsweb.com] On Behalf Of Tim Janzen Sent: Monday, November 25, 2013 12:19 PM To: autosomal-dna@rootsweb.com Subject: Re: [AUTOSOMAL-DNA] 2013 > 23andMe, Inc. 11/22/13 warning letter from the Feds Dear All, The letter doesn't say that 23andMe must discontinue testing or selling its product. In any case, the way I interpret this 23andMe will not be able to advertize on the internet, on TV, on radio, or in printed media until they have this situation resolved. Exactly what they will be able to say to promote their product on their web site remains to be seen. In any case, I would be very surprised if the FDA forces 23andMe to stop selling its kits. This situation will have a negative impact on autosomal DNA used for genetic genealogy purposes. Many of my matches at 23andMe tested initially for the health side of things and then got interested in the genealogical side after they had been tested. I think that this will also result in fewer transfers from 23andMe into the FTDNA Family Finder database, which is also not a good thing. Sincerely, Tim Janzen -----Original Message----- From: autosomal-dna-bounces@rootsweb.com [mailto:autosomal-dna-bounces@rootsweb.com] On Behalf Of Roberta Estes Sent: Monday, November 25, 2013 9:35 AM To: autosomal-dna@rootsweb.com Subject: Re: [AUTOSOMAL-DNA] 2013 > 23andMe, Inc. 11/22/13 warning letter from the Feds In 2010 the FDA sent warning letters. 23andMe has failed to comply. http://dna-explained.com/2013/11/25/fda-orders-23andme-to-discontinue-testin g/ ______________________________ For answers to Frequently Asked Questions about mailing lists, please see: http://dgmweb.net/MailingListFAQs.html ------------------------------- To unsubscribe from the list, please send an email to AUTOSOMAL-DNA-request@rootsweb.com with the word 'unsubscribe' without the quotes in the subject and the body of the message