FDA Tells Direct-to-Consumer Genetic Testing Company to Halt Marketing

Mary K. Caffrey
Published: Wednesday, Mar 12, 2014
FDAFederal regulators have ordered the direct-to-consumer genetic testing company 23andMe to stop marketing its saliva-based test without necessary approvals as a medical device, citing the potential for harm to patients who change medication doses or have unnecessary surgeries based on test results.

  1. US Food and Drug Administration. Inspections, compliance, enforcement and criminal investigations. November 22, 2013. http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ ucm376296.htm#.Upt_klMzTtk. email. Accessed December 1, 2013.
  2. US Government Accountability Office. Direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices. GAO 10-847T. July 22, 2010. http://www.gao.gov/products/GAO-10-847T. Accessed November 30, 2013.
  3. Loftus P. Genetic test service 23andMe ordered to halt marketing by FDA. WSJ.com. November 25, 2013. http://online.wsj.com/news/article_email/SB10001424052702304281004579219893863966448- lMyQjAxMTAzMDAw-MTEwNDEyWj. Accessed December 1, 2013.
  4. 23andMe website. 23andMe statement regarding FDA warning letter [press release]. November 25, 2013. http://mediacenter.23andme.com/press-releases/fda-letter-2013/. Accessed November 30, 2013.
  5. Dobbs D. The FDA and personal genetic testing. The New Yorker. November 27, 2013. http://www. newyorker.com/online/blogs/elements/2013/11/the-fda-vs-personal-genetictesting.html. Accessed December 1, 2013.
  6. 23andMe website. 23andMe provides update on regulatory review. December 5, 2013. http:// mediacenter.23andme.com/press-releases/23andme-inc-provides-update-on-fda-regulatory-review/. Accessed January 29, 2014.

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