FDA halts 23andMe personal genetic tests

March 19, 2014

Direct-to-consumer (DTC) genetic testing gained notoriety in the autumn of 2008. That was when two prestigious publications, The New Yorker and The New York Times, featured largely positive accounts of a celebrity “spit party”—at which notables dressed in cocktail attire ejected their saliva into test tubes for genetic analysis.1,2

That trendy gathering seemed to be the leading edge of a new era of personalized medicine. Companies selling saliva kits online promised that the tests would give customers medically crucial information about risks for a wide range of diseases. Some observers enthused that DTC gene tests would revolutionize medical care. 

But at least to date, the reality has fallen far short of such claims.

One major setback for the DTC gene test industry came in 2010, when the Government Accountability Office (GAO) issued a stinging report3 after it had submitted identical DNA samples to four DTC gene testing companies and gotten back contradictory results. The GAO’s report called DTC gene tests “misleading and of little or no practical use.” The same year, when Pathway Genomics tried to sell a DTC gene test kit at Walgreens, the U.S. Food and Drug Administration (FDA) intervened to stop it; now, the company offers genetic testing only in its accredited clinical laboratory. In 2012, gene testing companies deCODEme and Navigenics were bought out and discontinued their DTC products.

But the industry leader, 23andMe, had seemed unstoppable. It aggressively marketed its Saliva Collection Kit and Personal Genome Service (PGS). Until recently, it promised that, for just $99, customers could send in a saliva sample and shortly afterward receive online reports with details about their genealogy as well as their risks for 254 health conditions and traits. With huge investments from Google co-founder Sergey Brin and venture capitalist Yuri Milner, 23andMe seemed to shrug off an accumulation of studies demonstrating that the information its product provided was often unreliable.4 

Then, this past November, the FDA sent the company a warning letter5 that was unusually stern in tone and content, ordering 23andMe to “discontinue marketing the PGS” until such time as it can provide evidence to substantiate its broad marketing claims.

The FDA detailed 23andMe’s failure to demonstrate that its product has been “analytically or clinically validated” in “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications” since July 2009. The warning letter noted that, after these four years of discussions, 23andMe had suddenly stopped communicating with the agency altogether in May 2013. Shortly after that, the company launched an aggressive $5 million national television, radio, and online advertising campaign.

The unusual harshness of the FDA’s November warning was unmistakable even to casual readers, and it certainly did not go unnoticed in the DTC community. The days following the letters saw a storm of online debate about whether the FDA was doing its job or overstepping its authority. 

For its part, 23andMe posted a message on the home page of its website, explaining that it had suspended its health-related genetic tests in order to comply with the FDA directive. It pulled its advertising campaign. And CEO Anne Wojcicki stated that the “relationship with the FDA is extremely important to us” and that “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.”6 

It may not be only the FDA that 23andMe needs to convince. Five days after the FDA warning, a San Diego County woman filed a class action lawsuit against 23andMe for false advertising of health claims without analytical or clinical validation. Toward the end of 2013, a string of articles in The New York Times, Forbes, and Quartz reported on people whose 23andMe results were misleading, contradictory to other results, or simply wrong.7-9 In January 2014, news broke about a Federal Trade Commission lawsuit that forced another genetic testing company, GeneLink Biosciences, to stop selling “personalized” nutritional supplements that it claimed could treat diabetes, heart disease, arthritis, insomnia, and other ailments.10 The DTC gene testing controversy is far from over. 

The Center for Genetics and Society is a public interest organization working for responsible use and effective governance of human genetic technologies. We have long been wary of claims about DTC genetic tests that often overstate the influence of genes on complex diseases and traits. We affirm the role of public policy in protecting public health, and welcome the FDA’s steps towards responsible oversight of the direct-to-consumer genetic testing industry. 

When a test claims to be delivering medically meaningful and actionable results, oversight is needed to ensure that the information is factually correct, that medical guidance is available to put the information in its appropriate context, and that care is taken to ensure that the person on the receiving end understands it. 

In some situations, genetic tests can be helpful or medically crucial. That is precisely why they must be integrated into healthcare responsibly.

Marcy Darnovsky, PhD, is Executive Director and Jessica Cussins is Project Associate at the Center for Genetics and Society, a Berkeley, California-based nonprofit organization dedicated to the responsible development and application of human genetic technologies. 


  1. Shulman M. Ptooey. The New Yorker. Sept 22, 2008. http://www.newyorker.com/talk/2008/09/22/080922ta_talk_schulman. Accessed January 24, 2014.
  2. Salkin A. When in doubt, spit it out. The New York Times. September 12, 2008. http://www.nytimes.com/2008/09/14/fashion/14spit.html?pagewanted=all&_r=0. Accessed January 24, 2004.
  3. U.S. Government Accountability Office. Direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices. July 22, 2010. http://www.gao.gov/products/GAO-10-847T. Accessed January 24, 2014.
  4. Kalf R, Mihaescu R, Kundu S, et al. Variations in predicted risks in personal genome. Genetics in Medicine. 2014;16:85–91
  5. United States Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations Warning Letter.23andMe, Inc.11/22/13. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm. Accessed January 24, 2013.
  6. An update to regarding the FDA’s letter to 23andMe. http://blog.23andme.com/news/an-update-regarding-the-fdas-letter-to-23andme. Accessed January 24, 2014.
  7. Peikoff K. I had my DNA picture taken, with varying results. The New York Times. December 30, 2013. http://www.nytimes.com/2013/12/31/science/i-had-my-dna-picture-taken-with-varying-results.html?_r=0. Accessed January 24, 2014.
  8. Munos B.23andMe:A fumbling gene in Its corporate DNA? Forbes. November 29, 2013. http://www.forbes.com/sites/bernardmunos/2013/11/29/23andme-a-fumbling-gene-in-its-corporate-dna. Accessed January 24, 2014.
  9. Hartmann LF. Why 23andMe has the FDA worried: It wrongly told me I might die young. Quartz. November 26, 2013. http://qz.com/151311/why-23andme-might-have-the-fda-worried-it-gave-me-a-false-result. Accessed January 24, 2014.
  10. Maron DF. After 23andMe, another personal genetics firm is charged with false advertising. Scientific American. January 11, 2014. http://www.scientificamerican.com/article/after-23andme-another. Accessed January 24, 2014.