In its correspondence dated 22 November 2013, the American Federal Health Authorities, the FDA -Food and Drugs Administration-, instructed 23andMe to stop selling personalised DNA test kits (Gènéthique press review on November 25th, 2013). This instruction culminated in the closure of "six years of fruitless dialogue" with the company, which has just announced the suspension of advertising campaigns for these tests despite the fact that the latter are still available on the company’s website.
23andMe has come under considerable scrutiny by the FDA. Commercially available since 2007, these personalised DNA kits have been monitored by the FDA since 2010. In fact, the kits were sold as medical devices and were therefore subject to current Federal legislation, a fact to which 23andMe paid little (if indeed any) attention. The company was therefore prosecuted by the FDA for violation of Federal law. It also came under fire for the alleged compilation and commercial exploitation of a genetic database using the DNA of "thousands of individuals who used its services".
Moreover, the health authorities "are concerned about the “impact [in terms of health] of this ‘diagnostic’ tool on individuals in the absence of any proper medical follow-up and monitoring procedure”. The FDA denounced the high sensitivity of the MRI tests as superfluous and preventive double mastectomies as unjustified". It should be noted that these tests are available on the internet for $99 (€72) and claim to be capable of detecting the risks associated with certain diseases by screening no less than "240 genetic traits and congenital diseases". The reliability of these tests is questionable as results are deemed "insignificant". FDA experts have therefore instructed 23andMe to stop "false/deceptive advertising" in relation to its test kits. Proceedings are underway because a spokesperson for 23andMe failed to confirm that product sales had been well and truly suspended.