23andMe, the Google-backed direct-to-consumer genetic testing provider, has suspended its health-related genetic testing in response to FDA's November 22, 2013 Warning Letter. In the Warning Letter, FDA directed 23andMe to "immediately discontinue marketing [its Saliva Collection Kit and Personal Genome Service, "PGS"] until such time as it receives FDA marketing authorization for the device." While 23andMe will discontinue access to health-related services, 23andMe will continue to provide access to raw genomic data as well as ancestry-related applications. Also, customers who purchased 23andMe prior to FDA's Warning Letter will still have access to health-related results.

The Warning Letter deemed the PGS a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act"). 21 U.S.C. 321(h). Section 201(h) defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article" that is "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" or is "intended to affect the structure or any function of the body." FDA determined that the PGS fell within this definition, because it was marketed as providing, "health reports on 254 diseases and conditions." In particular, 23andMe was marketed as a "first step in prevention" for diseases like diabetes, coronary heart disease, and breast cancer.

FDA is particularly concerned about the "potential health consequences that could result from false positive or false negative assessments for high-risk indications." For example, a false positive BRCA-related risk assessment [A BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2. Harmful mutations in these genes produce a hereditary breast-ovarian cancer syndrome in affected families.] Mutations in BRCA1 and BRCA2 are uncommon, and breast cancer is relatively common, so these mutations consequently account for only five to ten percent of all breast cancer cases in women.[may lead to unnecessary prophylactic surgery or chemoprevention. On the other hand, a false negative may lead to a failure to appreciate actual risk. FDA was also concerned about drug response assessments, such as warfarin sensitivity or clopidogrel response. For example, a false positive BRCA-related risk assessment [a BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2 that is associated with a hereditary breast-ovarian cancer syndrome in affected families] may lead to unnecessary prophylactic surgery or chemoprevention.

The Warning Letter detailed numerous interactions with the Agency, including fourteen meetings, "hundreds" of e-mail exchanges, and "dozens" of written communications. The Letter stated, however, that, "even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses ..." FDA found that the PGS was a Class III medical device under Section 513(f) of the FDCA, thereby requiring a premarket approval application ("PMA")--the most restrictive classification for a medical device requiring adequate and well-controlled clinical data and preapproval prior to marketing. Because the PGS is not covered by any approved application or exemption, FDA found the PGS to be adulterated under Section 501(f)(1)(B) of the FDCA and misbranded under Section 502(o).

23andMe's public response to the Warning Letter stated that: "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns." And on the 23andMe blog, founder and Chief Executive Officer Anne Wojcicki stated that she was "highly disappointed that we have reached this point" but that "our goal is to work cooperatively with the FDA."