The FDA warned 23andMe CEO Ann Wojcicki that the company is marketing its "Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act," it said in a letter dated Nov. 22.
The letter was signed by Alberto Gutierrez, director of the Office of Invitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health. Elaborating on his concerns, Gutierrez explained that he remained skeptical of the company's service.
While the Personal Genome Service is marketed as a tool to empower consumers — by informing them of certain genetic risks and providing them with knowledge that would help them make better treatment choices — Gutierrez wrote, "We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses. ... Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."
In a brief response to the FDA's letter, posted on 23andMe's website, the company wrote, "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."