The Food and Drug Administration warned genetic testing company 23andMe Inc. Nov. 22 to immediately stop marketing its Saliva Collection Kit and Personal Genome Service (PGS).
In a letter to the company, FDA official Alberto Gutierrez ordered it to "immediately discontinue marketing the PGS" until it receives federal marketing approval for the product. Gutierrez is director of the Office of In Vitro Diagnostics and Radiological Health at the agency's Center for Devices and Radiological Health.
If the company fails to take corrective action, the agency said, the FDA could initiate regulatory action, including seizure, injunction, and civil monetary penalties.
Bradley Merrill Thompson, of Epstein Becker Green in Washington, said the letter "is a bit unusual in that the agency goes to great lengths to explain the effort the agency has put into helping this company come into compliance, apparently without success."
Thompson said the letter illustrates the sometimes fine line between disease-related claims, which the FDA regulates, and wellness-related claims, which it doesn't regulate.
"Generally, companies marketing a genetic test directly to consumers have been in a tug-of-war with the FDA to figure out exactly where the dividing line is between disease and wellness," he said. "Genetic testing companies argue that simply identifying the genetic makeup of a person is general information that allows for healthy living, but the FDA seems to be arguing on a case-by-case basis that they are going beyond that into the realm of disease diagnosis and treatment."