F.D.A. Orders Genetic Testing Firm to Stop Selling DNA Analysis Service

In a crackdown on genetic testing that is offered directly to consumers, the Food and Drug Administration has demanded that 23andMe immediately cease selling and marketing its DNA testing service until it receives clearance from the agency.

In a scathing warning letter that the agency posted on its website on Monday, it said that 23andMe had failed to provide adequate evidence that its product, Personal Genome Service, provided accurate results.

“F.D.A. is concerned about the public health consequences of inaccurate results from the P.G.S. device,” the agency said in its letter.

Of the personal genome testing companies, 23andMe may be the best known, in part because it is backed by Google. The company is also run by Anne Wojcicki, the wife of a Google founder, Sergey Brin, though they are separated.

Its $99 test is sold only through the company’s website, and has been used by about half a million people. It analyzes the DNA in a saliva sample to tell consumers, among other things, whether they might be at a higher or lower risk of developing certain diseases.

As such DNA tests have been released in recent years, questions have been raised about whether they require F.D.A. approval and whether using them constitutes the practice of medicine, with a doctor needing to be involved. Ms. Wojcicki’s company has long held that consumers are entitled to the information in their own DNA, though it has also been talking to and meeting with the agency about how its tests could receive regulatory approval since 2009.

In its letter, the agency said, “Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the P.G.S. for its intended uses, which have expanded from the uses that the firm identified in its submissions.”

The F.D.A. also said it had not heard from the company since May. “Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the P.G.S.’s uses and consumer base without obtaining marketing authorization from F.D.A.”

The company responded Monday with a statement emphasizing its relationship with the agency.

“We recognize that we have not met the F.D.A.’s expectations regarding timeline and communication regarding our submission,” it said. “Our relationship with the F.D.A. is extremely important to us, and we are committed to fully engaging with them to address their concerns.”

The company now has 15 business days to respond to the F.D.A.

The F.D.A. letter said it considered the Personal Genome Service a medical device that required approval.

The letter noted that 23andMe applied last year for approval for some uses of the test. It said, however, the company did not provide the additional information requested by the agency, so the company’s applications had lapsed.

The agency seemed most concerned about a test for mutations that indicate a woman would have a very high risk of getting breast cancer. It said a false positive on such a test could lead to an unnecessary preventive mastectomy.

Scott R. Diehl, director of the center for pharmacogenomics at Rutgers, welcomed the F.D.A. action. He said tests for breast cancer risk and drug side effects required guidance from doctors and genetic counselors, and “really have no place” being offered directly to consumers.

But Misha Angrist, an assistant professor at the Institute for Genome Sciences and Policy at Duke, said that with DNA sequencing becoming cheaper and easier, the F.D.A. would ultimately fail in keeping people from having access to their own genetic information.

“Is the only pathway for me to get access to the contents of my cells via some guy in a white coat?” he said. “F.D.A. clearly thinks the answer is yes. I find that disappointing and shortsighted and naïve.”

Dr. Angrist said it was “borderline absurd” to think someone was going to get a mastectomy based on a $99 test, without follow-up.

Elizabeth A. Mansfield, director of personalized medicine in the F.D.A.’s medical device division, said the agency agreed that people had a right to their genetic information. The concern, she said, was that 23andMe was also providing interpretations of what that data meant medically.

The company, which is privately held and based in Mountain View, Calif., also offers information on ancestry. Part of the company’s business plan is to use genetic information amassed from the tests to perform biomedical research, like finding genetic causes of diseases.

Ms. Wojcicki recently said the company hoped to reach a million customers by early next year.

The F.D.A. sent letters to 23andMe and some of its competitors in 2010 saying that regulatory approval would be required for the tests. Afterward, some of the other companies stopped offering tests to consumers.

“This issue has to be fundamentally settled,” Dr. Mansfield of the F.D.A. said. “It can’t go on like this.”