The Food and Drug Administration is calling for an immediate halt on the sale of 23andMe DNA tests. The FDA sent a warning letter Friday to Ann Wojcicki, 23andMe’s Chief Executive Officer, which states that the company’s product does not have FDA marketing clearance or approval. The letter states that this is in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).

23andMe sells a Saliva Collection Kit and Personal Genome Service (PGS). For $99 a customer receive information based on his or her DNA after providing a quick saliva sample. The 23andMe website claims that the results will tell customers about their health, risk factors and genetic traits, as well as ancestry information.

The FDA finds these claims worrisome. “FDA is concerned about the public health consequences of inaccurate results from the PGS device,” the letter reads. “The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”

And this shouldn’t come as news to Wojcicki and the 23andMe team. After listing several issues with the test’s claims, the letter states that the FDA has previously explained the issues “on numerous occasions.”

The Questionable Claims

The FDA states several particular issues as examples of situations in which testing results could lead to dangerous outcomes.

One part of the test gives information BRCA-related genetic risks, in other words, the genetic likelihood of developing breast cancer. The FDA letter explains that a false positive (stating a genetic risk when no such risk is present) could result in needless preventative measures such as a mastectomy. Likewise, a false negative could lead individuals to overlook actual risks.

Another part of the DNA test looks at a person’s potential tolerance for and reaction to different drugs. The FDA says that such information could lead people to self-manage their drug regimens. As an example, it talks about warfarin, a drug commonly used to treat and prevent blood clots. False information about warfarin drug response “could have significant unreasonable risk of illness, injury, or death to the patient.”

The Future of 23andMe

This isn’t the first time 23andMe has been in trouble with the FDA, according to Gizmodo. Similar concerns about the DNA results were raised in July, to which Wojcicki said, “23andMe is working proactively with the FDA to ensure the industry delivers high quality information that consumers can trust.”

Now, after an additional warning, 23andMe will hopefully make some changes to its business plan, which should include getting FDA approval of its testing.

It probably won’t take long for us to hear the outcome; the FDA letter requires that 23andMe take corrective action within 15 days.