The FDA has written a letter to Anne Wojcicki , founder of $99 DNA testing service 23AndMe, insisting it “immediately discontinue marketing the [Personal Genome Service] until such time as it receives FDA marketing authorization for the device.” The FDA accuses Wojcicki and her company of “marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).”

Reached for comment via email, a 23andMe spokesperson provided the following statement:

“We have received the warning letter from the Food and Drug Administration. 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.”

Anne Wojcicki Photo by Jeff Brown

Wojcicki told Fast Company for our November cover story that she has been working toward two goals: bringing the power of genetic testing to everyday consumers so they can better manage their own health care, and using the aggregated data from those tests to help doctors, scientists, hospitals, and researchers discover new cures for diseases that emanate from troublesome genetic mutations.

She went on to say her goal is to sign up a million customers by the end of 2013. Eventually, she said, “I want 25 million people. Once you get 25 million people, there’s just a huge power of what types of discoveries you can make. Big data is going to make us all healthier. What kind of diet should certain people be on? Are there things people are doing that make them really high-risk for cancer? There’s a whole group of people who are 100-plus and have no disease. Why?” 23andMe has about a half-million genotyped customers.

23andMe applied for medical device reviews in July and September of 2012. But today’s FDA letter insists that the reviews don’t cover all that the testing company is offering. The FDA writes, “As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.”

The problem, in a nutshell, the FDA claims, is the potential for false results that could result in someone taking incorrect or unnecessary medical action.