In a letter posted on its website, the FDA alleged 23andMe was being sold without clearance or approval in violation of the Federal Food, Drug and Cosmetic Act.
The FDA letter said the company's website of 23andMe said the personal genome service provides a "first step in prevention" that enables users to "take steps toward mitigating serious diseases" such as diabetes, coronary heart disease and breast cancer.
"Most of the intended uses for personal genome service listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the Federal Food, Drug and Cosmetic Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions," the FDA said in the letter.
"Some of the uses for which personal genome service is intended are particularly concerning, such as assessments for BRCA-related genetic risk -- for breast and ovarian cancer -- and drug responses such as warfarin sensitivity -- for heart disease -- because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these."
For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive that could lead a patient to undergo prophylactic surgery, chemotherapy, intensive screening, or other morbidity-inducing actions, while a false negative test result could result in a failure to recognize an actual risk of disease that might exist.
A false result for warfarin -- a blood thinner used to prevent clots from forming -- could have significant risk of illness, injury, or death to the patient due to thrombosis, or blood clot, or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anti-coagulant effect. Warfarin needs a regular blood test to determine the blood is not too thin, which could cause a stroke.
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