23andMe Genetic Testing Kit Sales Must Be Halted, FDA Warns

The U.S. Food and Drug Administration (FDA) has ordered an immediate halt of sales for 23andMe genetic testing kits, which are saliva-based DNA tests that have not been properly cleared for diagnosis of disease and may not be scientifically sound. The federal health officials indicate that this could lead consumers to make erroneous decisions about their medical care.  

The FDA issued a warning letter on November 22, indicating that the sale of 23andMe Saliva Collection Kits and Personal Genome Service kits violates the Federal Food, Drug and Cosmetic Act and poses a potential health risks to customers.

The test kits allow customers to take a swab of their salvia for DNA testing that is sent back to 23andMe. The company then checks for multiple diseases and medical conditions, such as breast cancer, diabetes, and coronary heart disease. The FDA says that the manufacturer failed to get FDA approval for the kits, which may provide a misdiagnosis of a major medical condition, leading customers to abandon treatment or pursue the wrong course of action for medical conditions. The FDA has jurisdiction over any and all medical apparatus designed to diagnose or treat illness and disease.

The warning letter claims that 23andMe is marketing the saliva-based DNA kits to diagnose diseases and other health conditions as well as cure, mitigate, treat, and prevent further disease and ailments. The warning letters states that on November 6, the website 23andMe.com claimed the DNA test kits are capable of accurately diagnosing 254 diseases and conditions.

Additionally, 23andMe promote the test kits to be the “first step in prevention” against heart disease, diabetes, and breast cancer by being able to identify women who carry the BRCA gene mutation that significantly increase the risk of breast and ovarian cancer, possibly leading women to undergo unnecessary screening, chemotherapy and surgery.

The FDA warning letter indicates that the agency has been in contact with 23andMe since 2007 regarding the veracity of the medical backing for the tests and have not received any assurance that the firm has analytically or clinically validated the test kits for intended uses. Since January 2013, the FDA stated there have been hundreds of emails addressing the marketing strategies of 23and Me’s test kits.

If the company fails to adequately respond to the FDA’s concerns, the agency could seize its inventory, get a court-issued injunction against the company, or level monetary fines against its owners.

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