The FDA issued a warning letter to DNA testing company, 23andMe, Inc., on November 22, 2013, requiring 23andMe to immediately halt marketing for their DNA testing kits until it secures FDA premarket approval, pursuant to the Federal Food, Drug and Cosmetic Act (FDC Act).
According to its website, 23andMe offers DNA test kits to public consumers, allowing individuals, for the price of $99.00, to learn about their ancestry and potential health risks, such as diabetes, arthritis, coronary heart disease, and breast cancer. The problem, according to the FDA, is that 23andMe has not received classification or premarket approval for most of the uses 23andMe markets their test kits for, meaning the FDA has been unable to determine whether the test kits function properly or not. False positives for breast or ovarian cancer genes, as an example, could potentially lead to invasive surgery, chemotherapy, or “other morbidity-inducing actions.” Conversely, false negatives could lead to a failure to diagnose actual life-threatening risks. Further, the test results for a consumer’s potential response to specific medications could lead to self-managed treatments and a substantial “risk of illness, injury, or death.”
The FDA further noted that 23andMe has failed to complete studies that could validate the effectiveness of the DNA test kits, failed to provide additional information requested by the Administration, and failed to communicate since May of 2013. In its company blog, 23andMe stated, “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.”
According to a CNN news report, although the FDA has stated that it will regulate genetic testing, the Administration has not issued any guidance on the matter to date. However, the Administration has been handling such matters on a case-by-case basis.
Also, as CNN reported, Erica Jefferson – an FDA spokeswoman – commented that “the FDA has worked and will continue to work closely with any company marketing direct-to-consumer genetic tests without stifling innovation.”
Nevertheless, pursuant to the FDA’s warning letter, 23andMe has 15 working days from November 22, 2013 to respond with actions it has or will take to remedy all of the FDA’s concerns.