The U.S. Food and Drug Administration (FDA) issued a letter on Friday to DNA testing company 23andMe ordering them to stop marketing their direct-to-consumer genetic test because they do not have market clearance or approval from its agency to do so.
The company has submitted premarket notifications to the FDA, and, in response to Friday’s letter, 23andMe issued a 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.
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