http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm
The Food and Drug Administration (FDA) is sending you this letter because you are 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)…..
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