3 ms·
Two things: 1. 23 and Me has a history of overhyping their science when it comes to medical claims. FDA back in 2013 threatened regulatory action due to their w
by skwb 8y ago
Two things:
1. 23 and Me has a history of overhyping their science when it comes to medical claims. FDA back in 2013 threatened regulatory action due to their wafarin (blood thinner) metabolism claim.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm376296.htm https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/...
2. FDA regulates marketing and claims that you can make for products including drugs/devices (but that whole regulatory framework is a story for another day). You need to have certain regulatory approval for formalized medical testing/reimbursement (remember that 23 and Me is targeting consumers, not traditional patients).