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by skwb
2689 days ago
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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/... 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). |
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