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I suspect 23andMe didn't provide documentation because they very much want to avoid being treated as a medical service, and fear submitting this documentation w
by cbsmith 13y ago
I suspect 23andMe didn't provide documentation because they very much want to avoid being treated as a medical service, and fear submitting this documentation would serve to further put them on this path.
There is a bit of a contradiction here that "natural supplements" get this huge pass from the FDA, but applying some math to very, very natural genetic data doesn't.
- EpicEng 13y agoSince when do "natural supplements" make medical diagnosis? Not even in the same ballpark.
- esrauch 13y agoNatural supplements are effectively marketed as medication (despite a label indicating the FDA has not evaluated the claims). Many people I have spoken to genuinely believe natural supplements to be actual medicine based on the way they are marketed. The issue with incorrect diagnosis is might lead to incorrect or ineffective treatments. "Natural supplements" are the incorrect or ineffective treatments themselves: the unregulated claims they make is very similar in substance and effect to the quasiregulated claims that 23andme is making.
- cbsmith 13y agoAnd which ballpark would you say is closer to the area of a "food" or "drug"? If you look at the FDA's mandate, it is pretty strongly oriented to products for treatment, not medical diagnosis. The medical diagnosis angle is mostly there due to certain forms of quackery.
- EpicEng 13y agoI develop medical devices use for diagnosis for a living. Some organization has to watch over this stuff, it just so happens to fall to the FDA. What's your proposal? Do you believe that these devices should not be regulated?
- cbsmith 13y agoIf your device is a pen and paper, I don't agree it has to be regulated.
- saalweachter 13y agoBlame Congress. While the executive branch may write regulations, they must operate within the mandate defined by Congress. The DSHEA of 1994 (authored by Orrin Hatch) explicitly forbids the regulation of dietary supplements by the FDA so long as they do not make health claims. Unless that bill is repealed, the FDA has no authority over supplements.