Re:FDA Warning Letter to 23andMe
by saalweachter on Monday November 25, 2013 @11:09PM
(#6799047)
Blame 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 Unless that bill is repealed, the FDA has no authority over supplements.
Oh I get this comes from congress and the tortured history of dietary supplements. I'm just taking issue with what might define as reasonable.
I don't see what reasonableness has to do with government.
Since when do "natural supplements" make medical diagnosis? Not even in the same ballpark.
Natural 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.
And 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.
I 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?
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.