Gluten In Pharmaceuticals And The FDA

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Hi All,

It appears that the FDA's Center for Drug Evaluation and Research, (CDER), has requested comments concerning the presence of gluten in both prescription and OTC drugs. Part of the project appears to be to identify reasons, (if they exist), why certain drug ingredients must be derived from wheat, barley or rye, and why the flexibility to use these grains as an ingredient source is important. As far as I can tell, there is absolutely no valid reason why any pharmaceutical ingredients should need to be sourced from wheat, rye, or barley.

http://www.ofr.gov/OFRUpload/OFRData/2011-32551_PI.pdf

Note that in that document the FDA lists a "conservative" tolerable daily intake level for gluten in individuals with celiac disease as:

0.4 milligrams (mg) gluten per day for adverse morphological effects and 0.015 mg gluten per day for adverse clinical effects

Evidentally, they are totally lost on the math involved, because Dr. Fasano's research on which most of the current standard proposals are based, used 50 mg and 10 mg of gluten per day, and 50 mg was deemed "safe", (even though one subject relapsed at 10 mg per day). Fasano's 50 mg quantity is 125 times as much as the FDA's stated threshold of 0.4 mg. Maybe they need to hire a mathematician over there at the FDA.

Tex