FDA Outlaws Food

It is thought that treatment with benfotiamine leads to increased intracellular thiamine diphosphate levels, a cofactor of transketolase. This enzyme directs advanced glycation and lipoxidation end products (AGE's, ALE's) substrates to the pentose phosphate pathway, thus reducing tissue AGEs. In humans, pyridoxamine protects against methylglyoxal. However, in the United States, the FDA ruled in January 2009 that pyridoxamine must be regulated as a pharmaceutical drug because it is the active ingredient in Pyridorin, a drug designed to prevent the progression of diabetic nephropathy.

In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and “may not be marketed as such.” Although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA determined that pyridoxamine is excluded under § 201(ff)(3) because: (1) pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public; and (2) there is no “independent, verifiable evidence” of prior marketing of pyridoxamine as a food or dietary supplement. Among the conclusions reached by FDA:
• an “article authorized for investigation as a new drug” includes not only the active ingredient (i.e., pyridoxamine hydrochloride), but also the active moiety (i.e., pyridoxamine);
• consistent with the position taken by FDA in Pharmanex v. Shalala, 2001 WL 741419, the “mere presence” of a substance in the food supply, even at high levels in foods, does not alone constitute marketing within the meaning of § 201(ff)(3)(B);
• affidavits, without more, are insufficient to support a claim of prior marketing.

I don't know about yours, but my vitamin supply of pyridoxamine will run out in another 3 months. If that is the way the FDA feels about things, it seems like they should all become vegetarians to eliminate pyridoxamine from their diet and be within the spirit of their ruling. Maybe I should have put a list of all the supplements and food I consume so the FDA would know that food is normal food and not drugs. Lawyers are so silly!