I just received this from the NPA, although we don't sell any it bothers me because if this goes through it can have a domino effect on many supplements you maybe taking today:
Special Request for Assistance with Response to FDA Regarding Pyridoxamine
Natural Products Association Supply Members:
The Natural Products Association needs your help. Enclosed is the Food and Drug Administration’s (FDA) response to a citizen petition filed on behalf of a pharmaceutical company (http://www.naturalpr....pdf?docID=9001). FDA has determined that products containing pyridoxamine, a form of vitamin B6 (the letter specifically cites "pyridoxamine dihydrochloride or any other compound containing pyridoxamine") are not dietary supplements within the meaning as indicated by DSHEA, specifically Federal Food, Drug, and Cosmetic (FFDC) Act § 201(ff) and "may not be marketed as such."
In a confusing twist, the agency goes on to clarify that although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA has determined by the petition 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; this includes the Natural Products Association’s (developed as NNFA) list of grandfathered ingredients.
While this development presents a number of problems, including the agency's interpretation of §301 (ll) of the FFDC Act (which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added), the Natural Products Association has contacted the agency regarding the submission of records and documentation to the agency demonstrating that products containing pyridoxamine were marketed pre-DSHEA. For that, the NPA needs your help. If you have sales records, shipping orders, labels and/or other relevant documentation that clearly demonstrates that pyridoxamine was in commerce prior to DSHEA, please contact Daniel Fabricant, Ph.D., NPA vice president, scientific and regulatory affairs, via e-mail (dfabricant@naturalproductsassoc.org) at your earliest convenience.
Please pass this on to suppliers and folks that are interested in this possibly large can of worms...
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