Pyridoxamine

Executive Summary

The Council for Responsible Nutrition requests a 90-day extension period to comment on the status of pyridoxamine as a dietary supplement. "There is very strong evidence" that the ingredient was marketed prior to the enactment of DSHEA, CRN maintains in a Dec. 16 letter to FDA. However, the group began contacting members in November for evidence of sale and "the search for documentary evidence is proving difficult and tedious." CRN has identified two firms "whose former employees believe they marketed pyridoxamine during that era" and who are continuing their search for evidence. FDA sought comment in a Nov. 18 Federal Register that "tentatively" concluded the ingredient was not a supplement ("The Tan Sheet" Nov. 21, 2005, p. 13). Debate began when a July citizen petition by BioStratum requested that sales of supplements containing pyridoxamine cease. The firm filed an investigational new drug application in 1999 for Pyridorin, which contains the ingredient...