FDA Invites Comments on Pyridoxamine (B6) Status

FDA Invites Comments on Pyridoxamine (B6) Status

WASHINGTONThe Food and DrugAdministration (FDA) has called for public comments on the status ofpyridoxamine , a member of the vitamin B6 family, following a citizen petitionfiled by BioStratum Inc., pharmaceutical manufacture of Pyridoxin, apyridoxamine dihydrochloride product. While the Council for ResponsibleNutrition (CRN) argues pyridoxamine is s grandfathered dietary supplement formof B6 (marketed before 1994), BioStratum claims it is pyridoxine that has beenused as vitamin B6 in dietary supplements. BioStratum filed an investigationalnew drug (IND) application for Pyridoxi in 1999 and contends supplementcontaining pyridoxamine are adultered.

Comments must be filed by Dec. 18 and can be submitted atwww.fda.gov/dockets/ecomments.