FDA Nixes Pyridoxamine in Supplements

WASHINGTON—Pyridoxamine, a form of vitamin B6, cannot be used in dietary supplements, according to FDA. The agency responded to a 2005 petition filed by Biostratum Inc. asking for clarification on the regulatory status of the ingredient; the company manufactures Pyridorin (pyridoxamine dihydrochloride) and has been the subject of investigational new drug studies since 1999. While no enforcement action will be taken against companies that have been marketing dietary supplements containing pyridoxamine, those products can no longer be sold as dietary supplements.

FDA’s decision, background information and comments can be seen online.

The Council for Responsible Nutrition (CRN) had filed comments with FDA regarding the Biostratum petition. In a statement from Andrew Shao, Ph.D., CRN’s vice president, scientific and regulatory affairs, the association said it was disappointed with FDA’s decision, and particularly with the extensive evidence the agency is seeking regarding the status of ingredients marketed as supplements prior to passage of the Dietary Supplement Health & Education Act (DSHEA). He noted, “Demanding that industry maintain these records, but failing to work with industry to develop an agreed-upon list of ‘grandfathered ingredients,’ places more burden on dietary supplement companies to be sure that they can substantiate that an ingredient has in fact previously been marketed as a dietary supplement.” Shao added the decision could set a precedent for companies to challenge the status of other dietary ingredients.