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CRA urges supplement and food companies to keep record of dietary supplement ingredients


WASHINGTON Responding to a recent Food and Drug Administration decision that defines pyridoxamine dihydrochloride, a form of vitamin B6, as a new drug, the Council for Responsible Nutrition reiterated its position that vitamin B6 has a long history sold as a dietary supplement.

“FDA’s decision suggests that companies need to produce even more extensive evidence supporting an ingredient’s marketing as a dietary supplement, including catalog and business records from more than 15 years ago,” stated Andrew Shao, CRN’s VP scientific and regulatory affairs. “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.”

The FDA’s decision precludes any dietary supplement manufacturer from marketing pyridoxamine without first obtaining FDA approval through a new drug application. CRN has argued that pyridoxamine has been on the market as a supplement even prior to the passing of the Dietary Supplement Health and Education Act. Under DSHEA provisions, an ingredient that has been sold as a supplement prior to being submitted as a new drug can continue to be sold as a supplement. Conversely, an ingredient cannot be marketed as a supplement following the submission of an NDA.

 “The Agency’s decision on pyridoxamine could set a precedent for the status of other dietary ingredients to be challenged,” Shao suggested. “As such, CRN strongly encourages supplement and food companies to keep careful records of ingredients and marketing materials to ensure that the ingredients that they are using and marketing can continue to be marketed as dietary supplement ingredients under the law.”

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