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January 29, 2009
The US Food and Drug Administration recently deemed that products containing pyridoxamine dihydrochloride, a form of B6, are not dietary supplements under the Dietary Supplement Health and Education Act. The decision places the accountability on the industry to keep careful records. The Council for Responsible Nutrition says DSHEA is very clear that an article may not be marketed as a dietary supplement or food if there is a prior history of investigation as a new drug and substantial clinical investigation.
"However, we are disappointed with FDA's response that apparently views as inadequate the evidence presented by the industry, including CRN, of the previous marketing of pyridoxamine, even prior to the passage of DSHEA," says Andrew Shao, Ph.D., vice president, scientific and regulatory affairs, CRN. "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."
Shao believes that the demand for record keeping while failing to work with industry to develop an agreed-upon list of 'grandfathered ingredients,' places a significant burden on dietary supplement companies to substantiate that an ingredient has in fact been previously marketed as a dietary supplement.
CRN is fearful that the decision on pyridoxamine could set a precedent to challenge the status of other dietary ingredients. 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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