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December 6, 2011
ROCKVILLE, Md.The U.S. Pharmacopeial Convention (USP) suggested new dietary ingredients (NDIs) that comply with compendial standards should be exempt from filling a new dietary ingredient notification (NDIN). In its comments on FDA's NDI Draft Guidance, the nonprofit said because USP monographs for dietary supplements include a threshold safety review and quality specifications pertaining to the quality, purity, identity and strength of the ingredient, FDA should recognize them as safe and able to enter the market without an NDIN.
USP said compendial standards can reduce regulatory and industry burden because they can show ingredients meet the same (equivalent or better) specifications for quality, purity, identity and strength, even if they are manufactured via different processes. Compendial quality standards can also address the concerns that different manufacturing processes might introduce different impurity profiles, USP said.
USP disagreed with FDA regarding its view that solvents other than aqueous ethanol and water chemically alter an ingredient, and thus would trigger the need for an NDIN. USP argued using hot water as a solvent may induce more chemical reactions (via hydrolysis) than another solvent, such as hexane or supercritical carbon dioxide. USP said its monographs limit the amount of residual solvents, and its Dietary Supplement Expert Committee (DSEC) decides the definition of "chemically altered" on a case-by-case basis. It suggested FDA make an exception to the NDIN requirement for botanical extracts that comply with USP monographs.
USP also said it considers the requirement for a NDIN for every supplement with an NDI redundant and burdensome. It said if an NDIN has already been filed that complies to compendia monograph specifications, a manufacturer that meets those specifications should not need to submit another NDIN.
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