April 30, 2012

2 Min Read
USP's New Dietary Supplement Resource

ROCKVILLE, MDThe US Pharmacopeial Convention (USP) has released its 2012 USP Dietary Supplement Compendium (DSC)  to help manufacturers, suppliers, laboratories and regulatory agencies ensure the quality of raw materials used in dietary supplements ingredients and products. The publication was designed to assist dietary supplement manufacturers in developing quality specifications, testing new products, qualifying raw materials and protecting their overall supply chains. According to USP, standards in the publication, which is updated and published every two years, also can be used as the basis for buyer-supplier relationships and contractual agreements regarding expected quality of dietary supplement components.

The DSC includes specifics on analytical methods and specifications, as well as essential information on the regulatory framework for dietary supplements, industry guidance documents and tables of dietary intake levels. Other practical features for manufacturers, ingredient suppliers, contract laboratories and regulatory agencies include checklists for Good Manufacturing Practice (GMP) audits used by the USP Dietary Supplement Verification Program; Good Agricultural Practices (GAPs) from the American Herbal Products Association (AHPA); and FTC and FDA guidelines on appropriate labeling for dietary supplements.

The publication is offered in a two-volume set containing: more than 550 monographs for finished products, ingredients and other components (includes info from USP's National Formulary (USP 35NF 30) and Food Chemical Codex (FCC), Eighth Edition, as well as 64 new dietary supplement and 150 excipient monographs);  revised admission safety reviews for 23 dietary supplement ingredients including black cohosh, decaffeinated green tea extract, melatonin, Boswellia serrata, Garcinia cambogia, maca and more (source: USP Expert Committees); and, more than 300 pages of full-color illustrations including macroscopic and microscopic photographs, diagrams, chemical structures, and TLC/HPTLC/HPLC/GC chromatograms that exemplify the performance of compendial tests.

While estimates vary, we know that a majority of Americans consume one or more dietary supplement products as part of their overall health strategy, said Praveen Tyle, Ph.D., executive vice president and chief science officer for USP. The quality of these products and the ingredients that go in to them should be paramount. The new USP Dietary Supplements Compendium offers international dietary supplement manufacturers of all sizes a comprehensive resource for finding suitable, unbiased and scientifically sound analytical methods, and specifications for the identity, quality and purity of ingredients and products.

For more information, visit USP's DSC page.



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