As raw materials used in dietary supplements are sourced from around the world and global manufacturing of finished products accelerates, a new resource now available can help manufacturers, suppliers, laboratories and regulatory agencies ensure the quality of these ingredients and products. Published by the U.S. Pharmacopeial Convention (USP), the 2012 USP Dietary Supplements Compendium(DSC) can assist dietary supplement manufacturers in developing quality specifications, testing new products, qualifying raw materials and protecting their overall supply chains.
“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.”
In addition to analytical methods and specifications,DSC includes essential information such as 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 Practices audits used by the USP Dietary Supplement Verification Program; Good Agricultural Practices from the American Herbal Products Association; and U.S. Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidelines on appropriate labeling for dietary supplements. DSC standards also can be used as the basis for buyer-supplier relationships and contractual agreements regarding expected quality of dietary supplement components.
Now offered in a two-volume set, DSC contains:
- More than 550 monographs for finished products, dietary ingredients and other components common to dietary supplement manufacturing, derived from the United States Pharmacopeia–National Formulary (USP 35–NF 30) and Food Chemical Codex (FCC), Eighth Edition. The 2012 DSC includes 64 new dietary supplement monographs and approximately 150 excipient monographs. New and revised standards include Ginkgo, Turmeric, Centella asiatica and more.
- New and revised admission safety reviews for 23 dietary supplement ingredients including Black Cohosh, Decaffeinated Green Tea Extract, Melatonin, Boswellia serrata, Garcinia cambogia, Maca and more. These reviews are conducted for the sole purpose of determining admission into USP compendia. Sources of information used by USP Expert Committees in making this determination include human clinical safety studies, adverse event reports from multiple portals, supplement interactions, animal pharmacological data, reproductive toxicity, contemporary and historical use and regulatory status.
- 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.