Standard reference materials for dietary supplement analysis

摘要

The National Institute of Standards and Technology (NIST), the National Institutes of Health Office of Dietary Supplements(NIH-ODS), and the Food and Drug Administration (FDA) are working in collaboration to produce dietary supplement Standard Reference Materials (SRMs). Efforts began following the creation of the NIH Office of Dietary Supplements by the Dietary Supplement Health and Education Act (DSHEA) of 1994 [1] and the establishment of the NIH-ODS Analytical Methods and Reference Materials Program (AMRM) in 2002 [2]. AMRM is responsible for ensuring that quality calibration materials and matrix-based certified reference materials (CRMs) are available to dietary supplement laboratories along with rugged, precise, and accurate analytical methods [3-7]. More recently, as of June 2010, the current Good Manufacturing Practices (cGMPs) published by the FDA are required for all dietary supplements produced in the United States [8] The cGMPs require that products be evaluated for identity, purity, and strength as well as for contaminants (toxic elements, bacteria, persistent organic pollutants, and other toxins) and adulterants (either unintentional or economically motivated), placing increased emphasis on the importance of the development of dietary supplement SRMs. NISTstaff are often asked about the status of new and existing SRMs; this manuscript is designed to provide an update on the dietary supplement Standard Reference Materials Program. The Certificates of Analysis for available SRMs can be found at nist.gov/SRMs [9] and can be searched for by keyword or SRM number. The brief descriptions of different dietary supplements are all taken from the NIH-ODS factsheets [10].