Lane C. Sander, Karen W. Phinney, Michele M. Schantz, Katherine E. Sharpless, Stephen A. Wise
In 1994, the U.S. Congress enacted the Dietary Supplement Health and Education Act to "protect the right of access of consumers to safe dietary supplements". In response to this legislation, 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, Center for Drug Evaluation and Research (FDA-CDER) are collaborating to develop Standard Reference Materials (SRMs) to support the measurement of chemical constituents in dietary supplements. Well-characterized reference materials are needed to promote quality and consistency in manufacturing, and accuracy in product labeling. Reference materials may also be useful in the development of new analytical methods and validation of these methods, and they provide a component in achieving traceability of measurements. The goal of this ongoing effort is to provide tools to the dietary supplement industry and measurement communities that will lead to improved quality of dietary supplements, and ultimately reduce public health risks that could potentially be associated with these products.
dietary supplement, DSHEA, GMP, NIH, ODS, QA, quality assurance, Standard Reference Material