The NIH/ODS Analytical Methods and Reference Materials Program for Dietary Supplements: Five-Year Accomplishments and Future Directions

Quality of natural health products remains a challenge to regulators, researchers, and manufacturers. Quality parameters include specifications for sanitation, contaminants, and content of natural chemicals. Validated analytical methods and reference materials to ensure the purity and strength of natural health products are essential. Because these products and their ingredients are often complex mixtures they pose analytical challenges, and methods validation may be difficult. In response to concerns about quality, in 2002 the U.S. Congress directed the Office of Dietary Supplements at the National Institutes of Health to accelerate methods validation, and the Analytical Methods and Reference Materials Program (AMRM) was created. The program is stakeholder driven and provides a coordinated approach to validation that facilitates methods validation and production of reference materials. The major accomplishments of the first five years of the AMRM program involve collaborative efforts with FDA, AOAC, and NIST. The program has resulted in 18 collaborative studies of analytical methods. Twelve methods have been approved as Official Methods of Analysis (OMA), and 3 of these are final action OMA. The NIST reference materials project has resulted in the production of 5 suites of standard reference materials, with an additional 12 suites in various stages of completion. The NIST has also created a pilot Laboratory Quality Assurance Program that will assist laboratories to become proficient at analysis. A more detailed account of these accomplishments and an outline of the future scope and direction of the program will be presented.