The NIH/ODS Analytical Methods and Reference Materials Program: Accomplishments and Future Directions

Assuring the quality of natural products is a challenge to manufacturers, researchers, regulators, and consumers. There are numerous ways to describe quality, often starting with botanical identity and sanitation and expanding to include specifications for pesticides, toxic elements, non-target plant material, and content of desirable and undesirable natural chemicals. Because plants contain complex mixtures of secondary metabolites, they pose unique analytical challenges. Evaluation of the accuracy, precision and reproducibility of chemical measurements made in these complex matrices is difficult. In 2002, the NIH Office of Dietary Supplements created a new program, the Analytical Methods and Reference Materials Program (AMRM), to provide tools to help members of the supplement community address these challenges. The program is stakeholder driven, with participation by government agencies, non-governmental organizations, academic researchers, and the private sector. The program provides the user community with several tools for demonstrating the integrity of analytical data: 1) published, publicly available methods that have undergone formal validation studies (useful for analysts just entering the field and for dispute resolution); 2) suites of certified matrix reference materials for use as method development and method evaluation tools; 3) certified calibration standard solutions for use in compound identification and instrument calibration; 4) no-cost laboratory quality assurance programs to assist laboratories in evaluating and improving method, analyst, and laboratory performance. The presentation will describe the structure and evolution of the NIH AMRM, provide an overview of accomplishments and resources made available by the program, and review suggestions for future program directions made by an external expert review panel charged with program evaluation.