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Dietary Supplement Analytical Methods and Reference Materials Program (AMRM)

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Analytical Methods and Reference Materials Program Evaluation

Expert Panel Meeting
Executive summary
August 29, 2012

This report provides an overview of the history, accomplishments, and responses to 2006 expert review panel (ERP) recommendations for the Analytical Methods and Reference Materials (AMRM) Program of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS). It also summarizes the discussions and recommendations of the ERP that met on August 29, 2012, to identify successful program outcomes, indicate where improvements may be needed, and suggest recommendations for the future.

ERP members unanimously endorsed the AMRM program and strongly advocated its continuation according to the recommendations listed below, subject to the availability of resources and ease of implementation. In establishing priorities for programmatic emphasis, panel members stressed that safety aspects should receive increased attention, and that AMRM/ODS should promote outreach and training on issues of safety to reach and educate the dietary supplement scientific community and consumers.

The recommendations for the AMRM program over the next 5 years were deliberated as ERP members discussed the responses to the seven key questions with which they were charged. This report presents the details of the discussion in Section 9, General Discussion About the AMRM Program and Its Progress, and Section 10, Panel Consideration of the Charge. The major recommendations include:

  • Develop an AMRM-led approach to methods development and validation that is independent of outside organizations (e.g. AOAC International), and takes a more direct leadership role in the selection and prioritization of ingredients and analytes and the review of candidate methods.
  • Pay more attention to non-targeted methods for screening and analysis for toxic contaminants and adulterants, with the inclusion of active components where known.
  • Continue the development of NIST Standard Reference Materials© (SRMs), including promotion of collaboration among National Institute of Standards and Technology (NIST) and qualified national and international groups to expedite production.
  • Encourage NIST to conduct a market analysis of reference materials.
  • Focus on advancing the development of plant DNA fingerprinting through the new initiative with NIST, and with other qualified partners where appropriate, expanding it to explore the application of this technology to the detection and identification of harmful microbial pathogens that may be present in supplements and that pose serious health threats.
  • Encourage NIST to continue to focus on vitamins, using vitamin D as a model where appropriate and applicable, and to coordinate the ODS/NIST Vitamin D Standardization Program with the Centers for Disease Control and Prevention (CDC).
  • Continue and expand the administrative supplement program initiated with the National Center for Complementary and Alternative Medicine (NCCAM) to include additional NIH Institutes and Centers (ICs), particularly in the biological and clinical areas of dietary supplement research.
  • Continue to support ICs by providing them with appropriate advice, and possibly supplemental funding, concerning the best methodology that they can use with respect to their specific needs.