Dietary Supplement Analytical Methods and Reference Materials Program (AMRM)

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Analytical Methods and Reference Materials External Program Review

External Expert Review Panel Meeting
Executive Summary
August 11, 2017

This report provides an overview of the history of the Analytical Methods and Reference Materials (AMRM) Program of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), along with its accomplishments, and response to the 2012 expert review panel (ERP) recommendations. This information was the basis for a discussion held by the most recent ERP that met on August 11, 2017 to identify successful program outcomes, indicate where improvements may be needed, and suggest recommendations for the program’s future. The deliberations and recommendations of this panel meeting are briefly presented below and in detail in later sections of this report.
All members of the ERP panel expressed complete support for the AMRM program and applauded its success at fulfilling its Congressional mandate and at expanding the knowledge of its stakeholders about the importance of creating and using valid methods to ensure product integrity.
The recommendations for the AMRM program over the next 5 years were deliberated as ERP members discussed the responses to the five key questions with which they were charged. The panel’s discussion identified the need for ODS to: be more visible as the leader of the AMRM program, to focus on and expand education activities, to support the expansion of innovative efforts to develop and distribute reference materials and to develop new mechanisms for encouraging method development and validation of existing methods. Key recommendations include: 

ODS should increase its visibility as the leader of AMRM program.
The panel began its deliberation with a firm agreement that ODS should take more ownership of the AMRM program and expand the visibility of its leadership throughout all program activities.
  • ODS should take more ownership of the AMRM program by creating more visibility for itself throughout all the program’s activities, including in publications that highlight, not just mention, AMRM.
  • Develop a steering committee of stakeholders that meets regularly to discuss AMRM concerns, activities and direction.
ODS should increase the emphasis of education activities within AMRM.
The panel agreed that education and outreach is a key low cost but high benefit activity and that all education activities should be brought together under ODS’s direct management. ODS should use its existing resources and collaborations with other organizations to increase its emphasis on education and its ability to reach a greater number of stakeholders in the dietary supplement scientific community. 
  • ODS should take the lead on all education activities.
  • ODS should use their current role as publication reviewers to educate publishing authors and journal editors about the importance of conveying information about product integrity.
  • Conduct active educational outreach (webinars) to educate people at all levels in the dietary supplement community (bench scientists to lab management to trade organization leaders).
  • Prepare workshops at meetings with multiple presentations to get a larger message out to the community (e.g., host a 2-3 hour symposium with different perspectives).
  • Help fund existing workshops (to increase the breadth of presenters) and promote workshops (prior to meetings) to increase the audience.
  • Use social media (e.g., twitter) to increase the public presence of AMRM and to promote specific workshops or activities.
  • Create a broad-based listserv of people throughout the dietary supplement academic and industry communities to expand outreach and education. Consider identifying existing listservs that could be piggybacked on to get information to stakeholders.
  • Make better use of the website by linking to other organizations for their information.
  • AMRM should not focus its efforts on DNA fingerprinting but can educate others about it.  
ODS should support the expansion of innovative efforts to develop and distribute reference materials.
The panel strongly suggested the exploration of different and innovative ways to support the development and distribution of CRMs or secondary reference materials at less cost. By supporting a generation of reference materials that people actually want to use, AMRM is more likely to increase the number of companies within the industry using valid methods.
  • Explore the use of secondary reference materials for the purpose of increasing the impact of the program.
  • Try to find innovative, creative ways to develop CRMs or secondary RMs at less cost, and to develop a mechanism for distribution. This is not meant to replace NIST’s CRM development, but rather to expand the overall development and availability of reference materials.
  • Promote the use of CRMs or secondary RMs to help drive the demand for these products, thus increasing the incentive for industry to supply these materials.
  • Conduct an industry-wide survey or a market analysis of the CRMs to better understand industry needs and perceptions to encourage reference material use. 
ODS should develop new and creative ways to encourage method development and validation of existing methods.
The panel suggested that AMRM deprioritize work on method validation but consider the option to obtain co-funding for this work from government agencies and private organizations. In general, however, it was strongly suggested that AMRM move away from relying on the AOACI method validation program, and rather promote the NIST Dietary Supplement Laboratory Quality Assurance Program (DSQAP), using CRMs and RMs for the development and ‘validation’ of non-targeted analytical methods.
  • Deprioritize the method validation activities of AMRM.
  • Evolve from prescription-based methods to performance-based methods by focusing on teaching companies how to develop their own methods, and then validate them using SRMs or CRMS (using the existing DSQAP activities).
  • Focus method development funding on broad screening, non-targeted methods and do not limit this to toxins.  
ODS should reprioritize program activities to emphasize education and de-emphasize method validation.
Having discussed each of the different program elements separately, the panel prioritized the program elements as follows:  
  • Education and outreach
  • Reference material development
  • Method Development
  • Method Validation