Dietary Supplement Analytical Methods and Reference Materials Program (AMRM)

Analytical Methods and Reference Materials Program Evaluation

Expert Panel Meeting
Executive summary
July 24, 2006

This report provides an overview of the operations and achievements of the Analytical Methods and Reference Materials (AMRM) program of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) since its inception in 2002, and summarizes the deliberations, findings, and recommendations of an expert panel appointed by the director of ODS to evaluate the achievements of the program and to recommend specific measures for improvement of its performance over the next 5-year cycle.

Panel members agreed that the program has been successful in increasing the total awareness of the dietary supplement industry and community, and the public, to the need of AMRM for the promotion of quality control and the need for good analytical methodology and reference materials (RMs) to achieve satisfactory standardization. However, members were concerned with the slow pace of progress in the development and validation of analytical methods and the production of RMs. Members have proposed some specific recommendations to address this deficiency. Members were also concerned that those who have the knowledge about the utilization of the dietary supplements (those who are using NIH funds on evaluating the biological effects of supplements) have not been significantly involved in these issues. Members recommended greater involvement of the biomedical research community in the overview and discussion of the different approaches adopted to achieve AMRM goals.

Recommendations for improving and expediting the AMRM program over the next 5-year cycle are discussed in detail in responses to questions posed by ODS. (See sections VII and VIII below.) The major recommendations are outlined below:

It is most important that the level of redundancy be minimized. Members believe that AMRM/ODS must play a greater leadership role in promoting collaboration between groups with expertise in methods development and validation and in the production of RMs.
The Interagency Agreement (IAG) with the U.S. Food and Drug Administration (FDA), currently providing support of the AOAC International (AOACI) contract, should be terminated when the present cycle is completed. A substantial portion of the funds currently allocated to that contract should be redirected to supporting a multiorganizational contract mechanism under the direct supervision of AMRM for performance of methods optimization and validation projects. Academic and research organization laboratories and contract facilities must be involved in the process.
To expedite the validation process, AMRM should regard the validation from Single Laboratory Validation (SLV) to Official Method of Analysis (OMA) as a separate process, and establish intermediate milestones from SLV through Multiple Laboratory Validation (MLV; collaborative studies) to OMA. Clear criteria as to what constitutes an SLV method need to be developed. Published methods could be reviewed by a panel of experts. If it is determined that the methods meet the SLV criteria, they could be publicized as such (proofs of concept) even before being officially validated. This would provide a basis for stakeholders to evaluate whether or not a method works.
The panel considers the production of suites of Standard Reference Materials© (SRMs) to be very important and recommends continuation of the IAG arrangement with the National Institute of Standards and Technology (NIST). Once more, there is concern about the slow pace of development of these RMs, and NIST must be encouraged to collaborate with other qualified research organizations to avoid duplication of effort and redundancy. In addition, NIST should be encouraged to start with identified and well-authenticated raw source materials, in addition to using “blended” purchased materials, in developing chemical analyses and production of suites of SRMs.
AMRM should identify pertinent Web sites with interests related to AMRM and link each to the ODS Web site. AMRM also should ensure that different components are all connected together, thereby enabling easy transfer from one site to another as interests evolve.

Complete report

Betz JM, Fisher KD, Saldanha LG, Coates PM. The NIH analytical methods and reference materials program for dietary supplements. Anal Bioanal Chem 2007 389:19-25.