Analytical Methods and Reference Materials (AMRM) Program

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AMRM Overview

The ODS Analytical Methods and Reference Materials (AMRM) Program was established in 2002 in response to a congressional mandate to create a program that supports and accelerates the development, validation, and dissemination of analytical methods and reference materials for dietary supplements and their ingredients.

Quantitative analytical methods are needed to:

• verify dietary ingredient identity,
• measure the amounts of constituents of interest in dietary supplement raw materials and finished products,
• measure ingredients and/or their metabolites in biomedical research and clinical assessments, and
• Identify and measure contaminants in supplements.

Reference materials that are well-characterized for their composition and properties are needed to:

• perform analytical instrument calibrations,
• verify the accuracy of specific measurements, and
• support the development of new measurement methodology

Accurate, precise, and reliable analytical methods and matching reference materials ultimately serve to enhance confidence in the quality of marketed dietary supplement products and to provide confidence in scientific research on dietary supplements. 

AMRM Program Goals

1. Develop and expand the availability of reliable, scientifically valid analytical methods for quantitative and qualitative characterization of dietary supplements and their ingredients.
2. Produce, and make available certified reference materials (CRM) appropriate for use in analytical method development, validation, and demonstration of method and laboratory performance.
3. Support public and private partnerships that will increase emphasis on the need for chemical and biological characterization of dietary supplements and their bioactive ingredients as part of a scientifically sound approach to exploring and understanding their biological effects.
4. Disseminate information and data about validated analytical methods and reference materials in the peer-reviewed scientific literature to expand their use by NIH/ODS partners and other interested parties.

AMRM Program Structure

The AMRM Program funds several activities in collaboration and coordination with multiple federal, academic, and private sector partners. Complementary program activity areas of method development and validation, reference material and calibration solution production, quality assurance programs, and education create a foundation for rigorous and reproducible basic and clinical research, expanding the capabilities of industry scientists, and enhancing the translational potential for dietary supplement research to improve public health.

Analytical community needs and Program priorities are identified through open meetings and met through collaborative efforts with Federal and non-Federal institutions. Industry, government, not-for-profit groups, and academic institutions participate in the process of identifying needs and setting priorities.

AMRM Program Outcomes and Accomplishments

• 17 single-laboratory (SLV) and 16 collaborative study publications
• Supported over 200 peer-review publications (including method development studies and guidance documents)
• Development of over 55 Certified Reference Materials (CRMs):
  • 48 food/supplement CRMs made available (>20 in-progress)
  • 10 clinical sample CRMs made available (5 in-progress)
• Funded 17 Administrative Supplements to NIH grants to conduct formal method validation studies
• Established the AOAC International Stakeholder Panel on Dietary Supplements
• Funded 25 ingredient specific AOAC International (AOAC) working groups
• 34 AOAC Standard Method Performance Requirements guidance documents
• 21 AOAC International Official Methods of Analysis SM (OMA)
• Funded 4 NIST laboratory quality assurance programs, with 33 exercises conduct to date and over 120 participating laboratories
• 3 formal validation guidelines for dietary supplement and botanical methods (AOAC Appendix K)
• Supported the development of botanical identification and documentation resources
• Supported development and publication of a textbook on botanical microscopy

AMRM Collaborating Organizations (past and present)

Federal Government

• NIH Institutes and Centers: NCCIH, NCI, NIDDK, NIEHS, and NIGMS
• U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition
• National Institute of Standards and Technology (NIST), Chemical Science and Technology Laboratory
• United States Department of Agriculture (USDA), Food Composition and Methods Development Laboratory
• United States Department of Agriculture (USDA), Poisonous Plant Research Laboratory

Non-governmental Organizations and Private Sector Companies

• AOAC International
• NSF International
• U.S. Pharmacopeial Convention (USP)
• Cerilliant Corporation

Academic Institutions

• NIH Botanical Research Centers

AMRM History

Following passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, there was rapid growth in the introduction of dietary supplement products and ingredients used to formulate these products. This growth in the number and variety of dietary supplement products and ingredients created the need for identity methods, quantitative chemical methods, and reference materials. In an effort to address these needs, Congressional appropriations language in 2002 and 2003 mandated that NIH ODS accelerate “collaborative efforts to develop, validate, and disseminate” analytical methods and reference materials for dietary supplements. In response to the mandate, the ODS held a series of open meetings to help shape the program. J AOAC Int. 2004 Jan-Feb;87(1):162-5

AMRM has been evaluated three times, in 2006, 2012, and 2017 by an external expert review panel (EERP). The purpose of these studies is to evaluate the program areas, review the response to previous EERP recommendations, and make specific recommendations on the future course of the program. These recommendations have helped shape the current program goals.