Dietary Supplement Analytical Methods and Reference Materials Program (AMRM)
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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 that permit:
- Verification of dietary ingredient identity,
- Measurement of the amounts of constituents of interest in dietary supplement raw materials and finished products, and
- Identify and measure contaminants in supplements.
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 was created in 2002 in response to a congressional mandate to create a program that supports and accelerates the development of analytical methods and reference materials for dietary supplements. In response to the mandate, the ODS held a series of stakeholders meetings to help shape the program. J AOAC Int. 2004 Jan-Feb;87(1):162-5
AMRM has been evaluated twice, in 2006 and 2012 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.
AMRM Program Goals
- Develop and expand the availability of reliable, scientifically valid analytical methods for quantitative and qualitative characterization of dietary supplements and their ingredients.
- Produce, and make available certified reference materials (CRM) appropriate for use in analytical method development, validation, and demonstration of method and laboratory performance.
- 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.
- Disseminate information and data about validated analytical methods and reference materials in the peer-reviewed scientific literature to expand their use by the NIH/ODS stakeholder community and other interested parties.
- 17 single-laboratory (SLV) and 16 collaborative study publications in the peer-reviewed literature
- 104 additional AMRM Program funded studies (includes method development studies) in peer-reviewed literature
- 33 Standard Reference Materials® (SRM) are currently available from the National Institute of Standards and Technology (NIST), and 44 are currently in-progress.
- Funded 19 ingredient specific AOAC International (AOAC) working groups
- 16 AOAC Official Methods of Analysis SM (OMA)
- Funded 3 NIST laboratory quality assurance programs. Over 100 laboratories have participated in the program
- Supported 7 collaborative study, and 16 SLV study courses from 2003-2010
- Supported the development of Botanical Identification and Documentation resources
- Supported development and publication of a textbook on botanical microscopy
AMRM Program Structure
Program needs are identified through open stakeholder 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 Funding Mechanisms
- Interagency Agreements (IAGs), e.g., between ODS and other US government entities such as the US Food and Drug Administration (FDA), the US Department of Agriculture (USDA), and National Institute of Standards and Technology (NIST).
- Administrative Supplements to current NIH funded grantees to conduct validation studies of analytical methods for natural products. Twenty applications were received from National Center for Complementary and Integrative Health (NCCIH) grantees, and 7 were funded. The program was renewed in 2013, with participation by the National Institute on Aging, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and National Cancer Institute.
- Contracts and acquisitions using NIH procurement mechanisms:
NIH funding opportunities and notices are available at the NIH Grants & Funding page .
Information on acquisitions is available at the Office of Acquisition Management and Policy (OAMP) home page .
AMRM Collaborating Organizations