Analytical Methods/Reference Materials (AMRM) Dietary Supplements Program Description

The ODS launched the Dietary Supplements Analytical Methods and Reference Materials (AMRM) Program in 2002. The program stimulates the development of validated analytical methods and reference materials to meet the needs of manufacturers, regulators, contract laboratories, academicians, and researchers.

Program Need: The rapid growth of the dietary supplement marketplace resulted in a profuse increase of ingredients and products. This growth outstripped development of reliable analytical methods and appropriate reference materials. Precise, accurate, and rugged analytical methods, reference materials, and calibration standards are essential to:

• verify dietary supplement ingredient identity,
• measure the amounts of declared ingredients in raw materials and dietary supplements, and
• identify and measure contaminants in supplements.

Goals: The AMRM Program goals are to:

• build an infrastructure for development, validation, and dissemination of analytical tools;
• support the development of validated methods, reference materials, and calibration standards for use with dietary supplements; and
• make these methods and materials readily available to the user community.

Description: The program is a broad-based, multiagency enterprise that supports the technical aspects of analytic methods and reference materials development, as well as the administrative and consensus-building foundation, needed to advance the field.

Validation Studies of Analytical Methods

• Funding available

Partners: The ODS works closely with several Federal government agencies, including:

• National Institute of Standards and Technology (NIST)
  • Material Measurement Laboratory
• US Department of Agriculture (USDA)
  • Food Composition and Methods Development Laboratory
• Food and Drug Administration (FDA)
  • Center for Food Safety and Applied Nutrition

In addition, the ODS supports the AOAC International, a nongovernment voluntary consensus standards body, to develop the program framework and technical aspects for analytical methods:

• AOAC International

Key Program Components:

• Reference materials and calibration standards development (NIST),
• Dietary Supplements Laboratory Quality Assurance Program (NIST),
• Analytical methods development and validation (USDA, FDA, AOAC International, NIST), and
• Outreach (education, presentation, training materials).

Achievements to date:

• NIST developed suites of NIST Standard Reference Materials®. [Standard Reference Materials]
• NIST initiated the Dietary Supplements Laboratory Quality Assurance Program. [Quality Assurance Program]
• AOAC International built infrastructure by establishing
  • the Presidential Task Force on Dietary Supplements to identify ingredients in need of validated methods,
  • Ingredient Ranking Subgroups to prioritize methods needs, and
  • Expert Review Panels to select the best methods for validation.
• AOAC International coordinated and published in the Journal of AOAC International an increasing number of single-laboratory and collaborative study validated methods, many of which are approved as AOAC Official Methods of Analysis^SM. [Analytical Methods]

References: The following publications provide more complete descriptions of the AMRM Program, as well as its progress and future:

1. 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. (Betz JM, et al., 2007, Anal Bioanal Chem 389:19-25)
2. Dwyer JT, Holden J, Andrews K, et al. Measuring vitamins and minerals in dietary supplements for nutrition studies in the USA. Anal Bioanal Chem. 2007 Sep;389(1):37-46. (Dwyer JT, Holden J, Andrews K, Roseland J, Zhao C, Schweitzer A, Perry CR, Harnly J, Wolf WR, Picciano MF, Fisher KD, Saldanha LG, Yetley EA, Betz JM, Coates PM, Milner JA, Whitted J, Burt V, Radimer K, Wilger J, Sharpless KE, Hardy CJ)
3. Saldanha LG, Betz JM, Coates PM. Development of the analytical methods and reference materials program for dietary supplements at the National Institutes of Health. J AOAC Int. 2004 Jan-Feb;87(1):162-5 (Saldanha et al., 2004, J AOAC Int. 87:162-5)
4. Methods for dietary supplements: Successful conclusion of a 5-year effort. J AOAC International 2008 91(3):74A-77A.