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
Partners: The ODS works closely with several Federal government agencies, including:
- National Institute of Standards and Technology (NIST)
- US Department of Agriculture (USDA)
- Food and Drug Administration (FDA)
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:
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:
References: The following publications provide more complete descriptions of the AMRM Program, as well as its progress and future:
- 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)
- 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)
- 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)
- Methods for dietary supplements: Successful conclusion of a 5-year effort. J AOAC International 2008 91(3):74A-77A.