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Development of reference materials for dietary supplements-analytical challenges, use, limitations, and future needs.

Stephen A Wise1, Sanem Hosbas Coskun2,3, Hugh V Hayes3

  • 1IFC Contractor in Support of the Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20817, USA. stephen.wise@nih.gov.

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Summary

This review details the development of dietary supplement reference materials over two decades, highlighting analytical challenges and advancements in creating reliable standards for botanical and multivitamin products.

Keywords:
Certified reference material (CRM)Inductively coupled plasma (ICP)Mass spectrometry (MS)PhytochemicalsStandard reference material (SRM)Toxic elements

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Area of Science:

  • Analytical Chemistry
  • Reference Materials Science
  • Pharmacognosy

Background:

  • The National Institute of Standards and Technology (NIST) and the National Institutes of Health Office of Dietary Supplements have partnered for 20 years.
  • This collaboration focuses on developing crucial reference materials for dietary supplements.
  • Initial efforts concentrated on botanical and non-botanical supplements, establishing foundational analytical methods.

Purpose of the Study:

  • To review the historical development and analytical challenges of dietary supplement reference materials.
  • To describe the evolution from first-generation Standard Reference Materials (SRMs) to second-generation Certified Reference Materials (CRMs).
  • To discuss future needs and advancements in the field of dietary supplement reference materials.

Main Methods:

  • Development of over 20 Standard Reference Materials (SRMs) for botanical and multivitamin supplements.
  • Application of multiple analytical techniques for value assignment of marker compounds and toxic elements.
  • Review and analysis of challenges encountered in producing complex supplement matrices.

Main Results:

  • Successful development of a range of botanical (e.g., ginkgo, green tea, soy) and multivitamin/multimineral (MVM) SRMs.
  • Identification of key analytical challenges, including matrix complexity and compound variability.
  • Establishment of a model for the subsequent generation of CRMs, incorporating lessons learned.

Conclusions:

  • The two-decade collaboration has significantly advanced the availability and reliability of dietary supplement reference materials.
  • Improvements in the second generation of CRMs address limitations of earlier materials, offering enhanced accuracy and scope.
  • Continued development is essential to meet future needs in the emerging research sector of supplement quality control.