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The NIH analytical methods and reference materials program for dietary supplements.

Joseph M Betz1, Kenneth D Fisher, Leila G Saldanha

  • 1Office of Dietary Supplements (ODS), National Institutes of Health, 6100 Executive Blvd, Bethesda, MD 20892-2082, USA. betzj@od.nih.gov

Analytical and Bioanalytical Chemistry
|June 2, 2007
PubMed
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Ensuring the quality of botanical products, like dietary supplements (DS), is challenging. The National Institutes of Health (NIH) established a program to validate analytical methods, standards, and reference materials for DS analysis.

Area of Science:

  • Pharmacognosy
  • Analytical Chemistry
  • Regulatory Science

Background:

  • Botanical product quality is a significant concern for consumers, clinicians, regulators, and researchers.
  • Existing definitions of quality encompass sanitation, adventitious agents (pesticides, metals, weeds), and natural chemical content.
  • Dietary supplements (DS) present analytical challenges due to their complex mixtures, complicating method validation.

Purpose of the Study:

  • To address product quality concerns and the need for validated, publicly available methods for DS analysis.
  • To accelerate the methods validation process for DS.
  • To establish the Dietary Supplements Methods and Reference Materials Program.

Main Methods:

  • The program was developed based on input from stakeholders.

Related Experiment Videos

  • It utilizes federal procurement and granting mechanisms in a coordinated framework.
  • Facilitates validation of analytical methods, analytical standards, and reference materials.
  • Main Results:

    • A coordinated framework has been established to address DS quality.
    • The program supports the validation of analytical methods crucial for DS.
    • Development of analytical standards and reference materials is facilitated.

    Conclusions:

    • The Dietary Supplements Methods and Reference Materials Program provides a structured approach to improving DS quality.
    • Validated methods and reference materials are essential for reliable DS analysis.
    • This initiative aims to enhance consumer safety and research integrity in the botanical product field.