Abstract
The increased utilization of metrology resources and expanded application of its’ approaches in the development of internationally agreed upon measurements can lay the basis for regulatory harmonization, support reproducible research, and advance scientific understanding, especially of dietary supplements and herbal medicines. Yet, metrology is often underappreciated and underutilized in dealing with the many challenges presented by these chemically complex preparations. This article discusses the utility of applying rigorous analytical techniques and adopting metrological principles more widely in studying dietary supplement products and ingredients, particularly medicinal plants and other botanicals. An assessment of current and emerging dietary supplement characterization methods is provided, including targeted and non-targeted techniques, as well as data analysis and evaluation approaches, with a focus on chemometrics, toxicity, dosage form performance, and data management. Quality assessment, statistical methods, and optimized methods for data management are also discussed. Case studies provide examples of applying metrological principles in thorough analytical characterization of supplement composition to clarify their health effects. A new frontier for metrology in dietary supplement science is described, including opportunities to improve methods for analysis and data management, development of relevant standards and good practices, and communication of these developments to researchers and analysts, as well as to regulatory and policy decision makers in the public and private sectors. The promotion of closer interactions between analytical, clinical, and pharmaceutical scientists who are involved in research and product development with metrologists who develop standards and methodological guidelines is critical to advance research on dietary supplement characterization and health effects.
Highlights
Metrology is the science of measurement and its practice emphasizes an assessment of traceability and measurement uncertainty, concepts that are not always given the attention they deserve in analytical chemistry (King, 1997)
The National Institute of Standards and Technology (NIST) Standard Reference Materials (SRMs) were obtained from an unidentified commercial company producing a black cohosh supplement
Awareness is increasing on the importance of analytical replicability and rigorous chemical characterization in DS, and powerful methods are available for such characterization
Summary
DefinitionMetrology is the science of measurement and its practice emphasizes an assessment of traceability and measurement uncertainty, concepts that are not always given the attention they deserve in analytical chemistry (King, 1997). Dietary supplements (abbreviated as DS throughout this article using the regulatory definitions and framework of the United States) include a variety of ingredients in different countries. They include food supplements and some botanical and herbal medicines in Europe and other regions, listed medicines in Australia, and Natural Health Products in Canada. The products sold often contain dozens of ingredients that vary greatly in their chemical composition, as well as in the information provided about their contents on packaging labels (Dwyer et al, 2018) Both consumers and practitioners expect that supplements contain the ingredients and amounts listed on their labels, and researchers require well-characterized, authenticated products to obtain replicable results. Ingredients listed on the label are absent, raising further questions about the quality of DS (Martinez-Sanz et al, 2017)
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