title: The Importance of Method Selection in Determining Product Integrity for Nutrition Research.
abstract: The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application.
authors.affiliation: Centre for Applied Research and Innovation, British Columbia Institute of Technology, Burnaby, Canada; and.
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Mudge
authors.affiliation: Office of Dietary Supplements, NIH, Bethesda, MD.
authors.forename: Joseph M
authors.identifier: http://orcid.org/0000-0002-7781-5246
authors.initials: JM
authors.lastname: Betz
authors.affiliation: Centre for Applied Research and Innovation, British Columbia Institute of Technology, Burnaby, Canada; and paula_brown@bcit.ca.
authors.forename: Paula N
authors.initials: PN
authors.lastname: Brown
mesh_terms: D035843:Biomedical Research / Q000379:methods* / Q000592:standards / Q000639:trends; D003226:Congresses as Topic; D019587:Dietary Supplements / Q000032:analysis*; D005504:Food Analysis / Q000379:methods* / Q000592:standards; D005506:Food Contamination / Q000517:prevention & control; D006801:Humans; D052756:Nutritional Sciences / Q000379:methods* / Q000639:trends; D064209:Phytochemicals / Q000032:analysis*; D028321:Plant Preparations / Q000737:chemistry*; D010945:Plants, Edible / Q000737:chemistry; D010946:Plants, Medicinal / Q000737:chemistry; D012107:Research Design / Q000592:standards / Q000639:trends; D054928:Validation Studies as Topic
chemical_list: D064209:Phytochemicals; D028321:Plant Preparations
keywords: botanical identification; dietary supplements; herbal medicine; method selection; phytochemicals