![]() ![]() (2019) outlines approaches for rigorous selection and characterization of botanical NPs for research.īotanical and Dietary Supplement Reference Materials Familiarity with the botanical and pharmacognosy literature is helpful for anticipating potential contaminants/adulterants and determining how they may be distinguished, but this literature may not provide useful guidance for the detection of novel adulterants. Importantly, targeted quantification of a biomarker compound or qualitative methods of authenticating plant material, such as organoleptic, anatomical, or molecular characteristics (e.g., chemical fingerprints), are not always sufficient for the rigorous characterization of NPs used in research. Several references describing good practices in authenticating botanical materials and archiving voucher specimens are provided in BC Sorkin et al., 2020. Botanical voucher specimens are preserved aboveground and/or belowground structures of an expertly identified representative plant that is associated with specific batches of plant matter used to prepare dietary ingredients and/or NP research materials. Use of material with an associated herbarium voucher is ideal for documenting authenticity (TM Culley, 2013). Furthermore, the method(s) used for authentication should be sufficiently broad to enable the detection of unanticipated contamination or adulteration. Guidance on the documentation needed to demonstrate authenticity differs between materials grown or collected by the applicant and purchased materials.Īnalytical methods used for botanical authentication must be carefully designed, controlled, and validated to ensure they are sufficiently sensitive and specific to reliably distinguish the species of interest from related species. Proper assessment and documentation of ingredient identity and/or source is a critical part of developing a standardized dietary supplement or herbal to be used in research or marketed commercially. Methodological Resources for NP Investigatorsīotanical Authentication and Selection for Research ![]() ODS guidelines for demonstrating product integrity are similar to those of NCCIH and focus on authentication of identity and assessments of the composition, purity, and stability of the dietary intervention(s). ODS requires co-funding awardees to demonstrate the integrity of the nutrient, botanical, or other NP interventions used in research. ODS Product Integrity Requirements for Dietary Supplement Research Fundingĭietary supplement ingredients and products used in research must be rigorously identified and characterized to ensure reproducibility and to support scientific progress. An extensive array of information is provided at. These guidelines are applicable to all investigators seeking funding for such research from NCCIH. The NIH National Center for Complementary and Integrative Health (NCCIH) has developed guidelines specific for the design and conduct of experiments that use NPs or their bioactive constituents. NIH has since elaborated upon these grant criteria ( ) and provided clarification on authentication of key resources ( ). To enhance rigor and reproducibility in NIH-supported research, authentication and/or validation of the key biological and chemical resources used in awards has been required since January, 2016 ( NOT-OD-16-011). NIH Policies and Guidelines to Promote NP Characterization and Improve Research Rigor Careful attention to these issues will be critical for researchers applying for funding from the National Institutes of Health's Office of Dietary Supplements (NIH ODS). Some important considerations and recommendations for NP and dietary supplement characterization in biomedical research are described and linked below. The characterization and standardization of NPs (such as dried source materials, extracts, or foods) is challenging because of their chemical complexity and inherent variability, as well as because of the very limited evidence for the contributions of specific chemical constituents to biological effects of interest, whether beneficial or deleterious. Reproducible research on natural products (NPs) requires the use of replicable, well-characterized NP preparations (BC Sorkin, et al., 2020) as well as rigorous and transparent reporting (JJ Gagnier et al., 2011) appropriate implementation of these processes is a prerequisite for NP integrity. The Importance of Natural Product Characterization Considerations to Improve Research Rigor/Integrity Through Prospective Research Registration.Select References for Designing, Conducting, and Reporting Natural Products Studies.NIH-Supported Resources for Natural Product Researchers. ![]()
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