Botanical Dietary Supplement Safety and Quality Evaluation

Non-Technical Summary: There is a lack of information concerning the quality and safety of dietary supplements. The use of these products, with their broad appeal and use by high-risk populations, creates safety concerns. The purpose of this project is to evaluate the microbiological quality and pharmaceutical safety of dietary supplements in an effort to make these products safer for consumers. <P> Approach: Procedures for the first objective involve identifying and quantifying microbial contaminants. Planned microbiological tests include aerobic plate counts, yeast and mold counts, coliform counts, and identifying the presence of potential bacterial pathogens such as E. coli, Salmonella spp., and Listeria monocytogenes. All laboratory methods will be performed according to procedures described in the American Public Health Association's Compendium of Methods for the Microbiological Examination of Foods, and the Food and Drug Administration Bacteriological Analytical Manual, 8th Edition Revision-A. Tests will be conducted on frequently consumed dietary supplements, including those used by high-risk and culturally diverse populations, as identified in the peer-reviewed literature. Planned evaluations include herbal products from the genera Echinacea, Astragalus, Matricaria, and Panax, and algal products containing the organism Spirulina spp. The procedures for the second objective include evaluating the pharmacological safety of dietary supplements by identifying potential drug interactions, contraindications, appropriate dosing, and acceptability of these products for self-administration. Information for these evaluations will be placed into a database for use by medical professionals. Current research needs should focus on helping clinicians identify the appropriateness of a dietary supplement for therapy based on potential hazardous effects of the supplement. Therefore, no human or animal research is planned, as evaluations will be based on the pharmacological activity of similar or known active constituents in the products.