Evaluation of Dietary Supplement Safety

NON-TECHNICAL SUMMARY: There is a noticeable lack of research concerning the quality and safety of dietary supplements. The use of these products, with their broad appeal and use by high-risk populations, creates a unique safety concern. 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.

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APPROACH: The procedures for the first objective focus on 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 evaluating the pharmacological safety of dietary supplements include identifying potential drug interactions, contraindications, appropriate dosing, and acceptability of these products for self-administration. Information for these evaluations will be gathered according to guidelines in the United States Pharmacopeia-National Formulary. Planned evaluations include the products identified in procedures for objective 1. 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.