Under the provisions of the DSHEA, the FDA has primary responsibility for ensuring that appropriate regulatory actions are taken against marketed products that present significant health risks or bear false or misleading label claims. Foundational to the evaluation of such risks and claims is an adequate scientific base for decision-making. For botanical dietary supplements, development of such as science based is especially problematic because of several unique features, including the complexity of the constituents, variability of sourcing, lack of availability of reference materials, lack of manufacturing controls and rapidly expanding uses in the marketplace. In continuation of our cooperative agreement with CFSAN/FDA, the NCNPR has established the following specific aims to assist in addressing these research needs for the FDA: 1. Identify botanical dietary supplements (BDS) of priority concern to FDA from a public safety perspective and determine research needs. 2. Acquire and characterize authenticated reference materials, including raw and processed plant materials and purified natural products of relevance to FDA for evaluation of safety. 3. Exchange technical and scientific information, methods and reference materials with FDA scientists. Collaborate with FDA scientists in research areas of mutual interest. 4. Coordinate scientific workshops and conferences on BDS topics of public health relevance to address high priority science and research needs. This proposal expands the research under the current agreement on BDS with potential safety issues, and extends the effort to additional emerging problem botanicals. CRITERIA: 1. Responsiveness to RFA All of the reviewers agreed that the applicant met the objectives of the RFA. The applicant has well-developed working relationships with botanists, and a very good track record on acquiring and authenticating botanical materials. The partnership between UM-NCNPR and the Missouri Botanical
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