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 a science base 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 use in the marketplace. In 2010 the FDA fully implemented the current good manufacturing practices (cGMP) for the botanical dietary supplement industry placing the onus of """"""""botanical identity and authenticity"""""""" on the manufacturers of botanical dietary supplements. However, these cGMP's have in many ways increased the complexity as to what constitutes a """"""""scientifically valid method"""""""" for the determination of the identity and authenticity of botanical materials. To address these complex issues surrounding botanical identity, authenticity, and safety and in continuation of our cooperative agreement with the FDA, the NCNPR has established the following specific aims to aid in the research needs of the FDA: 1. Assist in the identification and development of a list of BDS and botanical ingredients, based on safety concerns, trends, and knowledge of botanicals being marketed in the U.S., to prioritize for further research. 2. Acquire, validate, and characterize authenticated reference materials, including raw and processed plant materials and purified natural products of relevance to FDA, for evaluation of their safety. 3. Exchange technical and scientific information, analytical methods, and reference material with FDA scientists and other stakeholders. 4. Collaborate with FDA scientists in research areas of mutual interest. 5. Coordinate scientific workshops and conferences on BDS-related 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.
This project supports a research program on the quality and safety of botanical dietary supplements used in the United States. The study results provide information to support regulatory decisions by the US Food and Drug Administration regarding these products. The investigators will obtain authentic plants and reference materials, develop measurement and identification techniques for the active or toxic principles, and provide these tools to the FDA and to industry and trade associations.
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