For 21 years under the provisions of DSHEA, the FDA has had 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 ingredients, development of such a science base is wide-ranging because of several unique features, including the variability of sourcing, lack of manufacturing controls, complexity of the constituents, lack of availability of reference materials widespread usage in the marketplace and unknown adverse effects due to herb-herb, or herb-drug interactions. 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 dietary supplements containing various botanical ingredients. However, these cGMP's have highlighted the ambiguity of exactly what constitutes a ?scientifically valid method? for the determination of the identity authenticity and safety 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 dietary herbal supplements 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 the assessment of their fingerprinting, adulteration, safety and toxicity. 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
This project supports a research program on the quality and safety of botanical ingredients 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, Industry, Trade Associations, and other stakeholders.
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