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

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.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01FD004246-04
Application #
8729317
Study Section
Special Emphasis Panel (ZFD1)
Project Start
2011-09-15
Project End
2016-08-31
Budget Start
2014-09-01
Budget End
2015-08-31
Support Year
4
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Mississippi
Department
Type
Organized Research Units
DUNS #
City
University
State
MS
Country
United States
Zip Code
38677
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Parveen, Iffat; Gafner, Stefan; Techen, Natascha et al. (2016) DNA Barcoding for the Identification of Botanicals in Herbal Medicine and Dietary Supplements: Strengths and Limitations. Planta Med 82:1225-35
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Sagi, Satyanarayanaraju; Avula, Bharathi; Wang, Yan-Hong et al. (2016) Quantification and characterization of alkaloids from roots of Rauwolfia serpentina using ultra-high performance liquid chromatography-photo diode array-mass spectrometry. Anal Bioanal Chem 408:177-90
Avonto, Cristina; Chittiboyina, Amar G; Wang, Mei et al. (2016) In Chemico Evaluation of Tea Tree Essential Oils as Skin Sensitizers: Impact of the Chemical Composition on Aging and Generation of Reactive Species. Chem Res Toxicol 29:1108-17
Manda, Vamshi K; Avula, Bharathi; Chittiboyina, Amar G et al. (2016) Inhibition of CYP3A4 and CYP1A2 by Aegle marmelos and its constituents. Xenobiotica 46:117-25
Avonto, C; Wang, Y-H; Avula, B et al. (2016) Comparative studies on the chemical and enzymatic stability of alpha- and beta-arbutin. Int J Cosmet Sci 38:187-93
Carpenter, Jessica M; Criddle, Catherine A; Craig, Helaina K et al. (2016) Comparative effects of Mitragyna speciosa extract, mitragynine, and opioid agonists on thermal nociception in rats. Fitoterapia 109:87-90

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