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.

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.

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZFD1-SRC (99))
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University of Mississippi
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United States
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Avula, Bharathi; Wang, Yan-Hong; Ali, Zulfiqar et al. (2014) Chemical fingerprint analysis and quantitative determination of steroidal compounds from Dioscorea villosa, Dioscorea species and dietary supplements using UHPLC-ELSD. Biomed Chromatogr 28:281-94
Sagi, Satyanarayanaraju; Avula, Bharathi; Wang, Yan-Hong et al. (2014) Quantitative determination of seven chemical constituents and chemo-type differentiation of chamomiles using high-performance thin-layer chromatography. J Sep Sci 37:2797-804
Jones, Michael D; Avula, Bharathi; Wang, Yan-Hong et al. (2014) Investigating sub-2 ?m particle stationary phase supercritical fluid chromatography coupled to mass spectrometry for chemical profiling of chamomile extracts. Anal Chim Acta 847:61-72
Raman, Vijayasankar; Galal, Ahmed M; Avula, Bharathi et al. (2014) Application of anatomy and HPTLC in characterizing species of Dioscorea (Dioscoreaceae). J Nat Med 68:686-98
Avula, Bharathi; Wang, Yan-Hong; Wang, Mei et al. (2014) Quantitative determination of phenolic compounds by UHPLC-UV-MS and use of partial least-square discriminant analysis to differentiate chemo-types of Chamomile/Chrysanthemum flower heads. J Pharm Biomed Anal 88:278-88
Avula, Bharathi; Cohen, Pieter A; Wang, Yan-Hong et al. (2014) Chemical profiling and quantification of monacolins and citrinin in red yeast rice commercial raw materials and dietary supplements using liquid chromatography-accurate QToF mass spectrometry: Chemometrics application. J Pharm Biomed Anal 100:243-53
Wang, Mei; Avula, Bharathi; Wang, Yan-Hong et al. (2014) An integrated approach utilising chemometrics and GC/MS for classification of chamomile flowers, essential oils and commercial products. Food Chem 152:391-8
Manda, Vamshi K; Avula, Bharathi; Ali, Zulfiqar et al. (2014) Evaluation of in vitro absorption, distribution, metabolism, and excretion (ADME) properties of mitragynine, 7-hydroxymitragynine, and mitraphylline. Planta Med 80:568-76
Wang, Mei; Carrell, Emily J; Ali, Zulfiqar et al. (2014) Comparison of three chromatographic techniques for the detection of mitragynine and other indole and oxindole alkaloids in Mitragyna speciosa (kratom) plants. J Sep Sci 37:1411-8
Raman, Vijayasankar; Horner, Harry T; Khan, Ikhlas A (2014) New and unusual forms of calcium oxalate raphide crystals in the plant kingdom. J Plant Res 127:721-30

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