Abstract

? ? 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 ? ?

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01FD002071-06
Application #
7278555
Study Section
Special Emphasis Panel (ZFD1-CFSN-C (01))
Program Officer
Ganti, Usha
Project Start
2001-09-30
Project End
2011-06-30
Budget Start
2006-09-25
Budget End
2007-06-30
Support Year
6
Fiscal Year
2006
Total Cost
Indirect Cost

  Institution

Name
University of Mississippi
Department
Pharmacology
Type
Schools of Pharmacy
DUNS #
067713560
City
University
State
MS
Country
United States
Zip Code
38677

  Publications

Zhang, Zhihao; Ali, Zulfiqar; Khan, Shabana I et al. (2016) Cytotoxic monacolins from red yeast rice, a Chinese medicine and food. Food Chem 202:262-8
Tantry, Mudasir A; Idris, Ahmed; Khan, Ikhlas A (2013) Glycosylsphingolipids from Euonymus japonicus Thunb. Fitoterapia 89:58-67
Haron, M H; Avula, B; Khan, I A et al. (2013) Modulation of ethanol toxicity by Asian ginseng (Panax ginseng) in Japanese ricefish (Oryzias latipes) embryogenesis. Comp Biochem Physiol C Toxicol Pharmacol 157:287-97
Hammad, Mohamed A; Abdel-Bakky, Mohamed Sadek; Walker, Larry A et al. (2013) Tissue factor antisense deoxyoligonucleotide prevents monocrotaline/LPS hepatotoxicity in mice. J Appl Toxicol 33:774-83
Zhao, Jianping; Avula, Bharathi; Chan, Michael et al. (2012) Metabolomic differentiation of maca (Lepidium meyenii) accessions cultivated under different conditions using NMR and chemometric analysis. Planta Med 78:90-101
Avula, Bharathi; Wang, Yan-Hong; Rumalla, Chidananda Swamy et al. (2012) Simultaneous determination of alkaloids and flavonoids from aerial parts of Passiflora species and dietary supplements using UPLC-UV-MS and HPTLC. Nat Prod Commun 7:1177-80
Tantry, Mudasir A; Radwan, Mohamed M; Akbar, Seema et al. (2012) 5, 6-Dihydropyranobenzopyrone: a previously undetermined antioxidant isolated from Polygonum amplexicaule. Chin J Nat Med 10:28-31
Zhao, Jianping; Avula, Bharathi; Joshi, Vaishali C et al. (2011) NMR fingerprinting for analysis of hoodia species and hoodia dietary products. Planta Med 77:851-7
Hammad, Mohamed A; Abdel-Bakky, Mohamed Sadek; Walker, Larry A et al. (2011) Oxidized low-density lipoprotein and tissue factor are involved in monocrotaline/lipopolysaccharide-induced hepatotoxicity. Arch Toxicol 85:1079-89
Avula, Bharathi; Wang, Yan-Hong; Rumalla, Chidananda Swamy et al. (2011) Analytical methods for determination of magnoflorine and saponins from roots of Caulophyllum thalictroides (L.) Michx. using UPLC, HPLC and HPTLC. J Pharm Biomed Anal 56:895-903

Showing the most recent 10 out of 59 publications