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Ole Miss Natural Products Center Botanical Safety/Efficacy Research Planned

This article was originally published in The Tan Sheet

Executive Summary

The University of Mississippi National Center for Natural Products Research will use CFSAN funding to study botanical ingredients' safety and efficacy under a five-year grant program.

The University of Mississippi National Center for Natural Products Research will use CFSAN funding to study botanical ingredients' safety and efficacy under a five-year grant program.

The Center for Food Safety & Applied Nutrition will provide the center up to $1 mil. in FY 2001 to fund botanicals research, a notice in the May 3 Federal Register stipulates. The program will continue until 2005, "predicated upon acceptable performance and the availability of future fiscal year funding," the notice says.

Ole Miss researchers are to "design, implement and evaluate a comprehensive, multidisciplinary array of scientific activities in the broad area of natural products' ingredients," FDA explains. Specifically, the agency encourages research to "obtain and characterize authenticated reference materials" for botanicals. To obtain such materials, FDA suggests holding workshops, conferences and other means of information sharing, as well as literature reviews.

CFSAN classified NCNPR funding an "A" list priority for the current fiscal year in a January announcement. Congress had earmarked the funds for the Ole Miss center as part of FDA's FY 2001 budget (1 (Also see "FDA budget" - Pink Sheet, 16 Oct, 2000.)).

NCNPR was founded in 1999 as part of the Ole Miss School of Pharmacy's Research Institute of Pharmaceutical Sciences. Initiatives the center is undertaking include a joint project launched in December with the Centers for Disease Control & Prevention to study the biological and chemical properties of botanicals.

Underpinning FDA's motivation for funding the center is a desire to "ensure the safety or effectiveness of market products" containing botanical ingredients, "and the development of sound scientific principles and consensus-building for dealing with those ingredients and products," the notice says.

Moreover, "many of these issues...can only be addressed with close cooperation of the public and private sectors," the notice adds. The grant is FDA's latest effort to leverage resources from outside parties to study supplements. The Institute of Medicine is engaged in an FDA-funded two-year project examining supplement safety; a report is due in September 2002 (2 (Also see "IoM Supplement Safety Monographs Due September 2002" - Pink Sheet, 1 Jan, 2001.)).

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