The Botanical Safety Consortium: A Public-Private Partnership to Improve Botanical Safety

The Botanical Safety Consortium (BSC) is a public-private partnership aimed at enhancing the botanical safety evaluation toolkit. This partnership is the result of a Memorandum of Understanding between the US Food and Drug Administration (FDA), the National Institutes of Health’s National Institute of Environmental Health Sciences (NIEHS), and the Health and Environmental Sciences Institute (HESI). The BSC serves as a global forum for scientists from government, academia, consumer health groups, industry, and non-profit organizations to work collaboratively on developing and integrating new methods based on sound science into routine botanical safety risk assessments.

The objectives of the BSC are: to engage with a broad group of stakeholders to leverage the best scientific safety approaches; establish the appropriate levels of chemical characterization for complex botanical substances; identify pragmatic, fit-for-purpose, in vitro and in silico assays to evaluate botanical safety; evaluate the application of these tools via comparison to the currently available safety information; and to integrate these tools and approaches into a framework that can facilitate robust evaluation of botanical substances. Initial endpoints of focus are genotoxicity, hepatotoxicity & ADME, developmental & reproductive toxicity, and systemic toxicity. Additional working groups on chemical analysis and data analysis have also been initiated. This presentation will provide an overview on the structure, goals, and strategies of this new initiative.

Dr. Stefan Gafner, American Botanical Council

Stefan Gafner, PhD, is American Botanical Council (ABC)'s Chief Science Officer, the technical director of the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP), editor of the Botanical Adulterants Monitor, and writes articles for HerbalGram and HerbalEGram.

Dr. Gafner received his degree in pharmacy at the University of Bern School of Pharmacy in Bern, Switzerland. He earned his doctorate in pharmaceutical sciences - with a focus on phytochemistry (the chemistry of plants) - at the University of Lausanne in Switzerland, from the internationally respected phytochemist Professor Kurt Hostettmann. His doctoral thesis focused on the search for new antibacterial and antifungal compounds from African medicinal plants in three plant families (Asteraceae, Bignoniaceae, and Myricaceae). Dr. Gafner conducted his postdoctoral research at the University of Illinois – Chicago, in the College of Pharmacy’s highly regarded Department of Medicinal Chemistry and Pharmacognosy (the study of medicines from plants and other natural sources).

Highlights of Dr. Gafner’s impressive career include the discovery of dozens of new natural products, the development of more than 40 methods for the identification and authentication of herbal extracts, and the validation of methods for more than 20 over-the-counter drug ingredients for consumer products.

Dr. Cynthia Rider, National Toxicology Program

Cynthia Rider, PhD, DABT, is a toxicologist with the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), where she serves as project leader for a diverse portfolio of testing programs including polycyclic aromatic compounds, botanical dietary supplements, and industrial chemicals. Dr. Rider’s research interests are in evaluating and refining methods to predict mixture toxicity based on data from components or whole reference mixtures. She received her B.S. from Tulane University in Environmental Studies and Biology and her Ph.D. from North Carolina State University in Environmental Toxicology. She completed post-doctoral training in the Reproductive Toxicology Branch of the National Health and Environmental Effects Research Laboratory, U. S. Environmental Protection Agency and the Nicholas School of the Environment at Duke University.