Enhancing the botanical safety toolkit: The strategy of the Botanical Safety Consortium

Introduction Botanical substances are widely used as medicinal products and as dietary or food supplements. The Botanical Safety Consortium (BSC), a public-private partnership between the US FDA, the National Institutes of Health’s National Institute of Environmental Health Sciences (NIEHS), and the Health and Environmental Sciences Institute (HESI), aims at enhancing the toolkit for the in vitro safety evaluation of botanicals, as forum for scientists from government, academia, consumer health groups, industry, and non-profit organizations collaboratively developing in silico and in vitro methods and integrate them into a framework.

Aim Intention is to apply toxicological tools available for single chemicals to botanicals as complex mixtures.

Methods The BSC is identifying pragmatic, fit-for-purpose, in vitro and in silico assays and evaluating them via comparison to available safety information, to facilitate a robust safety evaluation.

Results Initial endpoints are genotoxicity, hepatotoxicity, absorption-distribution-metabolism-excretion (i.e. “ADME”), developmental and reproductive toxicity, cardiotoxicity, neurotoxicity, and systemic toxicity ([Fig. 1]). Supportive working groups perform chemical and data analyses, and pharmacognosy. A number of well-known botanicals has been identified to evaluate the assays.

Fig. 1  Structure of BSC (https://botanicalsafetyconsortium.org).

Discussion With selection and prioritization of botanicals as candidates, and pilot work on their chemical characterization, the basis for evaluating a set of screening level assays has been established. The ultimate aim is a robust, predictive toxicology testing strategy that integrates existing data with in silico and in vitro tools to provide actionable safety data for botanicals, while minimizing the need for mammalian animal testing.

Publication History

Article published online:
13 June 2022