Botanical Safety Consortium

In 2019, FDA, NIEHS, and the non-profit Health and Environmental Sciences Institute signed a memorandum of understanding establishing the Botanical Safety Consortium. The Consortium includes over 20 participants from industry, academia, and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness.

The Botanical Safety Consortium held virtual annual meetings in 2020 and 2021. The 2020 meeting provided a forum to articulate the needs for a scientific approach to assessing botanicals safety and refine the goals of the Consortium. Presenters at the 2021 meeting described a project to characterize cardiotoxicity of botanicals and provided overviews of applications of in silico modeling and NAMs to predict toxicity of botanicals.