HHS FDA - Botanical Safety Consortium - MRAS

The Department of Health and Human Services (HHS), in collaboration with the General Services Administration (GSA), is conducting market research to support the U.S. Food and Drug Administration's (FDA) Human Foods Program (HFP). This initiative aims to enhance the safety evaluation of botanical dietary supplements, which is a growing public health priority due to their widespread use and reports of adverse events associated with them. The FDA, alongside the National Institutes of Health (NIH) and its National Institute of Environmental Health Sciences (NIEHS), established the Botanical Safety Consortium (BSC) in 2019. The BSC serves as a collaborative platform bringing together scientists from various sectors to develop a robust scientific framework for assessing botanical safety using modern toxicology tools.

The contract seeks consulting services to provide strategic, administrative, and programmatic support for the BSC's activities. These activities include chemical characterization of complex botanical products, identifying appropriate toxicity testing approaches, and developing a public database containing toxicity outcome data for selected botanical ingredients. The goal is to ensure that all outputs from BSC collaborations are accessible publicly, thereby contributing valuable information towards improving quality assessments and safety evaluations of botanical dietary supplements.

Programmatic efforts under this contract will focus on exploring key areas such as chemical characterization and identifying suitable assays for evaluating specific toxicities like genotoxicity, neurotoxicity, hepatotoxicity, developmental toxicity, dermal toxicity, and cardiotoxicity. The consortium envisions characterizing an array of botanicals using in vitro assays while comparing results against existing safety/toxicity literature from human clinical trials and animal studies. This comprehensive approach aims to formulate recommendations for improved safety testing protocols for botanicals.

To achieve these objectives effectively, it will be crucial to engage with a diverse base of scientific experts across multiple disciplines while maintaining transparency through regular stakeholder engagement activities such as public meetings. These efforts will require scientific leadership along with strategic management capabilities provided by the contractor under this solicitation.