Document Type
Oral Presentation
Location
Oxford Conference Center, Oxford MS
Event Website
https://oxfordicsb.org/
Start Date
8-4-2025 3:00 PM
Description
The Botanical Safety Consortium (BSC) is a public-private partnership established in 2019 by the FDA, NIEHS, and HESI to address the unique challenges of botanical safety assessment. Botanicals, derived from plants, algae, and fungi, present inherent complexities due to their variable chemical compositions and the presence of hundreds of constituents. Traditional toxicity tests, designed for single chemical entities, fail to adequately assess these complex mixtures, necessitating the development of novel strategies. The BSC has made significant strides in advancing safety evaluations by employing New Approach Methodologies (NAMs) to address critical endpoints, including hepatotoxicity, genotoxicity, cardiotoxicity, neurotoxicity, dermal toxicity, and developmental and reproductive toxicity (DART). Key achievements include the creation of systematic literature review frameworks, the authentication of botanical materials for case studies, and the application of advanced chemical analysis and ADME modeling to contextualize toxicological findings. Selected botanicals, such as aristolochia and kava, have been used to evaluate NAMs. interpretation and assay refinement. Future efforts focus on broadening assay applicability, integrating in vitro and in silico data with real-world exposures, and addressing gaps in predictive modeling for botanical mixtures. Ongoing initiatives include expanding collaborations, publishing results to inform regulatory frameworks, and enhancing outreach through global training programs. These efforts aim to support the development of robust tools for botanical safety assessment, ensuring consumer protection and enabling innovation in the field. This presentation will highlight BSC’s progress, discuss case study findings, and outline future directions, emphasizing the consortium’s critical role in bridging gaps in botanical safety science.
Recommended Citation
Roe, Amy, "Advancing Botanical Safety Through Collaborative Innovation: Updates from the Botanical Safety Consortium" (2025). Oxford ICSB. 29.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/29
Publication Date
April 2025
Accessibility Status
Screen reader accessible, Searchable text
Included in
Advancing Botanical Safety Through Collaborative Innovation: Updates from the Botanical Safety Consortium
Oxford Conference Center, Oxford MS
The Botanical Safety Consortium (BSC) is a public-private partnership established in 2019 by the FDA, NIEHS, and HESI to address the unique challenges of botanical safety assessment. Botanicals, derived from plants, algae, and fungi, present inherent complexities due to their variable chemical compositions and the presence of hundreds of constituents. Traditional toxicity tests, designed for single chemical entities, fail to adequately assess these complex mixtures, necessitating the development of novel strategies. The BSC has made significant strides in advancing safety evaluations by employing New Approach Methodologies (NAMs) to address critical endpoints, including hepatotoxicity, genotoxicity, cardiotoxicity, neurotoxicity, dermal toxicity, and developmental and reproductive toxicity (DART). Key achievements include the creation of systematic literature review frameworks, the authentication of botanical materials for case studies, and the application of advanced chemical analysis and ADME modeling to contextualize toxicological findings. Selected botanicals, such as aristolochia and kava, have been used to evaluate NAMs. interpretation and assay refinement. Future efforts focus on broadening assay applicability, integrating in vitro and in silico data with real-world exposures, and addressing gaps in predictive modeling for botanical mixtures. Ongoing initiatives include expanding collaborations, publishing results to inform regulatory frameworks, and enhancing outreach through global training programs. These efforts aim to support the development of robust tools for botanical safety assessment, ensuring consumer protection and enabling innovation in the field. This presentation will highlight BSC’s progress, discuss case study findings, and outline future directions, emphasizing the consortium’s critical role in bridging gaps in botanical safety science.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/29