EuroTox 2025

14 – 17 September 2025 The Botanical Safety Consortium will be contributing to the EuroTox 2025 program, which will take place in Athens, Greece, from 14-17 September 2025. Session Title: “Botanical Safety: Toxicological Methods for Evaluating Complex Mixtures” Date/Time: Monday, 15 September 2025, 10:00-12:00 Chairs: Olaf Kelber (Bayer) and Connie Mitchell (HESI) Speakers: Catherine Mahony (P&G) Matthias Gossmann…

New publication: Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals

Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals. Roe et al., 2024. Journal of Dietary Supplements. https://doi.org/10.1080/19390211.2024.2417679   The HESI Botanical Safety Consortium‘s Hepatotoxicity Working Group has developed a screening strategy to identify hepatotoxicity and drug interaction risks associated with botanicals. Botanical products are complex mixtures that are difficult to test in traditional…

New publication: Botanical-induced toxicity: Liver injury and botanical-drug interactions. A report on a Society of Toxicology Annual Meeting symposium

Koturbash et al., 2024. Botanical-induced toxicity: Liver injury and botanical-drug interactions. A report on a Society of Toxicology Annual Meeting symposium. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2024.105708   This article addresses the growing public health concerns surrounding the use of botanical supplements and herbal products, focusing on their potential to cause liver toxicity and dangerous drug interactions. As the…

New publication: Chemical Standardization of Milk Thistle (Silybum marianum L.) Extract Using UHPLC-MS/MS and the Method of Standard Addition

A new paper from the HESI Botanical Safety Consortium describes the development and validation of a novel method for quantifying the constituents in milk thistle extracts to ensure consistency and reliability in efficacy and toxicity research. Milk thistle has been used for its purported hepatoprotective properties and other reported health benefits. Given that it is a complex…

New publication: Screening tools to evaluate the neurotoxic potential of botanicals: building a strategy to assess safety

A recent article from the Botanical Safety Consortium (BSC) Neurotoxicity Working Group aims to evaluate existing NAMs for neurotoxicity screening of botanicals as complex mixtures. The article provides background on three assays or models for neuroactivity screening (C. elegans, zebrafish embryos, and multi-electrode arrays) and well-studied botanicals used as case studies for neurotoxicity, including aconite and oleander. Article…

New publication: Prediction of physicochemical and pharmacokinetic properties of botanical constituents by computational models

A newly published study from the Botanical Safety Consortium, selected for the cover of Journal of Applied Toxicology, used computational models to predict the physiochemical and pharmacokinetic properties of botanical constituents.  This study investigated 103 major compounds from 13 botanicals (e.g., ashwagandha, kratom, and yohimbe), providing insights into their absorption, bioavailability, and safety profiles.  The in-silico…

New publication: Within-laboratory reproducibility of Ames test results: Are repeat tests necessary?

A cross-sector group of experts from the Health and Environmental Sciences Institutes (HESI)’s Botanical Safety Consortium (BSC) and Genetic Toxicology Technical Committee (GTTC) analyzed data from the National Toxicology Program (NTP) Ames test database to evaluate the need for repeat testing when assessing the mutagenic and carcinogenic potential of chemical compounds. Key Findings: High reproducibility for initial positive and…

Botanical Safety Consortium Summit 2024

Thursday October 10 and Friday October 11 2024 In-person: The National Institute of Environmental Health Sciences (NIEHS), Durham, NC, USA Virtual: TBA Draft Agenda – Online Only View The Recording The Botanical Safety Consortium (BSC) will hold it’s first in-person meeting (with virtual option) at NIEHS in Durham, NC in October 2024. The in-person meeting…

New publication: Advancing botanical safety

Advancing botanical safety: A strategy for selecting, sourcing, and characterizing botanicals for developing toxicological tools. Waidyanatha et al., February 2024. Food and Chemical Toxicology. https://doi.org/10.1016/j.fct.2024.114537 Increases in botanical use, encompassing herbal medicines and dietary supplements, have underlined a critical need for an advancement in safety assessment methodologies. This manuscript highlights: 1) Botanical Safety Consortium’s strategy for…

New publication in Food and Chemical Toxicology

Neuroactivity screening of botanical extracts using microelectrode array (MEA) recordings Regina G.D.M. van Kleef, Michelle R. Embry, Constance A. Mitchell, Remco H.S. Westerink. Food and Chemical Toxicology. https://doi.org/10.1016/j.fct.2024.114438 The HESI Botanical Safety Consortium collaborates to develop screening strategies that can efficiently identify botanical-induced toxicity. The study presented here evaluates the applicability of in vitro multi-well microelectrode…

EuroTox 2025

14 – 17 September 2025 The Botanical Safety Consortium will be contributing to the EuroTox 2025 program, which will take place in Athens, Greece, from 14-17 September 2025. Session Title: “Botanical Safety: Toxicological Methods for Evaluating Complex Mixtures” Date/Time: Monday, 15 September 2025, 10:00-12:00 Chairs: Olaf Kelber (Bayer) and Connie Mitchell (HESI) Speakers: Catherine Mahony (P&G) Matthias Gossmann…

New publication: Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals

Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals. Roe et al., 2024. Journal of Dietary Supplements. https://doi.org/10.1080/19390211.2024.2417679   The HESI Botanical Safety Consortium‘s Hepatotoxicity Working Group has developed a screening strategy to identify hepatotoxicity and drug interaction risks associated with botanicals. Botanical products are complex mixtures that are difficult to test in traditional…

New publication: Botanical-induced toxicity: Liver injury and botanical-drug interactions. A report on a Society of Toxicology Annual Meeting symposium

Koturbash et al., 2024. Botanical-induced toxicity: Liver injury and botanical-drug interactions. A report on a Society of Toxicology Annual Meeting symposium. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2024.105708   This article addresses the growing public health concerns surrounding the use of botanical supplements and herbal products, focusing on their potential to cause liver toxicity and dangerous drug interactions. As the…

New publication: Chemical Standardization of Milk Thistle (Silybum marianum L.) Extract Using UHPLC-MS/MS and the Method of Standard Addition

A new paper from the HESI Botanical Safety Consortium describes the development and validation of a novel method for quantifying the constituents in milk thistle extracts to ensure consistency and reliability in efficacy and toxicity research. Milk thistle has been used for its purported hepatoprotective properties and other reported health benefits. Given that it is a complex…

New publication: Screening tools to evaluate the neurotoxic potential of botanicals: building a strategy to assess safety

A recent article from the Botanical Safety Consortium (BSC) Neurotoxicity Working Group aims to evaluate existing NAMs for neurotoxicity screening of botanicals as complex mixtures. The article provides background on three assays or models for neuroactivity screening (C. elegans, zebrafish embryos, and multi-electrode arrays) and well-studied botanicals used as case studies for neurotoxicity, including aconite and oleander. Article…

New publication: Prediction of physicochemical and pharmacokinetic properties of botanical constituents by computational models

A newly published study from the Botanical Safety Consortium, selected for the cover of Journal of Applied Toxicology, used computational models to predict the physiochemical and pharmacokinetic properties of botanical constituents.  This study investigated 103 major compounds from 13 botanicals (e.g., ashwagandha, kratom, and yohimbe), providing insights into their absorption, bioavailability, and safety profiles.  The in-silico…

New publication: Within-laboratory reproducibility of Ames test results: Are repeat tests necessary?

A cross-sector group of experts from the Health and Environmental Sciences Institutes (HESI)’s Botanical Safety Consortium (BSC) and Genetic Toxicology Technical Committee (GTTC) analyzed data from the National Toxicology Program (NTP) Ames test database to evaluate the need for repeat testing when assessing the mutagenic and carcinogenic potential of chemical compounds. Key Findings: High reproducibility for initial positive and…

Botanical Safety Consortium Summit 2024

Thursday October 10 and Friday October 11 2024 In-person: The National Institute of Environmental Health Sciences (NIEHS), Durham, NC, USA Virtual: TBA Draft Agenda – Online Only View The Recording The Botanical Safety Consortium (BSC) will hold it’s first in-person meeting (with virtual option) at NIEHS in Durham, NC in October 2024. The in-person meeting…

New publication: Advancing botanical safety

Advancing botanical safety: A strategy for selecting, sourcing, and characterizing botanicals for developing toxicological tools. Waidyanatha et al., February 2024. Food and Chemical Toxicology. https://doi.org/10.1016/j.fct.2024.114537 Increases in botanical use, encompassing herbal medicines and dietary supplements, have underlined a critical need for an advancement in safety assessment methodologies. This manuscript highlights: 1) Botanical Safety Consortium’s strategy for…

New publication in Food and Chemical Toxicology

Neuroactivity screening of botanical extracts using microelectrode array (MEA) recordings Regina G.D.M. van Kleef, Michelle R. Embry, Constance A. Mitchell, Remco H.S. Westerink. Food and Chemical Toxicology. https://doi.org/10.1016/j.fct.2024.114438 The HESI Botanical Safety Consortium collaborates to develop screening strategies that can efficiently identify botanical-induced toxicity. The study presented here evaluates the applicability of in vitro multi-well microelectrode…

BOTANICAL SAFETY CONSORTIUM

A public-private partnership to improve botanical safety

The Botanical Safety Consortium (BSC) was officially convened in November 2019, as 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 non-profit Health and Environmental Sciences Institute (HESI).

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Our current charge is to evaluate the suitability of assays for botanicals as complex mixtures.

Latest News

BSC at the 70th International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA)

August 28-31, 2022 The BSC is planning a workshop during the 70th International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA),…

BSC at the International Conference on Environmental Mutagens, Ottawa

27 August – 1 September 2022 International Conference on Environmental Mutagens in Ottawa, Canada 27 August to 1 September 2022 – “A Strategy for Developing a Framework of Genotoxicity Assays for…

BSC at ICSB 2022

March 28-31st, 2022 The Botanical Safety Consortium will have a session at the International Conference on the Science of Botanicals (ICSB 2022) entitled “Botanical Safety Assessment: Updates from…

BSC at SOT 2022

March 27-31st, 2022 The Botanical Safety Consortium presented at the 2022 Society of Toxicology meeting, which was held virtually and in person in San Diego, CA March 27-31,…

Botanical Safety Consortium Stakeholder Council Webinar Series February 22, 2022 @ 11am EST

Chemical Safety of Phytomedicines – Perspectives for in vitro testing strategies? The Botanical Safety Consortium hosted an open webinar on Tuesday 22 February 11 am -12 pm ET.…

A public-private partnership to enhance the botanical safety toolkit

Botanical dietary supplement and herbal medicine use is increasing both in the United States and worldwide. Products made from botanicals can be variable in chemical composition, with many…

Botanical Safety Consortium Annual Meeting 2021

BSC 2021 Virtual Annual Meeting June 2021 Welcomes & Objectives (Connie Mitchell, HESI) Botanical Safety Consortium Introduction & Updates (Dr. Cara Welch, US FDA) Keynote 1: The hERG Screen Project:…

Session at ICSB 2021

20th Annual Oxford ICSB March 28th – 30th, 2022  The Oxford International Conference on the Science of Botanicals is an annual meeting to discuss approaches for post market…

2020 Virtual SOT Session

“Applying Modern Toxicology to Botanical Dietary Supplements” Click to access PDFs of the presentations: Applying Modern Toxicology to Botanical Dietary Supplements. Michelle Embry (HESI, Washington, DC) Chemical Analysis: The…

ABC’s Stefan Gafner and Colleagues Give Lecture on Botanical Ingredient Safety Evaluation for Pharmacy Students in Malawi

The BOTANICAL SAFETY CONSORTIUM will provide a sound scientific basis for integrating existing botanical safety & toxicity information with the latest toxicological tools. 

This multi-partite, multi-stakeholder international effort will bring together key scientific experts to enhance the botanical safety toolkit and bring clarity to botanical dietary ingredient assessments.

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