Development of a consensus approach for botanical safety evaluation - A roundtable report

Area of Science:

• Botanical safety science
• Risk assessment methodologies
• Natural product evaluation

Background:

• Growing consumer demand for natural botanical ingredients in food and dietary supplements.
• Need for updated risk assessment strategies to address evolving scientific tools and data.
• International roundtable convened scientists to discuss botanical safety evaluations.

Framework:

• Utilized a decision tree methodology for robust botanical risk assessment.
• Developed consensus statements on key elements of safety evaluations.
• Highlighted strengths and vulnerabilities in current risk assessment assumptions.

Implementation:

• Focused on an end-to-end safety approach for botanical products.
• Identified critical data gaps and areas for future research.
• Discussed the application of new tools and methodologies.

Implications:

• Need for improved understanding of botanical history of use.
• Systematic weight of evidence assessment is crucial.
• Integration of in silico, in vitro, and in vivo pharmacokinetic modeling is necessary.
• Consideration of threshold of toxicological concern and botanical-drug interactions is vital.