Advancing botanical safety through collaborative innovation

Botanical ingredients — derived from plants, algae, and fungi — are widely used in foods, supplements, cosmetics, and herbal medicinal products. Despite their popularity, evaluating the safety of these complex mixtures poses a significant challenge. Traditional toxicity testing methods, developed for single, well-defined chemical entities, are often ill-suited to capture the multifaceted nature of botanicals, which can contain hundreds of constituents that vary by source, preparation, and use. As a result, there is an urgent need for innovative approaches that can more accurately assess potential risks while supporting the continued development and safe use of botanical products. To meet this need, ongoing efforts have focused on developing and applying New Approach Methodologies (NAMs) to evaluate key toxicity endpoints relevant to botanical safety, such as liver toxicity, genotoxicity, and developmental and reproductive toxicity (DART), among others. Progress includes establishing systematic frameworks for literature review, authenticating botanical test materials, and integrating advanced chemical analyses and ADME modeling to improve interpretation of in vitro data. Select case studies using botanicals known for safety concerns, like aristolochia and kava, have helped stress-test these methods and refine assay approaches. Looking ahead, the focus is on expanding the relevance and predictive power of these tools across a broader range of botanicals and real-world exposure scenarios. This includes improved integration of in vitro and in silico data, closing key gaps in predictive modeling, and ensuring that scientific advances translate into regulatory practice. Training, transparent data sharing, and global engagement remain central to these efforts. Publication History Article published online: 05 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany