Advancing the safety assessment of botanicals and nutraceuticals

The global use of botanicals, nutraceuticals, herbal medicines, and other food supplements has increased substantially, driven by interest in preventive healthcare, functional nutrition, and plant-derived bioactive compounds. However, the perception that natural products are inherently safe can obscure important concerns, including toxicity, pharmacological variability, contamination, adulteration, inconsistent quality, and interactions with medicines, foods, and environmental contaminants. Variations in plant origin, cultivation, harvesting, extraction, formulation, and manufacturing further complicate the establishment of reliable safety profiles and reproducible biological effects.

Recent advances in analytical chemistry, omics technologies, computational toxicology, artificial intelligence, and predictive modelling have improved the characterization of complex botanical mixtures and the investigation of toxicity mechanisms. Nevertheless, evidence continues to identify risks associated with misidentified plant species, undeclared pharmaceutical ingredients, heavy metals, pesticide residues, mycotoxins, microbial contamination, and inappropriate or prolonged use. Botanical safety is an active area of interest for the European Food Safety Authority (EFSA), which has published scientific opinions and guidance on related risks, and the Botanical Safety Consortium, a collaborative initiative involving the US Food and Drug Administration, the National Institute of Environmental Health Sciences, and the Health and Environmental Sciences Institute. Despite these efforts, harmonized approaches for evaluating botanicals, nutraceuticals, and other food supplements remain limited.

This Research Topic aims to advance evidence-based approaches for assessing the safety of botanicals, nutraceuticals, and other food supplements across the product lifecycle. It will bring together experimental, computational, clinical, industrial, and regulatory perspectives addressing hazard identification, dose–response relationships, exposure assessment, toxicity mechanisms, quality assurance, authentication, standardisation, and risk–benefit evaluation. Contributions exploring regulatory convergence, traditional knowledge, real-world evidence, and next-generation safety assessment methods are particularly encouraged.

To gather further insights into the safety assessment of botanicals, nutraceuticals, and other food supplements, we welcome articles addressing, but not limited to, the following themes:
• Toxicological evaluation of plant-derived bioactives, herbal medicines, nutraceutical ingredients, and other food supplements
• In vitro, in vivo, ex vivo, in silico, and computational approaches to hazard characterization
• Omics technologies, artificial intelligence, machine learning, and predictive toxicology
• Mechanisms of hepatotoxicity, nephrotoxicity, neurotoxicity, cardiotoxicity, immunotoxicity, and endocrine disruption
• Herb–drug, herb–food, supplement–drug, and herb–xenobiotic interactions
• Contamination, adulteration, misidentification, authenticity, and traceability
• Mycotoxins, pesticide residues, heavy metals, microbial contaminants, and other emerging contaminants
• Analytical methods for identification, quantification, and standardization
• Dose–response relationships, bioavailability, pharmacokinetics, and long-term exposure
• Risk–benefit evaluation of traditional and modern formulations
• Quality control, good agricultural and manufacturing practices, and batch consistency
• Regulatory frameworks, EFSA assessments, Botanical Safety Consortium activities, and international harmonisation
• Sustainable cultivation, sourcing, processing, and environmental considerations
• Translational, clinical, post-market surveillance, and real-world evidence approaches
• Next-generation risk assessment and alternatives to conventional animal testing

Article types and fees

This Research Topic accepts the following article types, unless otherwise specified in the Research Topic description:

• Brief Research Report
• Case Report
• Community Case Study
• Conceptual Analysis
• Data Report
• Editorial
• FAIR² Data
• General Commentary
• Hypothesis and Theory
• ... View all formats

Articles that are accepted for publication by our external editors following rigorous peer review incur a publishing fee charged to Authors, institutions, or funders.

Article types

This Research Topic accepts the following article types, unless otherwise specified in the Research Topic description:

• Brief Research Report
• Case Report
• Community Case Study
• Conceptual Analysis
• Data Report
• Editorial
• FAIR² Data
• General Commentary
• Hypothesis and Theory
• Methods
• Mini Review
• Opinion
• Original Research
• Perspective
• Policy and Practice Reviews
• Policy Brief
• Review
• Study Protocol
• Systematic Review
• Technology and Code

Keywords: nutraceuticals, risk assessment, toxicology, Botanicals, food supplements, herbal medicines, botanical safety, natural products, food safety, regulatory science, contaminants, adulteration, herb–drug interactions, predictive toxicology, quality control

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.