Background. The dual-faced nature of some botanicals, which are used both as pharmaceuticals and dietary supplements for nutritional purposes, can lead to inconsistencies and contradictory outcomes from Food and Drug regulatory authorities in various countries. Aims. This overview aimed to identify the sources of inconsistencies in the assessment of evidence, ensure the safety, efficacy, and quality of botanicals, and propose potential solutions to address the issues, particularly in the field of multi-component botanicals, e.g., adaptogens used in prevention and treatment of complex etiology, stress-induced, and aging-related disorders. Overview. This review is focused on: (i) - the differences between the requirements for the quality of pharmaceuticals and dietary supplements of botanical origin, (ii) - progress, trends, pitfalls, and challenges in the adaptogens research, (iii) - Inadequate assignment of some plants to adaptogens, or insufficient scientific data in case of Eurycoma longifolia, (iv) - inconsistencies in botanical risk assessments in the case of Withania somnifera. Proposed solutions include: (i)- establish internationally harmonized guidelines for eval-uating botanicals based on their intended use (e.g., pharmaceutical vs. dietary Supple-ment), incorporating traditional use data alongside modern scientific methods, (ii)- en-courage peer review and transparency in national assessments by mandating public dis-closure of methodologies, data sources, and expert affiliations, (iii) - create a tiered evi-dence framework that allows differentiated standards of proof for traditional botanical supplements versus pharmaceutical candidates, (iv)- promote international scientific dia-logues among regulators, researchers, and industry to develop consensus positions and avoid unilateral bans that may lack scientific rigor. Conclusions. Harmonized standards, transparent methodologies, and a balanced, evidence-informed approach are necessary to ensure consumers receive effective and safe botanicals.
Panossian et al. (Thu,) studied this question.