Herbal Medicines and Dietary Supplements: The Need for Regulatory Harmonization and Scientific Evidence
DOI:
https://doi.org/10.70099/BJ/2026.03.01.6Keywords:
herbal medicines, dietary supplements, pharmaceutical regulation, clinical efficacy, pharmacovigilance, harmonization, Latin AmericaAbstract
Global consumption of herbal medicines and dietary supplements has steadily increased, driven by self-care trends and integrative medicine. However, the misconception that "natural" products are inherently safe persists despite growing evidence of adverse reactions, drug interactions, and toxicity. This narrative review critically analyzes the available evidence on efficacy and safety and evaluates how regulatory differences affect public health, with emphasis on Latin America. Searches were conducted in PubMed, Scopus, and regulatory sources (2015–2025), prioritizing systematic reviews, meta-analyses, and primary regulatory documents. Comparative analysis identifies three predominant regulatory models (United States–DSHEA, European Union–stratified framework, and Canada–risk‑proportional pre‑market licensing). Case-based synthesis (gastrointestinal phytomedicines, melatonin, valerian, Hypericum perforatum, curcumin, and probiotics) shows that efficacy is heterogeneous and critically dependent on standardization and quality. Herb- and supplement-induced liver injury is discussed as an emerging cause of acute liver damage, often underreported. It is concluded that products intended for therapeutic use should meet rigorous standards of scientific evidence, quality control, and pharmacovigilance comparable to those of conventional medicines.
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Copyright (c) 2026 Diego Valarezo-Sevilla, Vanessa Sarzosa-Terán (Author)
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