Hepatotoxicity of Herbal Medicines: Assessing Risks and Regulatory Challenges

Abstract

The increasing global use of herbal medicines has highlighted concerns regarding their hepatotoxic potential, as herbal medicine-induced liver injury has become a notable cause of drug-induced liver injury (DILI) worldwide. This mini-review examines the mechanisms behind hepatotoxicity in herbal products, focusing on common hepatotoxic agents and pathophysiological mechanisms, including oxidative stress, mitochondrial dysfunction, and immune-mediated damage. It also discusses key risk factors, such as genetic predisposition, preexisting liver conditions, and lifestyle choices, that can heighten susceptibility to liver injury. Current regulatory frameworks often fail to address the complexities of herbal products due to variability in quality and composition and insufficient safety testing. Regulatory approaches in the U.S. and the EU are compared to illustrate the need for consistent global standards. Strategies for minimizing risks, such as implementing standardized manufacturing practices, enhancing healthcare provider awareness, and advancing toxicological screening methods, are essential to improving consumer safety. This review calls for continued research into the safety profiles of widely used herbal medicines to protect public health while supporting access to alternative therapeutic options.