When regulation ignores evidence: The case of Denmark’s Ashwagandha ban and the Technical University of Denmark’s misguided risk assessment

Abstract

The recent ban on Ashwagandha (Withania somnifera (L.) Dunal) supplements in Denmark, based on a risk assessment by the Technical University of Denmark (DTU), exemplifies the challenges in regulating traditional herbal medicines within modern frameworks. This article critically examines the DTU report, highlighting methodological flaws including overreliance on animal studies and selective literature review. The report’s disregard for Ashwagandha's long history of traditional use and mischaracterization of its effects, particularly alleged abortifacient properties, contradicts a growing body of scientific evidence supporting its safety and efficacy. The current research demonstrating Ashwagandha's benefits in stress reduction, sleep improvement, and cognitive function further underscores the disparity between scientific findings and the DTU’s conclusions. The ban’s implications extend beyond Denmark, raising questions about regulatory consistency and proportionality in evaluating herbal products globally. The Indian Ministry of Ayush’s critique emphasizes the need for a more comprehensive, evidence-based approach for assessing traditional medicines. This controversy may catalyze the development of integrated evaluation methods, such as the Collaborative Medicine and Science framework, bridging diverse knowledge systems in regulatory decision-making. The case underscores the necessity for a global health paradigm that harmonizes traditional and modern medical approaches, ensuring public safety while preserving access to beneficial traditional remedies.