Ashwagandha: Is It Safe? Part 1: A Regulatory Review by Brendler et al. 2025 provides a comparative regulatory analysis of Withania somnifera across major global markets, with particular attention to how safety concerns have been interpreted by competent authorities in Europe, India, the United Kingdom, the United States, Canada, and Australia. The paper is not a toxicological risk assessment in itself; rather, it evaluates the regulatory consequences of emerging safety concerns, adverse-event reporting, and inconsistent classification of ashwagandha as a food, food supplement, traditional medicine, natural health product, or therapeutic good.
The central regulatory issue identified by the authors is the increasing scrutiny of ashwagandha in the European Union. EU concern has intensified around potential reproductive, endocrine, neurological, immune, and hepatic effects, culminating in a recommendation by the Heads of Food Safety Agencies working group for an Article 8 procedure under Regulation (EC) No. 1925/2006. If pursued, this procedure could result in ashwagandha being placed under Union scrutiny or potentially prohibited from use in food supplements. Because ashwagandha is not currently recognized as a traditional herbal medicinal product in the EU, removal from the food supplement category could effectively remove the ingredient from much of the EU marketplace.
The review demonstrates that regulatory responses to ashwagandha safety signals remain highly heterogeneous. Denmark has banned its use in food supplements; Poland has adopted intake limits; France, Germany, the Netherlands, and other authorities have issued precautionary advisories or initiated risk assessments; while several other jurisdictions continue to permit ashwagandha under notification, case-by-case evaluation, or existing botanical frameworks. This regulatory fragmentation reflects not only differences in legal classification, but also differences in how authorities interpret incomplete toxicological evidence, traditional-use data, clinical experience, adverse-event reports, and uncertainty around dose, extract type, plant part, and compositional standardization.
In contrast, India regulates ashwagandha within long-established Ayush medicinal systems and associated quality frameworks. The paper notes that Indian law provides mechanisms for regulating Ayush medicines, including quality, safety, efficacy, labeling, manufacturing standards, GMP requirements, pharmacopoeial standards, and pharmacovigilance. Ashwagandha is not listed among poisonous substances under the relevant Indian Ayush rules, and standards for identity, purity, and strength have been established through Indian pharmacopoeial and standards-setting bodies. This contrast is important: jurisdictions with deep traditional-use frameworks may evaluate ashwagandha through structured medicinal and pharmacopoeial systems, while other markets often assess it through food-supplement risk paradigms that may not fully account for traditional use, preparation form, or exposure history.
The authors also describe distinct North American and Australian approaches. In the United States, ashwagandha is primarily regulated as a dietary supplement under DSHEA, although some proprietary forms have been self-affirmed GRAS for specific food uses. The paper emphasizes that U.S. regulatory status depends heavily on intended use, product claims, manufacturing method, and whether a given preparation would be considered an old dietary ingredient or a new dietary ingredient. In Canada, ashwagandha is permitted in licensed Natural Health Products under a premarket authorization framework, but Health Canada has not accepted ashwagandha root extract as a supplemental ingredient for supplemented foods. In Australia, ashwagandha is permitted in listed complementary medicines, subject to therapeutic-goods quality and pharmacovigilance requirements, while its sale as a conventional food is more restricted because it has been treated as a non-traditional or novel food requiring safety assessment.
The paper’s conclusion is directly relevant to the mission of the Ashwagandha Standards Alliance. Brendler et al. argue that the present regulatory landscape is being shaped by inconsistent safety interpretations, incomplete product-specific toxicology, unclear compositional comparability among extracts, and insufficient transparency in specifications and analytical methods. They call for balanced risk–benefit assessment rather than reflexive prohibition, and they specifically recommend that manufacturers of branded extracts publish OECD-aligned toxicological investigations and disclose specifications using non-proprietary assay methods that permit comparative evaluation of dose, composition, and duration of use.
For ASA, the paper supports three core priorities: first, the need to distinguish safety questions by plant part, preparation type, dose, population, and duration of use; second, the need for transparent, reproducible analytical methods and public specifications; and third, the need for regulatory engagement that addresses legitimate uncertainty without collapsing the category into undifferentiated claims of toxicity. The review shows that ashwagandha’s future will likely depend less on whether regulators identify isolated safety signals, and more on whether industry and scientific stakeholders can provide coherent, product-specific, methodologically transparent evidence that allows those signals to be interpreted in context.
For more information on the regulatory status of ashwagandha, contact Ashwagandha Standards Alliance.