Ashwagandha: Evaluating its safety for human consumption

Ashwagandha ( Withania somnifera (L.) Dunal, Solanaceae) is a traditional herb used in Ayurvedic medicine. It is regarded as an adaptogen because it enhances an organism’s ability to tolerate, adapt to, and survive stress. The use of adaptogenic ingredients in dietary supplements and herbal medicines has grown in popularity. Among adaptogens, ashwagandha has shown the most rapid growth in the herbal supplement market. Evaluations of ashwagandha’s regulatory status in the EU have classified it as a food supplement. While it has traditionally been considered safe based on prolonged use, EU regulators have expressed concerns about the safety of ashwagandha as a supplement ingredient since 2013, culminating in a recent recommendation for an Article 8 procedure according to Regulation (EC) No 1925/2006 by the Heads of Food Safety Agencies working group “Food Supplements.” This process could lead to a ban on ashwagandha as a food supplement ingredient and, consequently, the effective removal of the ingredient from the EU marketplace altogether. Primary concerns regarding the safety profile of ashwagandha include its effects on the female reproductive system, male reproduction due to its impact on sex hormone levels, thyroid hormones, inhibition of acetylcholinesterase, the immune system, and hepatotoxicity (based on case reports). These concerns raise questions about safe dietary exposure and effects on vulnerable groups, including older adults and pregnant or breastfeeding women. Additionally, there is interest in whether ashwagandha preparations from root, leaf, and mixed plant parts have different safety profiles. This presentation summarizes findings compiled in a special issue of Phytotherapy Research, reviewing over 100 clinical trials for safety-related outcomes. Publication History Article published online: 05 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany