Ashwagandha, also known as Withania somnifera, is a staple of Ayurvedic tradition. Its root powder has been used for centuries to treat stress, anxiety, and sleep disturbances. Its status as non-novel in food supplements means that it can currently be used in food supplements in the EU.

Concerns over dosing, duration, effects, and safety, voiced by EU regulators as early as 2013, have led to some controversy. Between 2021 and 2024, 26 reports of dietary supplements containing ashwagandha being rejected at EU borders were received via the European RASFF portal (Rapid Alert System for Food and Feed). As a consequence, regulatory bodies such as the German Federal Institute for Risk Assessment (BfR) have published statements on ashwagandha addressing this.

In the BfR statement, the authority highlighted reported acute side effects of taking preparations containing ashwagandha, including gastrointestinal complaints such as nausea, vomiting, and diarrhea, as well as dizziness, headaches, light-headedness, drowsiness, and skin rashes.

The BfR further stated that preparations may affect the immune and endocrine systems (including cortisol and blood sugar levels, thyroid, and sex hormones). Case reports of liver damage, which may be linked to the consumption of preparations containing ashwagandha, give cause for particular caution from a risk assessment perspective. However, according to the BfR, the current data does not allow for a conclusive risk assessment, more precise statements on health risks, or a guideline for safe intake levels (BfR Communication 2024).

European Bans

Based on their own highly disputed assessment from 2019, Denmark was the first EU country to ban the use of ashwagandha in food supplements in 2023. More recently, food supplements containing ashwagandha have also been banned in France. Poland has limited the daily intake of ashwagandha to 3 grams of powder containing no more than 10 mg of withanolides. Belgium treats it as a medicinal substance and thus does not allow it in food supplements; in the Netherlands, it is under observation.

In 2024, due to these safety concerns, the Heads of Food Safety Agencies (HoA) recommended that a procedure be initiated under Article 8 of Regulation (EC) No 1925/2006. Should this come to pass, ashwagandha could be banned as an ingredient in food supplements across the EU, and, as it cannot obtain authorization as a traditional medicinal product, it would then disappear entirely from the EU market (Brendler et al., 2025).

India’s Ban on Ashwagandha Leaves

Most recently, India has banned the use of ashwagandha leaves in all food products, health supplements, and Ayurvedic drugs, and manufacture and export of leaf-containing ingredients, restricting manufacturers to root-only formulations as of mid-April 2026.

This directive, issued by the Food Safety and Standards Authority of India (FSSAI) and the Ministry of Ayush, stems from safety concerns regarding higher concentrations of withaferin A in leaves, which regulators linked to potential liver toxicity, gastrointestinal distress, and neurotoxic effects.

It should be noted that scientific investigation does not support these concerns.

Market Repercussions

The Article 8 procedure has not been initiated yet. Currently, ashwagandha can still be used in food supplements in the EU, even if some EU countries have taken national measures to limit or restrict its use.

If initiated, it would be a lengthy process in which manufacturers could submit their own safety data. It is currently unclear whether the plant can be marketed while the procedure is ongoing. Therefore, even if the outcome were to be positive, the ashwagandha market would still take a hit.

However, it is far from a foregone conclusion that the procedure will result in a ban. It is possible that the safety concerns stem from contamination, and that the plant itself, which, after all, has been used in India for centuries, is not to blame for the observed adverse events.

Much remains to be seen. At the moment, it is a strategic decision left to FBOs to either continue developing and/or marketing ashwagandha products in the EU, or to play it safe and wait for the verdict before committing to new products. If in doubt, it is best to double-check with experienced consultancies such as analyze & realize GmbH.

About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com

References & Resources

1. Bundesinstitut für Risikobewertung. Mitteilung 039/2024. https://www.bfr.bund.de/cm/343/ashwagandha-schlafbeeren-praeparate-mit-moeglichen-gesundheitsrisiken.pdf.
2. Rapid Alert System for Food and Feed (Withania somnifera)
3. T. Brendler, R. Al-Mondhiry, L. Lang, R. Marles, M. Tallon, A. Raghu. Ashwagandha: Is It Safe? Part 1: A Regulatory Review. Phytotherapy Research, 2025. https://doi.org/10.1002/ptr.70151
4. Brendler T. Is Ashwagandha an Abortifacient?. Phytotherapy Research. 2025 Dec 26.
5. Vollmer G, Brendler T. Evaluation of Potential Hormonal Activities of Ashwagandha (Withania somnifera). Phytotherapy Research. 2025 Dec 26.
6. Thomas Brendler, Elizabeth M Williamson. Ashwagandha: is it safe? Part 3: A review of clinical safety. Authorea. 06 March 2026. DOI: https://doi.org/10.22541/au.177282036.68024186/v1