Is ashwagandha being banned in Europe? The facts.

Ashwagandha (*Withania somnifera*) is not being banned across Europe — but several EU member states have imposed restrictions, and the European Union has opened a formal safety review that could lead to a continent-wide restriction within the next one to two years. Denmark banned it in food supplements in 2023. France followed with its own restriction. Belgium now classifies ashwagandha-containing supplements as medicinal products. India, the world's primary source of the root, banned the use of the ashwagandha leaf in any form in April 2026. And in 2024, the Heads of Food Safety Agencies across the EU recommended initiating an Article 8 procedure under Regulation (EC) No 1925/2006, which is the legal mechanism that could ultimately restrict or prohibit ashwagandha EU-wide. [1,2]

This is a complex regulatory picture, and most of the commentary circulating online gets the nuance wrong in one of two directions — either dismissing the concerns entirely or treating the situation as a settled ban on a dangerous substance. Neither reading is accurate. As a registered pharmacist with training in pharmacology and pharmaceutical formulation, I want to explain what is actually happening, why the regulatory concerns exist, and what it means for people using ashwagandha-containing supplements right now.

Why is ashwagandha under regulatory review in Europe?

The regulatory concerns centre on four main areas: potential effects on thyroid hormone levels, reproductive toxicity, immune system modulation, and — most prominently — reports of liver toxicity (hepatotoxicity). [2]

The hepatotoxicity concern deserves particular attention because it is the most clinically significant and the most misunderstood. Several case reports of liver injury have been published in peer-reviewed literature, some serious. However, a critical detail is often missing from consumer-facing accounts: the majority of these cases involved supplements that contained both ashwagandha root and leaf, or products where the precise composition was unclear or potentially adulterated. [3]

The root and the leaf of *Withania somnifera* have meaningfully different phytochemical profiles. Withanolides — the primary bioactive compounds responsible for ashwagandha's adaptogenic effects on the HPA axis and cortisol regulation — are concentrated in the root. Withaferin-A, a compound with demonstrated cytotoxic properties in preclinical studies and one proposed mechanism of liver injury, is found predominantly in the leaves. [4] A 2025 systematic review in *Phytotherapy Research* concluded that ashwagandha root extract demonstrates a superior safety profile compared to preparations containing aerial parts (leaves, stems), and that the root exhibits a better safety profile than most other herbal supplements reviewed. [5]

This is why the source of the extract, the standardisation specification, and the part of the plant used matter enormously — and why the April 2026 Indian government decision to ban ashwagandha leaf use in any form is scientifically coherent, even if it has generated anxiety about the plant overall.

What did Denmark actually do — and why?

Denmark was the first EU member state to formally ban ashwagandha in food supplements, with the restriction taking effect in 2023 based on a risk assessment carried out by the Technical University of Denmark (DTU). [1] The DTU assessment found that existing safety data were insufficient to establish a safe intake level for the general population, citing concerns about effects on thyroid hormones, reproductive function, and immune modulation.

The assessment drew significant criticism from the scientific and industry community. A 2024 paper published in the *International Journal of Ayurvedic Research* (and separately reviewed in *PubMed Central*) argued that the DTU report relied disproportionately on preclinical (animal and cell) data, and did not adequately weight the substantial body of human clinical trial evidence, which at the time included multiple well-designed randomised controlled trials demonstrating both efficacy and safety at doses of 300 to 600 mg of standardised root extract. [6]

This is a genuine scientific disagreement, not a conspiracy. Regulatory agencies operate on a precautionary principle — when the data to derive a safe dose are insufficient, restriction is the default. The industry position is that the human evidence base at standard supplemental doses of root extract is reassuring. Both positions are defensible, which is precisely why the Article 8 procedure is the appropriate next step: it will mandate a systematic EFSA review of all available evidence, after which a formal opinion will be issued.

What does the EU Article 8 procedure mean?

Article 8 of Regulation (EC) No 1925/2006 provides a three-tier mechanism for substances in food supplements where safety concerns exist. [2] Under this procedure:

The European Commission, acting on the recommendation of the Heads of Food Safety Agencies (which was issued in 2024), instructs EFSA to conduct a comprehensive safety assessment. During this period, the substance is placed on a restricted list — member states can maintain their current national positions. After EFSA delivers its opinion, the Commission can confirm safety and permit continued use, impose conditions (dose limits, specific extract forms), or restrict or prohibit use EU-wide.

This process typically takes two to three years from initiation. The outcome is not predetermined. If the EFSA assessment confirms that standardised root extract at supplemental doses is safe in the general population — which the published clinical literature on root-only preparations suggests is a plausible finding — the result may be proportionate labelling requirements or dose guidance rather than an outright ban.

Is root-only standardised ashwagandha safe?

The honest answer, based on current evidence, is that standardised root extract at doses in the range of 300 to 600 mg appears well-tolerated in the healthy adult population, based on multiple peer-reviewed randomised controlled trials. A 12-month prospective observational study published in 2025 in *Phytotherapy Research*, specifically examining standardised root extract in healthy adults, found no serious adverse events over the study period. [5] A 60-day randomised controlled trial involving 60 adults — the Lopresti 2019 study that underpins much of the clinical evidence — found a 23% reduction in serum morning cortisol versus placebo, alongside improvements in sleep quality and stress scores, with no clinically significant adverse effects. [7]

The caveat that applies to all of this evidence is that most trials are six to twelve weeks in duration, enroll healthy adults without comorbidities, and use well-characterised, standardised root-only extracts. Extrapolation to people with thyroid conditions, those on immunosuppressants or sedatives, or pregnant individuals is not supported. And the quality of ashwagandha products on the market varies widely — the clinical trial evidence is not transferable to products that fail to specify the plant part used, the withanolide standardisation percentage, or the extraction method.

What this means for people using ashwagandha supplements now

If you are using ashwagandha and living in the Netherlands, you are in a jurisdiction where the ingredient is currently under regulatory observation but not prohibited. The NVWA (Netherlands Food and Consumer Product Safety Authority) has indicated the plant is not recommended for use in new formulations, but existing products with correct notification remain on the market. The situation is actively evolving, and checking the NVWA's published guidance periodically is prudent. [8]

If you are buying ashwagandha supplements — from any brand — the questions worth asking are specific: Is this a root-only extract? Is it standardised to a defined withanolide percentage? What is the dose? Is there a clinical trial at this dose and this extract form? Vague labels that say "ashwagandha extract" without specifying plant part, standardisation, or dose are not providing you with the information needed to evaluate safety, and they are not the products that have been tested in clinical trials.

From a formulation perspective, this is precisely why ARC uses a root-only ashwagandha extract standardised to 7% withanolides at 300 mg — the form and dose used in the Lopresti 2019 RCT, and the form that the available safety literature most consistently supports. It is also why full dose disclosure on the label matters: you cannot evaluate a product's risk-benefit profile if the label does not tell you what is in it. [7]

The regulatory situation for ashwagandha in Europe is serious and worth following. It is not a reason for panic. It is a reason for precision.

Written by Cameron Webb, MPharm, PhD — Pharmacist and Founder of NutraWebb

FAQ

Is ashwagandha banned in the Netherlands?

Not currently. In the Netherlands, the NVWA has placed ashwagandha under observation and has indicated it should not be used in new supplement formulations, but existing notified products remain legally available. The EU is conducting a formal safety review under Article 8 of Regulation (EC) No 1925/2006, the outcome of which will determine whether further restrictions are imposed across member states.

Why is Denmark's ashwagandha ban controversial?

Denmark's 2023 ban was based on a DTU risk assessment that critics — including researchers published in peer-reviewed journals — argued placed too much weight on preclinical (animal and cell) data and insufficient weight on the human clinical trial evidence for standardised root extract. Multiple randomised controlled trials have demonstrated both efficacy and an acceptable safety profile for root-only preparations at doses of 300 to 600 mg. The EU's Article 8 procedure is intended to produce a systematic EFSA-led review that evaluates all available evidence before a final decision is made.

Does it matter whether ashwagandha is from the root or the leaf?

Yes, this is one of the most pharmacologically important distinctions in the current debate. Withaferin-A, a compound with cytotoxic properties and a proposed mechanism in hepatotoxicity case reports, is concentrated in the leaves. Root extract has a markedly different composition, with withanolides — the adaptogenic bioactives — predominant. India banned ashwagandha leaf use in all supplement forms in April 2026, a decision consistent with the published safety literature. Products that specify root-only sourcing, standardised withanolide content, and no aerial parts have a substantially better safety evidence base than mixed-plant preparations.

This article is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making changes to your supplement routine.

References

1. Olsen AK, et al. Danish ban on ashwagandha: truth, evidence, ethics, and regulations. *PMC*. 2024. PMC11403136. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11403136/

2. EU ashwagandha regulation: safety concerns, bans and market implications. Vitafoods Insights. Available at: https://www.vitafoodsinsights.com/regulations/eu-regulatory-update-on-ashwagandha

3. Potential adverse effects of ashwagandha: a critical review of preclinical and clinical evidence. *Phytotherapy Research*. 2025. doi:10.1002/ptr.70158

4. DNA damage by withanone as a potential cause of liver toxicity observed for herbal products of *Withania somnifera* (ashwagandha). *Journal of Ethnopharmacology*. 2021. doi:10.1016/j.jep.2021.S2666027X21000074

5. Safety of 12-months administration of ashwagandha (*Withania somnifera*) standardised root extract in healthy adults: a prospective, observational study. *Phytotherapy Research*. 2025. doi:10.1002/ptr.70096

6. When regulation ignores evidence: the case of Denmark's ashwagandha ban. *International Journal of Ayurvedic Research*. 2024. Available at: https://journals.lww.com/ijar/fulltext/2024/05030/when_regulation_ignores_evidence__the_case_of.2.aspx

7. Lopresti AL, et al. An investigation into the stress-relieving and pharmacological actions of an ashwagandha (*Withania somnifera*) extract. *Medicine*. 2019;98(37):e17186. doi:10.1097/MD.0000000000017186

8. NVWA (Netherlands Food and Consumer Product Safety Authority). Growing safety concerns over Ayurvedic ingredients. Available at: https://www.cbi.eu/news/growing-safety-concerns-over-ayurvedic-ingredients