About
Ashwagandha (Withania somnifera) is an adaptogenic botanical herb primarily derived from its roots, with deep roots in Ayurvedic and traditional medicine systems. It is incorporated into food supplements and functional foods, marketed for purported benefits including stress and anxiety relief, sleep improvement, and cognitive enhancement.
Safety summary
Ashwagandha has been associated with cases of drug-induced liver injury (hepatotoxicity) and potential thyroid-disrupting effects, prompting bans and regulatory scrutiny in several jurisdictions. The UK Food Standards Agency has recorded an increasing number of adverse incidents related to ashwagandha food supplements, and no safe maximum intake level has been formally established. Sensitive populations, including pregnant women, individuals with thyroid or liver conditions, and children, are advised to exercise caution or avoid use.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| Danish Veterinary and Food Administration (Denmark) | Banned | Denmark banned ashwagandha in food supplements and food products due to concerns about hepatotoxicity and thyroid-disrupting effects. The ban was enacted circa 2023 and has been the subject of scientific debate regarding the quality of the supporting evidence.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Restricted | Ashwagandha roots are permitted as a health supplement and nutraceutical ingredient under FSSAI's Food Safety and Standards (Health Supplements, Nutraceuticals, Functional Food and Novel Food) Regulations, 2016. Use of ashwagandha leaves (crude or extract or any other form) is strictly prohibited in food and Ayush drug products due to elevated Withaferin-A content. Specific health benefit claims require prior approval from the Food Authority.source |
| FDA (Food and Drug Administration) (United States) | Restricted | Ashwagandha is regulated as a dietary supplement ingredient under the Dietary Supplement Health and Education Act (DSHEA, 1994). It is not approved as a conventional food additive and does not appear in the FDA GRAS list for general food use. Manufacturers bear responsibility for the safety of products containing ashwagandha before marketing.source |
| EFSA (European Food Safety Authority) (European Union) |
Who should approach with care
Research citations
- 1other. Ashwagandha – Call for Evidence. food.gov.uk
- 2EFSA. Compendium of Botanicals – EFSA. efsa.europa.eu
- 3FSSAI. Advisory regarding non-use of Ashwagandha (Withania somnifera) leaves in crude or extract or any other form in food products, 2026. fssai.gov.in
- 4other. Final Minutes of the 21st October 2025 COT Meeting, 2025. cot.food.gov.uk
- 5PubMed. Danish ban on Ashwagandha: Truth, evidence, ethics, 2024. pmc.ncbi.nlm.nih.gov
