Ashwagandha Root Extract

About

What it is and where it shows up.

Ashwagandha root extract is derived from Withania somnifera (L.) Dunal, an evergreen shrub cultivated in tropical and subtropical regions of Asia, Africa, and Europe, long used in Ayurvedic and Unani traditional medicine. It is used in food supplements primarily as an adaptogen — a substance intended to help the body resist biological, physical, and chemical stressors — and is commercially marketed for stress relief, sleep improvement, and cognitive and athletic performance.

Safety summary

The regulatory and scientific consensus.

Ashwagandha root extract is generally considered safe at doses up to approximately 1,200–2,000 mg/day in short-term human trials; no formal ADI has been established by any major regulatory body. However, EU regulators are actively considering an Article 8 restriction procedure (Regulation EC No. 1925/2006) that could lead to a ban in food supplements, and Canada's Health Canada has declined to approve it as a supplemental food ingredient due to insufficient reproductive/developmental toxicity data. Reports of drug-induced liver injury (hepatotoxicity) and the potential to affect thyroid hormone levels make caution warranted, particularly in sensitive populations.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
Health Canada (Canada)	Restricted	Health Canada has declined to approve ashwagandha root extract as a supplemental ingredient in supplemented foods, citing insufficient reproductive/developmental toxicity data, genotoxicity data, and repeated-dose toxicity data. A reconsideration is possible upon submission of additional safety evidence. Ashwagandha may still be sold as a licensed natural health product (NHP) under separate NHP regulations.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Ashwagandha root extract is permitted as a botanical ingredient in health supplements and nutraceuticals under FSSAI's Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. FSSAI and the Ministry of Ayush have issued an advisory (April 2026) prohibiting use of ashwagandha LEAVES (crude or extract) in food products, mandating that only root preparations be used due to the presence of withaferin-A at higher levels in leaves.source
FDA (Food and Drug Administration) (United States)	Approved	Ashwagandha root extract is generally recognized as safe (GRAS) for use in dietary supplements under DSHEA. It is not formally listed as an approved food additive in 21 CFR but is self-affirmed GRAS by manufacturers for use in supplements. No formal FDA GRAS notice (GRN) for ashwagandha root extract as a conventional food ingredient has been finalized.source

Who should approach with care

Whose guidance would steer them away.

Pregnancy — Health Canada explicitly requires reproductive and developmental toxicity data before approving ashwagandha for the general population including pregnant individuals, and traditional Ayurvedic practice contraindicates its use in pregnancy due to potential uterine-stimulating effects.

Lactation — Insufficient safety data exists for ashwagandha root extract during lactation; Health Canada's decision specifically flagged this population as requiring dedicated evidence before the ingredient can be considered safe.

Infants — FSSAI regulations exclude children under 24 months from nutraceutical products, and no safety data supporting use in infants has been established by any regulatory body.

Children — FSSAI guidelines require products intended for children aged 2–5 to be given only under medical supervision, and Health Canada's safety review specifically called out children as a population requiring dedicated reproductive/developmental toxicity evidence.

Liver Disease — Multiple case reports cited by NIH LiverTox and referenced in regulatory reviews have associated ashwagandha supplement use with drug-induced liver injury (hepatotoxicity), making its use inadvisable in individuals with pre-existing liver conditions.

Research citations

The sources behind this verdict.

1NIH / ODS. Ashwagandha: Is it helpful for stress, anxiety, or sleep? — NIH Office of Dietary Supplements Fact Sheet for Health Professionals. ods.od.nih.gov
2other. Ashwagandha food supplements — Call for Evidence, UK Food Standards Agency. food.gov.uk
3NCCIH. Ashwagandha: Usefulness and Safety — National Center for Complementary and Integrative Health. nccih.nih.gov
4FSSAI. Advisory regarding non-use of Ashwagandha (Withania somnifera) leaves in crude or extract or any other form in food products — FSSAI, 2026. fssai.gov.in
5PubMed. Ashwagandha: Is It Safe? Part 1: A Regulatory Review, 2025. pubmed.ncbi.nlm.nih.gov
6FDA / Health Canada. Decision on ashwagandha root extract as a supplemental ingredient in foods — Health Canada, 2024.

Independently researched6 citations