About
KSM-66 is a proprietary, high-concentration, full-spectrum extract of Withania somnifera (ashwagandha) roots, standardized to a minimum of 5% withanolides by HPLC and manufactured via a green-chemistry aqueous extraction process without alcohol or synthetic solvents. It is used as an adaptogenic botanical supplement primarily to support stress resilience, sleep quality, and cognitive function.
Safety summary
KSM-66 is well tolerated in short-term clinical use (up to ~3 months) at doses of 300–600 mg/day; common side effects such as loose stools, nausea, and drowsiness are mild. A 90-day OECD-compliant repeated-dose toxicity study in rats established a NOAEL of 2,000 mg/kg bw/day, and mutagenicity testing found no clastogenic or cytogenetic damage up to 2,000 mg/kg. However, rare reports of hepatotoxicity exist, long-term safety data in humans are lacking, and no formal ADI has been established by any major regulatory body.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| Danish Veterinary and Food Administration (Denmark) | Banned | Denmark banned ashwagandha (including root extracts) for use in food supplements based on a 2020 risk assessment report by the Technical University of Denmark (DTU). The scientific basis of this ban has been contested by experts and the Ministry of AYUSH, Government of India.source |
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Approximately 320 medicines listed in the Australian Register of Therapeutic Goods (ARTG) include ashwagandha, indicating broad regulatory acceptance for therapeutic use.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Approved | Ashwagandha root use is permitted as a food/dietary supplement. The MHRA has approved an ongoing randomized controlled clinical trial (APRIL Trial) utilizing ashwagandha.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Withania somnifera (L.) Dunal is listed as a permitted botanical ingredient in Schedule I of the FSSAI Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods, and Novel Food Regulations, 2022. A 2026 FSSAI advisory specifically prohibits use of ashwagandha LEAVES in food products; root extracts such as KSM-66 remain permitted.source |
Who should approach with care
Research citations
- 1PubMed. Efficacy and safety of Ashwagandha (Withania somnifera) root extract on stress and weight management in adults: a prospective, randomized, double-blind, placebo-controlled study, 2025. pmc.ncbi.nlm.nih.gov
- 2PubMed. Danish ban on Ashwagandha: Truth, evidence, ethics, and regulations, 2024. pmc.ncbi.nlm.nih.gov
- 3PubMed. Mutagenicity and safety evaluation of Ashwagandha (Withania somnifera) root aqueous extract in different models, 2024. pmc.ncbi.nlm.nih.gov
- 4other. Ashwagandha: Is it helpful for stress, anxiety, or sleep? — NIH Office of Dietary Supplements Health Professional Fact Sheet, 2024. ods.od.nih.gov
- 5PubMed. Ninety-day repeated dose toxicity of Ashwagandha (Withania somnifera) root extract in Wistar rats, 2023. pmc.ncbi.nlm.nih.gov
- 6PubMed. A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults, 2012.