About
What it is and where it shows up.
Astragalus membranaceus root extract is a botanical extract derived from the dried roots of the legume Astragalus membranaceus, a plant used for centuries in traditional Chinese medicine. It is classified as an adaptogen and is used in food supplements for its purported immunomodulatory, antioxidant, antiviral, and anti-inflammatory properties.
Safety summary
The regulatory and scientific consensus.
At normal supplement doses in healthy adults, astragalus root extract has a broad safety record with uncommon and poorly defined side effects; large doses can cause gastrointestinal upset. It may potently inhibit the CYP3A4 enzyme system, raising significant herb-drug interaction concerns. Animal studies suggest fetal toxicity during pregnancy, and the extract may exacerbate autoimmune conditions.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| Health Canada (Canada) | Restricted | Health Canada has determined that astragalus root extract does not have a history of safe food use and that publicly available data are insufficient to establish acceptable conditions for its use as a supplemental ingredient in supplemented foods. A formal submission with full toxicological, reproductive/developmental, genotoxicity, and drug-interaction data is required before use can be permitted.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised as a novel food under Regulation (EU) 2020/1821 (amending Implementing Regulation (EU) 2017/2470) for use in food supplements only, for the general adult population. Labelling must state not for use by persons under 18 years of age or by pregnant women. Safe intake established at 0.5 mg/kg bw/day (35 mg/day) based on a NOAEL of 100 mg/kg bw/day with a safety factor of 200. Applies specifically to the combined Panax notoginseng + A. membranaceus (AstraGin™) extract. A low-ratio (2:1) single-herb A. membranaceus root extract in food supplements has been determined to be 'not novel' by the EU given a history of use since before 1997.source |
| FSA / COT (United Kingdom) | Approved | Authorised on 23 December 2020 (mirroring EU Regulation 2020/1821). Labelling of food supplements must state the product should not be consumed by persons under 18 years of age or by pregnant women. Applies to the Panax notoginseng + Astragalus membranaceus combined extract.source |
Who should approach with care
Whose guidance would steer them away.
Pregnancy — Animal studies indicate astragalus can be toxic to the fetus, and both EFSA (EU 2020/1821) and NCCIH explicitly exclude pregnant women from recommended use.
Infants — EU Regulation 2020/1821 mandates labelling that the product should not be consumed by persons under 18 years of age, and no safety data exist for paediatric or infant populations.
Children — EU Regulation 2020/1821 and UK FSA authorisation explicitly exclude persons under 18; no safety data support use in children or adolescents.
Other — Individuals with autoimmune diseases (e.g., lupus, rheumatoid arthritis, multiple sclerosis) should avoid astragalus as it may stimulate the immune system and exacerbate symptoms, per NCCIH guidance.
Other — Astragalus is a potent CYP3A4 inhibitor in vitro and in vivo, meaning it can alter the metabolism of numerous prescription medications including immunosuppressants, anticoagulants, and others; patients on any regular medication should consult a doctor before use.
Research citations
The sources behind this verdict.
- 1other. Astragalus: Usefulness and Safety – NCCIH. nccih.nih.gov
- 2other. Decision on astragalus root extract as a supplemental ingredient in foods, 2024. canada.ca
- 3other. Commission Implementing Regulation (EU) 2020/1821 authorising the placing on the market of an extract from Panax notoginseng and Astragalus membranaceus as a novel food, 2020. eur-lex.europa.eu
- 4EFSA. Safety of a botanical extract derived from Panax notoginseng and Astragalus membranaceus (AstraGin™) as a novel food pursuant to Regulation (EU) 2015/2283, 2020. efsa.europa.eu
- 5other. Astragalus – LiverTox (NIH/NCBI Bookshelf), 2019. ncbi.nlm.nih.gov
- 6other. Toxicological Evaluation of a Mixture of Astragalus membranaceus and Panax notoginseng Root Extracts (InnoSlim®), 2019.
Independently researched6 citations