About
Chasteberry leaf extract is derived from the leaves of Vitex agnus-castus (chaste tree), a deciduous shrub native to the Mediterranean and Central Asia, containing flavonoids, iridoid glycosides, and diterpene clerodadienols with dopaminergic and estrogenic activity. It is used as a botanical food supplement and in traditional medicine for women's hormonal health, though most regulatory and clinical evidence pertains to the fruit rather than the leaf specifically.
Safety summary
Adverse events in general adults are described as mild and reversible, including nausea, headache, gastrointestinal disturbances, acne, and skin reactions; no clinically apparent liver injury has been reported with oral preparations. The extract binds dopamine D2 receptors in the pituitary and exhibits estrogenic flavonoid activity, posing pharmacological interaction risks and raising concerns for hormone-sensitive individuals and those on dopaminergic medications. No formal Acceptable Daily Intake has been established, and safety data specific to the leaf preparation (as distinct from the well-studied fruit extract) remain limited.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FDA (Food and Drug Administration) (United States) | Restricted | Not listed in FDA's Food Additive Status List or GRAS inventory for use as a food ingredient; marketed exclusively as a dietary supplement under DSHEA. Manufacturers bear responsibility for safety but pre-marketing approval is not required for supplement use.source |
| German Commission E (Germany) | Approved | German Commission E approved Vitex agnus-castus (primarily fruit preparation) for irregularities of the menstrual cycle, premenstrual disturbances, and mastodynia; approval does not specifically extend to the leaf extract as a food ingredient.source |
| MHLW (Ministry of Health, Labour and Welfare) (Japan) | Approved | Vitex agnus-castus fructus extract (Prefemin brand) approved as an OTC drug in Japan for premenstrual syndrome; approval covers the standardized fruit extract product under the Western Traditional Herbal Medicines OTC guideline (2007), not the leaf extract as a food ingredient.source |
| EFSA (European Food Safety Authority) (European Union) | Under_review | EFSA Compendium of Botanicals lists Vitex agnus-castus among plant species reported to contain naturally occurring substances of potential concern for human health; the Compendium carries no legal force but flags the species for hazard identification in food supplement safety assessments.source |
Who should approach with care
Research citations
- 1EFSA. Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and food supplements. efsa.europa.eu
- 2PubMed. Chasteberry — Drugs and Lactation Database (LactMed), 2024. ncbi.nlm.nih.gov
- 3other. Chaste Tree — LiverTox: Clinical and Research Information on Drug-Induced Liver Injury, 2023. ncbi.nlm.nih.gov
- 4EMA. European Union herbal monograph on Vitex agnus-castus L., fructus — Revision 1, 2018. ema.europa.eu
- 5PubMed. Safety and efficacy of chastetree (Vitex agnus-castus) during pregnancy and lactation, 2008. pubmed.ncbi.nlm.nih.gov
- 6PubMed. Vitex agnus castus: a systematic review of adverse events, 2005. pubmed.ncbi.nlm.nih.gov