⚠ Banned in at least one country (ANSM) — see Regulatory alerts by country below.
Updated: 2026-05-29 · v2.0 · Prof. G. Pkhakadze, MD, MPH, PhDCiteEditorial
5
Avoid
Kava
Piper methysticum
Banned in ≥1 countryModerateRestricted
RDA
Typical 100–250 mg kavalactones
Target
Normal
Upper limit
No UL; max 6 months use
Products
—
Dosage by population group — reference
🔗 Best with: Passionflower, L-Theanine, Valerian
⚠ >100 hepatotoxicity cases including liver failure/death [1]
⚠ NEVER with alcohol or hepatotoxic drugs [1]
⚠ CYP pan-inhibitor (1A2, 2C9, 2C19, 2D6, 3A4) — major drug interaction potential [1]
⚠ New fatigue/dark urine/jaundice → STOP immediately, check LFTs [1]
⚠ Water extracts may be safer than ethanol-based [1]
ℹ️ Not obtained from food. Not applicable — this is not obtained from food in meaningful amounts; supplementation is the practical route.
🔬 Lab interpreter
Recommended test
ALT, AST, bilirubin
Reference range / target
Normal
When to test
Baseline and every 4 weeks during use [1].
Mandatory liver monitoring during kava use [1].
Full lab monitoring ↓
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Kava IS effective for anxiety (Cochrane confirmed). BUT: >100 hepatotoxicity cases including DEATHS. Banned/restricted in several countries. Water extracts may be safer than ethanol/acetone. Limit to 1–3 months. Monitor liver. No dependence (advantage vs benzodiazepines). The benefit-risk is a genuine clinical dilemma [1] [2].
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
AVOID — hepatotoxicity + potential uterotonic [1].
👦 Pediatric: See guidance
AVOID — hepatotoxicity [1].
🏃 Athletes: Standard dose
⚖️ Obesity: Standard dose
Fat-soluble compounds may require dose adjustment in obesity.
🩺 Renal: Consult specialist
Dose adjustment may be needed in renal impairment.
🌱 Vegan: Standard dose

How to take

🍽 Timing: Divided BID-TID [2].
💊 With food: With or without food [1].
🚫 Avoid: Alcohol. Hepatotoxic drugs. >3 months. Pregnancy [1].
2 Which form?
FormBioavailabilityVeganCost
['Water extract (traditional)', 'preferred', 'Traditional Pacific Island preparation. May be safer (aqueous extraction) [1].']StandardCheck label
['Ethanolic/acetonic extract', '', 'Used in European supplements. May be linked to higher hepatotoxicity risk [1].']StandardCheck label
['WS 1490 extract', '', 'Standardized. Used in the Cochrane-reviewed trials [2].']StandardCheck label
3 Common questions
Is kava safe? ▼
It IS effective for anxiety (Cochrane). But >100 hepatotoxicity cases (including deaths) are documented. The benefit-risk is debated. Water-based extracts may be safer. Limit to 1–3 months. Monitor liver symptoms. Avoid with alcohol or hepatotoxic drugs [1].
Why was kava banned in Germany? ▼
>30 hepatotoxicity cases in Germany led to a 2002 ban. The ban was partially lifted in 2014 after review concluded the overall benefit-risk was acceptable with appropriate warnings. Acetonic extracts may be riskier than traditional water preparations [1].
Kava vs benzodiazepines? ▼
Kava is effective but has liver risk. Benzodiazepines are effective but have dependence risk. Kava does NOT cause physical dependence — an advantage. But benzodiazepines don't cause liver failure — also an advantage [1] [2].
4 Clinical evidence

Strong

Cochrane review: kava is effective for anxiety (superior to placebo) [2]. >100 hepatotoxicity cases including deaths: well-documented pharmacovigilance data [1]. Kavalactone GABA-A modulation: confirmed pharmacology [1]. HIGH

Moderate

GAD: multiple positive RCTs at 120–240 mg kavalactones/day [2]. Sleep: some evidence for improved sleep quality [1]. Comparable to low-dose benzodiazepines for anxiety in some trials [2]. MODERATE

Insufficient

Depression [1]. ADHD [1]. Cancer [1]. Muscle relaxation [1]. LOW
5 Safety, toxicity & adverse events

Absolute contraindications

✕ Liver disease — documented risk of severe hepatotoxicity
✕ Concurrent hepatotoxic drugs or significant alcohol use
✕ Pregnancy and lactation

Relative

⚠ Parkinson's disease — may worsen motor symptoms
⚠ Concurrent benzodiazepines/CNS depressants — additive sedation
⚠ Do not drive after use; discontinue before surgery

🚩 Red flags

● ANY liver symptoms (fatigue, dark urine, jaundice) in kava user — STOP, check LFTs [1]
● Alcohol + kava — additive hepatotoxicity [1]
● Patient on multiple CYP-metabolized drugs — kava is a pan-CYP inhibitor [1]
6 Interactions

Drug interactions

Hepatotoxic drugs (acetaminophen, statins, etc.) Major
Mechanism: Additive hepatotoxicity. [1]
Effect: Liver injury/failure. [1]
Action: AVOID [1].
CYP substrates (broad) Major
Mechanism: Kava inhibits CYP1A2, 2C9, 2C19, 2D6, 3A4. [1]
Effect: Elevated drug levels across many medication classes. [1]
Action: Review ALL medications before starting kava [1].
CNS depressants Moderate
Mechanism: Additive CNS depression. [1]
Effect: Excessive sedation. [1]
Action: Avoid or use with caution [1].
7 Regulatory
Germany: Banned 2002, partially reinstated 2014 with restrictions [1].
France/UK: Restricted/banned at various points [1].
United States: Dietary supplement (no restrictions) [1].
Pacific Islands: Traditional ceremonial use for centuries [1].
8 Regulatory alerts by country
7 regulatory actions on record — 5 with a verified source link, 2 with the official reference being verified.
Banned · 5
🇫🇷
ANSM — Banned in supplements.
France ANSM: classified on the national list of narcotics/psychotropics (stupéfiants et psychotropes).
Source ↗ · 2024-01-01
🇩🇪
BfArM — Banned 2002, partially lifted but restricted.
Germany BfArM: herbal monograph / pharmaceutical classification restricting OTC supplement use of this substance.
Source ↗ · 2024-01-01
🇸🇬
HSA — Prohibited ingredient in supplements.
HSA Guidelines on Prohibited and Restricted Ingredients in Health Supplements and Traditional Medicines (HPRG, Oct 2025).
Source ↗ · 2025-10-01
🇬🇧
MHRA — Banned since 2003.
The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002 (SI 2002 No. 3170); prohibits sale, supply and importation of unlicensed medicinal products containing Piper methysticum. In force 13 January 2003.
Source ↗ · 2003-01-13
🇳🇱
NVWA — Prohibited.
Netherlands NVWA: prohibited under the Commodities Act (Warenwet) Herbal Preparations Decree.
2024-01-01 · official reference being verified
Restricted · 2
🇨🇦
Health Canada — Stop-sale order. Not permitted in NHPs.
Health Canada Natural Health Products Ingredients Database (NHPID): not permitted as a medicinal ingredient in NHPs or subject to specific restrictions.
2024-01-01 · official reference being verified
🇦🇺
TGA — Schedule 4 — prescription only.
Listed in the Poisons Standard (SUSMP), Therapeutic Goods (Poisons Standard—February 2026) Instrument 2026 — TGA scheduling controls availability.
Source ↗ · 2026-02-01
Browse all regulatory alerts by country →
Kava vs PassionflowerKava vs L-Theanine
9 References (2)
[1]National Institutes of Health, NCCIH. Kava. Updated 2024. www.nccih.nih.gov REVIEW Accessed: 2026-05-29
[2]Pittler MH, Ernst E. Kava extract versus placebo for treating anxiety. Cochrane Database Syst Rev. 2003;(1):CD003383. doi:10.1002/14651858.CD003383 REVIEW Accessed: 2026-05-29
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11 Cite this page
Vancouver: Pkhakadze G. Kava — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Jun 02]. Available from: https://www.tga.gov.au/resources/legislation/poisons-standard
APA 7th: Pkhakadze, G. (2026). Kava — Safety profile. Public Health Institute of Georgia. https://www.tga.gov.au/resources/legislation/poisons-standard
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Institution: Public Health Institute of Georgia (PHIG)
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: December 2026
References: 2 cited sources
COI: SupplementIndex receives no funding from supplement manufacturers. All content independently authored by PHIG.
Process: Systematic literature review
📄 License & reuse
Published under Creative Commons Attribution 4.0 International (CC BY 4.0). You may share and adapt for any purpose with attribution.
Pkhakadze G. "Kava — Safety Profile." SupplementIndex, PHIG, 2026. https://www.tga.gov.au/resources/legislation/poisons-standard CC BY 4.0.
GP
Prof. G. Pkhakadze, MD, MPH, PhD
Professor of Public Health · Head of Department, DTMU
Editor-in-Chief, Georgian Medical Journal (ISSN 3088-4322)
Chair, Public Health Institute of Georgia · UEMS Public Health Section
Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG