⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
About
Harpagoside inhibits COX-2, TNF-α and IL-1β; analgesic and anti-inflammatory
How it works (mechanism of action)
Used for osteoarthritis, low back pain and musculoskeletal inflammation. Common French pharmacy. EMA well-established use.
⚖️ Regulatory Status
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FR — Banned
ANSES recommended ban of kava following hepatotoxicity signals from nutrivigilance system.
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NZ — Banned
Medsafe NZ — ephedrine alkaloid supplements banned following FDA and TGA action.
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NL — Banned
NVWA prohibition (2004).
⛔
MY — Banned
NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.
⛔
SA — Banned
SFDA Saudi Arabia — ephedra and ephedrine alkaloid supplements prohibited. Controlled as prescription drug.
⛔
SE — Banned
Livsmedelsverket Sweden prohibition aligned with EU Directive 2002/46/EC.
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IT — Banned
Italian Ministry of Health — ephedra and ephedrine alkaloid supplements prohibited under EU Directive 2002/46/EC.
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AE — Banned
UAE MOH prohibition — ephedra supplements banned. Ephedrine controlled as pharmaceutical.
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SG — Banned
HSA Singapore prohibition (2004) — ephedra alkaloid supplements prohibited.
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ID — Banned
BPOM Indonesia — ephedra and ephedrine alkaloid supplements prohibited.
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PH — Banned
FDA Philippines — ephedra and ephedrine alkaloid-containing food supplements banned following international regulatory action.
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PL — Banned
GIS Poland prohibition aligned with EU Directive 2002/46/EC.
⛔
EU — Banned
European Commission ban (2002) under Directive 2002/46/EC — all ephedra and ephedrine alkaloid supplements.
⛔
ES — Banned
AEMPS Spain prohibition aligned with EU ban on ephedrine alkaloid supplements.
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DK — Banned
Banned (2023) — Danish Veterinary and Food Administration (DVFA). Liver toxicity and thyroid disruption reports. All preparations ordered off market.
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DE — Banned
BfArM banned kava-containing products in Germany in 2002 due to hepatotoxicity risk. Cases of liver failure and death reported.
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US — Banned
FDA ban (2004) — cardiovascular adverse events and deaths. Final rule 21 CFR 119. All ephedrine alkaloids banned from dietary supplements.
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CH — Banned
Swissmedic banned kava in Switzerland due to hepatotoxicity.
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CA — Banned
Health Canada ban (2002) — all ephedra and ephedrine alkaloid-containing supplements.
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BE — Banned
FASFC Belgium prohibition aligned with EU Directive 2002/46/EC.
⛔
AU — Banned
TGA ban (2003) — cardiovascular adverse events. Ephedra alkaloids banned from complementary medicines.
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PT — Banned
ASAE Portugal prohibition aligned with EU ban on ephedrine alkaloid supplements.
⚠️
TH — Restricted
FDA Thailand — ephedrine controlled as pharmaceutical. Not permitted in food supplements.
⚠️
IN — Restricted
CDSCO India (2004) — available only under prescription as pharmaceutical products.
⚠️
TW — Restricted
TFDA Taiwan — ephedrine controlled as pharmaceutical drug. Not permitted as health food ingredient. Products with ephedra claims require pharmaceutical registration.
⚠️
ZA — Restricted
SAHPRA (2004) — Schedule 2; pharmacist oversight required.
⚠️
KR — Restricted
MFDS South Korea (2003) — maximum dose restrictions. Not permitted for weight loss products.
⚠️
JP — Restricted
MHLW Japan (2003) — maximum dose limits; not permitted for weight loss marketing. Ephedrine controlled under pharmaceutical regulations.
⚠️
IE — Restricted
FSAI monitoring (2024) following Danish ban and hepatotoxicity reports. Products without adequate safety data may face withdrawal.
⚠️
HK — Restricted
Department of Health Hong Kong — ephedrine-containing preparations controlled as pharmaceutical products. Not permitted as health food supplements without pharmaceutical registration.
⚠️
GB — Restricted
MHRA (2004) — ephedrine alkaloid supplements restricted. Maximum doses apply under the Medicines Act.
⚠️
CN — Restricted
NMPA China — Ma Huang (ephedra) controlled. Ephedrine alkaloid content restrictions; not permitted for weight loss products. Export of ephedra controlled internationally.
💊
AT — Prescription only
AGES Austria — melatonin classified as prescription-only medicinal product. Not permitted as food supplement.
📊 Effectiveness
Osteoarthritis pain
Evidence Grade A · 12 studies · n=1,200 · Meta-analysis available
Lower back pain
Evidence Grade A · 10 studies · n=1,000 · Meta-analysis available
Evidence grades: A=Strong RCT evidence · B=Good clinical trials · C=Limited trials · D=Preliminary/traditional
👥 Safety by Population
🚫 Contraindications & Warnings
Consult a healthcare professional before use if pregnant, breastfeeding, taking prescription medications, or if you have a medical condition. Keep out of reach of children.
💊 Drug Interactions (4)
🟡 Warfarin
ModerateAnticoagulants
Management: Monitor INR when starting or stopping Devil's Claw.
⚪ Antacids
MinorGastrointestinal
Management: Avoid in peptic ulcer disease and with antacid medication.
⚪ Antidiabetic drugs
MinorAntidiabetic
Management: Monitor blood glucose.
⚪ Digoxin
MinorCardiac glycoside
Management: Monitor cardiac function.
🏷️ Other Names
Harpagophytum procumbens
Harpagophytum
Devil's claw root
References (3)
- National Institutes of Health. Vitamin C: Fact Sheet for Health Professionals. 2021. Available from: https://ods.od.nih.gov/factsheets/VitaminC-HealthProfessional/ Reference Source ↗
- European Commission. Regulation (EU) No 432/2012. Off J Eur Union. 2012;L 136:1-40. Regulatory document Source ↗
- Hallberg L, Hulthén L. Am J Clin Nutr. 2000;71(5):1147-60. RCT PubMed ↗
Evidence grades: SR = Systematic review / meta-analysis (highest) · RCT = Randomized controlled trial · Reg = Regulatory/official guidance