⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
SAFE
Boswellia serrata
Boswellia serrata (bark resin extract, boswellic acids)
Possibly Safe
V2 Verified
Botanicals
PubMed Studies
66
About
Indian frankincense resin extract. Acetyl-11-keto-β-boswellic acid (AKBA) selectively inhibits 5-lipoxygenase. Evidence-based anti-inflammatory for OA, IBD, and asthma. ESCOP monograph.
How it works (mechanism of action)
Acts on cellular signalling pathways relevant to the documented clinical indications. Contains bioactive compounds with enzyme-modulating, receptor-binding, or antioxidant properties studied in peer-reviewed literature.
⚖️ 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).
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MY — Banned
NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.
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SA — Banned
SFDA Saudi Arabia — ephedra and ephedrine alkaloid supplements prohibited. Controlled as prescription drug.
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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.
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EU — Banned
European Commission ban (2002) under Directive 2002/46/EC — all ephedra and ephedrine alkaloid supplements.
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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.
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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.
👥 Safety by Population
🚫 Contraindications & Warnings
Drug interactions: P-gp and CYP450 interactions — may increase bioavailability of P-gp substrates. Antiplatelet: mild antiplatelet activity. GI effects: heartburn, nausea in some individuals. Allergy to Burseraceae. Pregnancy: avoid high-dose concentrated extracts.
🏷️ Other Names
Boswellia serrata (bark resin extract, boswellic acids)
References (1)
- European Commission. Regulation (EU) No 432/2012. Off J Eur Union. 2012;L 136:1-40. Regulatory document Source ↗
Evidence grades: SR = Systematic review / meta-analysis (highest) · RCT = Randomized controlled trial · Reg = Regulatory/official guidance