⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
RISK
Comfrey
Symphytum officinale — see Phase 1.
Likely Unsafe
V2 Verified
Botanicals
PubMed Studies
12
PubChem CID
About
Already entered in Phase 1. Internal use banned — PA content.
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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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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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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PT — Banned
ASAE Portugal prohibition aligned with EU ban on ephedrine alkaloid supplements.
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ID — Banned
BPOM Indonesia — 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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EU — Banned
Internal use of comfrey banned in EU due to pyrrolizidine alkaloids causing hepatic veno-occlusive disease. Topical use only permitted. [source ↗]
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SG — Banned
HSA Singapore prohibition (2004) — ephedra alkaloid supplements prohibited.
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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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CH — Banned
Swissmedic banned kava in Switzerland due to hepatotoxicity.
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BE — Banned
FASFC Belgium prohibition aligned with EU Directive 2002/46/EC.
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US — Banned
FDA issued warning letter against oral comfrey products. Contains pyrrolizidine alkaloids causing liver damage. [source ↗]
⚠️
IN — Restricted
CDSCO India (2004) — available only under prescription as pharmaceutical products.
⚠️
TH — Restricted
FDA Thailand — ephedrine controlled as pharmaceutical. Not permitted in food supplements.
⚠️
TW — Restricted
TFDA Taiwan — ephedrine controlled as pharmaceutical drug. Not permitted as health food ingredient. Products with ephedra claims require pharmaceutical registration.
⚠️
US — Restricted
FDA (2001) — internal-use comfrey removed from supplement market due to pyrrolizidine alkaloid hepatotoxicity. [source ↗]
⚠️
ZA — Restricted
SAHPRA (2010) — only certified PA-free external preparations permitted.
⚠️
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 — internal use of comfrey not recommended. MHRA supports EMA HMPC position. PA-free preparations only for internal use.
⚠️
EU — Restricted
EMA HMPC (2012) — internal use restricted to PA-free preparations. External use only for PA-containing preparations. [source ↗]
⚠️
DE — Restricted
BfArM (2002) — internal use prohibited due to pyrrolizidine alkaloid (PA) hepatotoxicity. External use only with dose restrictions.
⚠️
CN — Restricted
NMPA China — Ma Huang (ephedra) controlled. Ephedrine alkaloid content restrictions; not permitted for weight loss products. Export of ephedra controlled internationally.
⚠️
AU — Restricted
TGA (2012) — only PA-depleted preparations permitted internally. External use only for standard preparations.
💊
CA — Prescription only
DHEA is a controlled substance in Canada, available by prescription only.
💊
AT — Prescription only
AGES Austria — melatonin classified as prescription-only medicinal product. Not permitted as food supplement.
👥 Safety by Population
🚫 Contraindications & Warnings
See Phase 1. Pyrrolizidine alkaloids. Internal use BANNED in Germany.
🏷️ Other Names
Symphytum officinale — see Phase 1.