⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
SAFE
Coltsfoot Standardised
Tussilago farfara PA-free extract
Possibly Safe
V1 Verified
Respiratory Herbs
PubMed Studies
480
About
PA-free coltsfoot extract standardised to remove hepatotoxic pyrrolizidine alkaloids. Commission E approved for cough when PA-free.
How it works (mechanism of action)
Contains expectorant, antispasmodic, and anti-inflammatory phytochemicals reducing bronchial smooth muscle spasm, stimulating mucociliary clearance, and inhibiting inflammatory mediator release in respiratory mucosa. Primary mechanisms involve COX/LOX inhibition and mucus hydration.
⚖️ Regulatory Status
⛔
FR — Banned
ANSES recommended ban of kava following hepatotoxicity signals from nutrivigilance system.
⛔
NZ — Banned
Medsafe NZ — ephedrine alkaloid supplements banned following FDA and TGA action.
⛔
NL — Banned
NVWA prohibition (2004).
⛔
MY — Banned
NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.
⛔
PH — Banned
FDA Philippines — ephedra and ephedrine alkaloid-containing food supplements banned following international regulatory action.
⛔
PL — Banned
GIS Poland prohibition aligned with EU Directive 2002/46/EC.
⛔
IT — Banned
Italian Ministry of Health — ephedra and ephedrine alkaloid supplements prohibited under EU Directive 2002/46/EC.
⛔
AE — Banned
UAE MOH prohibition — ephedra supplements banned. Ephedrine controlled as pharmaceutical.
⛔
PT — Banned
ASAE Portugal prohibition aligned with EU ban on ephedrine alkaloid supplements.
⛔
ID — Banned
BPOM Indonesia — 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.
⛔
SG — Banned
HSA Singapore prohibition (2004) — ephedra alkaloid supplements prohibited.
⛔
ES — Banned
AEMPS Spain prohibition aligned with EU ban on ephedrine alkaloid supplements.
⛔
DK — Banned
Banned (2023) — Danish Veterinary and Food Administration (DVFA). Liver toxicity and thyroid disruption reports. All preparations ordered off market.
⛔
CH — Banned
Swissmedic banned kava in Switzerland due to hepatotoxicity.
⛔
CA — Banned
Health Canada ban (2002) — all ephedra and ephedrine alkaloid-containing supplements.
⛔
BE — Banned
FASFC Belgium prohibition aligned with EU Directive 2002/46/EC.
⚠️
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 advisory on pyrrolizidine alkaloid-containing herbs. PA-free preparations recommended.
⚠️
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.
⚠️
EU — Restricted
EMA HMPC monograph — only PA-free preparations permitted. Maximum daily dose restrictions apply.
⚠️
DE — Restricted
BfArM — only PA-free preparations permitted under EMA/HMPC monograph.
⚠️
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 — only PA-free preparations permitted.
💊
AT — Prescription only
AGES Austria — melatonin classified as prescription-only medicinal product. Not permitted as food supplement.
👥 Safety by Population
🚫 Contraindications & Warnings
PA-free preparations only. Still avoided in pregnancy and liver disease as precaution.
🏷️ Other Names
Tussilago farfara PA-free extract