EU — Banned

Internal use of comfrey banned in EU due to pyrrolizidine alkaloids causing hepatic veno-occlusive disease. Topical use only permitted.

MY — Banned

NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.

NZ — Banned

Medsafe NZ — ephedrine alkaloid supplements banned following FDA and TGA action.

IT — Banned

Italian Ministry of Health — ephedra and ephedrine alkaloid supplements prohibited under EU Directive 2002/46/EC.

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.

ID — Banned

BPOM Indonesia — ephedra and ephedrine alkaloid supplements prohibited.

PT — Banned

ASAE Portugal prohibition aligned with EU ban on ephedrine alkaloid supplements.

SE — Banned

Livsmedelsverket Sweden prohibition aligned with EU Directive 2002/46/EC.

FR — Banned

ANSES recommended ban of kava following hepatotoxicity signals from nutrivigilance system.

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.

BE — Banned

FASFC Belgium prohibition aligned with EU Directive 2002/46/EC.

US — Banned

FDA issued warning letter against oral comfrey products. Contains pyrrolizidine alkaloids causing liver damage.

IN — Restricted

CDSCO India (2004) — available only under prescription as pharmaceutical products.

SG — Restricted

HSA Singapore — melatonin classified as pharmacy medicine (P1). Cannot be sold as general health supplement; requires pharmacist supervision.

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.

ZA — Restricted

SAHPRA (2004) — Schedule 2; pharmacist oversight required.

JP — Restricted

MHLW Japan — melatonin not approved as food additive or health food ingredient. Supplements sold in grey area; MHLW advises caution.

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.

KR — Prescription only

MFDS South Korea — melatonin classified as pharmaceutical product. Not permitted as health functional food.

NL — Prescription only

CBG-MEB Netherlands (2000) — classified as medicine. OTC sale as food supplement not permitted.

AE — Prescription only

UAE MOH — melatonin classified as prescription medicine. Not available OTC as food supplement. Import without prescription prohibited.

IE — Prescription only

HPRA (2007) — classified as prescription-only medicine (POM). Not available as food supplement.

SA — Prescription only

SFDA Saudi Arabia — melatonin classified as prescription-only drug. Not permitted as dietary supplement.

DE — Prescription only

BfArM (2000) — prescription medicine at doses above 0.5mg/day. OTC sale as food supplement not permitted.

CA — Prescription only

DHEA is a controlled substance in Canada, available by prescription only.

AU — Prescription only

TGA (2021) — adults max 5mg Schedule 3 (pharmacist only). Under-18s require prescription. Higher doses prescription-only.

AT — Prescription only

AGES Austria — melatonin classified as prescription-only medicinal product. Not permitted as food supplement.