⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
⚠️
Major drug interaction. This ingredient has clinically significant drug interactions. See Drug Interactions below before use.
Upper Safe Limit
Avoid in last trimester of pregnancy — may increase bleeding risk
PubMed Studies
100
PubChem CID
About
Gamma-linolenic acid (GLA) precursor to anti-inflammatory prostaglandin E1
How it works (mechanism of action)
Used for PMS, mastalgia and atopic eczema. Very common French pharmacy. Evidence moderate for mastalgia.
⚖️ 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.
⛔
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.
⛔
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.
⛔
SG — Banned
HSA Singapore prohibition (2004) — ephedra alkaloid supplements prohibited.
⛔
ID — Banned
BPOM Indonesia — 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.
⛔
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.
⛔
DK — Banned
Banned (2023) — Danish Veterinary and Food Administration (DVFA). Liver toxicity and thyroid disruption reports. All preparations ordered off market.
⛔
DE — Banned
BfArM banned kava-containing products in Germany in 2002 due to hepatotoxicity risk. Cases of liver failure and death reported.
⛔
US — Banned
FDA ban (2004) — cardiovascular adverse events and deaths. Final rule 21 CFR 119. All ephedrine alkaloids banned from dietary supplements.
⛔
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.
⛔
AU — Banned
TGA ban (2003) — cardiovascular adverse events. Ephedra alkaloids banned from complementary medicines.
⛔
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
PMS
Evidence Grade B · 14 studies · n=1,800
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 (5)
🔴 Phenothiazines (chlorpromazine)
MajorAntipsychotics
Management: Contraindicated with phenothiazine antipsychotics.
🟡 Warfarin
ModerateAnticoagulants
Management: Monitor INR. Avoid high doses with warfarin.
🟡 Aspirin
ModerateAntiplatelet drugs
Management: Use caution with antiplatelet therapy.
⚪ Insulin
MinorAntidiabetics
Management: Monitor blood glucose. Generally beneficial.
⚪ Anticoagulants
MinorAnticoagulant
Management: Stop 2 weeks before surgery.
🇪🇺 EU Health Claims Status
Art.13(1)
✓ AuthorisedNon-compliance with the Regulation because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.
Regulation EU 1924/2006 · ART13 1
Art.13(1)
✓ AuthorisedNon-compliance with the Regulation because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.
Regulation EU 1924/2006 · ART13 1
Art.13(1)
✓ AuthorisedNon-compliance with the Regulation because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.
Regulation EU 1924/2006 · ART13 1
Art.13(1)
✓ AuthorisedNon-compliance with the Regulation because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.
Regulation EU 1924/2006 · ART13 1
Art.13(1)
✓ AuthorisedNon-compliance with the Regulation because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.
Regulation EU 1924/2006 · ART13 1
Art.13(1)
✓ AuthorisedNon-compliance with the Regulation because on the basis of the scientific evidence assessed, this claimed effect has not been linked to a function of the body, as required by Article 13 of the Regulation.
Regulation EU 1924/2006 · ART13 1
🏷️ Other Names
EPO
Oenothera biennis
Evening primrose