⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
SAFE
Berberine + Milk Thistle Complex
Berberine HCl + Silymarin
Possibly Safe
V4 Verified
Herbs & Botanicals ⚠ Marketing term
Upper Safe Limit
No UL established; Berberine 500mg + Silymarin 150mg twice daily (typical formula)
PubChem CID
About
Combination of Berberine (blood sugar/lipid) with Milk Thistle (liver protection). Berberine is hepatically metabolised and can stress the liver at high doses. Milk thistle protects hepatocytes. This combination is common in metabolic health products and has additive evidence for NAFLD.
How it works (mechanism of action)
Berberine activates AMPK and inhibits PCSK9. Silymarin (from milk thistle) is hepatoprotective via antioxidant and anti-inflammatory effects. Silymarin may increase berberine bioavailability via P-glycoprotein inhibition.
⚖️ Regulatory Status
⛔
FR — Banned
ANSES recommended ban of kava following hepatotoxicity signals from nutrivigilance system.
⛔
NL — Banned
NVWA prohibition (2004).
⛔
MY — Banned
NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.
⛔
NZ — Banned
Medsafe NZ — ephedrine alkaloid supplements banned following FDA and TGA action.
⛔
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.
⛔
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.
⛔
DE — Banned
BfArM banned kava-containing products in Germany in 2002 due to hepatotoxicity risk. Cases of liver failure and death reported.
⛔
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.
⚠️
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.
⚠️
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.
⚠️
IT — Restricted
Italian Ministry of Health — berberine supplements restricted to max 10mg/day without medical supervision.
⚠️
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
EFSA (2023) — safety concerns at commonly marketed doses (>0.9mg/day). Several EU member states restricting high-dose products. EMA/HMPC review ongoing.
⚠️
CN — Restricted
NMPA China — berberine (berberine hydrochloride) registered as pharmaceutical (OTC drug) for specific indications. Not permitted as general health food ingredient at pharmaceutical doses.
💊
CA — Prescription only
DHEA is a controlled substance in Canada, available by prescription only.
💊
AU — Prescription only
DHEA is scheduled as a prescription-only medicine in Australia (Schedule 4).
💊
AT — Prescription only
AGES Austria — melatonin classified as prescription-only medicinal product. Not permitted as food supplement.
📊 Effectiveness
Liver protection
Evidence Grade B · 18 studies · n=960 · Meta-analysis available
Liver disease
Evidence Grade B · 14 studies · n=720 · Meta-analysis available
Evidence grades: A=Strong RCT evidence · B=Good clinical trials · C=Limited trials · D=Preliminary/traditional
👥 Safety by Population
🚫 Contraindications & Warnings
CYP3A4 and P-glycoprotein interactions (both compounds). Hypoglycaemia risk with diabetes medications. Avoid in pregnancy. Liver monitoring recommended with long-term use.
🏷️ Other Names
Berberine HCl + Silymarin