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Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
SAFE
Berberine Dihydrochloride
Berberine dihydrochloride
Possibly Safe
V1 Verified
Specialty Nutrients
PubMed Studies
2,200
About
Enhanced-solubility berberine salt form with improved absorption compared to standard HCl form.
How it works (mechanism of action)
Provides targeted nutritional substrate or pharmacological activity for specific biochemical pathways not adequately supported by standard dietary intake. Mechanism involves enzyme cofactor provision, receptor modulation, or membrane structural modification.
⚖️ Regulatory Status
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SG — Banned
HSA Singapore prohibition (2004) — ephedra alkaloid supplements prohibited.
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MY — Banned
NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.
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NL — Banned
NVWA prohibition (2004).
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NZ — Banned
Medsafe NZ — ephedrine alkaloid supplements banned following FDA and TGA action.
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PH — Banned
FDA Philippines — ephedra and ephedrine alkaloid-containing food supplements banned following international regulatory action.
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AE — Banned
UAE MOH prohibition — ephedra supplements banned. Ephedrine controlled as pharmaceutical.
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PL — Banned
GIS Poland prohibition aligned with EU Directive 2002/46/EC.
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ID — Banned
BPOM Indonesia — ephedra and ephedrine alkaloid supplements prohibited.
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PT — Banned
ASAE Portugal prohibition aligned with EU ban on ephedrine alkaloid supplements.
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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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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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DE — Banned
BfArM banned kava-containing products in Germany in 2002 due to hepatotoxicity risk. Cases of liver failure and death reported.
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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.
⚠️
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.
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ZA — Restricted
SAHPRA (2004) — Schedule 2; pharmacist oversight required.
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KR — Restricted
MFDS South Korea (2003) — maximum dose restrictions. Not permitted for weight loss products.
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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.
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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.
⚠️
FR — Restricted
ANSES (2013) — maximum dose restrictions following EFSA genotoxicity concerns.
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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.
👥 Safety by Population
🚫 Contraindications & Warnings
Same interactions as standard berberine: CYP3A4, antidiabetics, warfarin. Pregnancy: avoid.
🇪🇺 EU Health Claims Status
Art.13(1)
✓ AuthorisedThe claim may be used only for food which is at least a source of chloride as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006. The claim cannot be used on chloride from the source sodium chloride
Regulation EU 1924/2006 · ART13 1
Products containing this ingredient (2)
🏷️ Other Names
Berberine dihydrochloride