Upper Safe Limit
Lowers blood glucose — monitor in diabetics. Insufficient pregnancy data.
PubMed Studies
306
PubChem CID
About
Universal antioxidant (water and fat soluble); regenerates vitamins C, E, glutathione and CoQ10; improves insulin sensitivity; chelates heavy metals
How it works (mechanism of action)
Used for diabetic neuropathy, antioxidant support and weight management in French supplements. R-form preferred. Nutergia, Solgar.
⚖️ Regulatory Status
⚠️
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.
⚠️
EU — Restricted
EFSA (2010) — genotoxicity concerns. Maximum dose levels apply. Several EU member states have restricted high-dose products.
⚠️
FR — Restricted
ANSES (2013) — maximum dose restrictions following EFSA genotoxicity concerns.
⚠️
IT — Restricted
Italian Ministry of Health — berberine supplements restricted to max 10mg/day without medical supervision.
📊 Effectiveness
Diabetic neuropathy
Evidence Grade A · 18 studies · n=2,800 · Meta-analysis available
Blood sugar control
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 (1)
🟡 Antidiabetic drugs
ModerateAntidiabetic
Management: Monitor blood glucose closely.
🇪🇺 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 attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods.
Regulation EU 1924/2006 · ART13 1
Products containing this ingredient (3)
Alpha Lipoic Sustain 300mg
300 MG Tablet
Alpha Lipoic Acid 600mg
600 MG Capsule
Alpha Lipoic Acid 120mg
120 MG Capsule
🏷️ Other Names
ALA
Thioctic acid
Lipoic acid
R-lipoic acid
Alpha Lipoic
R-Alpha Lipoic Acid
