⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
SAFE
Bacopa monnieri
Bacopa monnieri (whole plant extract, bacosides)
Possibly Safe
V2 Verified
Botanicals
PubMed Studies
17
About
Ayurvedic nootropic herb (Brahmi). Bacosides modulate acetylcholine and GABA synthesis. RCTs support cognitive enhancement in healthy adults and children with ADHD. Requires 8-12 weeks for full benefit.
How it works (mechanism of action)
Bacosides enhance protein kinase activity in hippocampus promoting synaptic receptor synthesis. Inhibit acetylcholinesterase and butyrylcholinesterase. Reduce 5-HT2C receptor activity and tryptophan hydroxylase 2 decreasing serotonin turnover in chronically stressed states.
⚖️ Regulatory Status
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FR — Banned
ANSES recommended ban of kava following hepatotoxicity signals from nutrivigilance system.
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NZ — Banned
Medsafe NZ — ephedrine alkaloid supplements banned following FDA and TGA action.
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NL — Banned
NVWA prohibition (2004).
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MY — Banned
NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.
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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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IT — Banned
Italian Ministry of Health — ephedra and ephedrine alkaloid supplements prohibited under EU Directive 2002/46/EC.
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AE — Banned
UAE MOH prohibition — ephedra supplements banned. Ephedrine controlled as pharmaceutical.
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SG — Banned
HSA Singapore prohibition (2004) — ephedra alkaloid supplements prohibited.
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ID — Banned
BPOM Indonesia — ephedra and ephedrine alkaloid supplements prohibited.
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PH — Banned
FDA Philippines — ephedra and ephedrine alkaloid-containing food supplements banned following international regulatory action.
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PL — Banned
GIS Poland prohibition aligned with EU Directive 2002/46/EC.
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EU — Banned
European Commission ban (2002) under Directive 2002/46/EC — all ephedra and ephedrine alkaloid supplements.
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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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US — Banned
FDA ban (2004) — cardiovascular adverse events and deaths. Final rule 21 CFR 119. All ephedrine alkaloids banned from dietary supplements.
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CH — Banned
Swissmedic banned kava in Switzerland due to hepatotoxicity.
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CA — Banned
Health Canada ban (2002) — all ephedra and ephedrine alkaloid-containing supplements.
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BE — Banned
FASFC Belgium prohibition aligned with EU Directive 2002/46/EC.
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AU — Banned
TGA ban (2003) — cardiovascular adverse events. Ephedra alkaloids banned from complementary medicines.
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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.
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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.
⚠️
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
Memory and cognition
Evidence Grade B · 14 studies · n=1,400
Evidence grades: A=Strong RCT evidence · B=Good clinical trials · C=Limited trials · D=Preliminary/traditional
👥 Safety by Population
🚫 Contraindications & Warnings
Cholinergic activity: may inhibit cholinesterase — caution with anticholinergic drugs, cholinesterase inhibitors (donepezil, rivastigmine — additive). GI effects: nausea, diarrhoea (take with food). Drug interactions: calcium channel blockers, phenothiazines. Thyroid: minor reduction in T4 and T3 in some studies — monitor thyroid function. Pregnancy: insufficient data.
🇪🇺 EU Health Claims Status
Art.13(1)
✓ AuthorisedIn order to bear the claim, information shall be given to the consumer that in order to obtain the claimed effect, at least 2,0 L of water, from all sources, should be consumed per day. The claim may be used only on water complying with Directives 2009/54/EC and/or 98/83/EC
Regulation EU 1924/2006 · ART13 1
Art.13(1)
✓ AuthorisedIn order to bear the claim, information shall be given to the consumer that in order to obtain the claimed effect, at least 2,0 L of water, from all sources, should be consumed per day. The claim may be used only on water complying with Directives 2009/54/EC and/or 98/83/EC
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 is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.
Regulation EU 1924/2006 · ART13 1
Art.14(1)(a)
✓ AuthorisedNon-compliance with the Regulation because on the basis of the scientific evidence assessed,the proposed risk factors are measures of the disease and a risk factor in the development of a disease is not shown to be reduced
Regulation EU 1924/2006 · ART14
🏷️ Other Names
Brahmi
Water hyssop
Bacoside