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Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
CAU
Ashwagandha extracts (adaptogenic)
Withania somnifera (standardised extracts)
Use with Caution
V2 Verified
Hormonal & Endocrine
PubMed Studies
3,600
About
Standardised Ashwagandha extracts classified as hormonal/endocrine influencers due to thyroid-stimulating and potential cortisol-modulating effects. Includes KSM-66, Sensoril, and full-spectrum root extracts. BANNED in Denmark (2023) following hepatotoxicity and thyroid disruption reports.
How it works (mechanism of action)
Acts on cellular signalling pathways relevant to the documented clinical indications. Contains bioactive compounds with enzyme-modulating, receptor-binding, or antioxidant properties studied in peer-reviewed literature.
⚖️ Regulatory Status
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SG — Banned
HSA Singapore prohibition (2004) — ephedra 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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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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PL — Banned
GIS Poland prohibition aligned with EU Directive 2002/46/EC.
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PT — Banned
ASAE Portugal prohibition aligned with EU ban on ephedrine alkaloid supplements.
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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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SA — Banned
SFDA Saudi Arabia — ephedra and ephedrine alkaloid supplements prohibited. Controlled as prescription drug.
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ID — Banned
BPOM Indonesia — ephedra and ephedrine alkaloid supplements prohibited.
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SE — Banned
Livsmedelsverket Sweden prohibition aligned with EU Directive 2002/46/EC.
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FR — Banned
ANSES recommended ban of kava following hepatotoxicity signals from nutrivigilance system.
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EU — Banned
Internal use of comfrey banned in EU due to pyrrolizidine alkaloids causing hepatic veno-occlusive disease. Topical use only permitted.
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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.
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IN — Restricted
CDSCO India (2004) — available only under prescription as pharmaceutical products.
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TH — Restricted
FDA Thailand — ephedrine controlled as pharmaceutical. Not permitted in food supplements.
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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.
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IE — Restricted
FSAI monitoring (2024) following Danish ban and hepatotoxicity reports. Products without adequate safety data may face withdrawal.
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HK — Restricted
Department of Health Hong Kong — ephedrine-containing preparations controlled as pharmaceutical products. Not permitted as health food supplements without pharmaceutical registration.
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GB — Restricted
MHRA (2004) — ephedrine alkaloid supplements restricted. Maximum doses apply under the Medicines Act.
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CN — Restricted
NMPA China — Ma Huang (ephedra) controlled. Ephedrine alkaloid content restrictions; not permitted for weight loss products. Export of ephedra controlled internationally.
💊
CA — Prescription only
DHEA is a controlled substance in Canada, available by prescription only.
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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
BANNED in Denmark (2023 — all forms). MONITORED in Ireland (FSAI 2024). Thyroid hormone interaction: may increase T3/T4 — contraindicated in hyperthyroidism, Graves disease, Hashimoto thyroiditis. Hepatotoxicity reports (RUCAM-confirmed cases). Pregnancy: CONTRAINDICATED (abortifacient in animal studies). Autoimmune: may stimulate immune activity — caution in autoimmune disease. Drug interactions: thyroid medications, immunosuppressants, benzodiazepines.
🏷️ Other Names
Withania somnifera (standardised extracts)