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Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
About
Aristolochic acid is found in Aristolochia plants. SEVERELY NEPHROTOXIC — causes aristolochic acid nephropathy leading to kidney failure and urothelial carcinoma. Banned worldwide.
How it works (mechanism of action)
Forms DNA adducts causing characteristic A:T → T:A transversions. Direct tubular cell toxicity causing irreversible nephropathy. IARC Group 1 carcinogen.
⚖️ Regulatory Status
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INT — Banned
Globally banned. Causes irreversible renal fibrosis (AAN), end-stage kidney disease, and urothelial carcinoma. No safe dose exists. Contraindicated absolutely.
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ZA — Banned
SAHPRA prohibition (2002).
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VN — Banned
DAV Vietnam prohibition — aristolochic acid banned following international safety data.
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US — Banned
FDA advisory and import alert (2001). Causes Aristolochic Acid Nephropathy (AAN) leading to end-stage kidney disease. Products subject to seizure. [source ↗]
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TW — Banned
TFDA Taiwan prohibition (2003) — all Aristolochia species and aristolochic acid prohibited in medicinal products and health foods.
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TH — Banned
FDA Thailand prohibition — Aristolochia species prohibited in health products following international safety data.
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SG — Banned
HSA Singapore prohibition (1999). All Aristolochia-containing products prohibited.
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SA — Banned
SFDA Saudi Arabia prohibition — aristolochic acid banned in all health products.
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PH — Banned
FDA Philippines prohibition — aristolochic acid on banned substances list for food supplements and herbal medicines.
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NZ — Banned
Medsafe NZ prohibition (2001) aligned with international bans on aristolochic acid.
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NL — Banned
NVWA prohibition under EU Decision 2002/159/EC.
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MY — Banned
NPRA Malaysia prohibition — aristolochic acid banned in all traditional and complementary medicine products.
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KR — Banned
MFDS South Korea prohibition (2000) — all Aristolochia species prohibited.
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JP — Banned
MHLW Japan prohibition (1999) — following nephrotoxicity and urothelial carcinoma cases. All Aristolochia species and aristolochic acid-containing preparations prohibited.
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IT — Banned
Italian Ministry of Health prohibition — all Aristolochia species. EU Decision 2002/159/EC applies.
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AE — Banned
UAE MOH prohibition — aristolochic acid on banned substances list for dietary supplements.
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IN — Banned
CDSCO India prohibition (2007) — aristolochic acid products prohibited following international safety concerns.
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IE — Banned
HPRA prohibition (1999).
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ID — Banned
BPOM Indonesia prohibition — aristolochic acid prohibited in all traditional herbal products (jamu) and food supplements.
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HK — Banned
Department of Health Hong Kong prohibition (2004) — Chinese Medicines Board banned all Aristolochia species following nephrotoxicity cases linked to Chinese herbal medicines.
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GB — Banned
MHRA prohibition (1999) — following Chinese herbal nephropathy cases in UK. All Aristolochia species prohibited.
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FR — Banned
ANSM prohibition (2001).
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EU — Banned
European Commission Decision 2002/159/EC — all Aristolochia species prohibited across all EU member states. Causes irreversible renal fibrosis and urothelial carcinoma. [source ↗]
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ES — Banned
AEMPS Spain prohibition aligned with EU Decision 2002/159/EC.
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DE — Banned
BfArM prohibition (1981) — Germany was first country globally to ban aristolochic acid.
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CN — Banned
NMPA China prohibition — Aristolochia species removed from approved traditional medicine list following international safety concerns. Guanmuton, Qingmuxiang and related herbs banned.
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CH — Banned
Swissmedic prohibition (2001).
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CA — Banned
Health Canada prohibition (2001). No safe dose exists.
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BE — Banned
AFMPS Belgium prohibition aligned with EU Decision 2002/159/EC.
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AU — Banned
TGA prohibition (2001) — all Aristolochia species prohibited from all therapeutic products.
👥 Safety by Population
🚫 Contraindications & Warnings
BANNED WORLDWIDE. All products containing Aristolochia species are prohibited. No safe dose. Causes permanent kidney failure and cancer.
🏷️ Other Names
Aristolochic acid