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U.S. Department of Health and Human Services

Safety

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Aristolochic Acid

Audience: Healthcare professionals, particularly Urologists/Nephrologists, and consumers

FDA has issued a Consumer Advisory and sent updated letters to industry and health professionals to communicate concern about dietary supplements and botanical products, often marketed as "traditional medicines", that may contain aristolochic acid. Aristolochic acid has been associated with nephropathy leading to end stage renal disease and with urological malignancies. Visit the FDA Center for Food Safety and Applied Nutrition (CFSAN) Aristolochic Acid web page.

[April 11, 2001 - Consumer Advisory - FDA]
[April 4, 2001 - Letter to Health Professionals - FDA]
[April 9, 2001 - Updated Letter to Industry - FDA]
[Updated April 9, 2001 - Listing of Botanical Ingredients of Concern - FDA]
[April 9, 2001 - Botanical Products Determined by FDA to Contain Aristolochic Acid - FDA]

Product Recalls
[August 6, 2001 - Recall of capsules containing Akebia Trifoliata Caulis (Mu Tong) and Asarum Sieboldii Herba cum Radix (Xi Xin); - Pacific BioLogic Co. Press Release]
[May 24, 2001 - Recall of Joint Ease & Joint Comfort Complex - Vital Nutrients/RHG Press Release]
[January 25, 2001 - Recall of Neo Concept Aller Relief - BMK International Press Release]
[November 21, 2000 - Recall of Meridian Circulation and Quell Fire - East Earth Herb Inc. Press Release]

Past FDA Actions:
[May 16, 2000 - Letter to Industry - FDA]
[May 31, 2000 - Letter to Health Care Professionals - FDA]