Since mid 1999, health agencies in Europe and North America, notably the Medicines Control Agency (U.K.), Health Canada, and the U.S. Food and Drug Administration (FDA), have issued numerous letters and warnings concerning the potential health risks associated with the use of the botanical
aristolochia sp. and its derivatives, aristolochic acid in particular.
The following summary statement was released by the U.S. FDA on April 11, 2001:
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The agency has issued a Consumer Advisory and sent updated letters to industry and health professionals to communicate our concern about the use and marketing of dietary supplements or other botanical-containing products that may contain aristolochic acid. The use of products containing aristolochic acid, including botanical products marketed as traditional medicines, has been associated with nephropathy. Because of our concerns about botanical-containing products known or suspected to contain aristolochic acid, we will be pursuing appropriate regulatory action regarding these products.
The following list, continuously updated by
Preventive Health Today, summarizes all pertinent letters and advisories from the aforementioned agencies:
- May 16, 2002 - HC [ Warning ]
Health Canada has issued a warning concerning Longdan and Lung Tan Xie Gan herbal products, as they may contain the potentially dangerous aristolochic acid..
- Oct 5, 2001 - HC [ Advisory ]
Health Canada has issued an advisory identifying additional substances related to aristolochic acid that pose a potentially serious health risk..
- Sep 17, 2001 - HC [ Recall ]
Health Canada has issued a recall on a number of traditional Chinese medicines after determining they contain the potentially dangerous aristolochic acid.
- Aug 24, 2001 - HC [ Warning ]
Health Canada has issued a warning to consumers using the herbal product, Tao Chih Pien, because of possible health risk associated with the use of the substance, aristolochic acid.
- Aug 17, 2001 - HC [ Advisory ]
Health Canada has once again issued an advisory concerning herbal products containing aristolochic acid due to potential risk of cancer, changes in human cells and kidney failure.
- Jul 31, 2001 - FDA [ Recall ]
Pacific Biologic Recalls Seven Herbal Products That Contain the Herb Akebia Trifoliata Caulis (Mu Tong) and the Herb Asarum Sieboldii Herba Cum Radix (Xi Xin) Because of a Possible Health Risk.
- Jun 20, 2001 - FDA [ Recall ]
FDA Issues a Nationwide Alert on the Recall of Thirteen "Treasure of the East" Herbal Products Because of Possible Health Risk.
- May 21, 2001 - FDA [ Recall ]
Vital Nutrients Recalls Joint Ease and Verified Quality Brand Joint Comfort Complex Because of Adverse Health Risk Associated with Aristolochic Acid.
- Apr 11, 2001 - FDA [ Consumer Advisory ]
FDA Warns Consumers to Discontinue Use of Botanical Products that Contain Aristolochic Acid.
- Apr 9, 2001 - FDA [ Letter to Industry Associations ]
Safety Concerns Related to the Use of Botanical Products Containing Aristolochic Acid.
- Apr 9, 2001 - FDA
Botanical Products Determined by FDA to Contain Aristolochic Acids.
- Apr 9, 2001 - FDA
Listing of Botanical Ingredients of Concern.
- Apr 4, 2001 - FDA [ Letter to Health Professionals ]
Safety Concerns Related to the Use of Botanical Products Containing Aristolochic Acid.
- Jan 19, 2001 - FDA [ Recall ]
BMK International Voluntarily Recalls Neo Concept Aller Relief Because of Possible Health Risk.
- Nov 21, 2000 - FDA [ Recall ]
East Earth Herb Recalls Jade Pharmacy Brand Meridian Circulation and Quell Fire Because of Possible Health Risk.
- May 31, 2000 - FDA [ Letter to Health Care Professionals ]
FDA Concerned About Botanical Products, Including Dietary Supplements, Containing Aristolochic Acid.
- May 16, 2000 - FDA [ Letter to Industry ]
FDA Concerned About Botanical
Products, Including Dietary Supplements, Containing Aristolochic Acid.
- Jan 17, 2000 - MCA [ in PDF format ]
Further Proposals to Protect the Public from Unlicensed Medicines Containing Herbal Ingredients at Risk of Confusion With Aristolochia Species.
- Nov 3, 1999 - HC
Warning not to use products containing aristolochia due to potential risk of cancer, cell changes and kidney failure.
- Jul 28, 1999 - MCA
Renal failure associated with Aristolochia in some Chinese Herbal Medicines.