June 5, 2000
WASHINGTON--In early June, the Food and Drug Administration (FDA) issued a medical alert to industry and the medical community about possible nephrotoxicity associated with species of Aristolochia or its aristolochic acids. Industry associations including the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN) told members last week that FDA has ongoing concerns with adulteration of certain botanicals with species of Aristolochia and the toxicity of the aristolochic acids.
FDA has provided the organizations with a list of plants that may become adulterated with Aristolochia; species of this plant include birthwort, Dutchman's pipe and Virginia snakeroot. Among the plants that FDA considers to have a possibility of adulteration are Asarum canadense, Bragantia wallichi, and species of Akebia, Clematis, Cocculus, Diploclisia, Menispermum, Sinomenium and Stephania. There have been reported nephrotoxicity associated with aristolochic acids.
There is currently a ban through June 30, 2001, in place by Britain's Medicine Controls Agency (MCA) on the sale and import of Aristolochia; Canada's Health Protection Branch has also issued a consumer warning against using products that contain Aristolochia. According to CRN and AHPA, FDA plans to issue an import alert to automatically detain any product containing Aristolochia or a plant listed as having a possibility of adulteration. FDA also stated that any botanical containing aristolochic acid will be considered unsafe and adulterated.
APHA currently has trade recommendations in place that advise companies using Stephania tetrandra root, Clematis armandii stem or Akebia stem to test for Aristolochia adulteration. CRN and AHPA plan to work with the American Herbal Pharmacopoeia to evaluate and/or develop testing methods for determination of adulteration. To find FDA's notice to industry and the list of botanicals, visit www.fda.gov/medwatch/safety/2000/safety00.htm#aristo. For more information, contact AHPA at (301) 588-1171 or www.ahpa.org, or CRN at (202) 872-1488 or www.crnusa.org.
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