June 1, 2000
Aristolochia Poses Health, Contamination Concerns; FDA Plans ImportAlert
WASHINGTON--In early June, the Food and Drug Administration (FDA) issued a medicalalert to the industry and the medical community about possible nephrotoxicity associatedwith species of Aristolochia or its aristolochic acids. Industry associationsincluding the American Herbal Products Association (AHPA) and the Council for ResponsibleNutrition (CRN) told members that FDA has ongoing concerns with adulteration of certainbotanicals with species of Aristolochia and the toxicity of the aristolochic acids.
FDA has issued a list of plants that may become adulterated with Aristolochia;species of this plant include birthwort, Dutchman's pipe and Virginia snakeroot. Among theplants 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 is currently a ban in place through June 30, 2001, by Britain's Medicine ControlsAgency (MCA) on the sale and import of Aristolochia; Canada's Health ProtectionBranch 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 anyproduct containing Aristolochia or a plant listed as having a possibility ofadulteration, due to adverse event reports from Belgium and Britain. FDA also stated thatany botanical containing aristolochic acid will be considered unsafe and adulterated.
The adverse event reports included those reported by the New England Journal ofMedicine (NEJM). In its June 4 issue, it published a report showing that when used ina weight-loss preparation, Aristolochia damaged the kidneys of 105 patients at aBelgian clinic. David Kessler, former head of the FDA and commissioner when DSHEA waspassed, wrote in an accompanying piece that the report clearly shows that dietarysupplements can be very dangerous. "Since there is virtually no control over thequality of these products," he said, "it is not unusual not to know what isactually in herbal preparations and dietary supplements." One of the NEJM doctors,Dr. Joelle Nortier, admitted that the patients were not told that this particular herbwould be in their weight-loss preparations, and it was included by mistake.
APHA currently has in place trade recommendations that companies using Stephaniatetrandra root, Clematis armandii stem or Akebia stem test for Aristolochiaadulteration. CRN and AHPA plan to work with the American Herbal Pharmacopoeia to evaluateand/or develop testing methods for determination of adulteration. To find FDA's notice toindustry 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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