| U.S. Food and Drug Administration |
CFSAN, April 11, 2001
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling, and Dietary Supplements
April 11, 2001
FDA Warns Consumers to Discontinue Use of Botanical Products That Contain Aristolochic Acid.
Based on new information, the Food and Drug Administration (FDA) is
advising consumers to immediately discontinue use of any botanical products
containing aristolochic acid. These products may have been sold as
"traditional medicines" or as ingredients in dietary supplements. Aristolochic
acid is found primarily in the plant Aristolochia, but may also be
present in other botanicals. Consumption of products containing aristolochic
acid has been associated with permanent kidney damage, sometimes resulting in
kidney failure that has required kidney dialysis or kidney transplantation. In
addition, some patients have developed certain types of cancers, most often
occurring in the urinary tract.
Previously, in May 2000, FDA alerted health care professionals and the
dietary supplement industry of two patients in the United Kingdom who had
experienced serious, permanent kidney damage following the use of botanical
products containing aristolochic acid. These cases, along with the ones
previously reported from Belgium and France, resulted in FDA imposing an
import alert to detain botanical ingredients that are either labeled as
"Aristolochia" or, for other reasons, are suspected to contain aristolochic
acid. The ingredient will only be allowed to enter the U.S. when adequate
testing shows that the suspect ingredients are free of aristolochic acid.
Recently, FDA has received reports of two patients in the U.S. who
developed serious kidney disease associated with the use of botanical products
that were shown by laboratory analysis to contain aristolochic acid. In
addition, the agency analyzed a sample of 38 botanical products available in
the U.S. that were labeled as containing aristolochia or other herbs that
might contain aristolochic acid and found that 18 of these products contained
aristolochic acid. Based on these analytical results, FDA has requested that
the involved U.S. manufacturers or distributors initiate recalls of these
products.
Due to the potential serious public health risk, the agency is now advising
consumers to stop using any products that may likely contain aristolochic
acid. This includes products with the words "Aristolochia," "Bragantia" or
"Asarum" listed as ingredients on the label, or any of the products FDA has
found to contain aristolochic acid.
Consumers cannot be assured that products containing these ingredients are
free of aristolochic acid unless they have been tested in a laboratory. To
inquire about whether appropriate testing has been done, consumers may wish to
contact the manufacturer or distributor of the product.
FDA advises consumers who have taken any of these products of concern to
contact their health care provider immediately. Even if these products have
not been used recently, consumers should still inform their health care
provider about which product they took, so that an appropriate evaluation may
be conducted.
Attachments A-C:
Listing
of Botanical Ingredients of Concern Updated April 9, 2001
Attachment D:
Botanical
Products Determined by FDA to Contain Aristolochic Acids