FDA Revisits Aristolochic Acid 33103

FDA Revisits Aristolochic Acid

WASHINGTON--The Food and Drug Administration (FDA) has releaseda consumer advisory and letters to industry organizations and healthcareprofessionals firmly reiterating its stance and concerns regarding aristolochicacid. Following up the medical alert it released last May, FDA pointedly statedthat species of Aristolochia or plants that may have been adulteratedwith Aristolochia are a health concern that needs to be addressed bysupplement manufacturers and medical practitioners.

In its consumer advisory, dated April 11, the agency stated that past andcurrent medical reports have suggested that aristolochic acid is the cause ofrenal failure and certain cancers, especially uterine cancer. In addition, FDAanalyzed 38 U.S. botanical products and found 18 to be contaminated witharistolochic acid, including three bulk herbs (one of which was labeled Aristolochia).FDA, in response to the potential health risk of this constituent, has askedconsumers to stop using products containing or contaminated by ingredients suchas Aristolochia, Bragantia and Asarum (the full list ofingredients appears on www.cfsan.fda.gov/~dms/ds-bot2.html).

In its letter to industry organizations, FDA urges manufacturers to 1) reviewtheir current manufacturing practices to guarantee that products are free ofaristolochic acid and 2) have adequate procedures that collect and report to FDAadverse events that may have occurred from aristolochic acid.

Aristolochia is a known nephrotoxin and carcinogen. There is little tosupport the benefits of the Aristolochia species, Mark Blumenthal, executivedirector of the American Botanical Council (ABC), wrote in a February letter tothe Boston Globe. Blumenthal was responding to a Jan. 31 article titledSome Chinese Herb Remedies Called Toxic, which detailed FDAs actionsagainst BMK International for manufacturing products containing aristolochicacid. In fact, on the FDAs Web site, it has listed 16 botanical products thatcontain aristolochic acid, as well as the responsible manufacturers anddistributors.

Aristolochic acid should not be in dietary supplements, MichaelMcGuffin, president of the American Herbal Products Association (AHPA), told Insider.FDAs request [that manufacturers report adverse effects] is a reasonableexpectation. We have expressed concerns over some of the agencys managementof the adverse event reporting system for supplements; nevertheless, anymanufacturer or medical practitioner who is aware of any such reports would bewell-advised to inform FDA.

In addition, FDA has asked the medical community review all past cases ofrenal disease, as well as urothelial tract tumors, to see if patients had beentaking dietary supplements contaminated with aristolochic acid. To read more onthis, visit www.cfsan.fda.gov/~dms/.Any inquiries or comments on this matter can be directed to Dr. Robert Moore inthe Office of Nutritional Products, Labeling and Dietary Supplements at (202)205-4605 or [email protected].