FDA Revisits Aristolochic Acid

WASHINGTON--The Food and Drug Administration (FDA) has released a consumer advisory and letters to industry organizations and healthcare professionals firmly reiterating its stance and concerns regarding aristolochic acid. Following up the medical alert it released last May, FDA pointedly stated that species of Aristolochia or plants that may have been adulterated with Aristolochia are a health concern that needs to be addressed by supplement manufacturers and medical practitioners.

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

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

"Aristolochia is a known nephrotoxin and carcinogen. There is little to support the benefits of the Aristolochia species," Mark Blumenthal, executive director of the American Botanical Council (ABC), wrote in a February letter to the Boston Globe. Blumenthal was responding to a Jan. 31 article titled "Some Chinese Herb Remedies Called Toxic," which detailed FDA's actions against BMK International for manufacturing products containing aristolochic acid. In fact, on the FDA's Web site, it has listed 16 botanical products that contain aristolochic acid, as well as the responsible manufacturers and distributors.

"Aristolochic acid should not be in dietary supplements," Michael McGuffin, president of the American Herbal Products Association (AHPA), told Insider. "FDA's request [that manufacturers report adverse effects] is a reasonable expectation. We have expressed concerns over some of the agency's management of the adverse event reporting system for supplements; nevertheless, any manufacturer or medical practitioner who is aware of any such reports would be well-advised to inform FDA."

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