BMK Recalls, with Reservations, Product Containing Aristolochic Acid

WELLESLEY, Mass.--On Jan. 19, BMK International voluntarily recalled its product, Neo Concept Aller Relief, after the Food and Drug Administration (FDA) found trace amounts of aristolochic acid in the formulation. FDA's recalls began last June, when it issued a medical alert about possible nephrotoxicity associated with species of Aristolochia or its aristolochic acids (see www.naturalproductsinsider.com/hotnews/06h595454.html for details).

However, Phyllis Tan, co-founder of BMK, said that the study that instigated the FDA ban on products containing aristolochic acid was faulty and was conducted on people with pre-existing conditions, including anorexia (NEJM, 342(23): 1686-92, 2000). Also, the agency created a list of banned herbs belonging to the Aristolochia family, but Tan said 37 out of the 67 listed herbs did not contain aristolochic acid. "Apricots have cyanide, but eating them won't kill you," she said. "FDA is taking it out of the context of an herb versus an isolated chemical."

In addition, it was uncertain which ingredient in BMK's product was adulterated with the acid. Tan stated that although its product contained less than 1/1,000,000 of a percent of aristolochic acid, it would voluntarily recall its product, which was distributed nationwide to retail stores and licensed healthcare professionals. The recalled product comes in packages of 30 and 90 capsules, with lot numbers 003480 and 006480.

Customers can return product to their place of purchase for a full refund. Consumers with questions can contact BMK at (781) 235-9999. For additional information about aristolochic acid, visit FDA's site at www.fda.gov or the American Association of Oriental Medicine's at www.aaom.org.