The Food and Drug Administration has issued a letter to manufacturers of dietary supplements concerning supplements that contain undeclared drugs or drug analogues as their active ingredients.
FDA tests “have revealed an alarming variety of undeclared active ingredients in products marketed as dietary supplements,” including phosphodiesterase type 5 inhibitors, such as sildenafil (Viagra); anticoagulants, such as warfarin; and beta-blockers, such as propranolol, according to the letter. Among the illegally marketed products are those containing drugs that have been withdrawn from the market for safety reasons, including the weight-loss drugs sibutramine (Meridia) and fenfluramine.
Most of the tainted products were found in weight-loss, body-building, and sexual enhancement products.
In addition, the FDA announced a new RSS feed to alert consumers when a tainted product is identified and established new ways for industry to report products suspected of being tainted, either by sending an e-mail to TaintedProducts@fda.hhs.gov
Since 2007, the agency has issued consumer alerts about almost 300 tainted products containing an active drug ingredient. The FDA has received “numerous reports” of adverse events and injuries associated with these products, including stroke, kidney failure, pulmonary embolism, acute liver injury, and death, Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said during a press briefing announcing the new measures.