FDA To Expand Inquiry Into Dietary Supplements, Commissioner McClellan Indicates

The FDA will become "much more aggressive" about looking into the health effects of dietary supplements that it considers "potentially harmful" following the announcement of a ban on ephedra last month, FDA Commissioner Mark McClellan indicated in a speech at the University of Mississippi School of Pharmacy on Tuesday, USA Today reports (Weise, USA Today, 1/21). HHS Secretary Tommy Thompson announced last month that the federal government would begin banning products containing the dietary supplement ephedra (Gay Stolberg, New York Times, 12/31/03). The substance has been linked to about 16,000 adverse events, such as heart attacks, irregular heartbeats and strokes, and the FDA also has linked as many as 155 deaths to the supplement. The FDA classifies dietary supplements as food and does not require them to meet the same standards as prescription drugs. Under the 1994 Dietary Supplements Health and Education Act, supplements can enter the market without FDA approval, and manufacturers are not required to inform the FDA of any adverse effects that are associated with supplements (California Healthline, 10/29/03). According to the Wall Street Journal, the FDA has to prove that the supplements pose a "significant or unreasonable risk" in order to block their sale (Wilde Mathews, Wall Street Journal, 1/20). McClellan said that the agency is reviewing three ingredients in weight-loss supplements: bitter orange, aristolochic acid and usnic acid, a lichen derivative. Bitter orange has been used to replace ephedra in weight-loss supplements. Aristolochic acid, which is also used in weight-loss products, is a potential carcinogen and has been linked to permanent kidney damage. Usnic acid is an ingredient in Lipokinetix, which is a dietary supplement that has been associated with liver toxicity.

McClellan said that the FDA plans to issue a mandate laying out a framework to determine whether a supplement causes adverse health effects. He also said that the agency is looking to partner with more universities and researchers to help the FDA "take more effective steps to make sure that dietary supplements that people take are safe and have benefits that outweigh their risks" (USA Today, 1/21). Under the new framework, the FDA is expected to consider other sources of information about the safety of a supplement, including "pharmacological evidence, clinical evidence from small controlled studies and long- and short-term studies without strict scientific controls," according to the Journal (Wall Street Journal, 1/21). An FDA spokesperson said that the agency could announce the framework as early as next week (USA Today, 1/21).