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WASHINGTON, Jan 20, 2004 (United Press International via COMTEX) -- The U.S. Food and Drug Administration is expected to tighten oversight of herbal supplements.
FDA Commissioner Mark McClellan was expected to explain the agency's new policies on herbal supplements in a speech Tuesday, the Wall Street Journal reported.
Those supplements reportedly include bitter orange, or citrus aurantium, which is being marketed as a substitute for ephedra, recently banned by the FDA, usnic acid, which is derived from lichens and has been used in weight-loss aids, and aristolochic acid, sold for weight loss and to help with stomach problems.
Unlike drugs, herbal supplements do not require FDA approval before going on the market, so manufacturers typically don't have to do the large clinical studies that drugmakers perform.
The FDA is expected to unveil the rule formally for its ephedra ban in the next few weeks. Ephedra will be the first herbal ingredient banned by the agency under a 1994 law that set a high bar for restrictions. The move is likely to draw legal challenges.
Copyright 2004 by United Press International.