FDA: Backs Off Proposal to Limit Ephedra
The FDA has withdrawn a proposal designed to curb the use of the dietary supplement ephedra, which is used in some weight-loss products and to increase the energy level of athletes and bodybuilders, the Wall Street Journal reports. The proposal would have imposed set dosages and required warnings against using the product for extended periods. However, the General Accounting Office had raised concerns about the more than 800 reports the FDA had complied on the substance's harmful effects, saying that the agency did not have enough data to set dosages. Joe Levitt, director of the FDA's Food Safety Center, said, "There were concerns raised about specific data we used to support the proposal. Therefore, we say, fine, let's clear the deck." The FDA still plans to limit ephedra's use and will release 140 new reports of adverse reactions to the supplement, including heart attacks, strokes, seizures and some deaths. Further, the agency still might prohibit supplement makers from mixing ephedra with other ingredients that have stimulating effects, such as kola nut, willow bark and senna. But ephedra proponents argue that the FDA's adverse event reports are "scientifically flawed." Regardless, the ephedra case illustrates how difficult the FDA's quest to regulate dietary supplements can be, Larry Sassich, Public Citizen spokesperson, said (Lueck, 4/3).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.