April 21, 2005
It's a drug, not a 'food'
Last week's decision by a federal judge in Utah to lift the year-old ban on the sale of ephedra is less a vindication of the herbal supplement that has been linked to dozens of deaths than an indictment of the 1994 law that excused the makers of such "food" from proving that the products are safe.
After reviewing more than 133,000 pages of "scientific data, expert reviews, comments submitted by interested persons and other materials" since the early 1990s, the Food and Drug Administration announced in December 2003 that the higher risk of heart attack, stroke and death from taking ephedra outweighs its temporary effects of weight loss, enhanced athletic performance and increased energy. The ban took effect in April 2004, after the Broward County medical examiner had concluded that ephedra played a "significant role" in the Feb. 17, 2003, death of 23-year-old Baltimore Orioles pitcher Steve Bechler, who collapsed during spring training in Fort Lauderdale.
U.S. District Judge Tena Campbell ruled last week that for the FDA to take ephedra off the market, it must prove that "any dose amount, no matter how small, presents a significant or unreasonable risk of illness or injury." That's because Congress decided in 1994 that the FDA -- which relies on voluntary studies and voluntary reports of adverse incidents -- bears the burden of proof, not the manufacturer.
Judge Campbell, reiterating a point made by the manufacturer that sued the FDA over the ephedra ban, wrote that "if food producers were required to show a benefit as a precondition to sale, the sale of foods such as potato chips might be prohibited." By treating ephedra and other dietary supplements as "food" and not drugs, Congress wrongly presumes that herbal means "healthy."
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