The Slo-Mo Ban on Ephedra
By Michael King, Fri., Jan. 9, 2004
The FDA expressed its interest in restricting ephedra use back in 1997, but a 1994 federal law defines "nutritional supplements" as "food" and requires the agency to prove a "significant or unreasonable risk of injury" before they can be banned -- unlike new "drugs," which must be demonstrated to be safe before they can be marketed to the public. The 1994 law was hailed by marketers of natural health products as a needed protection for the growing field of alternative medicine from the depredations of the big drug companies. But it also tied the feds' hands in cases like ephedra, the sale of whose near-identical pharmaceutical equivalent -- ephedrine -- is already regulated by federal law. The 1994 law also means that it will be March before the ban, announced Dec. 31 by Secretary of Health and Human Services Tommy Thompson and FDA Commissioner Mark McClellan, can take effect.
In anticipation of federal action after the ephedra-related death of Baltimore Orioles pitcher Steve Bechler last spring, many of the major manufacturers of ephedra-based products halted distribution, but Thompson said the FDA has notified 62 manufacturers still operating that they must stop selling the product as of March 1. California, New York, and Illinois have already banned ephedra. Thompson said one reason for announcing the ban now is to warn consumers making New Year's resolutions to lose weight not to rely on ephedra-based products that may lead to high blood pressure, seizures, or worse.
Under the 1994 law the FDA cannot authorize scientific studies of nutritional supplements or even require the reporting of adverse health effects to the government. But significant evidence of risk had accumulated against use of ephedra in recent years, and the U.S. Department of Justice had launched a criminal investigation of Metabolife Inc. for apparently concealing adverse effects from the FDA. The Texas Department of Health became embroiled in the controversy in 2002, when it tried to enforce a regulation calling for an FDA "Medwatch" 800 number to be provided on all ephedra product labeling, to enable consumers to report adverse reactions. Metabolife lobbyists, including both Republican and Democratic politicians, lobbied against the regulation -- and at the request of state Sen. Jeff Wentworth, Secretary Thompson called the TDH in an unsuccessful attempt to dissuade the agency from imposing the requirement. Shortly after Bechler's death, Thompson changed his tune and began calling for stricter regulation. Following the Metabolife controversy, Wentworth sponsored legislation to ban lobbying of state agencies by sitting legislators. The regulation was enacted as part of the ethics reform law adopted last spring.
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