FDA To Consider New Labels, Potential Ban on Dietary Supplement Ephedra
HHS Secretary Tommy Thompson on Friday said that he would seek new restrictions on ephedra, such as labels to warn consumers about health risks of the dietary supplement and a potential ban on ephedra products, the Washington Post reports (Gugliotta, Washington Post, 3/1). Ephedra contains several chemicals, such as ephedrine, which stimulates the central nervous system (California Healthline, 2/21). Thompson will open public comment on a new label on ephedra to warn that "heart attack, stroke, seizure and death have been reported after consumption" of ephedra products, the New York Times reports (Pear/Grady, New York Times, 3/1). "I would not take this, I would not give it to my family, and I don't know why anybody would take these products," Thompson said at a news conference (Washington Post, 3/1). He also said that the FDA would collect more information about the supplement to meet the "tough standards" required for a ban, the New York Times reports (New York Times, 3/1). Under the 1994 Dietary Supplement Health and Education Act, which regulates dietary supplements such as ephedra, the FDA must "prove a supplement is dangerous before pulling it from the market," the Post reports (Washington Post, 3/1).
FDA Commissioner Dr. Mark McClellan said that he supports an ephedra ban because studies have found that the supplement "poses a significant and unreasonable risk to public health as it is currently marketed." McClellan said that ephedra products account for 1% of dietary supplement sales and 64% of reports of adverse reactions to the supplements (New York Times, 3/1). Thompson made the announcement on Friday in response to reports from medical examiners in Broward County, Fla., that ephedra likely contributed to the Feb. 17 death of 23-year-old Baltimore Orioles pitcher Steve Bechler, the Baltimore Sun reports (Schmuck, Baltimore Sun, 3/1). Thompson also made the announcement in response to the release of study on ephedra conducted by Rand and commissioned by the FDA. Thompson and McClellan said that the study found "no evidence" of benefits of ephedra, but Wes Siegner, an attorney who represents the ephedra industry, said that the study provided "clear clinical data" that individuals could use the supplement to lose weight. Dr. Paul Shekelle, lead author of the Rand study, said that the study "proved definitively" that ephedra can cause "anxiety, sweating, nausea and other mild side effects," the Los Angeles Times (Kemper, Los Angeles Times, 3/1).
Sen. Richard Durbin (D-Ill.) praised Thompson for the announcement but added, "I have been urging action for six months, and what he has offered as a response to the Rand study is less than necessary. The secretary should stick his neck out when that's required" (Washington Post, 3/1). Rep. Henry Waxman (D-Calif.) called the announcement a "weak and inadequate response" to reported problems with ephedra. He added, "The FDA has ample authority and overwhelming evidence to take this product off the market" (New York Times, 3/1). Sen. Charles Schumer (D-N.Y.) yesterday called for an immediate ban on ephedra and said that he will co-sponsor legislation with Durbin to prohibit over-the-counter sales of the supplement (Murphy, Long Island Newsday, 3/3). The House Energy and Commerce Committee on Friday opened an investigation into ephedra, and officials at Public Citizen said that the consumer advocacy group may file suit against the FDA to force a ban on the supplement (Neergaard, Associated Press, 3/2). CBS' "Evening News" on Friday reported on the Thompson announcement. The segment includes comments from Thompson and McClellan (Kaledin, "CBS Evening News," CBS, 2/28). A transcript of the segment is available online.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.