Thompson Orders FDA To Consider Mandatory Warning Label for Ephedra Products
HHS Secretary Tommy Thompson yesterday ordered the FDA to "evaluate the best scientific evidence available" and "recommend the strongest mandatory warning label" for ephedra, a dietary supplement used to lose weight and improve athletic performance that reports have linked to several health problems, such as seizures and heart attacks, the Wall Street Journal reports. The FDA does not have the authority to regulate dietary supplements, and agency officials said that "it is unclear what sort of warning label was justified -- or even possible." The Journal reports that Thompson's order marks the latest in a series of moves by the federal government to "crack down" on ephedra (Adams, Wall Street Journal, 10/9). "Based on the scientific data available, we will take appropriate steps to protect the public health," Thompson said, adding that the FDA will "move as aggressively as the law and science allow us to protect the public from the dangers of ephedra." In addition, the FDA officials announced yesterday that the agency will analyze ephedra products to determine whether they contain synthetic ingredients and will continue efforts to prevent the promotion of ephedra products as alternatives to illicit drugs (FDA release, 10/8). On Monday, the FDA blocked the sale of Yellow Jackets, a caffeinated ephedra product that contains kola bean extract (Recer, AP/Long Island Newsday, 10/9). A Dutch Web site advertised Yellow Jackets as "herbal XTC" that had "an extremely stimulating rush" (FDA release, 10/8).
In related news, Sen. Richard Durbin (D-Ill.) yesterday during a Senate subcommittee hearing criticized San Diego-based ephedra manufacturer Metabolife International and "renewed his calls" to ban the dietary supplement, the Journal reports (Wall Street Journal, 10/9). Durbin cited studies published in the New England Journal of Medicine and research conducted by the Mayo Clinic that linked ephedra to health problems (AP/Long Island Newsday, 10/9). In addition, congressional investigators have determined that Metabolife made false statements to the FDA about reports on side effects associated with ephedra. Metabolife recently submitted 13,000 consumer reports of adverse effects associated with ephedra to the FDA, although Metabolife officials told the agency in the late 1990s that the company has "never been made aware of any adverse health events by consumers of its products." Congressional investigators also said that the company's system to track adverse events associated with ephedra showed an "indifference to the health of consumers" (Wall Street Journal, 10/9). "We have mountains of evidence that this drug is not safe, and these manufacturers are being irresponsible about their marketing practices. Ephedra is not safe and should be taken off the market," Durbin added (AP/Long Island Newsday, 10/9). In addition, American Medical Association trustee Ron Davis said during the subcommittee hearing that dietary supplements "containing ephedra have significant risks" and "should be removed from the market." AMA officials also said that Congress should amend federal law to allow the FDA to regulate dietary supplements (Deardorff, Chicago Tribune, 10/9). NPR's "All Things Considered" yesterday reported on the Senate subcommittee hearing on ephedra (Prakash, "All Things Considered," NPR, 10/8). The full segment is available in RealPlayer Audio 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.