Justice Department Opens Investigation of Ephedra Maker Metabolife

The Justice Department has opened a criminal investigation into whether San Diego-based Metabolife International, the country's largest manufacturer of the dietary supplement ephedra, made false statements to the FDA regarding reports on side effects associated with the product, the Wall Street Journal reports (Adams, Wall Street Journal, 8/16). In 1994, the FDA began receiving reports from consumers that the supplement, which is used to lose weight and enhance athletic performance, caused several health problems, including seizures and heart attacks. The agency is prohibited by federal law from regulating plant-based dietary supplements unless they are proven to be dangerous. Since 1997, the FDA has attempted to gain access to reports Metabolife has received from consumers about possible side effects of the supplement, but the company has resisted. In 1998, Michael Ellis, then-president of Metabolife, said in a letter to the FDA that the company had never received any notice from consumers that the supplement had caused a serious health problem (Kemper, Los Angeles Times, 8/16). However, court records from lawsuits show that the company has received numerous reports of adverse reactions linked to the supplement, according to Justice Department attorney Eugene Thirolf. In a letter to the FDA, Thirolf said the Justice Department had opened an investigation into the company and was attempting to obtain the records (Hilts, New York Times, 8/16). The FDA will create a special task force to review the reports (Wall Street Journal, 8/16).

Hours after news of the criminal investigation leaked yesterday, Metabolife made a "surprise announcement" that it would give the FDA 13,000 reports from consumers about health issues related to ephedra, the AP/Philadelphia Inquirer reports. While Metabolife says the records do not indicate the supplement is dangerous when used as directed, a company lawyer said 80 of the reports mention death or serious adverse reactions, and 100 to 200 involve hospitalizations (Neergaard, AP/Philadelphia Inquirer, 8/16). Despite the timing of the release, Lanny Davis, an attorney for the company, said Metabolife had been planning to turn over the reports for months. In a statement, Metabolife said that "the company has not made any false statements to the FDA and these allegations have nothing to do with the safety and efficacy of Metabolife's products." FDA Deputy Commissioner Lester Crawford said the offer to release the reports was "disingenuous." He added, "News that so many reports exist greatly heightens our concern" (Wall Street Journal, 8/16).

CBS' "Evening News" yesterday reported on the ephedra investigation. A transcript of the segment is available online. In addition, a video clip of the segment is available online in RealPlayer. NPR's "Morning Edition" today included an interview with Crawford about the investigation (Montagne, "Morning Edition," NPR, 8/16). The full segment will be available online in RealPlayer Audio after noon ET.