Grand Jury Indicts Metabolife, Company Founder for Allegedly Making False Statements to FDA
A federal grand jury in San Diego on Thursday indicted San Diego-based Metabolife and its founder, Michael Ellis, each on six counts of making false statements to FDA and two counts of obstructing agency efforts to regulate dietary supplements containing ephedra, the Los Angeles Times reports. The indictment alleges that Metabolife and Ellis made false statements regarding Metabolife 356, the company's weight-loss supplement containing ephedra (Tamaki/Morain, Los Angeles Times, 7/23). In February, FDA issued a regulation stating that sales of ephedra must end by April 12. The substance, used for weight loss and athletic performance enhancement, has been linked to about 16,000 adverse events, such as heart attacks, irregular heartbeats and strokes, and FDA has linked as many as 155 deaths to the supplement (California Healthline, 2/9).
In the testimony, federal prosecutors said that when the Justice Department launched its initial investigations into Metabolife in August 2002, the company submitted to FDA about 13,000 consumer health complaints about Metabolife 356 dating back to 1997 (Crabtree, San Diego Union-Tribune, 7/23). However, the prosecutors alleged that Metabolife and Ellis made a series of false statements in letters to FDA dated April 17, 1998, and Feb. 9, 1999, that the company had a "claims-free history" and that "Metabolife has never been made aware of any adverse health events by consumers of its products" (Los Angeles Times, 7/23). During that time, federal and state regulators were holding hearings to discuss whether ephedra products should be more strictly regulated or banned (San Diego Union-Tribune, 7/23).
U.S. Attorney Carol Lam said, "It is never acceptable for corporations to lie to regulatory agencies, but it is particularly egregious when those lies threaten the public health." Acting FDA Commissioner Lester Crawford said, "We will pursue to the full extent of the law those who would seek to mislead consumers by providing false information or impeding investigations of risky products" (Hettena, AP/Contra Costa Times, 7/23). Attorney Steve Mansfield, who is representing Metabolife and Ellis, said the indictment was "utterly baseless," adding that the prosecutors were "doing the bidding of a disgruntled agency that has been seeking for the past 10 years to put the dietary supplement industry out of business" (San Diego Union-Tribune, 7/23). Mansfield said, "We will vigorously contest each and every allegation and look forward to our day in court" (Los Angeles Times, 7/23).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.