Metabolife, Company Founder Plead Not Guilty To Charges of Making False Statements to FDA
A lawyer representing San Diego-based dietary supplement manufacturer Metabolife on Tuesday in U.S. District Court in San Diego entered a not guilty plea on behalf of the company, and company founder Michael Ellis also pleaded not guilty to charges of lying to FDA about the safety of the company's now-banned weight-loss supplement containing ephedra, the AP/Denver Rocky Mountain News reports (Hettena, AP/Denver Rocky Mountain News, 7/28). A federal grand jury in San Diego on Thursday indicted Metabolife and Ellis each on six counts of making false statements to FDA regarding the supplement -- Metabolife 356 -- and two counts of obstructing agency efforts to regulate dietary supplements containing ephedra (California Healthline, 7/23). The maximum penalty for each count is five years in prison and a $250,000 fine (Somers, San Diego Union-Tribune, 7/28).
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, including heart attacks, irregular heartbeats and strokes, and FDA has linked as many as 155 deaths to the supplement.
In the testimony, federal prosecutors said that when the Department of Justice 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. 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" (California Healthline, 7/23). A motion hearing in the case is set for September (AP/Denver Rocky Mountain News, 7/28).
Metabolife said in a written statement Tuesday that it will contest the allegations in what it described as "recent government action involving standards made in the 1990s." The statement also described the company's new products and established that Metabolife no longer manufactures ephedra-based products (San Diego Union-Tribune, 7/28).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.