July 22, 2004
A federal grand jury has returned an eight-count indictment against San Diego-based Metabolife International, Inc., and its founder, Michael J. Ellis.
The indictment charges both defendants with six counts of making false, fictitious and fraudulent representations to the Food and Drug Administration (FDA), and two counts of corruptly endeavoring to influence, obstruct and impede proceedings concerning the regulation of dietary supplements containing ephedra being conducted by the FDA.
Until the FDA banned the sale of ephedra in the United States in 2003, Metabolife was one of the largest retailers of dietary supplements in the United States, based largely on sales of its ephedra-based product, Metabolife 356.
Metabolife and Ellis are charged with falsely representing a number of different material facts to the FDA in letters dated April 17, 1998 and February 9, 1999. These representations included false statements by the Defendants that Metabolife ha[d] never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356 and that the company had a claims-free history, according to United States Attorney Carol C. Lam.
"It is never acceptable for corporations to lie to regulatory agencies, but it is particularly egregious when those lies threaten the public health," Lam said.
"One of FDA's highest priorities involves our responsibility to ensure that information about products we regulate is truthful and not misleading, because people depend on that information to make informed choices," said Acting FDA Commissioner Dr. Lester M. Crawford. "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."
The defendants are scheduled to be arraigned before Magistrate Judge Louisa Porter in San Diego on Tuesday, July 27, 2004 at 10:30 a.m.
Each charge carries a potential penalty of five years in prison and a $250,000 fine.