Metabolife Founder Sentenced For Lying To FDA

The founder of San Diego-based Metabolife, who lied to the Food and Drug Administration about the regulation of ephedra-based supplements, was sentenced Monday to six months in federal custody.

Michael J. Ellis, 55, pleaded guilty Nov. 5 that he and his corporation sent letters to the FDA in 1998 and 1999 falsely stating that Metabolife had never received a notice from a consumer that any serious adverse health event had occurred because of taking the product Metabolife 356 and that the company had a "claims-free history."

Metabolife's own documents, however, showed that the company had received reports of seizures, heart attacks, strokes, losses of consciousness and other serious health events, often resulting in hospitalization.

At the time Ellis submitted the false claims to the FDA, the government agency was considering whether to regulate ephedra products more stringently. The FDA ultimately banned ephedra-containing dietary supplements as posing an unreasonable health risk to consumers.

Metabolife was formerly one of the largest retailers of dietary supplements in the United States, based largely on its sales of its ephedra-based product, Metabolife 356.

In 2002, Metabolife turned over to the FDA -- and then to the Department of Justice -- reports of more than 10,000 ephedra-related adverse events that the company had previously withheld, prosecutors said.

It was a result of those reports and further investigation that Ellis and Metabolife were indicted on July 22, 2004, for making false statements to the FDA.

On Aug. 17, 2006, the 10th Circuit Court of Appeals upheld the FDA's ban of ephedra, and the ban remains in effect.

Metabolife filed for Chapter 11 bankruptcy protection in 2005 in the wake of the indictment of Ellis and Metabolife, the FDA's ban on ephedra and numerous personal injury legal claims related to Metabolife 356.

Monday's sentencing was carried out by U.S. District Judge Napoleon Jones Jr. who ordered Ellis to surrender before Aug. 18 or appear in court to go into custody on that date.

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