07.01.08
The former chief executive of dietary supplement maker Metabolife International was sentenced to six months in federal prison yesterday (June 9) for lying to the U.S. Food and Drug Administration regarding an ephedra-based weight-loss product.
Michael J. Ellis, 55, pleaded guilty in November to one count of making false statements to the FDA in 1999 about Metabolife 356. In addition to prison time, U.S. District Judge Napoleon Jones Jr. ordered Ellis to pay a $20,000 fine.
According to prosecutors, Ellis and the company sent letters to the federal agency saying they had “never received a notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.”
Metabolife’s own documents showed that it had received many reports from consumers of seizures, heart attacks, strokes, loss of consciousness and other serious illnesses, said the U.S. Attorney’s Office.
At the time Metabolife was saying it had a “claims-free history,” the FDA was considering tighter regulations on products containing ephedra. Metabolife was one of the largest dietary supplement companies in the United States, largely based on sales of Metabolife 356.
In 2002, the company turned over reports of 14,000 ephedra-related events that the company had previously not disclosed to the FDA. The FDA eventually banned ephedra, and in 2004, Ellis and Metabolife were indicted on several counts of making false statements.
Metabolife filed for Chapter 11 bankruptcy reorganization in July 2005 in the wake of hundreds of civil lawsuits.
—Mike Freeman, SignOnSanDiego.com by the Union-Tribune, 6/10/08
Michael J. Ellis, 55, pleaded guilty in November to one count of making false statements to the FDA in 1999 about Metabolife 356. In addition to prison time, U.S. District Judge Napoleon Jones Jr. ordered Ellis to pay a $20,000 fine.
According to prosecutors, Ellis and the company sent letters to the federal agency saying they had “never received a notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.”
Metabolife’s own documents showed that it had received many reports from consumers of seizures, heart attacks, strokes, loss of consciousness and other serious illnesses, said the U.S. Attorney’s Office.
At the time Metabolife was saying it had a “claims-free history,” the FDA was considering tighter regulations on products containing ephedra. Metabolife was one of the largest dietary supplement companies in the United States, largely based on sales of Metabolife 356.
In 2002, the company turned over reports of 14,000 ephedra-related events that the company had previously not disclosed to the FDA. The FDA eventually banned ephedra, and in 2004, Ellis and Metabolife were indicted on several counts of making false statements.
Metabolife filed for Chapter 11 bankruptcy reorganization in July 2005 in the wake of hundreds of civil lawsuits.
—Mike Freeman, SignOnSanDiego.com by the Union-Tribune, 6/10/08