Metabolife Head Charged With Lying

Metabolife International Inc. and its founder were indicted Thursday on federal charges of lying to the Food and Drug Administration about the dangers of a popular diet supplement containing ephedra, the now-banned herbal stimulant linked to dozens of deaths.

Metabolife and Michael J. Ellis, who founded the San Diego company, were charged with six counts of making false statements to the FDA and two counts of trying to obstruct the agency's attempt to regulate supplements containing ephedra.

Ephedra has been linked to several deaths, including that of Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles who died during spring training last year.

Metabolife dismissed the allegations as "utterly baseless."

"The government has concocted a hypertechnical violation by taking statements to a regulatory agency out of context," attorney Steve Mansfield said.

He also accused the government of "heavy-handed and aggressive tactics" — including allegedly confronting people at gunpoint during the probe.

The Internal Revenue Service, the lead agency in the investigation, denied the charge. "We've conducted ourselves in a fair and businesslike manner," said Tami Stine, a spokeswoman for the IRS's criminal investigation division.

An attorney for Ellis, 51, did not immediately return calls for comment.

Until the Bush administration halted sales of ephedra earlier this year, Metabolife had been one of the nation's biggest sellers of dietary supplements, based largely on sales of its ephedra-based Metabolife 356. The privately held company's sales peaked in the 1990s at nearly $1 billion.

Federal prosecutors said Ellis lied when he told the FDA in 1998 and again in 1999 that his company had "never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356," according to the indictment.

Ellis also allegedly lied to the FDA about Metabolife 356.

"Metabolife informed the Food and Drug Administration that their product had a claims-free history, and in fact, they had received serious adverse-effect reports," said Assistant U.S. Attorney Phil Halpern.

Halpern declined to quantify how deaths or injuries were linked to Metabolife products, but Tom Reopelle of CBS radio station KNX says the government is alleging Metabolife received hundreds of complaints.

Ellis is scheduled to be arraigned Tuesday.

The FDA asked the Justice Department two years ago to pursue a criminal investigation into Metabolife. Agency head Lester Crawford complained Metabolife had refused and resisted the agency's probe of ephedra at every step.

"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," Crawford said Thursday.

In its statement, Metabolife called the FDA "a disgruntled agency" that has sought to put the dietary supplement industry out of business for 10 years.

In 1988, Ellis, a former police officer, was caught making methamphetamine. Ellis and another Metabolife founder, Michael Blevins, outfitted a home with equipment and chemicals to make at least 50 pounds of methamphetamine, court records show.

Ellis pleaded guilty to a lesser charge — unlawful use of a communication device to facilitate a drug trafficking offense — and served probation. Blevins spent time in prison.

Ephedra is similar to a key chemical ingredient of methamphetamine.

In 1989, Ellis developed the formula for what became Metabolife 356 to give his father the energy to battle terminal bone cancer, according to the company Web site.

"Mike's formula proved so successful that before he died, Joseph Ellis made his son promise to market it so others could reap its benefits," the site says.

Ellis founded Metabolife in 1995.