Federal charges that Metabolife International Inc. lied to the Food and Drug Administration about the dangers of a popular diet supplement are based on statements that were taken out of context, an attorney for the company said.
Metabolife and Michael J. Ellis, who founded the San Diego company, were charged Thursday 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, the now-banned herbal stimulant.
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.
Mansfield 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. IRS agents had raided company headquarters in July 2002, removing documents as part of an income tax investigation, authorities said at the time.
An attorney for Ellis, 51, did not return calls for comment Thursday.
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 that Metabolife 356 had a “claims-free history.”
Assistant U.S. Attorney Phil Halpern declined to quantify how deaths or injuries were linked to Metabolife products.
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.
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.
Ellis founded Metabolife in 1995.
