WASHINGTON – A federal grand jury indicted Metabolife International (search) and its founder on charges of making false statements and obstructing a government probe into the safety of the weight-loss supplement ephedra, law enforcement officials said Thursday.
In a statement, privately held Metabolife called the charges baseless.
U.S. regulators banned ephedra (search) in April after concluding it posed risks of heart attacks, strokes and deaths. San Diego-based Metabolife and other makers insisted the herbal supplement was safe when used as directed.
The grand jury in California indicted both Metabolife and its founder, Michael Ellis (search), on six counts of making false statements to the Food and Drug Administration (search) and two counts of obstructing government attempts to regulate ephedra supplements, according to a statement from the U.S. Attorney for the Southern District of California.
Prosecutors said Metabolife and Ellis falsely told the FDA the company "had never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356," the company's ephedra product.
In August 2002, Metabolife disclosed to the FDA that it had received about 13,000 complaints about the product. At the time, the company said it did not believe Ellis "knowingly or willingly" made false statements.
Steve Mansfield, an attorney for Metabolife, said the government's allegations were "utterly baseless."
"The prosecutor handling this case appears to be doing the bidding of a disgruntled agency that has been seeking for the past 10 years to put the dietary supplement industry out of business," Mansfield said in a statement.
"We will vigorously contest each and every allegation," he added.
Each charge carries a maximum penalty of five years in prison and a fine of up to $250,000.