Metabolife questioned over ephedra
investigation into Metabolife over the safety of some of the
company's ephedra-based diet products.
The US Food and Drug Administration has called for a criminal investigation into Metabolife International over the safety of some of the company's diet products that contain ephedra, reports Bloomberg.
The agency asked America's Department of Justice to launch an investigation three weeks ago, according to a statement issued by Lester Crawford, the FDA deputy commissioner, said the report.
The statement explained that regulators are questioning whether Metabolife offered complete information about reports of side-effects from consumers.
In a press conference yesterday, Metabolife said there have been about 100 to 200 reports of serious side-effects reported on its consumer information telephone line in the past five years. Serious events include heart attacks, seizures, stroke or death, said Lanny Davis, an attorney at Patton Boggs and a spokesman for Metabolife.
The company has not yet confirmed whether any of the reports have direct relationship to its dietary supplements, Boggs told the news service.
US law forbids most regulation of dietary supplements unless the FDA proves there are risks involved. Three years ago, the agency attempted to bar certain high doses of the supplement from being sold but industry protests killed the move.
Since then FDA officials have been pushing for warning labels, but in June, the Department of Health and Human Services instead called a review all scientific evidence of ephedra's safety, with results due later this year.
Canada recently warned consumers not to use ephedra, and it has been banned by the International Olympic Committee, National Football League and National Collegiate Athletic Association.