FDA Recommends Criminal Probe of Metabolife for False Statements

The U.S. Food and Drug Administration announced that it has recommended a criminal investigation of whether the leading ephedra seller Metabolife has made false statements to the agency about the safety of the diet supplement.

In 1998, Metabolife's president claimed that 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."

Court records from private lawsuits point to Metabolife having received reports of serious side effects prior to the statement being issued.

Also, the FDA accused Metabolife of being uncooperative in turning over 13,000 health complaints from consumers. Since at least 1997, the FDA has tried unsuccessfully to get adverse event reports from Metabolife.

'Metabolife has refused and resisted us every step of the way," said a recent statement from FDA Deputy Commissioner Dr. Lester Crawford.

Since the release of the FDA statement, Metabolife has finally turned over the health complaints to the U.S. Department of Health and Human Services. The FDA plans to have a special task force review them.

In response to the FDA's allegations, Metabolife released a statement claiming they have not made any false statements to the FDA and the allegations have nothing to do with the safety and efficacy of their products.

"Metabolife is surprised at FDA's statement criticizing Metabolife's pro-active, voluntary release of consumer information. Three experts reviewed this information and determined that the information does not demonstrate that Metabolife 356 is unsafe or poses any health problems when used as directed," the Metabolife statement said.

Consumers Union, the non-profit publisher of Consumer Reports magazine, has urged the FDA to require the withdrawal of ephedra products from the market. The publisher praised the FDA for its recent actions against Metabolife.

Other sources: FDA, Consumers Union