Metabolife International, the leading seller of the controversial weight-loss supplement ephedra, is the subject of a criminal investigation by the Justice Department, officials said Thursday.
The Food and Drug Administration announced that it asked Justice Department lawyers three weeks ago to determine whether the firm made false statements to the FDA regarding the existence of “adverse event reports.”
“Metabolife has refused and resisted us every step of the way,” said Deputy FDA Commissioner Lester Crawford in a statement. “Given their long history of being uncooperative, we view their offer to make these reports available now to be disingenuous.”
Metabolife said it had not been notified of the investigation but would “fully cooperate.” Company officials said they were not surprised by the probe, noting that they had previously received two subpoenas on other matters.
Metabolife also renewed its call for government regulation of all dietary supplements containing ephedra. Currently, the FDA does not have the authority to regulate dietary supplements, though it can act against companies making false claims.
Ephedra, also called ma huang, is widely used in weight-loss products. In 1999, more than 12 million people used the product.
But in recent years, the FDA has received unsubstantiated reports of at least 70 deaths and more than 1,400 adverse events linked to ephedra. Adverse effects included high blood pressure, insomnia, nervousness, tremors, headaches, seizures, heart attacks and strokes.
Companies who sell the supplement maintain that many of these cases aren’t necessarily linked to ephedra and that people adversely affected have often taken too much ephedra or have ingested products containing too much of the product.
The Ephedra Education Council, which represents the ephedra industry, wants the FDA to crack down on manufacturers making defective products.
In June, Secretary of Health and Human Services Tommy Thompson called for an extensive scientific review of the product, Crawford said.
“The Rand Corporation is conducting a comprehensive review of the existing science on ephedra, and the [National Institutes of Health] will use this information to guide an expanded research effort on the safety of the product,” he said.
Crawford said consumers may wish to consult their physicians before using the product.