The Justice Department confirmed Thursday that it has opened a criminal investigation into whether Metabolife, a leading seller of products containing the herbal stimulant ephedra, lied about its safety.
Lester Crawford, Deputy Commissioner of the Food and Drug Administration, said the agency, through litigation and other avenues, has been trying to obtain information about ephedra’s safety from Metabolife, a San Diego firm, for at least five years. ”Metabolife has refused and resisted us every step of the way,” Crawford said.
Dietary supplements containing ephedra and ephedra extract, also known as ma-huang, are widely promoted for weight loss and athletic performance enhancement. They can be purchased without prescriptions.
It’s estimated that sales of ephedra weight-loss products top more than $1 billion a year. Chemically similar to amphetamine, ephedra has been linked to heart attacks and strokes, some fatal.
The Justice Department declined to elaborate on the nature of the investigation, which was recommended by the FDA.
Last September, Public Citizen’s Health Research Group, a consumer watchdog group, petitioned the FDA to ban ephedra products.
Public Citizen President Sidney Wolfe said the FDA has received reports of more than 100 deaths linked to ephedra use.
Wolfe said Metabolife founder Michael Ellis wrote in a letter to the FDA dated April 17, 1998, that his company didn’t know of a single serious health problem linked to taking ephedra.
But in a letter sent to Health and Human Services Secretary Tommy Thompson on Thursday, before the criminal investigation was made public, Metabolife President David Brown wrote that Metabolife had received about 13,000 calls about ”health-related issues” from customers from 1997 to September 2001. But only about 80 reports even mention problems of concern to the FDA, such as strokes, Brown wrote, adding that he was submitting those records to the FDA.
Crawford called Brown’s offer to make the reports available ”disingenuous.” He said a special FDA task force will review them.