SAN DIEGO (CN) – The founder of Metabolife International on Monday was sentenced to 6 months in prison and fined $20,000 for making false statements to the FDA. Michael Ellis told the FDA that Metabolife had “never received a notice from a consumer that any serious health event has occurred because of the ingestion of Metabolife 356,” though the company had received reports of strokes, heart attacks, seizures, loss of consciousness and other problems, often resulting in hospitalization.
When Ellis lied to the FDA in 1998 and 1999, the regulatory agency was considering whether to regulate ephedra more strictly, whether to ban products that contained 8 milligrams or more of the drug, and whether to require warning labels on ephedra products, federal prosecutors said.
Metabolife was one of the biggest sellers of such dietary supplements, heavily relying on its ephedra-containing drug, Metabolife 356. In 2002, the company turned over to the FDA, for the first time, reports of 14,000 “adverse events” its customers had reported. Federal prosecutors then charged Ellis and his company with making false statements to the FDA.
The FDA banned ephedra-containing diet supplements, and the 10th Circuit upheld the ban in August 2006. It remains in effect.
Metabolife filed for bankruptcy in 2005. Ellis, 55, lives in San Diego.