Ex-Metabolife CEO Michael Ellis has been jailed in connection with adverse event reporting for an ephedra-based weight loss product.
Ellis, who pleaded guilty to a count of making false statements to the US Food and Drug Administration in 1999 about Metabolife 356, received a six-month sentence and was ordered to pay a $20,000 fine.
Prosecutors said Metabolife sent letters to the FDA stating the company "never received a notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356."
But the US Attorney's office said Metabolife's records showed it had received letters from consumers who experienced adverse events — including seizures, heart attacks, strokes, loss of consciousness and other serious illnesses — after taking Metabolife 365.
In 2002, Metabolife supplied the FDA with 14,000 reports of ephedra-related events the company had previously not disclosed to the agency. Consequently, Ellis and Metabolife were indicted on several counts of making false statements, and subsequent civil suits forced the company into Chapter 11 bankruptcy by 2005.
In the wake of the Metabolife episode, the US government tightened the rules surrounding AERs, culminating in the passing in December 2006 of the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. The legislation amended the federal Food, Drug and Cosmetic Act to require the reporting of serious adverse events for both over-the-counter drugs and dietary supplements to the FDA.
Prior to the new law, the only way to get access to adverse event reports was for someone to subpoena a company to gain those records. The Act also introduced new labelling rules, such as a requirement for companies to put a toll-free phone number on packs so that consumers can report any adverse events after taking dietary supplements.
Daniel Fabricant, vice president, scientific and regulatory affairs at the Washington, DC-based Natural Products Association, declined to comment on the Ellis case. But he said the NPA supported the strengthened rules.
"We are very supportive of AERs as an industry," he told Functional Ingredients. "First, by helping to change the perception by critics of the dietary supplement industry that it is not regulated. As we know, the AER requirements for supplements are just as stringent as those for other FDA-regulated products.
"Secondly, over time, the recordkeeping and reporting requirements will substantiate what many in the industry have been saying for some time: that the safety record of dietary supplements is exemplary, especially when compared to other health-related products."