Supplement Owner Fined for Distributing Prescription Drug in Weight-Loss Pills

NEW YORK CITY--The owner of a bankrupt dietary supplement firm has been fined for distributing weight-loss pills that contained a prescription drug used to treat heart failure, according to the FDA.

In Manhattan federal court, a U.S. magistrate judge fined Balanced Health Products (BHP) owner and CEO Nikki Haskell $60,000, FDA said Monday in a press release.  In March 2014, Haskell pleaded guilty to distributing the misbranded product called “Nikki Haskell’s StarCaps", the agency noted. 

The defunct company distributed StarCaps from at least November 2006 through December 2008, advertising the product as containing all-natural ingredients, according to the release. However, the pills actually contained bumetanide, a diuretic that is only available through a prescription and used to treat heart failure, kidney failure, high blood pressure and swelling (edema), FDA said. The agency noted certain professional sports organizations ban use of bumetanide because it can hide the presence of steroids and other banned doping substances.

FDA said the product has been permanently removed from the market.

“There is a strict regulatory process in the United States for the distribution and dispensing of prescription drugs, and dietary supplements cannot legally contain such drugs," said Philip Walsky, acting director of the FDA’s Office of Criminal Investigations, in a statement. “Consumers rely on the labels of dietary supplements to inform them about any potential health risks. The FDA will continue its vigilance over the dietary supplement market."

The investigation into BHP was led by agents from FDA’s Office of Criminal Investigations in the New York Field Office.