Distributor of misbranded supplements fined $60,000

SILVER SPRING, Md. — Nikki Haskell, the owner and CEO of Balanced Health Products, has been sentenced by a U.S. magistrate judge in a Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug, the Food and Drug Administration reported Monday.

From at least November 2006 through December 2008, BHP’s primary business was the distribution across the United States of “Nikki Haskell’s StarCaps." BHP advertised StarCaps as weight-loss pills containing only all-natural ingredients including, for example, papaya extract. The company failed to list on the product’s label that the pills also contained bumetanide, a powerful diuretic used clinically to treat heart failure, kidney failure, high blood pressure and swelling (edema). Bumetanide is available in the United States only by prescription from a licensed physician.

In March 2014, Haskell was convicted upon a guilty plea to distributing the misbranded StarCaps from BHP’s New York City-based location. Per Haskell, the company is now defunct and has filed for bankruptcy.

Agents from the FDA’s Office of Criminal Investigations, New York Field Office spearheaded this investigation, which led to the permanent removal of this tainted dietary supplement 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,” stated Philip Walsky, acting director of the FDA’s Office of Criminal Investigations. “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.”

Use of bumetanide is banned by certain professional sports organizations, including the National Football League, in part because bumetanide can mask the presence in the human body of steroids and other banned doping agents.