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Supplement Maker Swallows Hard Pill

Published on Jul 29, 2014 at 8:21 pm in Product Liability.

The U.S. Food and Drug Administration announced last week that a federal court has fined supplement maker Balanced Health Products as part of a criminal sentence. In March, the owner of New York City-based Balanced Health Products, Nikki Haskell, had pled guilty to misdemeanor criminal charges of distributing misbranded products.

Haskell sold an “all natural” weight-loss supplement called “Nikki Haskell’s StarCaps” or simply “StarCaps” that was found to contain prescription diuretics. In late June, a judge in Manhattan federal court sentenced Haskell to a $60,000 fine for distributing dietary supplements that contained a prescription drug. The prosecutors had pushed for a $100,000 fine and up to six months in prison.

The primary business of Balanced Health Products, for two years from November 2006 to December 2008, was to distribute the StarCaps product. They advertised the supplement as a weight loss aid and claimed it contained only natural ingredients such as papaya extract and garlic. The label did not disclose that the product contained bumetanide – a drug that in the U.S. – is only available by prescription.

Bumetanide is a strong diuretic that physicians prescribe to treat a variety of serious conditions. They include heart failure, kidney failure, high blood pressure and swelling (edema).

“Diet Queen to the Stars”

Haskell was once a TV host and travelled in New York’s society circles. She called herself the “Diet Queen to the Stars.”

Reuters reports that during the criminal hearing, Haskell said she was “completely unaware” StarCaps, which was manufactured in Peru, had bumetanide it, adding she had “…never even heard of the product until I heard these football players were using it.

In court she also said, “I’m still to this day shocked anything was in it.”

In 2008, the National Football League gave six players four-game suspensions after testing positive for bumetanide, and the NFL named StarCaps as a source for the drug. Two players, Jamar Nesbit of the Atlanta Falcons and Grady Jackson of the Saints, sued Balanced Health Products because its supplement caused them to test positive for bumetanide.

About the same time, the FDA launched an investigation, which led to the recall of StarCaps from the market. Bumetanide is now banned in the National Football League, as it can be used to mask the presence of steroids and other drugs.