FDA: Sales of cholesterol-lowering product are illegal

April xx, 1997
Web posted at: xxxx xxxx EDT

WASHINGTON (CNN) -- The U.S. Food and Drug Administration said Wednesday that a product sold as a dietary supplement to lower cholesterol was, in fact, not a dietary supplement but an unapproved drug that could not be legally sold in the United States.

The product, called Cholestin, is available over the counter in more than 37,000 stores. It is manufactured by Pharmanex and has been on the market since 1996.

The FDA said Cholestin contains lovastatin, which is part of the cholesterol-lowering prescription drug Mevacor.

"Under the terms of the Federal, Food, Drug and Cosmetic Act ... Cholestin is not a dietary supplement because lovastatin was not marketed as a dietary supplement or food before the FDA approved Mevacor as a drug," the FDA said.

Pharmanex says it will not pull the product off the market and plans to challenge the FDA's decision in court. A hearing has been scheduled for June 15.

Related stories:

• Cholesterol-lowering drugs often aren't taken - May 12, 1998
• Anti-cholesterol drugs may help more people - May 11, 1998

Related sites:

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• U.S. Food and Drug Administration
• Cholesterol-lowering drugs - How they work and who may need them
• JAMA - The Journal of the American Medical Association

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