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
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.