Pharmanex to Fight FDA on Cholestin’s Status

Pharmanex in Simi Valley is disputing the Food and Drug Administration’s conclusion that Pharmanex’s Cholestin is an unapproved drug rather than a dietary supplement.

The company said it will revive its lawsuit in federal district court in Utah to seek a ruling that will ensure continued availability of Cholestin to consumers. The FDA has agreed to an expedited court hearing, scheduled June 15 in Salt Lake City.

“Pharmanex continues to believe that Cholestin is a safe and beneficial dietary supplement,” said Pharmanex president Bill McGlashan. “FDA’s far-reaching ruling on Cholestin would restrict consumer freedom to choose among safe ways to promote and maintain health.”

Pharmanex officials said Cholestin is a natural dietary supplement composed of ground red yeast rice and is used to promote and maintain healthy cholesterol levels. Red yeast rice is a traditional dietary staple in Asia.