FDA Asks Twinlab to Stop Selling "Drug" Containing Lovastatin 36201

FDA Asks Twinlab to Stop Selling "Drug" Containing Lovastatin

WASHINGTON--In a letter dated July 31, the Food and Drug Administration (FDA) sent a letter to Twin Laboratories Corp. (www.twinlab.com) stating that one of its products, which containedlovastatin, was a drug and not a dietary supplement. Earlier this year, the U.S. District Court in Utah, in dismissing a lawsuit brought against FDA by Pharmanex Inc., re-affirmed that red yeast rice products are subject to drug regulation.

"Cholesterol-Power," which was being promoted by the company as a cholesterol-lowering agent, was labeled as containing red yeast (Monascus purpureus) extract and powder. In addition, Twinlab's Materials Requirement List and Certificate of Analysis use the word "lovastatin" as to what was going into Cholesterol-Power. According to Twinlab, it is in the midst of preparing a response for FDA, and the company's chief information officer Bill Rizzardi stated that it would respect FDA's wishes. He added that Cholesterol-Power was not a major product and it had had limited sales.