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) that one of its products, which contained lovastatin, 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, in both its Materials Requirement List and Certificate of Analysis, the papers 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. However, 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 limited sales.

On July 26, Twinlab launched another cholesterol-lowering product, Cholesterol Success, which contains 900 mg of the proprietary plant-based sterol/stanol blend Reducol. Based on an exclusive marketing agreement between Twinlab and Novartis Consumer Health, which provided Reducol, Cholesterol Success will be the only product that currently contains this proprietary ingredient. However, Rizzardi noted that this product is not taking the place of Cholesterol-Power. "That's like exchanging a VW bug for a tractor," he stated.