Food or Drug?
Smith, Elizabeth A, Drug Topics
In what many experts consider a pivotal debate within the industry, the Food & Drug Administration has declared Cholestin, marketed as a dietary supplement that helps maintain healthy cholesterol levels, an unapproved drug. As such, it may not be sold in the United States, ruled the agency in a 30-page letter sent to its manufacturer, Pharmanex, on May 20.
The Simi Valley, Calif., firm has countered that its product, composed of red rice yeast, is a food product containing naturally occurring HMGCoA reductase inhibitors that have been used for centuries in China. A hearing regarding the matter has been scheduled for June 15 in U.S. District Court in Salt Lake City.
The FDA said that it based its final decision on the fact that Cholestin contains lovastatin, an active ingredient in the prescription drug Mevacor, made by Merck to lower cholesterol.
"Under the terms of the federal Food, Drug & Cosmetic Act, as amended by the Dietary Supplement Health & Education Act (DSHEA) of 1994, 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," explained the agency. "The law is intended to maintain incentives for companies to establish the clinical safety and efficacy of drug products."
But Pharmanex argues that the product contains mevinolin, which, it says, is "different from the synthetically isolated purified, crystallized substance called lovastatin found in Merck's cholesterol-reducing drug." The same substance is also found in black oyster mushrooms, noted William McGlashan, president of Pharmanex.
As part of an extensive investigation to determine Cholestin's regulatory status, undercover FDA agents collected samples of red yeast rice and Cholestin from several stores and analyzed their contents. They determined that Cholestin's manufacturing process produced elevated levels of lovastatin, implying an intent to manufacture a drug.
Pharmanex argued that its manufacturing process is intended to standardize levels of mevinolin. "Pharmanex does not add, enhance, or maximize this natural constituent; it merely employs quality controls to ensure that consumers get the most consistent and highest-quality product. …