FDA Warns Against Red Yeast Rice Products

The U.S. Food and Drug Administration warned consumers Thursday to avoid three red yeast rice products sold as treatments for high cholesterol.

The FDA said the products being promoted on the Internet as dietary supplements have been found to contain an unauthorized drug that poses a potential health hazard.

Officials said the potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex sold by Swanson Healthcare Products Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., in that order; and Cholestrix, sold by Sunburst Biorganics.

The FDA said testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications, said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research.

The FDA issued warning letters advising the companies that promoting and selling the products violates the federal Food, Drug and Cosmetic Act.