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Red Yeast Rice and Cholesterol

Medical Authors: Dennis Lee, MD and Jay W. Marks, MD
Medical Editor: William C. Shiel, Jr., MD, FACP, FACR

What is red yeast rice?

Red yeast rice is rice that has been fermented by the red yeast, Monascus purpureus. It has been used by the Chinese for many centuries as a food preservative, food colorant (it is responsible for the red color of Peking duck), spice, and an ingredient in rice wine. Red yeast rice continues to be a dietary staple in China, Japan, and Asian communities in the United States, with an estimated average consumption of 14 to 55 grams of red yeast rice per day per person.

Red yeast rice also has been used in China for over 1,000 years for medicinal purposes. Red yeast rice was described in an ancient Chinese list of drugs as useful for improving blood circulation and for alleviating indigestion and diarrhea.

Recently, red yeast rice has been developed by Chinese and American scientists as a product to lower blood lipids, including cholesterol and triglycerides.

What is the present status of red yeast rice?

Small scale studies using pharmaceutical-grade red rice yeast have continued to demonstrate efficacy and safety. However, in the United States it is no longer legal to sell supplements of red yeast rice that contain more than trace amounts of cholesterol lowering substances. For example, the active ingredients of red rice yeast have been removed from Cholestin marketed in the United States. (Hypocol, another product containing red yeast rice is no longer being sold in the United States.)

The reasons the Food and Drug Administration (FDA) has ruled that it is illegal to sell red yeast rice that contains more than trace amounts of the cholesterol-lowering substances and to promote red yeast rice for lowering cholesterol levels.

  • First, statin drugs are associated with muscle and kidney injury when used alone or combined with other medications. There is concern that patients who already take statin drugs with or without these other medications may increase their risk of muscle or kidney injury.

  • Second, the FDA considers the products containing red yeast rice with high levels of cholesterol lowering substances to be new, unapproved drugs for which marketing violates the Federal Food, Drug, and Cosmetic Act.


Next: What are the different preparations of red yeast rice? »

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