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.
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