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 containing red yeast rice, and 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) removed red yeast rice from the market in the United States were several.
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 to be new, unapproved drugs for which marketing violates the Federal Food, Drug, and Cosmetic Act.
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