We do not make any medical claims about our Red Yeast Rice products nor do we make a claim for monacolin (or lovastatin) content. There has been an ongoing battle surrounding the legal status of the dietary supplement red yeast rice. The herbal supplement red yeast rice naturally contains the active ingredient monacolin K, also called lovastatin. This constituent of red yeast rice is also the main active ingredient in the popular statin drug Mevacor™. In 1998, the FDA determined that the proprietary red yeast rice was an unapproved drug and not a dietary supplement. Then, in February 1999, the Federal District court of Utah ruled against the FDA, stating that the proprietary red yeast rice was not a drug but a dietary supplement. However on July 24th, 2000, the 10th U.S. Circuit Court of Appeals ruled that the proprietary red yeast product is subject to regulation by the U.S. FDA. The FDA has not objected to the marketing of dietary supplements containing red yeast rice if they do not contain lovastatin or other substances that are approved drugs. As a result, the dietary supplement red yeast rice is not standardized to contain monacolin K, although it may occur naturally.
answered 4 years, 10 months ago