“A little more than a decade ago, a federal court ruled that over-the-counter red-yeast rice products were not drugs despite the fact that these products contained naturally occurring chemicals that were functionally indistinguishable from lovastatin, a cholesterol-lowering prescription drug. And so a major dietary supplement industry was born. By 2008, Americans were spending $20 million a year on red-yeast rice products, many on their doctors recommendation (and perhaps even via their doctor’s offices).”
Over-the-counter red-yeast rice products containing naturally occurring chemicals that are functionally indistinguishable from lovastatin have become a major dietary supplement industry. However, not all red-yeast rice products contain pharmacologically active concentrations of the fungal products, and there is no standardization of these levels across manufacturers. In a study conducted by cardiologist Ram Gordon and his colleagues, monacolin concentrations in a dozen commercial red-yeast rice products were assayed. One product contained less than a third of a milligram of total monacolins, while another hosted more than 11 milligrams per capsule. Citrinin, a potentially kidney-poisoning fungal toxin, was found in a third of the brands. The researchers do not identify the brands that they tested, so it is difficult to know which products are cholesterol-lowering agents and which are dangerous. It is also challenging to standardize herbal remedies because their constituents vary with the season, their nutrients, horticultural conditions, and even the presence of any pests or parasites. Cholestin, an early red-yeast rice product tested in previous studies, was not included in this study.