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Does Red Yeast Rice Extract Lower Your Cholesterol?

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Updated December 19, 2012

Red yeast rice extract is an Asian product developed by fermenting rice with the organism Monascus purpureus, otherwise known as red yeast. This product is used as a coloring and flavoring agent in many Asian foods. Although red yeast fermented rice extract has gained popularity over the years because of its ability to lower cholesterol levels, it has been the center of a huge legal and regulatory debate between the U.S. Food and Drug Administration and the manufacturers of red rice fermented yeast extract.

When red rice fermented yeast extract supplements first hit the pharmacy shelves, they were highly effective. This was because of the red rice fermentation process, during which a by-product, known as monacolin K, was produced. Monacolin K is structurally and functionally similar to lovastatin (Mevacor®), a cholesterol-lowering medication that is only available by prescription in most countries. Like lovastatin, as well as other statins, red rice yeast extract positively affected all aspects of the lipid profile: LDL, HDL, and triglycerides . For instance, most studies have shown that around 1,200-2,400 mg of red rice yeast extract (or 2400-4800 mg of monacolin K component) lowers LDL on an average of 23 percent, lowers triglycerides by about 25 percent, and raises HDL by 14 percent. Once lovastatin was discovered as the major ingredient of red rice fermented yeast extract, the FDA became interested and wanted to have tighter regulation over what they considered to be a drug.

The FDA regulates foods, nutritional supplements, and drugs differently. The nutraceutical companies manufacturing red rice yeast extract were arguing that it was a nutritional supplement, which is not subject to the stringent regulation that drugs are held to. The FDA, on the other hand, contended that since red rice yeast extract contained a prescription drug in it (lovastatin), it should be categorized as a drug and be more tightly regulated. Through many battles in the U.S. Courts beginning in 2000, the FDA has won this position and the formulation of red yeast fermented rice extract was subsequently changed.

So, does red yeast fermented rice extract work? Yes, if it is fermented in such a way that results in the byproduct monacolin K (lovastatin). Do the currently available red yeast fermented rice extract supplements work? Because of the judgment in favor of the FDA to consider the monacolin K (lovastatin) component of red yeast rice extract a drug, nutraceutical companies have had to change the way the red rice is fermented.

As a result, these supplements contain very minute, if any, amounts of the cholesterol-lowering drug, lovastatin. Because of this, the red yeast fermented rice supplements you see on the shelves would not be effective and should not be expected to significantly lower cholesterol levels.

Sources:

Pizzorno JE, Murray MT. Textbook of Natural Medicine. New York, NY: Churchill Livingstone; 1999:689-692.

Thorne. Monascus purpureus (Red Yeast Rice). Alt Med Rev. 2004; 9(2) 208-210.

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