dmark consulting LLC

Whoever said that in life there is no second act has not been following the red yeast rice story. Left for dead when banned from the U.S. dietary supplement market in 2001, red yeast rice (RYR) products are now back on the market with a vengeance – offered by over a dozen brands. How has this come to pass?

The first act was the rise and fall of red yeast rice as a dietary supplement. Monascus purpureus is a type of yeast grown on rice, traditionally used in China to generate a safe reddish food coloring (hence ‘red yeast rice’). Think Chinese-style barbequed ribs, duck, etc. In the 1990’s Chinese scientists working with the Monascus purpureus Went strain, using specific and carefully monitored growing conditions, were able to make powdered red yeast rice which, when taken orally at 1.2 to 2.4 grams per day, lowered serum cholesterol and LDL-cholesterol of people with elevated cholesterol. The active principal was a family of chemically related compounds referred to as monacolins, and in particular monacolin K. It is essential to realize that most red yeast rice strains used in foods have little to no monacolin content. In contrast, the Went strain producted a final product that was approximately 0.4% monacolins, with half of that monacolin K.

The beneficial effect was confirmed in multiple clinical trials, including one conducted in the U.S. and published in the American Journal of Clinical Nutrition [1999;69:231-236]. Literature searches on “red yeast rice, cholestin,” and “xeuzhikang” will identify more than ten well-conducted studies – the most recent published in 2005.

Lest one think that Monascus is a Johnny-come-lately to the statin scene, research dating back to the 1970’s showed Monascus-derived monacolin K and Aspergillus-derived mevinolin (lovastatin, Mevacor®) as chemically identical compounds. “The Origin of the Statins” [Atherosclerosis Suppl 2004;5:125-130] nicely summarizes how the two isolations, documentations and patent applications were just months apart. Lovastatin went on to be a blockbuster drug for Merck. And monacolin K came back as a compound in a dietary supplement.

Cholestin® was the brand name of a RYR product by Pharmanex LLC. The Food and Drug Administration moved to ban Cholestin® and other RYR products in 1998. The FDA position was that the products were unapproved new drugs. The protracted legal effort ended with a U.S. District Court decision in March 2001 that RYR products “…that contain lovastatin are subject to regulations as drugs… and are not dietary supplements.” Shortly thereafter, the FDA sent Warning Letters to all wholesalers and retailers of red yeast rice, and the product disappeared from the market.

The second act began with the reappearance of RYR products on the U.S. market in 2003. Brands include Solaray®, Veglife®, KAL®, Action Labs®, Thompson®, Source Naturals®, NOW® Foods Products, Doctor’s Best®, HPF Cholestene®, and so on. While the first five are actually all from Nutraceutical International Corporation, it is still an impressive list for a banned product! Interestingly, Pharmanex has Cholestin® back on the market again to “Maintain existing normal cholesterol levels” but it now contains no red rice yeast – instead it is dependent on the function of Policosanol, an extract of honeybee beeswax.

A reasonable guess is that these new RYR products are not the Went stain (or not cultured to maximize monacolins). Most of the labels and websites say no more than “fermented according to traditional Asian methods” or “similar to that used in culinary applications.” A 2004 review of ten capsule or tablet products labeled as red yeast rice reported a 30-fold range of monacolin content [J Pharm Biomed Anal 2004;35:1101-12]. U.S. products in this survey were at 2% to 50% of a standard reference RYR.

Why sell monacolin-free RYR? When questioned in December 2004, the FDA replied “The agency 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.”

So, companies that want to market RYR in the U.S. are in a Catch-22 situation: sell RYR that they know contains monacolins (and thus lowers cholesterol), but risk the wrath of the Food & Drug Administration, or sell a monacolin-free RYR (with no evidence that it works) and claim nothing, thus avoiding the FDA and ducking the FTC, but defrauding the customer. Many of the products now on the market make no mention of monacolin content or of cholesterol lowering, so they appear to be taking the second path. A few are risking the first path.

The third choice, of course, is to not sell Red Yeast Rice (and probably sleep better at night). A number of the better known dietary supplement companies have made this decision.