History of Red Yeast Rice (Monacolin-K)

RED YEAST RICE EXTRACT (RYR), which is solid-fermented by artificial inoculation of Monascus purpureus on steamed rice [1], has been widely used for thousands of years by China and its neighbors. It has various names in different cultures [2]. For example, it is called Chiqu, Hongqu, Red rice, Fuqu, etc., in China; Koji, AngKhak, Beni-Koji, and Red-Koji in Japan; Rotschimmelreis in Europe; and Red Mold or Red mold rice in the USA. In ancient times, Fujian, Zhejiang, and Taiwan were considered to be the places of origin of RED YEAST RICE EXTRACT (RYR), especially Gutian (a town in Fujian province) which has been confirmed as the genuine origin of RYR because of the high quality and production there [3,4]. The earliest record of RED YEAST RICE EXTRACT (RYR) has it being used as a food flavoring, colorant, and brewing agent, such as in fermented bean curd, pork stew, roast meat products, and rice wine [5]. Subsequently, the ancients discovered that RYR has therapeutic effects.The therapeutic effects have been recorded in the Compendium of Materia Medica, an ancient Chinese pharmacopoeia written by Li Shizhen during the Ming dynasty in 800AD [6], which narrated in detail how RYR has “the effect of promoting the circulation of blood and releasing stasis, invigorating the spleen and eliminating digestion.”

Since 1979, monacolin K, which can lower lipids in blood, has been extracted from Monascus species [7]. A modern-era use as a dietary supplement developed in the late 1970s after researchers were isolating lovastatin from Aspergillus and monacolins from Monascus, respectively, the latter being the same fungus used to make red yeast rice (monacolin-K). Chemical analysis soon showed that lovastatin and monacolin K were identical. Nowadays, RYR comes in two forms on the market [8]: common RYR, which is used as a source of natural pigments for coloring in the food and textile industries. The fermentation conditions of common RYR are relatively quick and simple. According the “Food additives Red yeast rice GB1886.19-2015,” the quality of common RYR is evaluated by color [9]. The other type is called functional RYR, which has a definite lipid-lowering effect. The fermentation conditions of functional RYR need to be optimized scientifically, including through screening of Monascus strains and determination of optimal fermentation conditions (temperature, moisture content, time, etc.). The quality of the functional RYR is evaluated by the contents of monacolin K, which is one of the secondary metabolites of Monascus [10,11]. Because of the well-known lipid-lowering efficiency of functional RYR, there are many Chinese patent medicines containing functional RYR for reducing lipids on sale in the market.

Lovastatin became the patented, prescription drug Mevacor. [5] Red yeast rice (monacolin-K) went on to become a non-prescription dietary supplement in the United States and other countries. In 1998, the US Food and Drug Administration (FDA) initiated act ion to ban a dietary supplement containing red yeast rice (monacolin-K) extract. The FDA position was that red yeast rice (monacolin-K) products that contain monacolin K are identical to a prescription drug and, thus, subject to regulation as a drug. The US District Court in Utah ruled in favor of allowing the product to be sold without restriction. This decision was reversed on appeal to the US Court of Appeals in 2001.

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