Culinary with
misua noodles Red yeast rice is used to color a wide variety of food products, including
fermented tofu, red
rice vinegar,
char siu,
Peking duck, and Chinese pastries that require red food coloring. In China, documentation dates back to at least the first century AD. It was called a "koji" in
Japanese, meaning "grain or bean overgrown with a mold culture". Red yeast rice (
angkák in
Filipino) is also used widely in the
Philippines to traditionally color and preserve certain dishes like fermented shrimp (
bagoóng alamáng),
burong isdâ (fermented rice and fish), and
balao-balao (fermented rice and shrimp).
Traditional Chinese medicine In addition to its culinary use, red yeast rice is also used in
Chinese herbology and
traditional Chinese medicine. Medicinal use of red yeast rice is described in the Chinese pharmacopoeia
Ben Cao Gang Mu compiled by Li Shizhen ca. 1590. One reference provided the Li Shizhen health claims as a quotation "...the effect of promoting the circulation of blood and releasing stasis, invigorating the spleen, and eliminating [in]digestion." Lovastatin became the patented, prescription drug Mevacor. Red yeast rice went on to become a non-prescription
dietary supplement in the United States and other countries. Lovastatin and other prescription
statin drugs inhibit cholesterol synthesis by blocking action of the enzyme
HMG-CoA reductase. As a consequence, circulating total
cholesterol and
LDL-cholesterol are lowered by 24–49% depending on the statin and dose. Different strains of
Monascus fungus will produce different amounts of monacolins. The 'Went' strain of
Monascus purpureus (purpureus=dark red in Latin), when properly fermented and processed, will yield a dried red yeast rice powder that is approximately 0.4% monacolins, of which roughly half will be monacolin K (chemically identical to lovastatin).
U.S. regulatory restrictions The US
Food and Drug Administration (FDA) position is that red yeast rice products that contain monacolin K are identical to a prescription drug and, thus, subject to regulation as a drug. In 1998, the FDA initiated action to ban a product (Cholestin) containing red yeast rice extract. The U.S. District Court in Utah ruled in favor of allowing the product to be sold without restriction. This decision was reversed on appeal to the U.S. Court of Appeals in 2001. In 2007, the FDA sent warning letters to two dietary supplement companies. One was making a monacolin content claim about its RYR product and the other was not, but the FDA noted that both products contained monacolins. Both products were withdrawn. In a press release the FDA "...is warning consumers to not buy or eat red yeast rice products... may contain an unauthorized drug that could be harmful to health." The rationale for "harmful to health" was that consumers might not understand that the dangers of monacolin-containing red yeast rice are the same as those of prescription statin drugs. Many of these avoid FDA regulation by not having any appreciable monacolin content. Their labels and websites say no more than "fermented according to traditional Asian methods" or "similar to that used in culinary applications". The labeling on these products often says nothing about cholesterol lowering. If products do not contain lovastatin, do not claim to contain lovastatin, and do not make a claim to lower cholesterol, they are not subject to FDA action. Two reviews confirm that the monacolin content of red yeast rice dietary supplements can vary over a wide range, with some containing negligible monacolins.
Clinical evidence The amount typically used in clinical trials is 1200–2400 mg/day of red yeast rice containing approximately 10 mg total monacolins, of which half are monacolin K. A
meta-analysis reported LDL-cholesterol lowered by 1.02 mmol/L (39.4 mg/dL) compared to placebo. The incidence of reported adverse effects ranged from 0% to 5% and was not different from controls. A second meta-analysis incorporating more recent clinical trials also reported significant lowering of total cholesterol and LDL-cholesterol. Within the first review, These heart attack and cardiovascular death outcomes appear to be better than what has been reported for prescription statin drugs. A 2008 review pointed out that the cardioprotective effects of statins in Japanese populations occur at lower doses than are needed in Western populations, and theorized that the low amount of monacolins found in the
xuezhikang product might have been more effectively athero-protective than expected in the Chinese population for the same reason.
Safety The safety of red yeast rice (RYR) products has not been established. Some supplements have been found to contain high levels of
citrinin, which can be toxic to the liver, kidneys, and cellular DNA. From a review: "The potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions." The European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food concluded that when red yeast rice preparations contained monacolins, the Panel was unable to identify an intake that it could consider as safe. The reason given was case study reports of severe adverse reactions to products containing monacolins at amounts as low as 3 mg/day. Red yeast rice is not recommended during pregnancy or breast-feeding. In March 2024, the Japanese
Ministry of Health ordered stores to remove three RYR dietary supplements (Benikoji ColesteHelp, NaishiHelp Plus Cholesterol and Natto-kinase Sarasara Tsubu) produced by Kobayashi Pharmaceutical after reports of thousands made ill. The suspect batch was manufactured in 2023. Some analysts have placed the blame on industry
deregulation, intended to boost economic growth by facilitating the approval of health products.
Benikoji products such as
miso paste, crackers,
food coloring, and a vinegar dressing made by other companies were also recalled. Kobayashi Pharmaceutical officially discontinued production of
beni koji products on 8 August 2024. ==See also==