Red Yeast Rice / Policosonal Complex and Cholestrix

Red Yeast Rice, / Policosonal Complex and Cholestrix

Warning Foreign Product
2007-152
On 25 October 2007
For Immediate Release

Health Canada advises consumers not to use the products described in the table below due to the risk of possible side effects. More info

Date of warning: On 25 October 2007
Source of the alert: Food and Drug Administration (FDA) (United States)
Product Name: Red Yeast Rice, Red Yeast Rice / Policosonal Complex and Cholestrix

Manufacturer, place of origin
Red Yeast Rice and Red Yeast Rice / Policosonal Complex sold by Swanson Healthcare Products, Inc.. (Fargo, ND, USA) and manufactured by Nature's Value Inc. and Kabco Inc.

Cholestrix is sold by Sunburst Biorganics (Baldwin, NY, USA)

Product Description
Red Yeast Rice, Red Yeast Rice / Policosonal Complex and Cholestrix sold as dietary supplements to reduce cholesterol.

Reason for caution
The U.S. FDA advises against the use or purchase of these products because they contain lovastatin, a prescription drug used to lower cholesterol, you should take only under the supervision of a professional of Health.

Possible side effects
Lovastatin is associated with serious side effects such as liver problems, kidney and muscle. It is not recommended for people with kidney or liver problems or vulnerable people such as seniors and pregnant or lactating. One should not combine lovastatin with other drugs such as cholesterol or antibiotics (erythromycin or clarithromycin) because the combination may increase the risk of drug interactions and serious side effects.

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Media Inquiries
Carole Saindon
Health Canada
613-957-1588

For more details on these alerts for products from abroad, please consult the Health Canada website.

The sale of this product is not authorized in Canada and it is not available on the Canadian market. However, it may be that Canadians have bought during a trip abroad, are imported into Canada for personal purposes or have purchased over the Internet.

We caution Canadians have this product do not use and consult a health professional if they are worried about their health.

The label of any drug or natural health product whose sale is permitted in Canada features a digital identification code of eight digits (DIN), a Natural Product Number (NPN) or a homeopathic medicine number (DIN-HM ). This code confirms that Health Canada has assessed the safety, efficiency and product quality.

Health Canada encourages Canadians to contact the Branch Inspectorate Health Products and Food at 1 800 267-9675, if they are on the market the product described in the table below.

Consumers seeking additional information on this notice may contact Health Canada at (613) 957-2991 or 1 866 225-0709 (toll free).

At the publication of this notice, no adverse effects that might be associated with the use of this product had been reported in Canada.

Red Yeast Rice Uses

Uses

[edit] Culinary

The dried grain can be prepared and eaten in the same manner as white rice—a common practice among Asians. It can also be added to other foods.

Red yeast rice is used to colour a wide variety of food products, including pickled tofu, red rice vinegar, char siu, Peking Duck, and Chinese pastries that require red food colouring. It is also traditionally used in the production of several types of Chinese wine, Japanese sake (akaisake), and Korean rice wine (hongju), imparting a reddish colour to these wines.[2][3]

Although used mainly for its colour in cuisine, red yeast rice imparts a subtle but pleasant taste to food and is commonly used in the cuisine of Fujian regions of China.

[edit] Traditional Chinese medicine

In addition to its culinary use, red yeast rice is also used in traditional Chinese herbology and traditional Chinese medicine. Its use has been documented as far back as the Tang Dynasty in China in 800 A.D. and taken internally to invigorate the body, aid in digestion, and remove "blood blockages".

[edit] Modern medicine

Red yeast rice when produced using the 'Went' strain of Monascus purpureus contains significant quantites of the HMG-CoA reductase inhibitor lovastatin which is also known as mevinolin, a naturally-occurring statin. It is sold as an over the counter dietary supplement for controlling cholesterol (See ref.: Medicine Net). There is strong scientific evidence for its effect in lowering blood levels of total cholesterol, low-density lipoprotein/LDL ("bad cholesterol"), and triglyceride levels (see below). Because an approved drug is identical to the molecule it is therefore regulated as a drug by the Food and Drug Administration (FDA).

In 1998, the FDA tried to ban a product (Cholestin) containing red yeast rice extract but the U.S. district court in Utah allowed the product to be sold without restriction. This was reversed on appeal. (Moore, 2001) (see ref.: PDRhealth). Cholestin as a product continues to be marketed but no longer contains red yeast rice (RYR). Other companies sell red yeast rice products but most of them use a different strain of yeast or different growing conditions, resulting in RYR with a negligible statin content. The labeling on these new products often says nothing about cholesterol lowering. As late as August 2007, FDA noted supplements being sold containing significant lovastatin levels.(FDA, 2007)

In 2006 Liu et al. published a meta-analysis of clinical trials (Chinese Med 2006;1:4-17). The article cited 93 published, controlled clinical trials (91 published in Chinese). Total cholesterol decreased by 35 mg/dl, LDL-cholesterol by 28 mg/dl, triglycerides by 35 mg/dl, and HDL-cholesterol increased by 6 mg/dl. Zhao et al. reported on a four-year trial in people with diabetes (J Cardio Pharmacol 2007;49:81-84). There was a 40-50% reduction in cardio events and cardio deaths in the treated group. Ye et al. reported on a four-year trial in elderly Chinese patients with heart disease (J Am Geriatr Soc 2007;55:1015-22). Deaths were down 32%. There is at least one report in the literature of a statin-like myopathy caused by red yeast rice (Mueller PS. Ann Intern Med 2006;145:474-5).

An article in the June 15, 2008, issue of the American Journal of Cardiology found that red yeast rice may provide benefits beyond those provided by statins. The researchers reported that the benefits seemed to exceed those reported with lovastatin alone.^[1]

ConsumerLab.com found large variation in the active compounds between red yeast rice supplements, and also found that some of them were contaminated with citrinin, a nephrotoxic mycotoxin.^[2][3] Evidence about the side effects of red yeast rice is limited, but it may have similar side effects to the drug lovastatin, which include kidney problems and other side effects.^[4] Regular medical monitoring is needed to detect such effects.

Red Yeast Rice Production

Production

Red yeast rice is produced by cultivating Monascus purpureus on polished rice. The rice is first soaked in water until the grains are fully saturated. The raw soaked rice can then either be directly inoculated, or steamed for the purpose of sterilizing and cooking the grains prior to inoculation. Inoculation is done by mixing M. purpureus spores or powdered red yeast rice together with the processed rice. The mix is then incubated in an environment around room temperature for 3–6 days. During this period of time, the rice should be fully cultured with M. purpureus, with each rice grain turning bright red in its core and reddish purple on the outside.

The fully cultured rice is then either sold as the dried grain, or cooked and pasteurized to be sold as a wet paste, or dried and pulverized to be sold as a fine powder. China is the world's largest producer of red yeast rice.

Due to the low cost of chemical dyes, some producers of red yeast rice have tried to adulterate their products with red dye #2 Sudan Red G [1](in Chinese).

Red yeast rice

Red yeast rice (Chinese: 紅麴米, 红曲米; pinyin: hóng qú mǐ; lit. "red yeast rice"), red fermented rice, red kojic rice, red koji rice, or ang-kak, is a bright reddish purple fermented rice, acquires its colour from being cultivated with the mold Monascus purpureus. In Japan, it is known as beni-koji (べにこうじ, lit. "red koji") or akakoji (あかこうじ, also meaning "red koji") and in Taiwan it is sometimes also called âng-chau (紅糟) in Taiwanese. Among the Hakka, it is known as fungkiuk. In China, it is widely available under the brand name XueZhiKang (血脂康), and in Singapore it is available as Hypocol.

Red yeast rice is sold in jars at Asian markets as a pasteurized wet aggregate, whole dried grains, or as a ground powder. It was a commonly used red food colouring in East Asian and Chinese cuisine prior to the discovery of chemical food colouring. It has also been used in Chinese herbal medicine.