red yeast rice and cholesterol

I've been meaning to post about red yeast rice for some time. Red yeast rice, is produced by cultivating the yeast strain Monascus purpureus, either spores or a prior fermented rice, on rice. Each rice grain turns 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.

Many red yeast rice products contain monacolin K, a compound identical to the drug marketed in the U.S. as lovastatin. Red yeast rice products that contain monacolin K, are banned in the by the Food and Drug Administration in the United States, which has stated that such products are identical to a 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 allowed the product to be sold without restriction. This decision was reversed on appeal to the U.S. District Court. Shortly thereafter the FDA sent warning letters to companies selling red yeast rice,and the product disappeared from the market for a few years.

In 2003 red yeast rice products began to reappear in the U.S. market (see the Wikipedia discussion referenced above) and avoid FDA requirements by making no claims about cholesterol lowering. Some contain no monacolin K. Two reviews referenced on the Wikipedia site indicate that monacolin content of red yeast rice varies widely. The FDA also issued a warning press indicating that consumers should “…not buy or eat red yeast rice products…[which] may contain an unauthorized drug that could be harmful to health.” The rationale for “…harmful to health…” was that consumers might not understand that red yeast rice might have the same side effects as prescription statin drugs.

In my view, this is absurd and is like saying that because tomatoes have potassium we are now banning tomatoes since potassium is marketed by itself as a drug and can be harmful to people with kidney failure who might not realize that they contain potassium. All Americans should be up in arms at these FDA rules. There seems to be no other reason for this than the financial well-being of the pharmaceutical companies selling statins. No pre-existing foodstuff, extract, or supplement, should be banned simply because a drug company decides to isolate and sell a compound in it for profit. If it requires regulation, then regulate it, and if it is identical to a drug, then it should be lawful just like that drug. If it does not require regulation (which I believe), then perhaps its drug cousins should be made over the counter too. Many of our OTC drugs have dangers which consumers need to know about, but regulating them through prescription is ineffective and just makes them expensive.

I welcome my reader's views on this topic!