A Public Health Scandal

FDA Bans Red Yeast Rice

y the time you receive this issue of Life Enhancement, red yeast rice will no longer be available in this country, thanks to the FDA. This is a public health scandal, because red yeast (from which red yeast rice is fermented) comes from a natural plant source and is known to substantially reduce high cholesterol, the condition most responsible for cardiovascular disease and the cause of nearly 1,000,000 deaths in the United States last year. The FDA, however, says that red yeast is a drug, not a dietary supplement.

Yet for at least 2000 years, red yeast (Monascus purpureus) has been used in China as a spice, a food-coloring agent, and an herbal remedy for improving blood flow. By contrast, the principal active ingredient of red yeast, lovastatin, was patented by Merck & Co. only in 1988. Lovastatin is one of a class of cholesterol-reducing drugs that now dominate this multibillion-dollar segment of the health care industry.

Merck probably learned about natural statins from earlier Japanese red yeast studies, and in 1987 they finally synthesized lovastatin, the first synthetic statin to be sold as a cholesterol-reducing drug.* With a mechanism of action similar to that of red yeast, and producing similar beneficial effects, the statin drugs have monopolized the spotlight in the battle against cholesterol, but at the cost of serious side effects.

*The authoritative Merck Index lists lovastatin as a fungal metabolite derived from Monascus yeasts.

A typical daily serving of red yeast rice contains only about one-quarter as much natural lovastatin (along with other statins) as a standard daily dose of synthetic lovastatin, reducing the likelihood of side effects. Nevertheless, the FDA claims that red yeast is a drug because it contains lovastatin.

This is incredible! It is as if the FDA one day declared that vitamin C was a legal drug and thereafter held that any food containing it was an illegal drug - oranges, for example. The Dietary Supplement Health and Education Act of 1994 states that substances already marketed in the United States as dietary supplements or foods before the bill was signed may not be declared to be drugs.

As American Founding Father Dr. Benjamin Rush once said, "Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship to restrict the art of healing to one class of men and deny equal privileges to others." Alas, that time has come.

The Greek physician Galen (131-201 A.D.) advocated the use of foods to treat disease, as have countless others since then. While science is now unraveling the health mechanisms of many common foods, this fact does not make them into drugs. It is our inalienable right to control our own lives, and it is our obligation to preserve and expand our freedom to use dietary supplements.

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