RYR AND THE FDA

In a press release on May 20, 1998 the FDA ruled that Cholestin, a health supplement containing red yeast rice, can no longer be sold legally in the United States. The FDA based its decision on the fact that Cholestin contains an ingredient almost chemically identical to lovastatin, the active ingredient in the common prescription medication Mevacor. Since lovastatin was approved for use as a drug and was not, according to the FDA "marketed as a dietary supplement or food", the agency believes it is a violation of current labeling laws to sell Cholestin as a cholesterol-lowering supplement.

Overturning the FDA's position, the Federal District Court in Utah on February 16, 1999 ruled that Cholestin could be sold as a dietary supplement since it is not a drug. The ruling rejected the FDA's position that the Cholestin product label advertised cholesterol-lowering abilities. The makers of Cholestin did not claim it prevented atherosclerosis, but that it could lower cholesterol. Since cholesterol levels naturally vary in people and since the claim is only that Cholestin could lower cholesterol, the court ruled to allow importation of red yeast rice.

But then, on July 21, 2000, the US Court of Appeals for the Tenth Circuit ruled in favor of the FDA, and the makers of Cholestin were forced to remove it from the market within the United Sates. The Appeals Court remanded the matter back to the district court for resolution of certain factual issues.

Subsequently, the United States District Court for the District of Utah (Judge Dale A. Kimball) denied Pharmanex Inc.'s motion to Set Aside Administrative Decision, and granted the FDA's motion to Affirm Administrative Decision, in the Cholestin matter (Pharmanex v. Shalala).

Later that year, some other suppliers of RYR received letters from the FDA's Department of Health and Human Services directing them to stop all sales of RYR. The FDA claims that RYR's principal ingredient, monacolin, also known as lovastatin, is an unapproved drug. Therefore, as a drug, RYR cannot be sold without FDA approval, and even if it had this approval, it would only be available with a doctor's prescription.

To quote the FDA: "Accordingly, red yeast rice products containing lovastatin are unapproved new drugs. The introduction or delivery for introduction of an unapproved new drug into interstate commerce is prohibited under the Federal Food, Drug, and Cosmetic Act (FDCA), sections 301(d) and 505(a). The manufacture, importation, or distribution of red yeast rice products containing lovastatin may also violate other provisions of the FDCA."

The situation is not clear. Some suppliers of RYR have stopped selling it and some have not. It is still available online and in health food stores, but may not be much longer.

Note that the FDA has never challenged the safety and effectiveness of RYR. There have been no reports of harm or injury to any user during over six years of sales in this country. This is just another example of how our government is run by moneyed interests. You can be sure that drug companies are working behind the scene, applying all the pressure they can to have RYR banned forever. The bosses at the FDA know that very lucrative jobs await them in the drug industry anytime they want them, provided that they protect drug company interests while in bureaucratic office. Our "cash and carry" government at work as usual.

The prescription drugs called statins that are being taken by so many people are life-threatening. Bayer's drug Baycol had to be removed from the market in August, 2001 because it caused over 100 deaths. Yet, the FDA wants to force you to take these drugs rather than the much safer RYR.

Here are two letters that are part of the FDA file on this matter. Such human misery does not carry any weight at the FDA. Life and death doesn't matter. In that kingdom, money rules.

From: celesteb@ev1.net
Sent: Wednesday, June 13, 2001 12:48 AM
To: fdadockets@oc.fda.gov
Subject: Re: Red Yeast Rice

I was shocked when I heard that you were removing the chinese herb Red Yeast Rice from being used as an alternative to prescription drugs.

I am 63 years old and can not take prescription medication...too many side effects and also too strong for someone my age.

I have been taking CholesteSure by Natrol^* with my physician's knowledge and he is very happy with the results of the lowering of my cholesterol. I tried one of the drug companies' cholesterol lowering drugs last November, 2000 and almost died. I had an allergic reaction and my doctor told me to stop taking it. I did. He said we would just monitor my cholesterol and for me not take any prescription medications. I decided to do a little research on the web and found many studies done on Red Yeast Rice. I talked to my doctor in January, 2001 and he agreed that I should try it. I did and after 3 months my total cholesterol dropped down from 286 to 225. I have had no side effects. Also my blood pressure is lower. ^* Editor's note: Due to FDA pressure, Natrol no longer carries Red Yeast Rice products.

Please don't remove the only cholesterol lowering product that has helped me and many other older Americans.

I have never in my life ever asked the government to do anything for me personally, but this decision by the FDA could be life threatening to me and many others. I am not an activist or belong to any groups; I am not a vegetarian...I just want help.

Thank you for listening to me,
Celeste Wright
1006 Bell Springs Rd.
Dripping Springs, TX 78620

 
From: W22852@aol.com
Sent: Friday, June 22, 2001 7:26 AM
To: fdadockets@oc.fda.gov
Subject: Red Yeast Rice

I am infuriated that I can no longer get my red yeast rice that has wonderfully lowered my cholesterol level and inverted my HDL and LDL. Once again, the Pharmaceutical Companies are bed partners with the FDA. All the statin drugs, i.e. Lipitor, Mevacor, etc. have potential terrible side effects and have been published even in our local papers; yet the natural form in the red yeast rice has no side-effects. As taxpayers we have the right to choose what form of "medicine" we want to take. Just publish the information and let us judge; we're not all stupid here in the USA. I'm 50 years old and I can slowly see the day this country will be a police state where our rights will be few or none. It appalls me that you don't take into account that natural medicine has been around for centuries. I intend to find the red yeast rice over the internet and have it shipped directly to me. What's next, Hawthorne Berry? Will you take that away from us?

W. Young

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