FDA

FDA Moves to Shut Down Red Yeast Rice Distributors Online

Thursday, September 20, 2007 by: Bradley R. Chappell
Tags: red yeast rice, health news, Natural News

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(NaturalNews) On August 9th the FDA issued a warning to the public against buying or consuming three red yeast rice products sold on the internet. The FDA stated as their primary reasons for this action; "The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol."
 
The FDA goes on to list the "potentially harmful products" and the companies involved; Swanson Healthcare, Nature's Value, Kabco and Sunburst Biorganics. The letter states, "FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol." It goes on to say," "This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment."
 
In keeping with FDA policy warning letters were sent to Swanson and Sunburst Biorganics advising them to halt promotion and sales of the products at the risk of further legal action.
 
At face value this would seem to be nothing more than a caring, compassionate act of a Government organization, intent on your safety and health. But is there more to it than this?
 
An uneasy alliance
 
In a News Target article by Jessica Fraser she states, "Red yeast rice has been used for over 1,000 years in China to improve circulation and treat indigestion and diarrhea. It is made from rice fermented by a red yeast known as Monascus purpureus and is frequently used as a food preservative and food color, as well as a spice and a component of rice wine.".
 
 
According to research on PubMed red yeast rice consists of 14 monacolin compounds such as monacolin K, a natural lovastatin. Some scientists believe that these other monacolins, along with its naturally occurring unsaturated fatty acids and anti-oxidants, may work together favorably with lovastatin to enhance its cholesterol-lowering effects, as well as its ability to lower triglycerides and increase HDL cholesterol. This is red yeast rice in its natural state of which the average daily consumption in Asia is 14 to 55 grams per person.
 
Enter, the FDA policies. According to FDA, Swanson's products, if taken as advertised on the company's website, provide more than 5 mg of lovastatin daily, or half the lowest-recommended daily dose of FDA-approved formulations of the drug.

FDA stated that Sunburst's product, Cholestrix, is advertised as containing "1.35% of naturally occurring lovastatin," with two tablets daily providing 10 mg of the drug. Sunburst's website featured an image of the Cholestrix bottle with the label clearly stating that the product is "Standardized to Contain 1.35% Lovastatin."

FDA contends that traditional red yeast rice contains, at the most, trace levels of lovastatin and described the purported supplements as unapproved drugs that have been "enhanced" with lovastatin, which has been regulated as a drug since 1987. Since none of the other companies that manufacture red yeast rice have concentrated their product through standardization they have been able to fly under the FDA radar. Most have a recommended dosage of 600 to 1200mg a day, which is about 10% of what they consume on a daily basis in Asia.

The second issue addresed by the FDA was the companies' websites making claims that the red yeast products are intended for the diagnosis, cure, prevention or treatment of diseases. Supplement makers and distributors are prohibited under the federal Food, Drug, and Cosmetic Act from making such claims for their products; unless you manufacture Traditional Chinese Medicine evidently. There is a concentrated red yeast rice formulation called Xuezhikang which, according to research, "could readjust human blood-fat levels and long term use could lower the occurrence rate of the disease by over 45 percent and the recurrence rate of non-fatal myocardial infarctions by some 60 percent." Yet as of this date they are free to advertise their claims freely on the internet.
 
A statin by any other name
 
The primary issue for the FDA seems to be the danger of accidental abuse of the very dangerous drug, lovastatin, even though a person would have to take twice as much to equal one dose of Mevacor. Aside from which, people use alternative methods of healing to get away from pharmaceuticals, not as an adjunct, therefore it is unlikely health conscious people would be using Mevacor and the red yeast rice together.
 
The FDA is correct; there is a definite proven danger to using statin drugs. In an article by Sally Fallon and Mary G. Enig, PhD we are told, "The most common side effect (of statin drugs) is muscle pain and weakness, a condition called rhabdomyolysis, most likely due to the depletion of Co-Q10, a nutrient that supports muscle function." Rhabdomyalysis is a common, many times lethal, tearing down of the muscle tissue which is then distributed into the bloodstream. The article goes on to say, "Dr. Beatrice Golomb of San Diego, California is currently conducting a series of studies on statin side effects. The industry insists that only 2-3 percent of patients get muscle aches and cramps but in one study, Golomb found that 98 percent of patients taking Lipitor and one-third of the patients taking Mevachor (a lower-dose statin) suffered from muscle problems." When your doctor says, "Let me know if you have any discomfort in your calves or back so we can adjust your dosage", this is what he is watching out for.
 
Many times the side effects take time to manifest. Here is one case Fallon and Enig relate concerning Mevacor (lovastatin); " John Altrocchi took Mevacor for three years without side effects; then he developed calf pain so severe he could hardly walk. He also experienced episodes of temporary memory loss."
 

More often, however, the debilitating side effects of statin drugs are much quicker to manifest as in the case of Bayer's short lived contribution to the market Baycol, which was approved in 1997 and voluntarily pulled from the market a short 4 years later. (Take note of the fact that Bayer chose to withdraw this drug after 60 rhabdomyolysis related deaths and not at the prompting of the FDA).

The headlines of a news release dated August 8, 2001 read "BAYER VOLUNTARILY WITHDRAWS BAYCOL" which claimed, "FDA today announced that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision."

Duane Graveline MD MPH Former USAF Flight Surgeon, Former NASA Astronaut and Retired Family Doctor states, "In August 2001 the statin drug, Baycol, was removed from the market after causing at least 60 deaths. As a result, the safety of all statin drugs has subsequently come into question". (For a complete history of Baycol from pre-market strategies, through FDA complicity and into the post-withdrawal litigation read the Journal of Medical Marketing (2007) article by Reinhard Angelmar)
 
In my research I was unable to find even one case of red yeast rice related death or debility but as a health consultant I would advise anyone considering using RYR to ere on the side of caution and seek professional advice.
 
To sum up, the FDA may have had a legitimate reason to come down on these companies for making claims that only the FDA approved drug companies can legally make but it is up to you to decide if the FDA was actually safeguarding our health or simply guarding their own fiscal interests.

About the author

My name is Bradley R. Chappell (the Cosmicbear). I have been an educator and speaker in Southern Arizona for the past 10 years on subjects concerning Constitutional liberties, the FDA/AMA involvement in setting health policies in America, herbal therapeutics and Chinese medicine and philosophy. I am presently involved in researching Homeopathic and Flower Essence healing models. I am best known for my in depth research and integrity.

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