“We own it” said the pharmaceutical industry in the US with the help of the FDA
And now, Red Yeast Rice on the shelves in the US is stripped of its beneficial ingredient
For centuries red yeast rice (RYR) has been used as a staple in China and Japan. It has been consumed as a preservative, food colorant, spice, and as an ingredient in rice wine
Red yeast rice is a product of the fermentation of red yeast (Monascus purpureus) on rice. Since 800 A.D. the Chinese have used red yeast rice medicinally to improve circulation, alleviate indigestion, as an anti-diarrheal, and since the 1970’s…both Japanese, Chinese, and US scientists have recognized its ability to lower plaque causing blood lipids… LDL cholesterol and triglycerides.
In 1977, Professor Endo in Japan discovered a natural cholesterol-lowering substance that is produced by a strain of Monascus yeast. This substance inhibits an enzyme that is important for the production of cholesterol in the body. Professor Endo named this substance moncacolin K. Since then, scientists have discovered a total of eight monacolin-like substances that have cholesterol-lowering properties. They are all derived from red yeast rice.
The active ingredients in RYR were developed into a supplement that was available over the counter in health food stores under the trade names Cholestin and Hypocol; Both products were produced through the fermentation of selected strains of Monascus purpureus, using a proprietary process that produces a certain concentration of monacolin K. It is interesting to note that lovastatin (the cholesterol lowering drug known as Mevacor) is currently made of monacolin K.
Studies have shown that red yeast rice can significantly lower levels of total cholesterol and specifically LDL, or “bad” cholesterol. One showed that taking 2.4 grams per day of red yeast rice reduced LDL levels by 22% and total cholesterol by 16% in 12 weeks. Another study showed that taking 1.2 grams per day lowered LDL levels by 26% in just eight weeks.
Although studies showed that using RYR did safely lower cholesterol and triglycerides ….the FDA soon determined it was ILLEGAL to market RYR that contained more than trace amounts of monacolin K. The products that were available over the counter that worked to safely lower cholesterol and triglycerides were pulled. Although Cholestin is still sold (HypoCol is not), the monacolin K had to be reduced to trace amounts. It was no illegal to sell RYR that contained monacolin K in an amount that would help lower lipids.
Note that at this time, the pharmaceutical manufacturer of Mevacor argued that it owned the rights to the ingredient lovastatin. So, the FDA approved the use of monacolin K for pharmaceutical manufacture and distribution. As a side note: the minimum amount of the cholesterol lowering piece of Mevacor is 10mg. Also, serious side effects have been linked to statins including possible damage to the kidneys, liver, and muscles.
These are the reasons the FDA gave for making RYR manufacturers scale back their cholesterol lowering ingredients to trace amounts:
Statin drugs are associated with muscle and kidney injury when used alone or combined with other medications. There is concern that patients who already take statin drugs with or without these other medications may increase their risk of muscle or kidney injury. (Perhaps RYR would negate the need to take the statins?)
Second, the FDA considers the products containing red yeast rice with high levels of cholesterol lowering substances to be new, unapproved drugs for which marketing violates the Federal Food, Drug, and Cosmetic Act. (The statins contain high levels of cholesterol lowering substances)
So….The FDA acknowledged that statins are potentially harmful to muscles, liver, and kidneys. Monacolin K in RYR might actually lower cholesterol without people being tied into a lifetime of costly statins. The FDA promptly removed the beneficial levels of RYR from the US market.
As previously mentioned, the statin Mevacor is made of highly purified and concentrated lovastatin (monacolin K). It is STRONG MEDICINE. The monacolin K in HypoCol and Cholestin was much lower in concentration. In each 600mg capsule of Cholestin, there was less than 2.4mg of lovastatin. Mevacor tablets have 10mg or more per tablet!
In fact, Cholestin and HypoCol contained a mixture of the eight yeast-produced monacolins, unsaturated fatty acids, and certain anti-oxidants. Some scientists believe that these other monacolins, unsaturated fatty acids, and anti-oxidants may work together favorably with the lovastatin to enhance its cholesterol-lowering effects, as well as its ability in lowering triglycerides and increasing HDL cholesterol.
No large, long-term studies of red yeast rice products for the prevention of heart attacks have yet been conducted. However, animal studies are underway at UCLA comparing red yeast rice to a statin drug (such as Mevacor) for the prevention and treatment of atherosclerosis.
As for side effects of RYR, human trials in China and the US, although lasting months and not years, showed only rare and minor side effects like heartburn or indigestion. No liver, kidney, or muscle toxicity was reported. Come to think of it, the Chinese have been consuming RYR for centuries without side effects. This is much more than we can say for our statins.
Unfortunately, the RYR products currently available in the US do not contain sufficient cholesterol lowering substances to aid in lipid reduction.
What says the Mayo Clinic about RYR?
Since the 1970s, human studies have reported that red yeast lowers blood levels of total cholesterol, low-density lipoprotein/LDL (“bad cholesterol”), and triglyceride levels.
Preliminary evidence shows that taking Monascus purpureus by mouth may result in cardiovascular benefits and improve blood flow. Additional study is needed before a firm recommendation can be made.
Early human evidence suggests the potential for benefits in diabetics. Additional study is needed before a firm recommendation can be made.
If RYR were available in beneficial dosages, it might not be safe for everyone. You would not take it if you:
- Have kidney disease
- Have liver disease
- Are pregnant
- Are breastfeeding
In addition, the following medications should not be mixed with RYR
- Statins to control cholesterol such as Crestor, Lescol, Lipitor, Pravachol, Mevacor, and Zocor
- Other cholesterol drugs such as Lopid and Tricor
- Drugs to suppress the immune system, like cyclosporine
- Antifungal drugs such as Diflucan, Nizoral, and Sporanox
- The antibiotics erythromycin and Biaxin
- Serzone, an antidepressant
- Protease inhibitors, used to treat HIV
People who have allergies to fungus or yeast should also be wary of using red yeast rice.
Always talk to your doctor before you start using red yeast rice or any other supplement.
As for RYR, it is possible to obtain it out of the US. The problem is that you will not be sure of its purity, actual concentration of monacolin K, additives, etc. It’s a shame that a natural substance that has been ingested for over 1000 years without incident, known to lower LDL cholesterol and triglycerides in less than ¼ the dose in the lowest dose of a statin, and would be very affordable was removed from US access so that the pharmaceutical industry could market it in a super powerful dose with known side effects…and a hefty price tag.