FDA Warns Consumers To Avoid Red Yeast Rice Products Promoted On Internet As Treatments For High Cholesterol

12 Aug 2007
http://www.medicalnewstoday.com/articles/79392.php

The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. 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 potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature's Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. 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.

"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. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.

The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm's websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act. The warning letters are available on FDA's Web site: http://www.accessdata.fda.gov/script...ecentfiles.cfm.

FDA advises consumers who use any red yeast rice product to consult their health care provider if they experience problems that may be due to the product.

http://www.fda.gov

and want to rush out to buy these products? Once trust is lost....

Is this stuff by any chance from China?

Another huge recall due at 10 am. Houston, we have a problem.

In China, the disgraced businessmen commit suicide, as the toy company CEO just did. Regulations sound more reasonable and would create jobs in India?

I don't know about this global economy.

paula

Swanson Health Products has issued a statement regarding the FDA's letter about their red yeast rice products:

The FDA notified Swanson Health Products that we cannot sell our current red yeast rice formulations, and therefore we have pulled the products from sale. Lovastatin is a naturally occurring component of red yeast rice; however, the FDA has taken issue with the level of lovastatin that is in our products based on their testing. The products will be reformulated and returned to our shelves as soon as possible.

For years Swanson Health Products has far exceeded the quality assurance standards set by the federal government for dietary supplements. Since 2001, we’ve participated in the GMP (Good Manufacturing Practices) program of the Natural Products Association, and we have consistently received their “A” rating for our compliance to it. Swanson Health Products is committed to complying with all laws and regulations pertaining to our products.


Swanson Health Products is located in Fargo, ND, and has been a leading vitamin and health products company since 1969. Our customers are number one and to prove that, we offer powerful guarantees. All products are backed by a 100% Satisfaction, Money-Back Guarantee. If you are not satisfied with your purchase for any reason, simply return the unused portion for a full refund of the purchase price.

Red yeast rice has been used in china for ~ 2 centuries for coronary disease. In the 1980's, merck decided to isolate the active ingredient in RYR to determine if it could be artifically produced. Red Yeast Rice IS a statin. The active component in RYR was isolated and synthesized by Merck -active component was labeled "mevacolin K". Merck produced this artifically and developed "mevacor". Isolating the ingredient without synthesizing it would not help the pharmaceutical industry--they are unable to patent a naturally occurring substance; thus too much competition . the amount of mevacolin K in RYR is very low in comparison to mevacor--and very very low in comparison to other statins such as lipitor. though the FDA is insisting upon scare tactics in listing all the potential side effects from RYR--and with statins, drugs that are infinitely stronger than RYR, the literature keeps dowmplaying these potential effects, restating the adverse effects #'s of 2 %, highlighting the "low number"--a number not truly reflective of the studies....I am no champion of the supplement industry--being an unregulated industry, there are many many opportunistic, dishonest individuals within that sector. It is thought that the statements about RYR were prompted by the pharm industry. the statin market has taken a decided downturn within the last 6 months; they wish to get rid of the competition....