August 13, 2007

"Nutritional Supplement" Contains Prescription Drug, FDA Warns

Red yeast rice, a nutritional supplement that has gained some popularity for its ability to reduce cholesterol levels, actually works! The bad news is that it works because it contains a prescription drug called lovastatin (brand names Mevacor and Altocor), a prescription drug sold by legitimate dispensaries in controlled doses. Lovastatin interacts with many other drugs and even some foods, most notably grapefruit juice, and so is prone to producing side effects that can be very harmful, even fatal, when not used with care.

Long story short, red yeast rice can kill you despite its rather innocent-sounding name.

The FDA has issued a warning on this supplement and ordered its distributors to stop selling it. As of this morning, however, I went onto a website run by one of the companies that has been notified by the FDA and can still purchase the stuff. No mention of the warning is made anywhere on the site, for that matter. I noticed that many of the products sold on this website as "cholesterol/cardio aids" contain red yeast rice.

The following is a copy of the FDA warning, reproduced from the FDA website:

FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol
Products found to contain unauthorized drug

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:

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.

Report adverse events related to these products to MedWatch, the FDA’s voluntary reporting program:; 800-332-1088; Fax: 800-332-0178; and MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.
It is also worth noting that this isn't the first time that this company has been warned by the FDA about its products. This 2004 warning letter was sent in reference to several of Sunburst's products which, the company claimed, were used to treat cancer and arthritis.

It should be noted that this is an especially egregious case. According to the warning letter sent to Sunburst on August 7:
Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Because Cholestrix contains red yeast rice with enhanced or added lovastatin, and bears a claim about the "powerful cholesterol fighting" benefits supplied by this ingredient, it cannot be marketed as a dietary supplement. Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(ff), specifically excludes from the dietary supplement definition articles that are approved as new drugs under section 505 of the Act, 21 U.S.C. § 355, unless the article in question was marketed as a dietary supplement or food before its approval as a drug. 21 U.S.C. § 321(ff)(3)(B). FDA approved Mevacor as a new drug on August 31, 1987; neither lovastatin as a single ingredient, nor any red yeast rice product manufactured and promoted for lovastatin content, was marketed as a dietary supplement or as a food before that date. Therefore, lovastatin's approval as a new drug preceded its marketing as a food or dietary supplement, and your lovastatin-enhanced product is excluded from the dietary supplement definition.
So much for alternative medicine not relying on "big pharma." Apparently, the folks who make red yeast rice products may be in the habit of adding lovastatin to their "supplement." It turns out that in this case, alt-medicine true-believers were taking a prescription medication all along but, unlike the case with real doctors, nobody bothered to tell them.

Isn't it about time that the special protection of "nutritional supplements" was removed? This label is all-too-frequently abused by providing the many unscrupulous marketers of woo to sell dangerous drugs like they were candy. By not being classified as either food or drugs, these so-called supplements escape immediate scrutiny by the FDA and so have an opportunity to net those who sell them a nice chunk of change regardless of the significant harm they may wind up doing to the unknowing and/or uneducated consumers who buy them.

In this case, the "nutritional supplement" in question is quite volatile stuff. Not only is there a significant danger of overdose, but lovastatin can interact with everything from prescription anti-depressants to over the counter vitamins. If you've been taking red yeast rice supplements, talk to your doctor even if you haven't noticed any side effects. The kind of damage done here can take a long time to be noticed and, by then, could be quite severe. Why risk it?

The best way to put these poison-pushers out of business is to not fall for their claims in the first place. Don't buy junk medicine like this and talk to a qualified professional before you put anything in your body that isn't food!

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