HerbalEGram: Volume 4, Number 9, September 2007

The US Food and Drug Administration (FDA) issued a press release on August 9 advising consumers to not buy or consume 3 dietary supplement products containing red yeast rice (Monascus purpureus). The FDA argued that the products contain excessive levels of a substance called lovastatin, which, although naturally found in red yeast rice in small levels, was detected at unusually high levels. Therefore, according to FDA, the products are unapproved drugs potentially endangering consumer health.¹ The FDA identified the 3 products as Red Yeast Rice (Swanson Health Products Inc., Fargo, ND), Red Yeast Rice/Policosonal Complex (Swanson Health Products Inc., Fargo, ND), and Cholestrix (Sunburst Biorganics, Baldwin, NY).

According to the FDA press release, the agency tested the products and found that they contained relatively high levels of lovastatin, the active pharmaceutical ingredient of the prescription drug Mevacor® (Merck), which is approved for marketing in the United States as a treatment for high cholesterol. Lovastatin can cause severe muscle problems leading to kidney impairment in some patients, particularly in patients who take high doses of lovastatin or who concurrently take medications that increase the risk of muscle adverse reactions. The FDA has claimed that traditional red yeast rice does not contain more than trace amounts of lovastatin, if any.²

Steven Galson, MD, director of FDA’s Center for Drug Evaluation and Research, argued that the lovastatin content of these dietary supplements could be harmful to consumers: “The 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.”¹

The FDA sent a warning letter to Swanson, stating that the company’s 2 products would provide more than 5 mg of lovastatin per day if consumed as directed, which is approximately half the lowest recommended daily dose of lovastatin in Mevacor.² According to the FDA, this constitutes “significant levels of lovastatin.” The FDA further argued that Swanson’s products are promoted on the company’s website as being able to prevent, treat, or cure disease conditions or affect the structure or function of the body, thus making them unapproved new drugs rather than dietary supplements.

Swanson issued a press release on August 14, alerting consumers that the company has pulled its red yeast rice products from the market.³ According to the release: “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.”

The FDA’s warning letter to Sunburst Biorganics pointed out that the company’s website claimed Cholestrix would provide “10 mg of natural lovastatin” at the recommended daily dose.⁴ As was written to Swanson, the FDA informed Sunburst that lovastatin is a pharmaceutical ingredient that is found, at most, in trace levels of natural red yeast rice. The agency also argued that the product is marketed with unauthorized claims, making it an unapproved new drug.

“We’ve removed [Cholestrix] from our website and we’re going to recall the products,” said Jerry Reminick, vice president of Sunburst Biorganics, according to an article published on August 21 by Newsday.⁵ “We weren’t aware that lovastatin at that level was a drug.”

This is not the first time that the FDA has become involved with red yeast rice over the issue of lovastatin levels. In 1997 the FDA informed Pharmanex (Provo, UT) that the company’s cholesterol-lowering red yeast rice supplement Cholestin® was an unapproved new drug due to the naturally occurring statin-like compounds within red yeast rice.⁶ The FDA then issued an import alert for red yeast rice in 1998. Pharmanex sued the FDA, and Federal District Judge Dale Kimball of Utah’s District Court sided with Pharmanex in 1999, ruling that the company could continue marketing its product as a dietary supplement. The FDA appealed to the 10^th Circuit Court of Appeals, which ruled in 2000 that Judge Kimball’s ruling was incorrect and remanded it to his court. Judge Kimball subsequently reversed his decision.⁷ Pharmanex ultimately reformulated its supplement Cholestin using the ingredient policosanol, which the company launched on July 1, 2001. (Policosanol is a complex of alcohols derived from sugar cane, rice bran and/or beeswax. Research conducted in Cuba and elsewhere suggests that policosanol reduces high cholesterol levels, however its efficacy has been questioned by the negative results of recent trials.) According to the Pharmanex website, Cholestin has been reformulated with a proprietary blend of ingredients including Lipidol^TM.⁸ Many other red yeast rice products were also removed from the market, following the 2000 court decision.⁷

-Courtney Cavaliere

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