In fact, all people looking to lower their cholesterol levels should think twice before taking red yeast rice, Dr. Becker advises. Red yeast rice is “quite a bit stronger” than other dietary supplements used to lower cholesterol, he says, and the market is poorly regulated.
In 2008, the supplement-industry watchdog group ConsumerLab.com analyzed 10 brands of capsules whose labels advertised 600 milligrams of red yeast rice. When the products were tested in a lab, however, they were found to contain wildly different amounts of lovastatin and other compounds. “There was a 100-fold difference from the lowest to the highest,” says ConsumerLab.com president Tod Cooperman, MD. An unexpectedly large dose of lovastatin could cause serious side effects and could interact with other drugs.
The uncertain lovastatin content of red yeast rice products have led to a long-running dispute between the manufacturers of the pills and the federal government. A decade ago, the FDA successfully sought to regulate a red yeast rice extract known as Cholestin, claiming that the lovastatin it contained made it an unapproved statin rather than a supplement.
Any red yeast product containing more than trace amounts of lovastatin can also be regulated (and effectively banned) by the FDA, but red yeast rice products containing monacolin K have remained on the market. And though the FDA does continues to monitor the industry—in 2007, the agency warned three manufacturers that their red yeast rice products were unapproved drugs—the woolly marketplace for supplements should make consumers wary.
“I would never, under any circumstances, suggest that someone take red yeast rice,” says Dr. Phillips. “It’s not controlled, it’s not safe, and it hasn’t been approved by the FDA in such a way that it’s formulated to be consistent.”
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