A study published June 16 in the Annals of Internal Medicine showing the cholesterol-lowering benefits of red yeast rice triggered a cascade of news stories in the popular press—a welcome change from all of the negative headlines published over the last month about dietary supplements being unregulated, ineffective and, in some cases, dangerous.
In the study, researchers followed 62 patients who had tried taking prescription statins to lower their cholesterol but had to stop because the medications caused severe muscle pain, a common side effect of statins. All of the patients received nutrition and exercise counseling and half also received 1,800 mg of red yeast rice supplements every day. After 12 weeks, those taking the supplements saw their LDL or “bad cholesterol” drop by a significant 27%. Those who did not take the red yeast rice supplements experienced a 6% drop in LDL.
“I was pleasantly surprised with the degree of LDL lowering,” Daniel Rader, MD, a lipid specialist at the University of Pennsylvania School of Medicine and an author of the study told ABC News. “I have to confess, I did not expect this degree of LDL lowering. And there were many fewer side effects than expected.”
The news was not all positive for the supplement industry, however. In nearly every story that was published about the red yeast rice study, reporters erroneously stated that supplements are not regulated. Several stories also used the research to talk about the quality problems that have surfaced for red yeast rice and to issue warnings about supplement use. As a case in point, here’s what CNN reported:
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. 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. [Paul[ Phillips [a cardiologist who runs a clinic for statin-related muscle complications at Scripps Mercy Hospital in San Diego]. “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.”
Such a statement is just one more reason why supplement quality and adherence to the FDA’s supplement GMPs (which go into effect for mid-size companies next week) are of the upmost importance. As Keri Marshall, medical director for Gaia Herbs, told Nutrition Business Journal recently: “GMPs will make the good companies stand out and will identify the outliers that are putting bad products on the market. They are also a great example of how the supplement industry is, in fact, regulated.”
According to NBJ research, U.S. consumer sales of red yeast rice grew 6% to $20 million in 2008. More than half of sales—$11 million—were rung up in natural & specialty retailers.