When does a diet supplement become a medication?
Sometimes, it's hard to tell. Consider red yeast rice, the supplement Celeste Wright uses to lower her cholesterol.
"It works," says Wright, a 66-year-old mother of two from Dripping Springs, Texas, who has been taking it since 2001.
Wright had high cholesterol levels five years ago, when she began taking Pravachol, a popular prescription drug known as a statin that reduces cholesterol levels. Prone to allergies, she suffered a reaction to the drug that made her throat swell, her eyes burn and her skin break out in rashes.
On the Internet, she learned about red yeast rice, which she and others say contains the same basic ingredient. So she talked to her doctor and began taking the supplement in January 2001. Four months later, her cholesterol level had dropped from 286 to 227.
She buys 130 capsules for about $8 over the Internet, takes one 600-milligram dose each day and is convinced that it's safe.
"There are hardly any reports of deaths from dietary supplements and herbs, but there have been many from prescription drugs," she said.
But how safe is red yeast rice? And how effective?
The National Center for Complementary and Alternative Medicine says it's important to find out. It wants researchers looking into the effectiveness of supplements - a $20 billion market that's largely unregulated - to address the lack of reliable research on red yeast rice and thousands of other alternative medicines.
Unveiling a five-year strategic plan this week, the agency recommended that scientists focus on treatments that work, verify their ingredients and figure out how they work.
Its 84-page document sets priorities for future research, including managing pain, enhancing physical and mental health and preventing disease. It also recommends that researchers use a systematic approach rather than concentrating on individual drugs or therapies. "They're saying we need to look at complex systems of care, like Chinese medicine as a whole, rather than any individual aspect of it," said Dr. Brian Berman, director of the Center for Integrative Medicine at the University of Maryland Medical Center.
Red yeast rice is an intriguing example of a supplement that has the potential for competing with known and profitable prescription drugs - statins that lower cholesterol.
The situation has sometimes put supplement makers and loyal users at odds with the Food and Drug Administration. And it illustrates the issues that researchers, doctors, patients and regulators face in dealing with alternative medicines.
Based on an ancient Chinese recipe, red yeast rice is made by fermenting red yeast over rice. It's sold in pill form without a prescription, in health supplement stores, as well as online.
An FDA advisory panel recently voted to prohibit commercially approved statins with similar ingredients from being sold over the counter because of safety concerns. Statins can cause liver and muscle problems and should not be taken by women who are pregnant.
But under a 1994 federal law, supplements such as red yeast rice are regulated like foods and not drugs. Their manufacturers - unlike drug companies - don't have to demonstrate the safety or efficacy of their products. The FDA can halt sales only with evidence of a "significant or unreasonable risk of injury or illness."
Agency officials declined requests for interviews about red yeast rice. But in e-mailed responses to written questions, they said red yeast rice products can be sold as long there's no complaint, backed by evidence, that they contain FDA-approved statin ingredients.
They added that some red yeast products now on the market might contain other statins - never approved as drugs - that might lower cholesterol. But they won't say if red yeast rice is safe - only that there's "insufficient reliable scientific information" to determine if it is dangerous.
Meanwhile, the law allows supplement manufacturers to tout the general health benefits of their products but bars them from making specific medical claims. "We can say that this product promotes the body's ability to metabolize lipids. We can't say it reduces cholesterol," said Kim Pearson, staff counsel for Thorne Research Inc., an Idaho firm that markets red yeast rice.
Some doctors recommend red yeast rice for patients who worry about adverse reactions to prescription drugs, who prefer natural supplements or who have cholesterol levels that aren't quite high enough to warrant commercial statins.
"I do prescribe it, I do have good results, and I haven't had a single patient with side effects," said Dr. Peter Hinderberger, a homeopathic physician at the Ruscombe Mansion Community Health Center in Baltimore.
Still, he and other doctors urge patients to see a physician before taking red yeast rice. There have been a few problems associated with the supplement, including reports of loss of muscle function among patients using it in Toronto and Tennessee.