ALTERNATIVE MEDICINE: FDA Takes On Herbal Remedies
Today's New York Times looks at the Food and Drug Administration's efforts to regulate the growing herbal supplement market. The article notes that a pending case in Utah "is being watched as a pivotal battle between the agency, which is chafing at a 1994 law that left it almost powerless to regulate vitamins and herbal products, and the dietary supplement industry, which has been growing wildly since the law was passed." The case involves Utah-based Pharmanex and its product Cholestin -- a pill made from powdered red yeast and rice. Pharmanex markets the pill as a cholesterol-lowering therapy, but the FDA objects to the fact that the pill also contains lovastatin -- "a key component of a cholesterol-lowering drug." The FDA insists that the 1994 Dietary Supplement Health and Education Act "gives them the authority to take Cholestin off the market, because it bars companies from bringing dietary supplements to market if they contain the same active ingredients as previously approved drugs." Pharmanex, however, contends that "lovastatin occurs naturally in the rice and that Cholestin is more akin to a food than to a drug." The Times notes that the FDA's suit to remove Cholestin from the market will be heard by U.S. District Judge Dale Kimball starting June 15.
According to the Times, the case against Pharmanex "raises crucial questions: Is there a distinction between these herbal products, which may contain naturally occurring chemicals as potent as those in any drug, and the drugs themselves? Must products like Cholestin be subjected to the rigorous testing that drugs undergo?" William Schultz, the FDA's deputy commissioner for policy, said: "You see more and more dietary supplements sold right next to over-the- counter drugs. There is a risk that the line will blur." Dr. David Kessler, former FDA commissioner, said: "Just walk into your pharmacy; it's out of control. Efficacy is now defined as what sells off the shelves. The agency is powerless." But Loren Israelson, the head of the Utah Natural Products Alliance, argued that the FDA's effort is misdirected: "Foods are medicines; medicines are foods. If you drink coffee in the morning, why are you drinking coffee? You're looking for the caffeine, a stimulant. That same caffeine is sold over the counter as No Doz. That's a drug when it's in a pill form, and it's a food when it's in coffee. Why is that?"
The Nutrition Business Journal notes that since the 1994 dietary supplement law went into effect, sales of herbal remedies in the U.S. "skyrocketed, jumping to nearly $12 billion last year from more than $8 billion in 1994" (Stolberg, 6/10).