ORLANDO, Fla. (AP) -- A controversial dietary supplement produced by a Nu Skin subsidiary has been shown to be a powerful means of lowering cholesterol.
The results of one of the first two U.S. studies of the substance, called Cholestin, were presented Thursday in Orlando at a medical conference sponsored by the American Heart Association.It showed that people with mildly elevated levels can drop their cholesterol about 35 points by taking four capsules of Cholestin a day. Cholestin's main ingredient, mevinolin, is created from a red rice yeast through a natural fermentation process.
Pharmanex, which is owned by Nu Skin and produces Cholestin, recently won a court decision allowing it to continue to market the product as a dietary supplement, even though mevinolin is a naturally occurring form of lovastatin, a prescription cholesterol-lowering medicine.
U.S. District Judge Dale A. Kimball ruled that the Food and Drug Administration exceeded its authority when it declared the dietary supplement was a drug. The case was the first legal test of the Dietary Supplement Health Education Act of 1994, sponsored primarily by Sen. Orrin Hatch, R-Utah.
Cholestin's introduction in 1997 blurred the already fuzzy line between food supplements, which can be sold without a prescription, and drugs that require approval of the Food and Drug Administration.
The FDA had tried to block its sale. It has not said whether it will appeal Kimball's decision.
Until now, all of the data on Cholestin's health effects have come from China, where the rice extract has been used for centuries as a spice in such foods as Peking duck.
Lovastatin, sold by Merck Inc. as Mevacor, was the first of a powerful new class of cholesterol-lowering medicines known as statins. The smallest lovastatin pill on the market is 10 milligrams, while a daily four-pill regimen of Cholestin adds up to 5 milligrams of lovastatin.
Cholestin can be bought without a prescription, but the price is similar to Mevacor. A month's supply of Cholestin costs about $30. A month of 40 milligram Mevacor pills costs about $150. But these pills can be cut into four pieces, bringing a 10 milligram-a-day dose down to $37 monthly.
Pharmanex's sponsorship of scientific research to back up its health claims is relatively unusual among supplement makers. Another study nearing completion will look at the effects of Cholestin when eaten in a twice-daily power bar.
Nu Skin recently announced it is withdrawing the supplement from chain drugstores and will sell it exclusively through mail order and independent pharmacies.
Deseret News staff writer Lois Collins contributed to this report.