MSNBC Article on Cholestin
Pharmanex Web Site
FDA Position on Cholestin
(2/17/99)
A Utah Federal Judge has ruled on a case that affects a nation of supplement users.
The FDA has lost an attempt to regulate a cholesterol-reducing capsule.
Court specialist Richard Piatt reports from the Federal Courthouse.
That supplement is distributed right here in Utah: Cholestin.
But to people across the United States, this case was about more than just this one product.
Cholestin is made by a company called Pharmanex, owned by NuSkin of Provo.
Studies show the little red capsule promotes healthy cholesterol levels.
A Chinese red yeast rice is a key ingredient in Cholestin. In that rice product is an ingredient that closely resembles an ingredient in a prescription cholesterol-reducer called Mevacor.
Since Mevacor is a regualted drug, the FDA went to court to try to regulate Cholestin.
A Utah Federal judge rejected that request.
William McGlashan, of Pharmanex, says, "For the FDA to be able to pull this off the market, purely because one of its constituents was too similar to Mevacor, was outrageous."
For years, the health-food industry has been fighting off FDA regulations on a host of supplements.
This latest fight reflects just another chapter in that effort.
The significance of this ruling goes well beyond one product to almost every herbal remedy on the shelves. Those in the complimentary health care industry fear that once one product is regulated, then it will be followed by another and then another, on down the line, until all of the products require a prescription.
Right now, all these supplements must meet a different set of criteria than do prescription drugs.
Many argue that those requirements are enough.
Rae Howard, of Good Earth Natural Foods, says, "There are enough regulations now to keep these products safe, on the shelf, with good appropriate information about those products."
An FD-A spokesperson didn't return phone calls for comment on the ruling.
But the makers of Cholestin are keeping watch for a possible appeal of this ruling.
During the court proceeding, Pharmanex has continued to sell Cholestin.
But recently the company sells it by mail-order only.
