SIMI FIRM SUES FDA IN TEST CASE OVER DIET SUPPLEMENT.

Byline: Mike Carter Associated Press 

The Simi Valley-based maker of the dietary supplement Cholestin claims it promotes healthy cholesterol, which it very well might do because it contains traces of a chemical that doctors prescribe to lower people's cholesterol.

But the presence of that naturally occurring chemical, known as mevinolin, in red yeast powder from China has prompted the Food and Drug Administration to ban importation of the substance.

In a case that could define the FDA's ability to regulate over-the-counter diet supplements, a federal judge said Monday that he would rule as early as today on whether to order the FDA ban lifted.

Pharmanex, which markets the yeast powder under the name Cholestin, has asked U.S. District Judge Dale Kimball to stop the FDA from interfering with the company's imports.

``This represents a total failure of the FDA to obey Congress and the law,'' said Richard Cooper, an attorney for Pharmanex. ``Their decision is arbitrary and capricious.''

Cooper said Pharmanex is within five days of exhausting its supply of red yeast rice powder and would be irreparably harmed if the judge doesn't order the FDA to back off.

Mevinolin is identical to a synthetically produced cholesterol-reducing drug, lovastatin. The pharmaceutical giant Merck & Co. sells lovastatin under the brand name Mevacor.

The dispute is the first challenge to the FDA's powers under the 1994 Dietary Supplement Health and Education Act. The law provided for the widespread sale of herbs, teas and capsules containing ingredients that are not FDA-approved as safe and effective. But it also set two major restrictions.

First, any FDA-approved drug ingredients cannot also be sold as dietary supplements unless they were sold as a supplement or a food before the drug was approved. Second, supplement manufacturers may claim only general benefits for the ingredient, rather than cures, preventions or treatments of diseases.

FDA regulators say Cholestin - which is sold in 35,000 stores nationwide - runs afoul of the law on both counts: It was not sold as a supplement before Mevacor was approved, and Pharmanex has made improper claims about its effectiveness.

Pharmanex lawyer Dan Kracov contends the FDA is trying to use the 1994 law to smother distribution of the yeast.