Red-yeast product is no drug, court says.

In a setback for the Food and Drug Administration, a federal district court ruled last week that the agency had unlawfully attempted to restrict an herbal supplement as a prescription drug.

Pharmanex of Simi Valley, Calif., began marketing capsules of rice fermented with a red yeast in November 1996. Almost immediately, FDA ordered the company to stop selling the cholesterol-lowering product, sold as Cholestin, charging that it is a drug. Studies had shown that the fermented rice contains a natural compound that is chemically indistinguishable from lovastatin, the active ingredient in a cholesterol-lowering prescription drug (SN: 11/14/98, p. 311).

Pharmanex fought the drug designation for its over-the-counter product, however, citing a 1994 law known as the Dietary Supplement Health and Education Act (DSHEA). When FDA countered by ordering the company to stop importing its bulk fermented rice from China, Pharmanex sued in what became the first legal test of DSHEA.

Last June, pending a thorough study of the case, Judge Dale A. Kimball of the Federal District Court in Salt Lake City restrained FDA from imposing its ban on the Chinese rice. Kimball's final decision now decrees that Cholestin indeed is a food as defined by DSHEA.

The judge noted that Congress, in explaining a clause in the legislation, had acknowledged, "On occasion, a substance that is properly included as a dietary ingredient in a dietary supplement (food) product may also function as an active ingredient in a drug." That's the case here, Kimball said.

For now, FDA is "reviewing the court's decision and evaluating what steps we might take," says Brad Stone, a spokesman in Rockville, Md.