In a landmark ruling with far-reaching implications, a federal judge in Salt Lake City said Tuesday that the Food & Drug Administration exceeded its authority when it declared Cholestin a drug.
U.S. District Judge Dale A. Kimball ruled that Cholestin, which is marketed by Pharmanex Inc. as a cholesterol-fighting product, is in fact a dietary supplement.And as such, the judge said it is regulated by the Dietary Supplement Health Education Act of 1994, a law designed by its sponsors -- chiefly Sen. Orrin Hatch, R-Utah -- to "protect the right of access of consumers to safe dietary supplements."
The Cholestin case is the first legal test of the 1994 law and has been watched closely by Congress, the $30 billion-per-year dietary supplement industry, federal regulators and consumers.
The California-based Pharmanex took the test case to court in Utah in 1997 after the FDA declared Cholestin a drug and banned the import of its chief ingredient from China. Cholestin is encapsulated at a plant in Farmington and sold nationwide.
Pharmanex argued that Cholestin's key ingredient, mevinolin, comes from a red rice yeast through a natural fermentation process that dates back hundreds of years. The product is targeted at consumers suffering from moderately high cholesterol levels -- 200 to 240 -- where prescription treatments may be unwarranted.
However, the FDA insisted that the yeast in Cholestin was not the traditional strain of mevinolin but rather a substance that is virtually indistinguishable from lovastatin, the active ingredient in the prescription drug Mevacor.
In his sweeping 17-page ruling issued Tuesday afternoon, Kimball came down squarely on the side of Pharmanex and set aside the FDA decision. According to the judge, the 1994 law was intended to remove unreasonable regulatory barriers that limit or slow the flow of safe products to consumers.
The law accomplishes that goal by placing the burden on the FDA to prove that a dietary supplement is unsafe before it can be removed from the marketplace, he said.
Applying those principles to the Pharmanex case, Kimball found that Cholestin, "like most other dietary supplements and unlike drugs, has nutritive value." He also noted that the FDA had not questioned the safety or effectiveness of Cholestin.
Instead, the FDA determined that Cholestin was excluded from the category of dietary supplements because it was not marketed as a dietary supplement or food before 1987, when lovastatin was approved as a drug.
"Although the relevant legal and factual materials are complex, the ultimate merits of this case depend on one basic issue: whether Cholestin is a dietary supplement," Kimball said.
The judge cited evidence showing that Cholestin consists solely of milled red yeast rice, "a traditional food that has been eaten and valued for its health benefits in China and elsewhere in East Asia for centuries and in the United States for decades."
Under the plain language of the law, Cholestin is a "product intended to supplement the diet," the judge wrote. "Accordingly, Cholestin fits within the definition of dietary supplement."