Health

Judge Orders FDA To Lift Ban

June 16, 1998 / 7:20 PM EDT / AP

In a case that challenges the government's ability to regulate natural remedies, a federal judge on Tuesday ordered the Food and Drug Administration to lift its ban on imports of a dietary supplement containing a cholesterol-reducing drug.

The chemical lovastatin occurs naturally in red yeast rice powder from China and the company, which markets the powder under the name Cholestin, had sought a preliminary injunction against the FDA.

In a three-page order late Tuesday, U.S. District Judge Dale Kimball said Pharmanex would suffer irreparable injury if the FDA's ban remained in place.

He also found the company has "raised substantial and serious questions regarding the lawfulness of FDA's interpretation" of the 1994 Dietary Supplement Health and Education Act.

Moreover, Kimball defined Cholestin as a dietary supplement, not a new drug that would be subject to FDA approval.

"The threatened injury to (Pharmanex) greatly outweighs whatever damage the proposed injunction may cause to defendants," Kimball wrote, pointing out that the FDA does not consider Cholestin dangerous.

Kimball's decision followed about 90 minutes of arguments Monday from attorneys representing both sides.

Pharmanex said it was within five days of exhausting its supply of the powder, which is identical to a synthetically produced cholesterol-reducing drug, which Merck & Co. sells under the brand name Mevacor.

Merck, based in Whitehouse Station, N.J., previously was reported as examining whether Cholestin violates Mevacor patents.

Pharmanex originally said it was targeting 58 million Americans with moderately high cholesterol levels. Most doctors would not prescribe cholesterol-reducing medication for those patients unless they had other risk factors.

After the FDA considered that a drug claim, Pharmanex started advertising only that Cholestin promotes healthy cholesterol.

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 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 food before the drug's approval. 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.

The company is based in Simi Valley, Calif., and turns out 90,000 Cholestin capsules daily from its Farmington, Utah, plant.

Consumers spend $5 billion a year on dietary supplments, and the 1994 law was sponsored by Sen. Orrin Hatch, R-Utah, a regular user of supplements and champion of the industry.

Critics of Hatch's law contend it blurred the line between minimally regulated supplements and federally approved, rigorously tested drugs. Before the act, supplements were regulated either as foods or drugs.