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June 17, 1998

Judge Rebuffs FDA on Effort to Ban Diet Supplement

By SHERYL GAY STOLBERG

WASHINGTON -- The Food and Drug Administration on Tuesday lost the first round of its legal battle with the manufacturer of Cholestin, an herbal remedy that is being marketed as a dietary supplement to reduce cholesterol but which the agency is trying to declare an illegal drug.

In a brief three-page decision, a U.S. judge in Salt Lake City ordered the agency to permit the manufacturer, Pharmanex Inc., a small, 3-year-old company in Simi Valley, Calif., to continue making Cholestin while the court case proceeds.

"Plaintiff's Cholestin product is preliminarily declared to be a dietary supplement, and not a drug, within the meaning of the Federal Food, Drug and Cosmetic Act," Judge Dale Kimball of U.S. District Court wrote.

Kimball added that Pharmanex would "clearly suffer irreparable injury" if it could not continue to make the herbal remedy.

The ruling came one day after lawyers for both sides argued the case before Kimball. It is now up to the judge to make a final decision about whether Cholestin will be allowed to remain on the market as a dietary supplement.

"We are obviously very gratified by the judge's decision," William McGlashan Jr., the president of Pharmanex, said in an interview. "It's an important first step."

The lawyer who handled the case for the drug agency, Neal Parker, declined to comment on the ruling. But Lorrie McHugh, the FDA's chief spokeswoman, said the agency intended to pursue the case despite Tuesday's setback.

The case is being watched as a pivotal battle between the food and drug agency, which is struggling to exert its authority under a 1994 law that left it almost powerless to regulate herbal products, and the dietary supplement industry, which has been growing at a furious pace since the law was passed.

At issue is not whether the product is unsafe; the FDA does not argue that it is. Rather, the agency asserts that Cholestin is an illegal, unapproved drug under the Dietary Supplement Health and Education Act of 1994 because it contains a natural form of lovastatin, the key chemical in Mevacor, a cholesterol-lowering drug made by Merck & Co.

Cholestin is made from a pulverized strain of rice fermented with red yeast, which is then ground up into a brick-colored powder and put into capsules. The rice is imported from China, where it has been used for more than 2,000 years, as an herbal remedy and a food.

Officials at Pharmanex say that the lovastatin occurs naturally in the rice and that, under the law, the FDA cannot take Cholestin off the market unless it believes the product is unsafe.

About a year ago, the agency, prompted by complaints from officials at Merck, began an investigation of Cholestin. While the inquiry proceeded, the agency impounded 10 tons of the red yeast rice. Then, last month, agency officials declared Cholestin a drug, and insisted that the product undergo the same rigorous testing as any pharmaceutical. That prompted Pharmanex's suit.

At a hearing on Monday before Kimball, the company asked that the hold on its red yeast rice be released. The judge complied, ordering the agency to permit the rice to enter the United States immediately and to allow Pharmanex to import an additional 6 tons every three months, or however much the company needed to meet its demand.



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