CHOLESTEROL DRUG BAN LIFTED; RULING BENEFITS SIMI VALLEY COMPANY.Byline: Ben Sullivan Daily News Staff Writer In a case with broad implications for the nutritional supplements Nutritional Supplements Definition Nutritional supplements include vitamins, minerals, herbs, meal supplements, sports nutrition products, natural food supplements, and other related products used to boost the nutritional content of the diet. industry, a federal judge Tuesday lifted a Food and Drug Administration ban on imports of a dietary supplement Noun 1. dietary supplement - something added to complete a diet or to make up for a dietary deficiency diet - a prescribed selection of foods vitamin pill - a pill containing one or more vitamins; taken as a dietary supplement that contains a cholesterol-reducing drug. U.S. District Judge Dale Kimball, in a three-page preliminary injunction A temporary order made by a court at the request of one party that prevents the other party from pursuing a particular course of conduct until the conclusion of a trial on the merits. A preliminary injunction is regarded as extraordinary relief. , said Simi Valley-based Pharmanex Inc. would be irreparably damaged if the FDA's ban remained in place. The chemical lovastatin lovastatin /lo·va·stat·in/ (lo´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated with occurs naturally in red yeast rice red yeast rice, n See monascus. powder that Pharmanex imports from China and sells in the United States under the name Cholestin. Drug giant Merck & Co. sells a synthetic but chemically identical prescription drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, under the brand name Mevacor. The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. had banned imports of the lovastatin-containing yeast, claiming that because Merck sold the drug first, it must be considered a drug, albeit a naturally occurring one. But Kimball on Tuesday defined Cholestin as a dietary supplement, not a drug subject to FDA approval, and said until he makes a final ruling in the coming months, Pharmanex must be allowed to import and sell the product. ``The threatened injury to (Pharmanex) greatly outweighs whatever damage the proposed injunction may cause to defendants,'' Kimball wrote, noting that the FDA does not consider Cholestin dangerous. Pharmanex Chief Executive Bill McGlashan said the injunction was welcome news. ``We'd nearly run out'' of yeast to package, he said, adding that the 35,000 stores that sell Cholestin would have seen their shelves empty of the product within a few weeks. Merck, based in Whitehouse Station, N.J., previously was reported as examining whether Cholestin violates Mevacor patents. The Cholestin dispute is the first challenge to the FDA's powers under the 1994 Dietary Supplement Health and Education Act, which provides for the widespread sale of herbs, teas and capsules containing ingredients that are not FDA-approved as safe and effective. Under the act, companies selling such nutritional supplements are prevented from making medical claims for their products, another area in which the FDA claimed Pharmanex ran afoul of the law. --- The Associated Press contributed to this story. |
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