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In Brief: Pharmanex v. FDA

This article was originally published in The Tan Sheet

Executive Summary

Pharmanex v. FDA: Agency files April 29 motion to dismiss the Pharmanex request for a federal court declaratory judgment that Cholestin cholesterol reduction claims are acceptable under the Dietary Supplement Health & Education Act and that FDA should not take regulatory action against the product as a drug. The agency argues that the complaint should be dismissed because the court lacks "subject matter jurisdiction" and because it seeks to preempt a possible enforcement action based on an informal position taken by FDA in a meeting and thus the matter is not "ripe for review." The complaint was filed in Salt Lake City, Utah federal court April 7 ("The Tan Sheet" April 14, p. 1)...

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