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FDA investigation into ED drug ends in guilty plea

This article was originally published in The Tan Sheet

Executive Summary

The marketer of an herbal supplement called Vinarol, which was advertised as promoting sexual enhancement, pleads guilty to introducing misbranded drugs into interstate commerce, among other charges, after failing to disclose the presence of sildenafil citrate in the product. Sildenafil citrate is the active pharmaceutical ingredient in Pfizer's erectile dysfunction drug Viagra. Timothy Keay Isaac of Scottsdale, Ariz., filed for Chapter 11 bankruptcy protection in 2004 without disclosing his interest in the companies Ultra Health, Bionate and Johnston-Keay, through which Vinarol was marketed, the Office of the U.S. Attorney, District of Arizona, said June 26. FDA's Office of Criminal Investigations conducted the investigation of Isaac and his business associates that led to an indictment in federal court in Phoenix. A sentencing hearing is scheduled for Sept. 14. Food and drug attorney Marc Ullman, of New York-based Ullman, Shapiro & Ullman, said Vinarol clearly is not the only adulterated supplement on the market. "It's about time that FDA brought a case like this," given the number of questionable and adulterated products being marketed as dietary or herbal supplements without proper testing, Ullman said

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