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Dietary Supplement Obesity, Erectile Dysfunction Claims Barred By Court

This article was originally published in The Tan Sheet

Executive Summary

An FDA consent decree barring the sale of dietary supplements purporting to treat obesity and erectile dysfunction follows repeated warnings to the marketers of the products, the agency announced Oct. 8

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Hi-Tech CEO Could Face Jail For Violating Court Order To Recall Weight Loss Products

A federal judge soon will decide whether Hi-Tech Pharmaceuticals CEO Jared Wheat goes to jail for failing to recall weight loss products marketed with false claims. Wheat has a history of run-ins with FDA, FTC and DEA for marketing supplements adulterated with drugs and making false claims for products.

Hi-Tech CEO Could Face Jail For Violating Court Order To Recall Weight Loss Products

A federal judge soon will decide whether Hi-Tech Pharmaceuticals CEO Jared Wheat goes to jail for failing to recall weight loss products marketed with false claims. Wheat has a history of run-ins with FDA, FTC and DEA for marketing supplements adulterated with drugs and making false claims for products.

Hi-Tech sex supplement on recall

The Norcross, Ga.-based firm voluntarily recalls all lots of its Stamina-Rx Maximum Sexual Stimulant supplement product, after FDA found samples containing the active pharmaceutical ingredient benzamidenafil. The API is in the same class as substances found in FDA-approved Rx erectile dysfunction treatments Viagra (sildenafil) and Cialis (tadalafil), Hi-Tech Pharmaceuticals said June 15. The agency determined Stamina-Rx is an unapproved new drug, not generally recognized as safe for uses suggested in Web-based labeling, and poses danger to consumers with high blood pressure or cholesterol. Since September 2003, Hi-Tech CEO Jared Wheat has been under a consent decree with FDA barring him from selling Stamina-Rx and other impotency remedies (1"The Tan Sheet" Oct. 13, 2003). Wheat was sentenced to 50 months in federal prison in February, and Hi-Tech was placed on five years' probation for the production and sale of counterfeit drugs (2"The Tan Sheet" Feb. 9, 2009, In Brief)

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