miércoles, 18 de noviembre de 2015

Drug Information Update - FDA takes action to protect consumers from potentially dangerous dietary supplements

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration, in partnership with other government agencies, yesterday announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro.
Led by the U.S. Department of Justice, the sweep included the FDA, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency.
An 11-count indictment was unsealed earlier today against USPlabs, a Dallas, Texas company that formerly manufactured highly popular workout and weight loss supplements. The indictment charges USPlabs, S.K. Laboratories Inc. and their operators with a variety of charges related to the sale of those products. The defendants were arrested/surrendered to the U.S. Marshal’s Service today. Along with the arrests, FDA and IRS special agents seized assets in dozens of investment accounts, real estate in Texas, and a number of luxury and sports cars.
The indictment alleges that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory. 
The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. To the contrary, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.
For more information, please visit: USPlabs

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