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FDA Takes Action to Protect Consumers from Potentially Dangerous Dietary Supplements

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The U.S. Food and Drug Administration announced the results of a collaborative effort with other government agencies to identify potentially unsafe or tainted dietary supplements. The yearlong effort resulted in various civil injunctions and criminal actions against 117 manufacturers and distributors of dietary supplements and products falsely marketed as dietary supplements.

The U.S. Department of Justice led the effort, in partnership with the FDA, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defence, and the U.S. Anti-Doping Agency.

Among the cases announced against the various manufacturers is a case against USPlabs LLC and several of its corporate officers. The Dallas company that previously manufactured popular workout and weight loss supplements is being charged with a variety of offenses related to the sale of their products.

The indictment alleges that USPlabs was part of a conspiracy to import ingredients from China using false certificates of analysis and false labelling, and further lied about the nature and source of these ingredients after it put them in its products. According to the indictment, USPlabs claimed to use natural plant extracts in products called Jack3d and OxyElite Pro, when in reality, 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 inquiring into the safety of these ingredients. In fact, the indictment notes that the company knew of studies that linked its products to liver toxicity.

Once OxyElite Pro was implicated in an outbreak of liver injuries, according to the indictment, USPlabs told the FDA it would cease distribution of the product. However, despite this promise, the indictment alleges that USPLabs immediately began an “all-hands-on-deck effort” to sell as much OxyElite Pro as possible.

Several defendants were arrested by the U.S. Marshal’s Service, while FDA and IRS special agents seized assets in a number of luxury and sports cars, real estate, and dozens of investment accounts.

The FDA continues to warn consumers about the risks associated with over-the-counter products falsely marketed as dietary supplements to aid in weight loss, body building, and sexual enhancement. These products often contain hidden active ingredients that can be devastating. Just last year, the FDA warned of over 100 products found to contain such hidden active ingredients.

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