The U.S. Department of Justice (DOJ), the Food and Drug Administration (FDA), and the U.S. Attorney’s Office for the Northern District of Texas have been investigating GNC Holdings, Inc. for the company’s failure to ensure that GNC’s retail products are actually legal in the U.S. As a result of the government’s recent investigation, it has been discovered that GNC allowed a misbranded supplement, OxyElite Pro Advanced Formula, to be sold at its stores nationwide. The supplement is manufactured by USP Labs LLC, who GNC claims made false assurances and provided fake documentation representing that the supplement contains the natural plant extracts listed on the label, when in fact it contains synthetic stimulants made in China.
According to state and federal investigations into USP Labs LLC, the company allegedly was involved in a conspiracy to import ingredients from China using false certificates of analysis and false labeling. USP Labs LLC allegedly represented that it used natural plant extracts in some of its products, when in fact it was using synthetic stimulants manufactured in a Chinese chemical factory. Despite USP Labs LLC’s fraudulent conduct, GNC should have taken the necessary steps to ensure that the retail products on its shelves are safe and legal. Instead, GNC did not take any action to verify that the ingredients in the supplement stocked on GNC shelves were as represented, nor did GNC conduct any testing on the supplement or require additional certifications.
As a result of the investigation into GNC, the company agreed to pay $2.25 million to settle the allegations that it sold mislabeled dietary supplements. In exchange for an agreement from the government not to prosecute the company, GNC also agreed to improve its practices regarding potentially illegal ingredients in supplements to better determine which products should be approved for sale, and further agreed to focus on improving the quality and purity of supplements in the industry. According to the DOJ, if the FDA issues a public notice that OxyElite Pro Advanced Formula is not legal or safe, GNC has agreed that it will immediately remove the product from its shelves. Benjamin C. Mizer, Principal Deputy Assistant Attorney General for the DOJ, said in a statement:
Unlawful dietary supplements are an important enforcement priority for the department. Today’s resolution is a significant step forward in reforming an industry rife with alarming practices.
Lawyers at Beasley Allen have handled many cases involving fraud and deceit with respect to a manufacturer’s representations of its products. If any of our readers are aware of these type of “alarming practices,” contact Ali Hawthorne, a lawyer in our firm’s Consumer Fraud & Commercial Litigation Section, at 800-898-2034 or by email at Alison.Hawthorne@beasleyallen.com.
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