GNC Holdings Inc. (GNC), the world’s largest dietary supplement retailer, agreed to pay $2.25 million under a non-prosecution agreement to resolves the retailer’s liability for selling dietary supplements produced by a firm under indictment. GNC also agreed to reform its practices related to potentially unlawful dietary ingredients and pledged to undertake voluntary initiatives designed to improve the quality and purity of dietary supplements.
The FDA, the U.S. Attorney’s Office for the Northern District of Texas, and the Consumer Protection Branch of the Department of Justice’s (DOJ’s) Civil Division conducted an investigation which revealed the inadequacy of GNC’s practices regarding the legality of the products on its shelves. The investigation found, in 2013, GNC sold, nationwide, OxyElite Pro™ Advanced Formula, a product of Dallas-based USPlabs LLC (USP Labs). GNC sold the product based upon representations from USP Labs that the product and its ingredients complied with the law. However, GNC did not undertake additional testing or require additional certifications to confirm those representations.
In 2015, USP Labs was indicted and is currently awaiting trial. The indictment alleges that USP Labs conspired to import ingredients from China using false certificates of analysis and false labeling. USP Labs subsequently lied about the source and nature of those ingredients after it put them in its products. Additionally, the indictment alleges that USP Labs told retailers it used natural plant extracts in some of its products, when, in fact, it was using synthetic stimulants manufactured in a Chinese chemical factory.
Under GNC’s non-prosecution agreement, the retailer has agreed to:
- Immediately suspend the sale of a product upon learning that the FDA has issued a public written notice that a purported dietary supplement or an ingredient contained in a purported dietary supplement is not legal and/or not safe;
- establish two lists—a “restricted list” containing ingredients that are not to be used in dietary supplements and a “positive list” containing ingredients that are approved for sale;
- substantially revise its internal approach to dealing with the vendors whose products GNC sells, including requiring more explicit guarantees from its vendors that their products do not contain ingredients on the “restricted list”;
- voluntarily work to develop an industry-wide quality seal program; and
- update its adverse event reporting policy to ensure that its employees understand the proper procedures to employ if a customer complains of injuries associated with a dietary supplement bought at GNC.