GNC Agrees To Improve Efforts To Keep Illegal Dietary Supplements Out Of Its Stores

When you buy a dietary supplement, you never know quite what you’re getting, because supplement manufacturers don’t have to prove to the Food and Drug Administration that their products work — or are even safe — before putting them on the market. GNC, the world’s largest dietary supplement retailer, has now agreed to try to ramp up efforts to ensure that the products it sells are safe and legal.

As part of a deal with the U.S. Department of Justice [PDF], GNC Holdings Inc. says it will reform its practices related to potentially unlawful dietary ingredients and dietary supplements, the DOJ announced today.

It is also promising to conduct a series of voluntary initiatives aimed at improving the quality and purity of dietary supplements.

Related: Anyone Can Make & Market A Dietary Supplement, Including Consumer Reports

GNC agreed to the non-prosecution deal to resolve its liability for selling certain dietary supplements produced by a company that’s currently under indictment. The retailer will also pay $2.25 million to the U.S. and cooperate in dietary supplement investigations conducted by the government.

The agreement comes on the heels of an investigation by 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 Civil Division, “which revealed that GNC’s practices related to ensuring the legality of products on its shelves were lacking,” the DOJ says.

In a statement of facts that both sides agreed on, GMC’s actions and failure to act allowed a misbranded supplement called OxyElite Pro Advanced Formula, made by Dallas-based USPlabs LLC — to be sold at GNC locations nationwide in 2013.

GNC sold the products based on representations from USP Labs that the ingredients in the product complied with law, but GNC didn’t do any additional testing to confirm that, or verify that the ingredients were actually what USP Labs said they were. USP Labs was indicted in Nov. 2015 for allegedly engaging in a conspiracy to import ingredients from China using false certificates of analysis and fake labeling, and then lied about the source and nature of those ingredients after using them in products. USP Labs is currently awaiting trial.

Related from Consumer Reports: The Truth About Supplements

Here are the changes GNC has agreed to commit to in its effort to keep unlawful dietary supplements out of its stores:

• GNC promises to take immediate action to suspend the sale of any product or products upon learning that the FDA has issued a public written notice indicating that a purported dietary supplement or an ingredient contained in a purported dietary supplement is not legal and/or not safe.

• The company will establish two lists: first, “restricted list” containing ingredients that are not to be used in dietary supplements; and second, a “positive list” containing ingredients that are approved for sale. These lists won’t have the force of law, but GNC will use them to guide the company in determining which products should be approved for sale. If a product contains novel ingredients that aren’t on either list, GNC will require further internal action and approval before offering it for sale.

• GNC will “substantially” revise its internal approach to dealing with the vendors whose products it sells, including requiring more explicit guarantees from its vendors that their products do not contain ingredients on the “restricted list” and that their products comply with federal law.

• The company has also agreed to develop an industry-wide quality seal program. Once it’s off the ground, GNC has agreed to stop paying its retail salespeople bonus commissions, or “promotional money,” to direct customers to products in its stores not carrying the seal.

Related: What Do Those Seals On A Dietary Supplement’s Label Actually Mean?

• And finally, GNC will 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.

“Unlawful dietary supplements are an important enforcement priority for the department,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “Today’s resolution is a significant step forward in reforming an industry rife with alarming practices. Companies like GNC need to do more to ensure that they are not selling products containing questionable and untested ingredients. The American public deserves better, and the Department of Justice appreciates GNC’s efforts in resolving its issues and moving forward in the best interests of American consumers.”