It's part of a wide-ranging "non-prosecution agreement" that followed a lengthy investigation of GNC's practices by the Justice Department and FDA. It also includes a $2.25 million fine and a pledge by GNC to cooperate in government investigations and prosecutions of supplement manufacturers.
“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."
"We are pleased to have reached an agreement with the DOJ related to certain products manufactured by USP Labs which were removed from GNC’s shelves years ago," GNC said in a statement to ConsumerAffairs. "We are pleased to have put this matter behind us and remain committed to providing our customers with the highest quality products available, using the purest and most effective ingredients, to help them live healthier lives.”
As part of the agreement, GNC admitted that it "engaged in acts and omissions" that allowed a misbranded supplement -- OxyElite Pro Advanced Formula, a product of Dallas-based USPlabs LLC (USP Labs) --to be sold at GNC locations nationwide in 2013.
GNC sold the product based on USP Labs' claim that ingredients contained in the product complied with the law and did not make any attempt to test the products or verify USP Labs' claims.
USP Labs was indicted in November 2015 and is awaiting trial. The indictment alleges that USP Labs imported 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.
GNC's obligations
The agreement obligates GNC to:
- Immediately remove from its shelves any product containing an ingredient that FDA has branded as unsafe;
- Establish a "restricted list" of ingredients that are not to be used in any dietary supplements it sells and a "positive list" of ingredients that are approved for sale;
- Require more explicit guarantees from vendors that their products don't contain ingredients on the restricted list
- Work to develop an industrywide quality seal program.
- Once the seal is established, stop paying its salespeople bonuses for directing customers to products that don't carry the seal; and
- Strengthen its adverse event reporting policy.
Earlier efforts
It's not the first attempt to rein in questionable practices at GNC. Last March, the company entered into a similar agreement with New York Attorney General Eric T. Schneiderman after a study by the AG's office found the majority of supplements being sold by GNC, Target, Walgreens, and Walmart did not contain the ingredients they claimed.
Under that agreement, GNC agreed to perform DNA barcoding on the “active” plant ingredients used in its products; implement testing for contamination with allergens, both before and after production; and post prominent signage advising consumers of the processed, chemical nature of extracts.
The agreement applied to all 6,000 GNC stores and was the first nationwide requirement calling for improved testing standards for herbal supplements.