GNC Holdings Inc., the world’s largest global nutritional supplement retailer, has agreed to settle with the US government and pay $2.25 million to avoid federal prosecution.
The settlement stems from GNC’s alleged sales of illegal dietary supplements, including a misbranded supplement sold in 2013 called OxyElite Pro Advanced Formula, made by Dallas-based nutritional supplement manufacturer USP Labs.
While USP Labs was indicted in a federal court in November 2015, GNC has continued to claim it did nothing wrong.
Nevertheless, Reuters cited a senior Juice Department official who hailed the settlement as, “A significant step forward in reforming an industry rife with alarming practices.”
GNC also agreed to reform some of its practices as part of the settlement.
USP Labs Allegedly Added Illegal Synthetic Chinese Stimulants to Its Supplement
USP Labs appears to be the real guilty culprit here: the US government charged USP Labs with conspiring to import ingredients from China using false certificates of analysis and false labeling, according to the Justice Department.
The USP Labs case has not gone to trial. However, it’s alleged that USP Labs added synthetic Chinese-made stimulants to its supplements while claiming they were natural plant extracts.
GNC, meanwhile, claims they removed USP Labs products from store shelves “years ago”.
The US government’s settlement with GNC affirms that GNC is in “full compliance” with the Federal Food, Drug, and Cosmetic Act, according to GNC. They added that USP Labs had provided “false assurances” about its products.
A separate probe into the nutritional supplement industry was conducted by the FDA’s Office of Criminal Investigations (OCI) last year. During that probe, undercover agents purchased supplements at GNC, the Vitamin Shoppe, and Vitamin World, and found no evidence of wrongdoing. All supplements – including some made by USP Labs – came back with a clean bill of health after being tested in the FDA’s labs.