On Tuesday, a criminal case brought against USPLabs was the center point of a multi-party news conference put on by government regulators that included officials from FDA, FTC and other agencies. The case, which named USPLabs, contract manufacturing partner S.K. Laboratories and executives of both companies, alleged the companies had colluded to import illegal ingredients under false names. The indictment also alleged that USPLabs used an ingredient in products which it had reason to believe presented a plausible risk of liver toxicity but went ahead on the unsubstantiated notion that the specific form and inclusion level chosen for the ingredient would avoid problems.
“While none of the recent allegations made against USPLabs relate to the current formulations of any of its products and we have no reason to believe that there are any health and safety issues with respect to any USPlabs products currently sold by GNC, it is in the best interest of our customers to suspend the sale of the company's products pending further review,” said Michael Archbold, CEO of GNC.
Long history with DMAA
GNC had chosen in the past to continue to offer USPLabs products even after the company had run into difficulties with FDA and never bought in to the government’s argument that the ingredient DMAA was potentially unsafe. FDA first challenged the marketing of DMAA via a series of warning letters in 2012. FDA alleged at that time that no safety information on the ingredient had been submitted to the agency, making products that contained it adulterated. USPLabs finally cut the ingredient from its products in the spring of 2013. At least until late spring 2013, GNC chose to continue to sell DMAA-containing products manufactured by USPLabs in an effort to sell out its inventory and only chose to destroy its remaining inventory when forced to do so by FDA.
“Reality is, it's been 15 months the military has been investigating DMAA. They found nothing that came back. We went to them three times, obviously concerned that if there was any safety issue, we wanted the product off the table. They have nothing,” said then-CEO Joe Fortunato in April, 2013.
Effort to camouflage ingredient
The core of the government’s current case is a series of communications between USPLabs and S.K. Labs executives about how to hide the importation and provenance of DMAA, which FDA had said was not a legal dietary ingredient because it lacked proper NDI notification documentation and because it was believed to be wholly synthetic. This was the same time frame during which GNC was selling significant quantities of the supplements. The most recent sales of the reformulated, DMAA-free USPLabs supplements have been characterized by GNC as “immaterial.”
"As an industry leader GNC has always gone above and beyond the minimum requirements in pursuing quality for our consumers, and we will continue to lead the efforts for higher standards with regard to the products we manufacture along with the products manufactured by third parties and carried in our stores,” Archbold said.