FDA reportedly inspected the warehouse in Leetsdale, a suburb of Pittsburgh, on June 4 and June 10. The agency subsequently informed the company that the 1,542 cases of Jack3d and Oxylite Pro it found there that contain DMAA were considered adulterated under the law.
On April 11, FDA had issued a statement saying it “is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.”
The statement went on to say, “FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal.”
GNC: Ingredient is safe
In April, in an earnings conference all with stock analysts, GNC CEO Joe Fortunato said the company was selling through its remaining stock of DMAA-containing products.
“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,” Fortunato said during the call.
“I think they issued a quick warning on those products the night before the story (on NBC). And I'm sure they did that so that they would not be pegged as saying the FDA didn't do anything about this,” he said. “But this product is safe and I think the FDA has pretty much said that just from the fact that they haven't pulled (DMAA-containing products) from the shelves.”
Game of chicken?
Observers of the situation said it seemed as if GNC had drawn a line in the sand as to how far it was willing to go to accommodate FDA on the DMAA affair.
“That’s a silly statement to make. FDA has come out a number of times that they think it is unsafe. Whether they were going to do anything about it was the question,” said Justin Prochnow, an attorney with Greenberg Traurig.
“I’m not surprised that FDA did this at all. I think GNC was daring the agency to take a more serious enforcement action,” said Marc Ullman, an attorney with Ullman, Shapiro & Ullman.
In a statement released to the media, GNC said, “The two detained products, Jack3d and OxyELIiTE Pro, are third party products distributed by USPlabs. They represent a very small fraction of products at the Leetsdale facility.”
GNC will sell out inventory
In a statement reiterated Fortunato’s statements in the earnings call that GNC believes DMAA is safe and that the company had received no information from FDA backing the assertion that the ingredient is unsafe. The company said it intends to continue to sell out its remaining DMAA inventory in its stores.
“(The) current inventory of products in stores will be exhausted within weeks. It is unclear then to GNC why the FDA has initiated this action at this point given DMAA-containing products are no longer being made,” the company said.
“DMAA-containing products are widely sold across the country. Yet, to the best of GNC's knowledge, the FDA has not taken any action against the same products residing in other distributors' warehouses or in any stores throughout the country. DMAA-containing products may continue to be sold and/or distributed everywhere in the US except this one GNC distribution facility. Given this situation, it is hard to view this action as anything other than a biased agency action against GNC in retaliation for GNC's stance on DMAA,” the statement concluded.