More than 1,500 cases of products containing the banned dietary supplement known as DMAA, stored in a GNC Holdings warehouse in Leetsdale, are subject to a federal seizure complaint filed today in U.S. District Court.
The civil complaint indicates that the Food and Drug Administration inspected the warehouse from June 4 through June 10, collecting samples, photographing boxes and examining shipping labels. On June 11, the FDA notified GNC that the 1,542 cases of Jack3d and OxyElite Pro Super Thermogenic are, under the law, considered adulterated.
The complaint said they contain dimethylamylamine, or DMAA, which the FDA in April declared to be unsafe. That declaration followed reports of deaths, including several on military bases, of people whose fitness regimens included use of DMAA.
The products are made by the Texas company USPLabs.
"The two detained products, Jack3d and Oxyelite Pro, are third party products," a GNC spokesman wrote in an email response to questions. "They represent a very small fraction of products at the Leetsdale facility.
"GNC believes that DMAA is a safe, legal dietary ingredient," GNC's statement continued. "The products are widely available over the Internet and through various retailers across the country. We are unaware if FDA has detained these same products in other retailers' distribution facilities."
GNC, the statement continued, will not distribute the products until the dispute over their safety, between the FDA and USPlabs, is resolved.
The filing of the complaint requires that GNC keep the product in its warehouse during the litigation. If a judge approves the forfeiture complaint, the products must be destroyed. If it is not approved, the products can be sold.mobilehome - breaking - businessnews - neigh_north
Rich Lord: firstname.lastname@example.org, 412-263-1542 or Twitter @richelord