USPLabs Destroys $8 Million of Jack3D, OxyElite Pro

October 3, 2013 — After nearly a year of fighting the U.S. Food and Drug Administration (FDA), USPLabs voluntarily destroyed more than $8 million worth of dietary supplements containing DMAA (1,3-dimethylhexanamine or methylhexanamine). The products include Jack3D and OxyElite Pro, which are the most popular DMAA supplements.

Timeline of FDA actions against USPLabs:

• April 24, 2012 — FDA issues a Warning Letter to USPLabs, stating “synthetically produced dimethylamylamine is not a dietary ingredient.”
• December 4, 2012 — FDA inspects USPLabs and issues a lengthy Warning Letter citing violations of current Good Manufacturing Practices (cGMP).
• April 16, 2013 — USPLabs finally agreed to remove DMAA from Jack3D and OxyElite Pro. According to a statement from the company: “USPlabs stands by the safety and legality of its products containing the dietary ingredient 1,3-DMAA. We disagree with FDA’s position. … The company has nevertheless concluded for business reasons to phase out products containing 1,3-DMAA.”
• April 18, 2013 — FDA reviews evidence from USPLabs linking DMAA to a natural source, and concludes that DMAA is not part of the geranium plant and, therefore, it is not a legal ingredient in dietary supplements.
• June 2013 — The New York Times reports that federal prosecutors asked judges in Pennsylvania and South Carolina to seize more than 3,200 cases of DMAA from GNC warehouses.
• July 2, 2013 — FDA publishes a Q&A reporting that USPLabs voluntarily destroyed DMAA-containing products located at a facility in Dallas, Texas. The products, OxyElite Pro and Jack3D, are estimated to have a retail value of $8 million.

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