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USPLabs Destroys $8 Million of Jack3D, OxyElite Pro

USPLabs Destroys $8 Million of Jack3D, OxyElite Pro

October 3, 2013 — The U.S. Food and Drug Administration (FDA) has reported that USPLabs, the largest manufacturer of dietary supplements containing DMAA, has agreed to destroy about $8 million worth of their most popular products, Jack3D and OxyElite Pro.

Timeline of FDA actions against USPLabs:

  • April 24, 2012 — USPLabs and 10 other manufacturers receive Warning Letters from the FDA, which state: “Synthetically produced dimethylamylamine is not a dietary ingredient.” USPLabs is the only manufacturer to fight the FDA enforcement.
  • December 4, 2012 — FDA inspectors find many violations of current Good Manufacturing Practices (cGMP), and USPLabs is issued another Warning Letter.
  • April 16, 2013 — USPLabs announces their intention to stop selling DMAA and reformulate Jack3D and OxyElite Pro, stating: “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 — USPLabs submits data from clinical studies linking DMAA to the geranium plant. The FDA finds many contradictions, inconsistencies, and deficiencies, and concludes that DMAA is not part of the geranium plant.
  • June 2013 — Over 3,200 cases of DMAA products are seized from GNC warehouses in Pennsylvania and South Carolina, according to the New York Times.
  • July 2, 2013 — In an updated Q&A, the FDA reports that $8 million worth of OxyElite Pro and Jack3D have been destroyed at a USPLabs warehouse in Dallas, Texas.

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