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After Recall, USPLabs Destroys $22 Million of OxyElite Pro

After Recall, USPLabs Destroys $22 Million of OxyElite Pro

November 18, 2013 — Last week, the FDA threatened to force USPLabs LLC to recall OxyElite Pro if they did not agree to do so voluntarily. Now that OxyElite Pro is off the market, the FDA will oversee the destruction of $22 million worth of the product, according to a Consumer Update.

This is the second time the FDA has ordered USPLabs to destroy OxyElite Pro. In July, the FDA announced that $8 million worth of OxyElite Pro containing DMAA would be destroyed. DMAA was an illegal stimulant that was associated with 86 reports of severe side effects, including high blood pressure, heart attacks, seizures, psychiatric disorders, and death.

After DMAA was taken off the market, USPLabs re-formulated OxyElite Pro with another illegal ingredient, aegeline. According to Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs:

“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law. Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”

The FDA does not require proof of a supplement’s safety or effectiveness before it is allowed on the market. However, manufacturers must submit a New Dietary Ingredient (NDI) notification 75 days before they start selling a new supplement. USPLabs never provided an NDI for DMAA or aegeline.

Health officials have reported at least 56 cases of liver damage in 13 states. The first cluster of 7 illnesses was reported in Hawaii in September. Since then, 43 cases have occurred in Hawaii, including one woman who died of liver failure.

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