November 18, 2013 — USPLabs, LLC, the beleaguered manufacturer of OxyElite Pro supplements, will destroy $22 million worth of the recalled supplement, according to an FDA Consumer Update. The FDA will oversee destruction of the product.
The FDA issued a similar update in July, after they ordered USPLabs to destroy $8 million worth of OxyElite Pro containing DMAA (dimethylamylamine). The illegal stimulant was linked to high blood pressure, heart attacks, seizures, psychiatric disorders, and death.
Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs, launched the investigation with state officials in Hawaii and the Centers for Disease Control (CDC). Fabricant warned:
“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.”
According to the FDA, manufacturers of dietary supplements do not need to prove that their products are safe or effective. However, they do need to notify the FDA of plans to include a new dietary ingredient 75 days before the product goes to market. USPLabs failed to provide a notification for DMAA in OxyElite Pro. After the FDA issued a warning, USPLabs re-formulated OxyElite Pro with aegeline — but again, they failed to notify the FDA.
As of late October, there were 56 cases of acute liver failure or acute hepatitis (liver inflammation) linked to OxyElite Pro, including 43 in Hawaii. At least 13 states have reported cases of liver damage associated with OxyElite Pro, including California and Ohio.
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