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SILVER SPRING, Md. — Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.
In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials that it will destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA will oversee the destruction of the product.
"As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention," Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs stated. "Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace."
FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.
The supplement was advertised as an aid to losing weight and building muscles. FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
While FDA's investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1.
Earlier this year, a stockpile of another formulation of OxyElite Pro was destroyed after being held through an FDA administrative detention order. A stimulant included in those products, DMAA, or dimethylamylamine, can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.
After removing DMAA from its products, USPLabs substituted aegeline, among other ingredients, in certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree (Agele marmelos).
"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," Fabricant said. "Losses to the company should also serve as a reminder that FDA's laws and regulations serve a purpose and must be followed."