The US Food and Drug Administration has utilized newly granted enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in getting a dangerous supplement off the market.
The agency has demanded that Texas-based USPLabs recall products it sells under the brand OxyElite Pro and the company has agreed, additionally agreeing to destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA will oversee the destruction of the product.
The product has been linked to several dozen cases of acute liver failure and hepatitis, along with one death and liver damage so severe that many require liver transplants.
"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 (CDC)," said Daniel Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Programs. "Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace."
The FDA regards certain OxyElite Pro products and another supplement, VERSA-1, sold as weight loss and muscle building aids, to be adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree (Agele marmelos).
The FDA stresses that consumers should avoid both OxyElite Pro and VERSA-1.
"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," said Fabricant. "Losses to the company should also serve as a reminder that FDA's laws and regulations serve a purpose and must be followed."
Source: FDA Consumer Health Information