Texas-based USPlabs, LLC., has agreed to recall and destroy its OxyElite Pro dietary supplements that have purportedly been linked to dozens of cases of acute liver failure and hepatitis, including one death. In addition to recalling the products, USPlabs has reportedly assured the U.S. Food and Drug Administration (FDA) that it will destroy warehouse stocks of the supplement, worth about $22 million.
According to FDA, USPlabs took the action after receiving a letter from FDA stating that if the company did not initiate a voluntary recall, the agency could by law order it to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing them. FDA’s action reportedly marks the second time the agency has exercised its recall authority under the Food Safety Modernization Act (FSMA), which allows it to act quickly in the face of a potential danger to public health. Noting that the agency’s aim is to prevent the occurrence of such events, Director of FDA’s Division of Dietary Supplement Programs Daniel Fabricant said that FSMA has been "instrumental" in the agency’s enforcement actions regarding the OxyElite Pro dietary supplements.
Calling the national recall "appropriate as a precautionary measure," USPlabs said that "epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii." More information on FDA’s investigation into OxyElite Pro may be found in Issue 13 of this Report. See FDA News Release, November 10, 2013.