Regulatory Focus™ > News Articles > USPlabs Succumbs to Regulatory Pressure, Recalls Supplement Linked to Hepatitis Outbreak

USPlabs Succumbs to Regulatory Pressure, Recalls Supplement Linked to Hepatitis Outbreak

Posted 12 November 2013 | By Alexander Gaffney, RAC 

Dietary supplement manufacturer USPlabs has announced the recall of one of its workout supplements, succumbing to vigorous pressure from regulators who said the company's products had been associated an outbreak of non-viral hepatitis.

Background

In early October 2013, US Food and Drug Administration (FDA) issued a statement saying that it was coordinating with the Centers for Disease Control and Prevention (CDC) to investigate 29 cases of acute non-viral hepatitis associated with use of Oxy Elite Pro, a product used as a "thermogenic" with the stated purpose of allowing users to lose fat. The only common risk factor among patients was the ingestion of Oxy Elite Pro, FDA said.

FDA explained that at the time of its statement, one patient had already died from liver-related issues, while another two had received liver transplants and 11 had been hospitalized with acute hepatitis. As a result, FDA said it was in the process of re-inspecting USPlabs' manufacturing facility and distribution records to determine if the outbreak was caused by Oxy Elite Pro or by counterfeit versions of the product.

USPlabs, meanwhile, had defended the safety of its products, implying that the affected patients might have taken a counterfeit version of the product.

"There is no objective evidence to link OxyELITE Pro to these cases of illness," the company said in a statement. "At this point, speculation and unscientific theories only hurt the ability to identify the cause of the injuries in question and risks skewing the investigation away from the actual causes of injury, which is not helpful for the people of Hawaii."

However, the company said it would stop marketing the product out of an abundance of caution.

'Voluntary' Recall

Now USPlabs is going one step further, just weeks after FDA sent the company a Warning Letter indicating that the company needed to "immediately cease distribution" or risk immediate enforcement action.

In a 10 November 2013 recall statement, the company said it was, as a result of the Warning Letter, voluntarily recalling certain lots of its OxyElite Pro supplement.

FDA said that if the company had not taken the action, regulators would have forced it to do so under the authority of the Food Safety Modernization Act (FSMA). The Warning Letter's inclusion of this threat was only the second time in FDA's history that it had threatened to use the authority, which it received in 2011.

In the same statement in MedWatch, FDA's adverse event reporting program portal, FDA said it had concluded that there was a link between the product and hepatitis, and that the link extended to other cases "in a number of other states." The wider extent of the cases had not yet before been revealed by FDA to the public.

"FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1," another weight lifting supplement manufactured by USPlabs, it wrote.


FDA Recall Statement


Tags: Recall

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