Regulatory Focus™ > News Articles > With Food Safety Division hit by Shutdown, FDA Tries to Confront Outbreak of Hepatitis Related to Su

With Food Safety Division hit by Shutdown, FDA Tries to Confront Outbreak of Hepatitis Related to Supplement

Posted 09 October 2013 | By Alexander Gaffney, RAC

The US government shutdown has left the US Food and Drug Administration (FDA) without many of its employees at its Center for Food Safety and Applied Nutrition (CFSAN). Now a major safety notice issued by the agency is illustrating why that could not have come at a worse time for its dietary supplements division.

In a statement published on 8 October 2013, the agency said it was coordinating with the Centers for Disease Control and Prevention (CDC)-another agency that has been hard-hit by the shutdown-to investigate 29 cases of acute non-viral hepatitis associated with use of a dietary supplement labeled as OxyElite Pro.

The statement's use of the word "labeled as" is notable, as officials said the official makers of OxyElite Pro, USPlabs LLC, have said counterfeit versions of the drug could be to blame for any safety issues.

And those issues are severe, with FDA explaining that one patient has died from liver-related issues, while another two have received liver transplants and 11 have been hospitalized with acute hepatitis.

At present, the issues appear to be localized in Hawaii, but FDA and CDC are "looking at other cases of liver injury nationwide that may be related," they said in a statement. At present, regulators said consumers should stop using any supplements labeled as OxyElite Pro while their investigation into the root cause of the safety problems continues.

"In the interest of protecting public health, we are moving quickly to learn as much as possible," CDC and FDA wrote. "We recognize that people will be concerned about these illnesses, and we will provide updates as the investigation develops."

FDA said it is in the process of analyzing the composition of collected product samples involved in the liver injuries, and has also initiated inspections of USPlabs' manufacturing facilities and distribution records. To do so, CFSAN has already recalled several FDA staff members who had been furloughed, Reuters reports.

The news comes just months after another safety-related issue forced USPlabs to voluntarily recall and destroy its "Jack3d" dietary supplement, which contained the ingredient 1,3-dimethylamylamine, methylhexanamine, better known by the acronym DMAA. FDA said DMAA was unsafe for use, calling it a synthetic-not "natural"-stimulant that required new drug approval to be legally marketed.

A second supplement was also destroyed at that time, officials said: OxyElite Pro. According to several news reports, the company has since reformulated the drug to exclude DMAA, though it still contains a "proprietary blend" of ingredients that collectively act as a "thermogenic" to "reduce body fat."

A question for regulatory officials will presumably be: Did this reformulation introduce new and unknown risks to patients, or is this the fault of an outside counterfeit product?

Stay tuned for answers, regulators said.


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