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FDA Exercised FSMA Recall Authority for OxyElite Pro Dietary Supplements

In fiscal year 2014, the U.S. Food and Drug Administration (FDA) exercised its recall authority granted by the Food Safety and Modernization Act (FSMA) for the second time.

OxyEliteProFDA published its second annual report to Congress this past week on the use of mandatory recall authority, stating that it had issued a Notification of Opportunity to Initiate a Voluntary Recall letter to USPlabs LLC of Dallas, TX. The notification gave the company the chance to stop distributing and recall OxyElite Pro-branded products.

FDA also published three public health advisories about the dietary supplement linked to dozens of cases of acute liver failure and hepatitis, including one death.

The company ultimately agreed to recall the products of concern.

In order to issue a mandatory recall order, FDA must first provide the responsible party with the opportunity to cease distribution and to conduct a voluntary recall of the article of food in question. If the responsible party refuses, the agency may proceed under the mandatory recall authority.

Before FSMA was enacted in 2011, FDA generally had to rely on manufacturers’ voluntary recall efforts or obtain a court order to remove contaminated or misbranded foods from the food supply.

In 2013, FDA, along with the Centers for Disease Control and Prevention (CDC), the Department of Defense Armed Forces Health Surveillance Center, and state and local health officials, investigated an outbreak of acute non-viral hepatitis that began in Hawaii.

According to CDC, 97 people with acute non-viral hepatitis were identified in this outbreak, 72 of whom had reported exposure to an OxyElite Pro-branded product. Of these cases, at least 47 were hospitalized, at least 3 received a liver transplant, and 1 death was reported. The estimated illness onset dates ranged from April 10, 2013, to Oct. 24, 2013.

On Oct. 11, 2013, FDA issued a warning letter to USPlabs LLC informing the company that the dietary supplements OxyElite Pro and VERSA-1 were adulterated, and that failure to immediately cease distribution of these products could result in enforcement action.

The warning letter stated that the products were deemed to be adulterated because they contained aegeline, a new dietary ingredient (e.g., a dietary ingredient not marketed in the United States before Oct. 15, 1994) that was not the subject of a required notification to FDA.

Specifically, USPlabs LLC failed to provide FDA with evidence, as required by law, that aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, was reasonably expected to be safe for use in its dietary supplements.

In a letter dated Nov. 6, 2013, FDA notified USPlabs, LLC about findings indicating a link between the use of certain OxyElite Pro products and a cluster of liver illnesses reported in Hawaii. The letter also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states and summarized the results of FDA’s review of 46 medical records of cases from the outbreak.

The reviewed records indicated that 27 of the 46 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of these 27 patients reported that OxyElite Pro was the only dietary supplement they were taking. One death had occurred among these patients, another patient had required a liver transplant, and others were awaiting liver transplants.

Based on review of the medical records and other evidence obtained in FDA’s investigation, the letter concluded that there was a reasonable probability that the OxyElite Pro dietary supplements listed in the letter were adulterated and that use of, or exposure to, the dietary supplements would cause serious adverse health consequences or death to humans.

The letter also notified USPlabs LLC that if the company did not initiate a voluntary recall, FDA could order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements.

On Nov. 9, 2013, USPlabs LLC recalled the OxyElite Pro dietary supplement products that were the subject of FDA’s Nov. 6, 2013, letter. On Nov. 19, 2013, USPlabs LLC expanded the recall to include another flavor of one of the products.

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