Food and Drug Administration investigations have become second nature for Dallas-based USP Labs, after a recent look by the federal agency linked one of the company’s supplements to a hepatitis outbreak in Hawaii.
The FDA issued a warning last week linking the company’s bodybuilding supplement OxyElite Pro to an outbreak of non-viral hepatitis. Nearly 30 patients have been hospitalized with acute heptatitis so far, two dozen of whom had used OxyElite Pro. Two of those have required liver transplants, and one has died.
“The warning letter states that the products are deemed adulterated because they contain a new dietary ingredient (an ingredient not previously present in the food supply, and for which there is no history of use or other evidence of safety when used as suggested in the labeling) which lacks adequate information to provide reasonable assurance of safety,” the FDA said in a statement. “Specifically, USP Labs failed to provide the 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 safe for use in its dietary supplements.”
As a precaution, USP Labs has halted distribution of OxyElite Pro, saying in a statement that “the company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii.”
According to the company, OxyElite Pro is the “number one selling fat loss formula in America.” The company claims that the product is backed by university studies that prove that it works to remove fat from the body by turning off fat receptors. It also says that OxyElite Pro’s “super thermogenic” formula kick-starts users’ metabolism, improves mental focus, and decreases appetite.
As news of the investigation broke, the NFL Players Association took the rare step of tweeting a photo of the supplement, warning players of its supposed health risks:
— NFLPA (@NFLPA) October 9, 2013
This is the second wave of investigation into USP Labs, which is based in a warehouse off Interstate 35, in northwest Dallas. In April, the FDA announced that the stimulant dimethylamylamine was an illegal dietary ingredient and could pose serious health risks to users. Regulators said the stimulant could elevate blood pressure and potentially lead to heart attacks. Later that month, Dallas-based USPlabs said that it would stop producing DMAA products and instead create products without the stimulant. But the company continued to distribute its remaining inventory of Jack3d and OxyElite Pro, the FDA announced, which prompted the agency to ask the company to destroy them.
On July 2, USPlabs voluntarily destroyed $8 million worth of its DMAA-containing products located at its Dallas facility, the FDA reported.
As for the most recent investigation, the FDA is reviewing the medical records and histories of patients identified by the Hawaii Department of Health, and is also analyzing the composition of product samples that have been collected from some of these patients.
Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records. Because USP Labs has informed the FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the U.S. and have been on the U.S. market for some time, the FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.