A central function of the U.S. Food and Drug Administration is to oversee and regulate drugs in the domestic marketplace, ensuring their purity and safety. That mandate extends to both pharmaceutical drug offerings and over-the-counter products, such as dietary supplements.
The latter type of product has been implicated in a big way recently via news stories that have emerged from Hawaii and have immediate relevance for consumers in Ohio and all other states. What has been described as a “cluster of liver toxicity that has occurred in Hawaii” is alarming national health regulators and presenting clear product liability concerns for the maker of a fat-burning supplement that is now under strong scrutiny.
That supplement is called OxyElite Pro, a product that is undoubtedly familiar to many Ohioans, given its nationwide distribution. What has been reported recently in connection with the supplement is truly scary: In Hawaii, one person has reportedly died from its use, and two other consumers have undergone liver transplants. More than two dozen other people are stated to have liver failure or acute hepatitis from their use of the supplement, according to Hawaii health officials.
OxyElite Pro is manufactured by USPlabs, which states that its products, including the supplement in question, are uniformly safe. Notwithstanding that statement, however, the company has agreed to stop its domestic production of OxyElite Pro products “out of an abundance of caution.”
USPlabs states that the liver toxicity outbreak may be connected to counterfeit versions of its products that have penetrated the United States market.
Source: CNN Health, “Fat-burning supplement OxyElite pulled, linked to liver failure,” Jacque Wilson, Oct. 9, 2013