Charges Brought Against Makers of OxyElite Pro
USPlabs LLC has been indicted on charges that it intentionally misbranded its dietary supplement products and lied to customers, the Justice Department announced. Star Advertiser reports that the company is accused of engaging in behavior intended to place its products on the shelves, even if it was dangerous to consumers. USPlabs has come under scrutiny following cases of liver damage and death related to its supplement product OxyElite Pro. According to the indictment, USPlabs deceived consumers about the nature and source of its ingredients, which were shipped from China. Four company executives, a consultant and S.K. Laboratories were indicted.
Principal Deputy Assistant Attorney General Benjamin Mizer, who is head of the Justice Department’s civil division, said “They falsified labeling and marketing materials to convince consumers, who prized natural ingredients, to buy their products,” according to Star Advertiser. “All of these people — regulators, retailers and consumers — trusted that the defendants were telling the truth about their products. All of these people were deceived.”
The U.S. Food and Drug Administration (FDA) has taken issue with the company in the past, and these problems were covered in the Justice Department’s allegations. In 2013, the FDA ordered USPlabs to stop producing OxyElite Pro, a weight loss and muscle building supplement. The product was linked to cases of liver damage; some users even needed life-saving liver transplants. Even though the company agreed to stop distributing the supplement, the Justice Department alleges it engaged in a “surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible,”
Safety concerns over OxyElite Pro became especially prevalent in Hawaii, which saw a rise in liver damage and acute hepatitis linked to the product in October 2013. The state Health Department recalled the product in response. The DOH said it was investigating 40 cases of liver problems, including acute liver inflammation (nonviral hepatitis) associated with the use of OxyElite Pro. According to Star Advertiser, two people underwent liver transplants and two more died of liver failure.
In recent years, the dietary supplement industry has been criticized for its lack of safety measures. Unlike drugs, dietary supplements are subject to few regulations by the FDA. The Justice Department has been conducting a yearlong sweep against supplement makers, resulting in the indictment; the department says criminal or civil charges have been brought against 117 people or entities.
