Deaths Linked To Dietary Supplement OxyELITE Pro. A Texas company whose dietary supplement has been linked to cases of liver injury has been indicted in two deaths in Hawaii linked to the supplement, OxyELITE Pro.
Executives of the company were also indicted on charges that USPlabs intentionally misbranded their products and deceived consumers, the Justice Department announced on November 17. The indictment accuses USPlabs LLC of importing chemicals from China and then lying about the nature and source of those ingredients through misleading product labels.
Prosecutors say this was part of a pattern of deception designed to put products on store shelves regardless of safety risk, the Associated Press (AP) reports.
Principal Deputy Assistant Attorney General Benjamin Mizer, head of the Justice Department’s civil division, said USPlabs “falsified labeling and marketing materials to convince consumers, who prized natural ingredients, to buy their products.”
Regulators, retailers and consumers all “trusted that the defendants were telling the truth about their products
Regulators, retailers and consumers all “trusted that the defendants were telling the truth about their products. All of these people were deceived,” Mizer said.
In 2013, the Food and Drug Administration (FDA) directed USPlabs to cease production of a weight loss and muscle-building supplement after the product was linked to liver damage. Several users needed liver transplants to save their lives, the AP reports.
The company promised it would stop distributing OxyELITE Pro, but instead engaged in a “surreptitious, all-hands-on-deck effort to sell as much OxyELITE Pro as it could as quickly as possible,” according to the Justice Department.
In October 2013, Hawaii’s health department ordered retailers to pull OxyELITE Pro from their shelves. The health department investigated more than 40 cases involving people who had developed acute liver inflammation, also known as nonviral hepatitis, after consuming various versions of OxyELITE Pro, according to the AP. Two people underwent liver transplants and two others died of liver failure.
The indictment charges four company executives and a consultant as well as S.K. Laboratories, Inc., a California firm that prosecutors say was responsible for manufacturing many products for USPlabs, and one of its executives.
nationwide action against makers and marketers of dietary supplements
The indictment was announced as part of a yearlong nationwide action against makers and marketers of dietary supplements. The Justice Department said the action has resulted in criminal or civil cases against 117 people and entities.
The multi-billion-dollar dietary supplement industry has come under increasing scrutiny from lawmakers and regulators, who are concerned that companies are skirting rules preventing supplements from being marketed for specific diseases and conditions.
The FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Dietary supplements do not receive FDA clearance before coming to market, but manufacturers of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.
Supplement makers are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Dietary Supplement Health and Education Act (DSHEA) and other FDA regulations. The FDA can take action against any adulterated or misbranded dietary supplement product only after it reaches the market.