Justice Department Announces Indictments of Dietary Supplement Maker with Product Linked to Two Deaths in Hawaii

On November17, the Justice Department has announced indictments of a Texas company whose dietary supplement—OxyELITE Pro—has been linked to cases of liver injury and two deaths in Hawaii.

The indictment accuses USPlabs LLC of importing chemicals from China and then using misleading product labels to disguise the nature and source of those ingredients.. 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. Executives of the company were also included in the indictment.

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. 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. Despite promises to stop distributing OxyELITE Pro, USPlabs instead engaged in a “surreptitious, all-hands-on-deck effort to sell as much OxyELITE Pro as it could as quickly as possible,” the Justice Department charges.

In October 2013, Hawaii’s health department, alarmed by a rash of cases of nonviral hepatitis linked to OxyELITE Pro, ordered retailers to pull the supplement from store shelves. The health department investigated more than 40 cases of acute liver inflammation in people who used various versions of OxyELITE Pro, according to the AP. Two of those people died of liver failure and two others suffered such severe liver damage that they needed liver transplants.

Along with the company itself, the indictment charges four company executives, a consultant, and S.K. Laboratories, Inc., and one of its executives. Prosecutors says the California firm was responsible for manufacturing many products for USPlabs, the AP reports. The indictments are part of a yearlong nationwide action involving 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 about risks to the public when supplement makers evade rules to prevent supplements from being improperly marketed for specific diseases and conditions. In addition to misleading marketing, numerous supplements have been found to contain undeclared drug ingredients, which can lead to overdoses and dangerous drug interactions and side effects.

Dietary supplements fall under different regulations than “conventional” foods and drug products. Dietary supplements do not need FDA clearance before coming to market, but manufacturers are prohibited from marketing products that are deemed adulterated or misbranded under FDA definitions. Supplement makers are responsible for evaluating the safety and labeling of their products prior to selling them 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 adulterated or misbranded dietary supplements only after the product reaches the market.

from Parker Waichman http://www.yourlawyer.com/blog/justice-department-announces-indictments-of-dietary-supplement-maker-with-product-linked-to-two-deaths-in-hawaii/