As lawsuits alleging liver toxicity have been filed against the maker of the supplements Jack3d and OxyElite Pro, the U.S. Food and Drug Administration, in partnership with other governmental agencies, filed a criminal case in November against USPlabs LLC. The government's legal action coincided with the FDA's yearlong probe to identify unsafe ingredients contained in dietary supplements.
The FDA's supplements sweeps led to civil injunctions and criminal actions against 117 makers and distributors of dietary supplements as well as tainted products that have been marketed as dietary supplements. Known by the FDA for its widely popular workout and weight loss supplements, USPlabs happened to be snagged in the net.
The sweep involved the Justice Department, Internal Revenue Service, Federal Trade Commission, Postal Inspection Service, Defense Department and Anti-Doping Agency.
"This joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements and products falsely marketed as dietary supplements," said Howard Sklamberg, the FDA's deputy commissioner for global regulatory operations and policy. "The criminal charges against USPlabs should serve as notice to industry that if products are a threat to public health, the FDA will exercise its full authority under the law to protect Americans and bring justice."
The Justice Department echoed that sentiment, emphasizing public health.
"The Justice Department and its federal partners have joined forces to bringing to justice companies and individuals who profit from products that threaten consumer health," said Principal Deputy Assistant Attorney General Benjamin C. Mizer. "The USPlabs case and others brought as part of this sweep illustrate alarming practices the Department found - practices that must be brought to the public's attention so consumers know the serious health risks of untested products."
The feds arrested people and seized assets, alleging the Dallas-based company:
· "Engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory."
· "Sold some of their products without determining whether they would be safe to use," although they "knew of studies that linked the products to liver toxicity."
· "Told the FDA in October 2013 that it would stop distribution of OxyElite Pro, once the product had been implicated in an outbreak of liver injuries," but instead it "engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible. It was sold at dietary supplement stores across the nation."
Attorneys representing plaintiffs in 17 OxyElite Pro and Jack3d lawsuits filed court documents in 2014 that stated, in part, "The 17 actions share common factual allegations that OxyElite Pro and Jack3d are unsafe, 'adulterated,' and cause injury and/or damages. The plaintiffs in each action have alleged that USPlabs wrongly marketed and/or promoted its products by labeling and advertising that the products were safe and effective. Each complaint alleges that USPlabs misled and/or was negligent in its representations and manufacturing of the products and the use of their constituent ingredients. Furthermore, each complaint relies upon the statements and purported representations of the FDA as the basis for its factual allegations against USPlabs. Plaintiffs further allege that their injuries/damages arose from this common nucleus of facts."
Plaintiffs didn't invent the safety issue. This is what happened. People got sick, the FDA investigated the reports of liver illnesses, and the agency took the prudent step of issuing a warning. The November 2015 FDA announcement recapped the warning as follows:
"In November 2013, the FDA warned consumers not to use certain USPlabs products that were found to contain a new dietary ingredient that had not been shown to be safe for use by consumers. The ingredient, aegeline, is a synthetic version of an alkaloid (a chemical compound) that exists, in natural form, in a tree that grows in parts of Asia. In addition, the products had adverse events linked to acute liver failure or non-viral hepatitis so severe that several patients needed liver transplants, and one resulted in death."
Users of OxyElite Pro and Jack3d who since were diagnosed with a liver condition may call toll-free 1-866-LAW-2400 for a free consultation as to whether they are entitled to compensation for medical expenses and for other damages.