Federal investigators have issued a criminal indictment against the manufacturers of popular workout supplements Jack3d and OxyElite Pro, following a year long investigation that revealed the company violated multiple federal laws and allegedly used unapproved synthetic ingredients that caused dozens of liver injuries and at least one death among users.
The U.S. Department of Justice (DOJ) unsealed an 11-count indictment against USPlabs and their operating partners on November 17, outlining a variety of charges.
The allegations include conspiracy to falsify mailing certificates to import factory made synthetic ingredient from China, false product labeling, and lying to the FDA about ceasing distribution of a product containing an ingredient that had been linked to reports of liver injuries.
As part of a year-long investigation by the DOJ and several other federal agencies, over 100 manufacturers and marketers of dietary supplements have had criminal and civil cases pursued against them for not including all ingredients on product labels and marketing the products for health or disease treatment that have not been adequately supported by scientific evidence. The sweep of civil and criminal cases spanned across 18 states and included 117 individuals or entities alleged of illegitimate product labeling and marketing.
The indictment states that USPlabs LLC of Dallas, Texas and S.K. Laboratories Inc. of Anaheim, California, along with their operators, used a synthetic stimulant made in China in their dietary and workout supplements Jack3d and OxyElite Pro. However, the companies marketed the products and told retailers that the supplements were made from 100 percent natural plant extracts.
After more than 60 reported liver injuries that caused dozens to be hospitalized, including at least two cases where individuals required a liver transplant and one death, the FDA forced an OxyElite Pro recall in October 2013.
USPlabs and its principals agreed to stop the distribution of the product, but the indictment alleges that the company engaged in an “all-hands-on-deck” effort to sell as much OxyElite Pro as quickly as possible to dietary supplement stores across the nation. The DOJ’s investigation alleges that during this time, USPlabs company executives ordered the synthetic non-labeled offending substances be removed from the formula.
Included in the indictment are also charges that the illegal synthetic ingredient imported from China was shipped using false certificates of analysis to pass through the Unites States Postal Service undetected. The DOJ implied the company was well aware of studies that linked the supplements to liver failures which would explain why the synthetic ingredients were imported discretely and never listed on the product label.
The DOJ stated that reports from the Internal Revenue Service indicate UPSlabs LLC had over $400 million in sales from the two products between 2008 and 2013.
Since the indictment was released, the DOJ has arrested four of the six owners of USPlabs and S.K. laboratories and anticipates the other two will self-surrender. Yesterday, the FDA and the IRS-CI special agents seized the company’s assets in dozens of investment accounts, real estate in Texas and a number of luxury and sports cars.
Dozens of OxyElite Pro and Jack3d lawsuits have been filed against USPlabs LLC by consumers of suffered acute hepatitis and liver injuries.
Several requests to centralize and consolidate all OxyElite pro and Jack3D liver damage lawsuits have been rejected by the U.S. Judicial Panel on Multidistrict Litigation (JPML), which determined that there are still too many unique factors involved in each case to justify establishing a federal multidistrict litigation (MDL).
The panel stated in its denial that the centralization was not warranted because the involved actions focused on different formulations of the products, alleged different health risks, and alleged distinct regulatory responses to the DMAA and aegeline products at issue. The panel additionally concluded that with majority of the lawsuits and injuries arising from Hawaii that the district would be able to coordinate and rule appropriately.
In a 2015 publication of the New England Journal of Medicine, researchers from the CDC found more than 23,000 emergency room visits related to dietary supplements occur every year, resulting in an average of 2,154 hospitalizations annually. The CDC indicated that 72 percent of the emergency room visits were related to the use of weight loss or energy products that led to heart palpitations, chest pains, and rapid heartbeats with majority of the patients ranging between 20 and 34 years of age.