A recall has been issued for the workout supplement OxyElite Pro after numerous reports of serious liver complications in those using the supplement. OxyElite Pro is marketed as a weight loss and muscle building supplement by Dallas based manufacturer USPlabs, LLC. The recall was announced by USPlabs on November 10, 2013 after it received a letter from the FDA noting that the product had been linked to reports of liver illnesses. The letter further stated that if the company did not voluntarily recall the supplements, the FDA would order a stop to distribution of the product immediately and notify all distributors and retailers to stop its sale.
Just last month the FDA warned USPlabs that it deemed OxyElite Pro to be adulterated because it includes an ingredient called aegeline. The FDA considers aegeline, a compound found in an Asian tree, to lack a history of use or other evidence of safety in the United States before 1994. USPlabs sent a response to the FDA arguing that the compound had been used safely for centuries. Nonetheless, the company decided to discontinue use of the ingredient in the U.S. due to negative publicity and has promised to reformulate the product.
Over the past few months, more than 50 cases of liver damage resulting from OxyElite Pro have been reported nationwide, with the majority of those identified reporting that they used the supplement within 60 days prior to the illness. Almost 20 of the cases required hospitalization for hepatitis or liver failure. Two people required a liver transplant and at least one person is dead. It is still unclear at this time whether aegeline is the root cause of these liver illnesses associated with OxyElite Pro.
USPlabs is no stranger to controversy regarding the safety of its products. In fact, a prior version of OxyElite Pro contained dimethylamylamine, or DMAA, a dangerous ingredient that the FDA has been working to eliminate from the supplement industry. The agency said that DMAA can cause increased blood pressure, shortness of breath, chest tightening, cardiovascular problems and even heart attacks.
DMAA was also present in another USPlabs product, Jack3d. Pronounced “jacked”, the pre-workout supplement comes in powder form and claims to increase strength, speed, and endurance. However, in the case of Jack3d, USPlabs is facing more than just an FDA recall. In February of this year, the parents of Michael Sparling, a soldier who died after taking Jack3d, filed a wrongful death suit against the company. Sparling died of a heart attack in the summer of 2011 after taking Jack3d prior to fitness exercises. The lawsuit alleges that Sparling took the recommended dose of Jack3d after buying it at a GNC store. During a moderate workout with his unit, which included a short run and lunges up a hill, Sparling, 22, collapsed. He died at a hospital several hours later of respiratory failure and cardiac arrest. Just months later, a second solider, 32, collapsed during a physical fitness test at the same base after taking Jack3d. He died one month later due to cardiac failure. The Defense Department subsequently decided to remove all products containing DMAA from stores on military bases.
The wrongful death lawsuit filed earlier this year isn’t the only litigation USPlabs has faced to date. In December of 2012, the company paid $2 million to settle a false-advertising lawsuit filed in California by consumers who bought Jack3d and OxyElite Pro. Per the settlement, USPlabs did not formally admit wrongdoing, but agreed to change the labeling to make warning statements on the products larger and easier to understand.
In an attempt to defend Jack3d’s reputation, the company has been on the plaintiff side of litigation as well. In October of 2012, USPlabs filed a defamation lawsuit against the owner of a supplement store in Nevada after he gave a televised interview about the supplement. Philip Tracy, owner of Max Muscle Reno, described Jack3d as an “amphetamine compound” that “speeds up your heart rate” and could “possibly” lead to death. The suit, filed in Texas, was ultimately dismissed for lack of jurisdiction.
The recent inquiry into the safety of USPlabs products highlights a larger regulatory problem in the $30 billion dollar dietary supplement industry in the U.S. Under federal law, supplements are defined as natural products that contain only dietary ingredients. The FDA regulates dietary supplements under a different set of regulations than those covering “conventional” food and drug products. The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed. Only after the product reaches the market is the FDA responsible for taking action against any unsafe dietary supplement. The bottom line is that companies like USPlabs can continue to introduce new supplements to the market without prior approval from the FDA. “It’s a pharmaceutical-grade product which is being directly introduced into the supplement marketplace with absolutely no regulatory oversight,” says Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School.
Until the government decides that the FDA can tighten restrictions on dietary supplement manufacturers, consumers should be be cautious. The next time you’re at your local GNC or Vitamin Shoppe remember that most of the products there likely haven’t been approved for use by the FDA prior to hitting the shelves. If you do choose to use dietary supplements please do some research and educate yourself on the ingredients contained in these products and any of the possible side effects.
If you’ve already used Jack3d, OxyElite Pro, or any other product containing DMAA or aegeline and suffered injury as a result, please contact the Sibley Dolman Gipe Accident Injury Lawyers, PA. Our experienced attorneys are here to give you a free consultation and case evaluation. Call us anytime at (833) 606-DRUG . To discover information about defective drugs and medications read more at https://www.dolmanlaw.com/practice-area/defective-medications-bad-drugs/