As concerns continue to mount nationwide about links between reports of liver problems and OxyElite Pro, the manufacturer of the weight loss and body building supplement now faces a class action lawsuit filed last week over false and misleading advertisements.
The OxyElite Pro class action lawsuit (PDF) was filed in the U.S. District Court for the Northern District of Florida on November 13, against the manufacturer USPLabs LLC and GNC Corporation. In addition to problems with OxyElite Pro, the class action cites issues with Jack3d, another supplement sold by the companies.
A group of four plaintiffs seek class action status to bring the case on behalf of all consumers who purchased the supplements, focusing on the use of DMAA in the products, which is a “long forgotten, ineffective, extremely dangerous and potentially lethal ingredient,” according to the complaint.
DMAA, 1,3-dimethylamylamine is in a drug class known as sympathomimetic, which ephedrine and amphetamines also belong to. The plaintiffs allege that side effects of OxyElite Pro and Jack3d may cause dangerous cardiavascular problems, including elevated blood pressure, increased heart rates, stroke, heart attack, atrial fibrillation, loss of consciousness and other issues. The dietary supplements also also contain caffeine, which is known to exacerbate the effects of sympathomimetic drugs. DMAA has been banned in multiple countries and was placed on the banned substances list of Major League Baseball.
According to allegations raised in the consumer rights class action, USPLabs and GNC Corporation used false advertising claims to market the supplements, containing statements that asserted the products were “university studied,” “scientifically reviewed”, supported by “clinical studies” and “proven to be safe and effective.” Plaintiffs maintain that these statements are false and lack any adequate substantiation.
In response to concerns about the safety of DMAA, the FDA banned the ingredient from OxyElite Pro, Jack3d and other dietary supplements in April 2012. A year later, after indicating that at least 60 reports of illness and death were attributed to products containing DMAA, the FDA issued a consumer warning in April 2013, indicating that the ingredient is too dangerous to be placed in dietary supplements.
OxyElite Pro Hepatitis and Liver Injury Concerns
More recently, USPLabs has faced concerns about OxyElite health problems, which may be associated with a different ingredient that has recently been included in the dietary supplement, aegeline.
Over the past few months, a growing number of reports have surfaced nationwide involving users of OxyElite Pro diagnosed with hepatitis and liver failure, which may result in the need for a liver transplant or result in death.
Nearly 60 cases of liver damage from OxyElite Pro have been identified by state and federal health officials, leading to a removal of the dietary supplement from the market and indications from USPLabs that it will further reformulate the product before it is re-introduced.
The FDA was able to force the OxyElite Pro recall because it was found to contain the unapproved ingredient aegeline. While FDA does not approve dietary supplements before they are introduced, if a new ingredient is used, it is the manufacturer’s responsibility to provide the FDA with information concerning the safety before it can be used. The FDA was able to remove OxyElite Pro from the market recently because the new ingredient was used without proper notification and approval. USPLabs has also promised to destroy all inventory of the supplement containing aegeline.
In addition to the class action, USPLabs will likely face a number of OxyElite Pro liver injury lawsuits in the coming months from former users who experienced problems that may have been caused by the supplement.