In a class action lawsuit, four consumers accused USPLabs LLC and GNC Corp. of downplaying the serious health risks associated with weight-loss supplements Jac3d and OxyElite Pro, both of which contain 1,3-dimethylamylamine (DMMA).
The complaint, filed in Tallahassee on November 13 in the U.S. District Court for the Northern District of Florida, alleges that the defendants marketed the supplements as safe, when in fact DMAA can cause adverse cardiovascular events such as heart attack, stroke, heart arrhythmias, heart palpitations, dizziness, loss of consciousness and even death.
The lawsuit states, “Animal testing in a variety of models demonstrated that DMAA was a potent pressor drug causing increase in blood pressure that is comparable to ephedrine. The structure of and mechanism by which DMAA increases blood pressure is thus similar to ephedrine. Dietary supplements containing ephedra, the natural form of ephedrine, were ordered off the market by the U.S. Food and Drug Administration (FDA) in 2004 because the blood pressure and heart rate effects were associated with a number of serious adverse events to users including heart attack, stroke and death.
USPLabs received a warning letter from the FDA on October 11, which stated that certain OxyElite products have been linked to liver illnesses and that the products are adulterated. In response, USPLabs recalled those OxyElite products on November 9.
In that letter, it stated that, “The FDA along with the Centers for Disease Control and Prevention and state and local health officials are investigating more than 50 cases of acute non-viral hepatitis. As of October 31, 2013, 56 cases had been identified. Among these cases, 22 people have been hospitalized, two people have received liver transplants, and one person has died.”
The lawsuit also asserts that the defendants deceived the consumers by promoting these products in magazines, online, and even on the packaging and labeling of the products themselves. Additionally, the lawsuit alleges that defendant GNC Corp. promoted these products in their stores, on their websites, and by other means as well.
In 2012, the FDA issued a warning which notified companies that the products containing DMAA would need to be taken off the market or reformulated without any DMAA. According to the FDA website, most of the companies who received this warning took down the products that contained the DMAA. The lawsuit claims that GNC responded to this warning letter by stating that it is “completely opposed to this unilateral, factually and legally unfounded action by the FDA.” They also claimed that DMAA is safe, so long as it is taken as directed.
However, in February 2012, GNC pulled the products containing DMAA from its store on military bases. They still market and sell the supplements elsewhere, though.
In the complaint, the plaintiffs state that, “Without requisite proof, defendants claim that the supplements are safe, effective, and proven by research. For the type of marketing claims at issue, the Federal Trade Commission rules, mirroring common law duties of fair representation, require the defendants actually have the level of proof claimed, here clinical proof, at the time the claims are made. However, the defendants did not, and have never possessed the requisite proof. The health problems associated with the supplements manifest themselves when consumers consume them at recommended dosage levels.”
The FDA warning label explained that “to the best of the FDA’s knowledge, there is no history of use or other evidence of safety establishing that dimethylamylamine will reasonably be expected to be safe as a dietary ingredient. In fact, dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequency leads to elevated blood pressure.” This could potentially lead to a fatal heart attack.
What do you think about these accusations? Do you think that all DMAA products should be taken off the market until more research is conducted? Do you side with GNC in that DMAA is safe to consume?
We look forward to hearing your comments. Feel free to comment on this blog post. For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).