A Federal Class Action Lawsuit was recently filed against MusclePharm for all of the latter’s products that contain Amino Nitrates. The lawsuit alleges that these amino nitrates do not provide the claimed advantages over their standard counterpart amino acids, and additionally that they are not proven safe as required for new dietary ingredients [per 413(d) of the Federal Food, Drug, and Cosmetic Act (the “FDCA”), codified at 21 U.S.C. 350b(d)]. It was filed in United States District Court for the Southern District of California, on December 17th, 2015 (Case No: ‘15CV2848 W-JMA), and lists six separate civil violations with a total of eight counts altogether.
Although it was filed just recently, the company was given the opportunity to rectify this situation without litigation, as they were notified about the issues with their products on July 27th, via certified mail, and failed to take action (and avoid the current situation).
month prior to the July 27th letter, Ryan Drexler became chairman of MusclePharm, and the class action was filed exactly one week after The New England Journal of Medicine reported on a long-term Creatine nitrate user being diagnosed with cancer.
The lawsuit specifically names all MusclePharm amino nitrate products (i.e. everything that contains Creatine nitrate or any amino nitrate):
- MusclePharm Arnold Schwarzenegger Series Iron Pump
- MusclePharm Arnold Schwarzenegger Series Iron Cre3
- MusclePharm Iron Dream
- MusclePharm Creatine
- MusclePharm Assault
The lawsuit further alleges that each of those products contain a newly formulated ingredient that does not provide the benefits advertised, and that these ingredients have not been proven safe or efficacious and that MusclePharm has not provided the FDA with the required 75-Day Premarket Notification showing a history of Creatine/Arginine/BCAA Nitrate’s harmless use in food products/supplements or any other evidence of safety. Additionally, it references the patent holder’s rejected premarket notification, and the fact that the FDA has serious concerns for the safety of Creatine nitrate.
So in effect we have two major points that are being made, namely that the products are not as effective as claimed, as well as the fact that the products have not been proven safe to the required standard (and are therefore prohibited for sale). Adulterated products have, according to the law, zero economic value, and therefore the consumer of such a product is entitled to a full refund…which is a lot of money, considering the sheer number of products named, plus the fact that we are talking about full retail purchase price (several hundred percent more than MusclePharm would have banked on the majority of them, which would have been sold to distributors or retailers for far less money).
via Anthony Roberts