SAN DIEGO (Legal Newsline) – A sports nutrition and supplements company facing a class action lawsuit claiming its ingredients are not Food and Drug Administration-approved is standing behind its products.
On Dec. 17, in the U.S. District Court for the Southern District of California, Mason Dabish and Bill Bohr filed a class action lawsuit against MusclePharm Corp, accusing the company of breach of warranty, negligent misrepresentation and violations of California State Laws.
According to the plaintiffs, MusclePharm allegedly sells products containing newly formulated ingredients designed to increase effectiveness by fusing an amino or organic acid with a nitrate.
The plaintiffs claim that MusclePharm promotes these ingredients as safe and advertises them as having addition benefits over products containing traditional compounds. But the plaintiffs disagree.
MusclePharm released the following statement to Legal Newsline:
“MusclePharm adheres to the strictest standards to deliver the safest, most effective products on the market. We are confident that the allegations are without merit and MusclePharm will defend the lawsuit vigorously. We stand by the safety, efficacy, and legality of every ingredient we use.
"To date, we have spent over $10 million dollars in research and development to ensure our customers have the most innovative, yet safest products possible.”
The lawsuit claims that the new ingredients fall into the “new dietary ingredients” category, and thus, MusclePharm must submit evidence to the FDA that these ingredients are not harmful.
The plaintiffs allege that MusclePharm has not provided the required information to the FDA, and also claim that the supplements do not provide the benefits as advertised.
The plaintiffs are seeking compensation in excess of $5 million in actual damages, restitution, disgorgement, punitive and statutory damages, interests, attorney fees and costs of the lawsuit.
MusclePharm went on to defend the company’s use of nitrates, asserting that they are used widely within the industry.
“Nitrates are a commonly used ingredient in pre-workout products. Top respectable brands use it—in fact the #1 selling pre-workout in the market uses nitrates and has for years.
"In addition, the safety of dietary nitrate ingredients is supported through multiple studies, including a published clinical study by MusclePharm Sports Science Institute, in conjunction with the University of Tampa. This research can be viewed (at this link)."
MusclePharm markets a variety of sports nutrition products and supplements for athletes, including pre-workout, protein powder and post-workout drinks. Some of its products include the Arnold Schwarzenegger Series Iron Pump Pre-Workout Powder, MusclePharm Arnold Schwarzenegger Series Iron Cre3 Creatine Powder, MusclePharm Creatine Supplement, MusclePharm Arnold Schwarzenegger Series Iron Dream Nighttime Support Powder and MusclePharm Assault Pre-Workout Powder.
This is not the first time a class has made accusations against the company. In January 2015, a lawsuit was filed against MusclePharm in a California federal court alleging that the sports nutrition company was misleading customers about the amount of protein its products contain, specifically the MusclePharm Arnold Schwarzenegger Series Iron Mass.
Other sports nutrition and supplements companies have faced similar “protein-spiking” allegations. In July 2014, NBTY Inc., United States Nutrition Inc. and Healthwatchers Inc. faced a class action suit alleging that the three companies engaged in "protein-spiking" in the popular Body Fortress line of protein powders.
Marianna Naum, Strategic Communications and Public Engagement Staff for the FDA informed Legal Newsline that the FDA defines a “new dietary ingredient” as a vitamin, mineral, herb/other botanical, amino acid, dietary substance used to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent or extract.
The FDA also specifies that a new dietary ingredient is one that has not been sold in a dietary supplement in the U.S. before Oct.15, 1994.
If a manufacturer or distributor plans to sell a new dietary ingredient in a dietary supplement anywhere in the country, it is required to notify the Dietary Supplement Health and Education Act (DSHEA) and provide information explaining why the ingredient is “reasonably” expected to be safe for consumption.
Once the information is submitted, the FDA has 75 days to acknowledge its receipt in writing, and specifies the date the notification was received. The manufacturer or the distributor is not allowed to market the new dietary ingredient for the first 75 days after the filing date.
The FDA states that it “takes numerous actions on dietary supplements to protect public health.”
MusclePharm was founded in 2010 and is headquartered in Denver. Its products are sold in more than 120 countries.