Can an electrical muscle stimulator (EMS) cause you to lose belly fat and give you “six pack" abs? No, says the complaint for this class action. In fact, it alleges that the Flex Belt from Slendertone Distribution, Inc. is a Class II medical device that requires approval from the Food and Drug Administration (FDA).
The class for this action is all persons in California, who, at any time between May 7, 2015 and the date the class is certified in this action, bought a Flex Belt for their own personal, family, or household use and not for resale.
The complaint says in its introduction, “Class II Medical Devices are devices for which general controls, by themselves, are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.”
When Slendertone advertises the device, the complaint says, it uses phrases like “FDA-cleared technology,” saying, that the Flex Belt is “the first Ab Belt Toning system cleared by the FDA,” suggesting that the FDA has approved the device for weight loss and building up abdominal muscles. However, the complaint quotes quotes the FDA as saying, “While an EMS device may be able to temporarily strengthen, tone or firm a muscle, no EMS devices have been cleared at this time for weight loss, girth reduction, or for obtaining ‘rock hard’ abs.”
Slendertone markets the Flex Belt as being able to help with weight loss, improve body contouring, develop visible “six pack” abs, and do this without exercise, says the complaint, “each of which [claims] the FDA has refuted and continues to refute.”
The complaint says, “[N]o science has ever supported, and several studies specifically refute, that EMS use can provide the same health benefits as a traditional physical workout.” It says that “EMS technology is primarily used to address health or injury, not to address appearance.” For that reason, “while the Flex Belt might help temporarily boost strength and endurance in a situation where a user was previously injured or otherwise incapable of traditional exercise, it will not provide even close to the results promised by its broad claims.”
In fact, in 2002, the complaint says, the Federal Trade Commission (FTC) brought actions against three electronic ab exercise belts for falsely claiming that users will get “six pack” or “washboard” abs without exercise.
The complaint claims that “EMS devices cannot cause or even assist in the loss of weight, inches, or fat from the human body” and that “[t]here is no scientific evidence of any biophysical mechanism that would cause EMS to eliminate fat under the skin…” which is what reduces the definition of abdominal muscles.
The complaint alleges violations of California consumer laws and breaches of warranties.