The Scoop on Muscle Stimulators

Question: Why does FDA regulate electrical muscle stimulators?

Answer:
Electrical muscle stimulators are considered devices under the Federal Food, Drug, and Cosmetic Act. Under this law and the agency's regulations, the FDA is responsible for regulating the sale of all electrical muscle stimulators in the United States. Therefore, firms must comply with appropriate FDA premarket regulatory requirements before they can legally sell their stimulators. Most electrical muscle stimulators (EMS devices) that have been reviewed by FDA are intended for use in physical therapy and rehabilitation under the direction of a health care professional. If a company wants to sell EMS devices directly to consumers, the company needs to show FDA it can be used safely and effectively in that setting.

Question: These electrical muscle stimulators are advertised not only to tone, firm, and strengthen abdominal muscles, but also to provide weight loss, girth reduction, and "rock hard" abs. Do they really work?

Answer:
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.

Question: Is FDA concerned about the unregulated marketing of these devices?

Answer:
Yes. FDA has received reports of shocks, burns, bruising, skin irritation, and pain associated with the use of some of these devices. There have been a few recent reports of interference with implanted devices such as pacemakers and defibrillators. Some injuries required hospital treatment. It is very important that these devices be properly designed, manufactured, and labeled with clear and complete instructions for use and that anyone using them follows the instructions carefully. FDA is also concerned because many of these devices have cables and leads. If those cables and leads do not comply with electrical safety standards, there is the possibility of electrocution by users and other household members. FDA is currently investigating firms that are illegally marketing EMS devices.