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.