Question: Why does FDA
regulate electrical muscle stimulators?
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?
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?
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.
Question: What does FDA regulation accomplish?
Firms that market EMS devices are required to comply with appropriate FDA
premarket regulatory requirements before they may legally sell their devices.
The firm must be able to demonstrate that these devices are as safe and as
effective as similar devices that are legally marketed. Devices may only be
marketed for uses that are established for the device or for uses that the firm
can support with data. At this time, FDA is not aware of scientific information
to support many of the promotional claims being made for numerous devices being
widely promoted on television, infomercials, newspapers, and magazines.
Question: Why should I select an electrical muscle stimulator that is legally
marketed according to FDA regulations?
Electrical Muscle Stimulators that have not met FDA premarket requirements
are illegal, and the FDA has not determined whether or not they are properly
designed, manufactured, and labeled to provide reasonable assurance that they
are safe and effective.
Question: Does that mean that it's unsafe to use an electrical muscle stimulator
that has not met FDA requirements?
Using a product that has not met FDA requirements isn't necessarily unsafe
or dangerous. But it could be. FDA has received reports of shocks, burns,
bruising, skin irritation, pain, and interference with other critically
important medical devices (e.g., pacemakers) associated with the use of
unregulated products. Unregulated devices also may have safety problems
associated with cables and leads that can lead to accidental shock and
electrocution by users and other household members, including children.
Question: If I use an electrical muscle stimulator that has met FDA regulatory
requirements, will it give me the same kind of effect that lots of sit-ups,
stomach crunches and other abdominal exercises will?
Using these devices alone will not give you "six-pack" abs.
Applying electrical current to muscles may cause muscles to contract.
Stimulating muscles repeatedly with electricity may eventually result in muscles
that are strengthened and toned to some extent but will not, based on currently
available data, create a major change in your appearance without the addition of
diet and regular exercise.
Question: But hasn't FDA cleared electrical muscle stimulators to treat medical
Yes. The FDA has cleared many electrical muscle stimulators for
prescription use in treating medical conditions. Doctors may use electrical
muscle stimulators for patients who require muscle re-education, relaxation of
muscle spasms, increased range of motion, prevention of muscle atrophy, and for
treating other medical conditions which usually result from a stroke, a serious
injury, or major surgery. Again, the effect of using these devices is primarily
to help a patient recover from impaired muscle function due to a medical
condition, not to increase muscle size enough to affect appearance.
Question: Are there any Over-The-Counter EMS devices that have met FDA's regulatory requirements?
Yes. At this time, Slendertone Flex marketed by BMR NeuroTech, Inc., has
been cleared by FDA for toning, strengthening and firming abdominal muscles.
Question: How do I report a problem with an EMS device?
Medical device malfunctions can be reported directly to the manufacturer.
You can also report to MedWatch, the FDA's voluntary reporting program. You may
submit reports to MedWatch one of four ways: online at http://www.accessdatAnswer:fdAnswer:gov/scripts/medwatch/
by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch,
Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857
For additional information, please visit the following areas:
- Pump Fiction
- Avoiding the Muscle
Hustle: Tips for Buying Exercise Equipment
- "Rock Hard Abs"
- Healthy Living Center
Portions of the above information was provided with the kind permission of the
Food and Drug Administration
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