`Six-pack abs’ electronically?
You’ve probably seen the ads on television that promise six-pack abs” without a workout. Can you really tone your muscles using an electrical muscle stimulator while lounging around the pool like the models on TV?
In May, the Federal Trade Commission (FTC) filed complaints against three manufacturers of these devices, alleging that they have made false claims in their advertising seen in heavily aired infomercials on national cable television, shorter television commercials, and ads in the print media.
The unfounded claims cited by the FTC include the promise of “six pack” or “washboard” abs without exercise, claims that the devices will give users a trimmer waist or cause fat loss, and that use of the device is equivalent to (or better than) regular abdominal exercises, such as sit-ups or crunches. The FTC complaints also allege that the advertising claimed falsely that the stimulators are safe for all to use, and did not disclose adequately the possible health hazards for some people.
Here’s more information about the devices, what they can and can’t do, and how they are regulated by the Food and Drug Administration’s Center for Devices and Radiological Health.
Q. Why does the FDA regulate electrical muscle stimulators?
A. Electrical muscle stimulators are considered medical 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 the 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 the FDA that the device can be used safely and effectively in that setting.
Q. 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?
A. 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.
Q. Is the FDA concerned about the unregulated marketing of these devices.
A. Yes. The 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 all users follow the instructions carefully. The 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 that users and other household members could be electrocuted. The FDA is currently investigating firms that are illegally marketing EMS devices.
Q. What does FDA regulation accomplish?
A. Before they may legally sell their devices, firms that market EMS devices must be able to demonstrate that these products are as safe and as effective as similar devices that are legally marketed. Devices may be marketed only for uses that are established for the device or for uses that the firm can support with data. At this time, the 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.
Q. Why should I select an electrical muscle stimulator that is legally marketed according to FDA regulations?
A. Electrical muscle stimulators that have not met FDA 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.
Q. Does that mean that it’s unsafe to use an electrical muscle stimulator that has not met FDA requirements?
A. Using a product that has not met FDA requirements isn’t necessarily unsafe or dangerous. But it could be. The FDA has received reports of injuries and interference with other critically important medical devices 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 of users and other household members, including children.
Q. 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?
A. Using these devices alone will not give you “six-pack” abs. Applying electrical current to muscles may cause them 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 weight loss and regular exercise.
Q. But hasn’t the FDA cleared electrical muscle stimulators to treat medical conditions?
A. 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 that 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.
Q. Are there any over-the-counter EMS devices that have met the FDA’s regulatory requirements?
A. Yes. At this time, Slendertone Flex, marketed by BMR NeuroTech Inc. of Phoenix, has been cleared by the FDA for toning, strengthening and firming abdominal muscles.
Q. How do I report a problem with an EMS device?
A. Medical device malfunctions can be reported directly to the manufacturer. You also can report problems to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch in one of four ways:
* online at www.fda.gov/ medwatch/how.htm
* by telephone at 1-800-332-1088
* by fax at 1-800-332-1078
* by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
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