| ave probably seen plenty of advertisements extolling | | | | not only to tone, firm, and strengthen abdominal |
| how Electronic Abdominal Stimulators can melt your | | | | muscles, but also to provide weight loss, girth |
| belly fat fast and quickly. Most of these | | | | reduction, and "rock hard" abs. Do they really work? |
| advertisements will also claim that their electronic abs | | | | A. While an EMS device may be able to temporarily |
| stimulators can also flatten your tummy to reveal | | | | strengthen, tone or firm a muscle, no EMS devices |
| your six pack abs muscle. They even claim that by | | | | have been cleared at this time for weight loss, girth |
| using electronic abs stimulators for X minutes is | | | | reduction, or for obtaining "rock hard" abs. |
| better that 300 sit ups or crunches, so you can say | | | | Q. Is the FDA concerned about the unregulated |
| bye bye to diets and exercise forever. Too good to | | | | marketing of these devices? |
| be true? | | | | A. Yes. The FDA has received reports of shocks, |
| On the other hand, you may also have come across | | | | burns, bruising, skin irritation, and pain associated with |
| many articles and messages from the health and | | | | the use of some of these devices. There have been |
| fitness industry or from your fitness personal trainers | | | | a few recent reports of interference with implanted |
| who refute the advertisers claiming that the only | | | | devices such as pacemakers and defibrillators. Some |
| way to get a flat tummy with well defined six pack | | | | injuries required hospital treatment. The FDA is also |
| abs muscle is through healthy eating and exercise. | | | | concerned because many of these devices have |
| Now that is hard work isn’t it? So you will | | | | cables and leads. If those cables and leads do not |
| rather take a chance with an electronic abs stimulator | | | | comply with electrical safety standards, there is the |
| won’t you? | | | | possibility that users and other household members |
| So who is telling the truth? Ok, instead of joining in | | | | could be electrocuted. The FDA is currently |
| the controversy, this article points out what the | | | | investigating firms that are illegally marketing EMS |
| authorities such as U.S. Food and Drug Administration | | | | devices. |
| has got to say. Below is an excerpt from U.S. Food | | | | Q. What does FDA regulation accomplish? |
| and Drug Administration, FDA Consumer magazine | | | | A. Before they may legally sell their devices, firms |
| July-August 2002. You can read the full report at :- | | | | that market EMS devices must be able to |
| “In May, the Federal Trade Commission (FTC) | | | | demonstrate that these products are as safe and as |
| filed complaints against three manufacturers of these | | | | effective as similar devices that are legally marketed. |
| devices, alleging that they have made false claims in | | | | Devices may be marketed only for uses that are |
| their advertising, seen in heavily aired infomercials on | | | | established for the device or for uses that the firm |
| national cable television, shorter television | | | | can support with data. At this time, the FDA is not |
| commercials, and ads in the print media. | | | | aware of scientific information to support many of |
| The unfounded claims cited by the FTC include the | | | | the promotional claims being made for numerous |
| promise of "six pack" or "washboard" abs without | | | | devices being widely promoted on television, |
| exercise, claims that the devices will give users a | | | | infomercials, newspapers, and magazines. |
| trimmer waist or cause fat loss, and that use of the | | | | Q. Does that mean that it's unsafe to use an |
| device is equivalent to (or better than) regular | | | | electrical muscle stimulator that has not met FDA |
| abdominal exercises, such as sit-ups or crunches. The | | | | requirements? |
| FTC complaints also allege that the advertising | | | | A. Using a product that has not met FDA |
| claimed falsely that the stimulators are safe for all to | | | | requirements isn't necessarily unsafe or dangerous. |
| use, and did not disclose adequately the possible | | | | But it could be. Unregulated devices also may have |
| health hazards for some people. | | | | safety problems associated with cables and leads |
| Q. Why does the FDA regulate electrical muscle | | | | that can lead to accidental shock and electrocution of |
| stimulators? | | | | users and other household members, including children. |
| A. Electrical muscle stimulators are considered medical | | | | Q. If I use an electrical muscle stimulator, will it give |
| devices under the Federal Food, Drug, and Cosmetic | | | | me the same kind of effect that lots of sit-ups, |
| Act. Under this law and the agency's regulations, the | | | | stomach crunches and other abdominal exercises will? |
| FDA is responsible for regulating the sale of all | | | | A. Using these devices alone will not give you |
| electrical muscle stimulators in the United States. | | | | "six-pack" abs. Applying electrical current to muscles |
| Therefore, firms must comply with appropriate FDA | | | | may cause them to contract. Stimulating muscles |
| premarket regulatory requirements before they can | | | | repeatedly with electricity may eventually result in |
| legally sell their stimulators. Most electrical muscle | | | | muscles that are strengthened and toned to some |
| stimulators (EMS devices) that have been reviewed | | | | extent but will not, based on currently available data, |
| by the FDA are intended for use in physical therapy | | | | create a major change in your appearance without |
| and rehabilitation under the direction of a health-care | | | | the addition of weight loss and regular |
| professional. If a company wants to sell EMS devices | | | | exercise.” |
| directly to consumers, the company needs to show | | | | Now, who is telling the truth about electronic muscle |
| the FDA that the device can be used safely and | | | | stimulator being able to melt tummy fat and reveal |
| effectively in that setting. | | | | your six pack abs? Well, you be the judge and come |
| Q. These electrical muscle stimulators are advertised | | | | to your own verdict. |