[U.S. Food and Drug Administration]

FDA Medical Bulletin * October 1996 * Volume 26 Number 3

FDA TAKES ACTION
AGAINST FRAUDULENT DEVICES

Health care practitioners are encouraged to contact FDA if they believe their patients have been harmed by fraudulent medical devices. Reports by practitioners and consumers are important for two reasons: they serve to alert FDA about specific fraudulent devices, and they are helpful to the agency when it takes action against the manufacturers of fraudulent devices.

In some cases, patients are harmed directly by a fraudulent device. In other cases, the harm occurs because the patient has delayed seeking necessary medical treatment as a result of the claims associated with the device. Patients especially susceptible to using fraudulent devices are those who have not derived favorable results from accepted treatment modalities.

FDA defines health fraud as the deceptive promotion, advertisement, distribution, or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes. Such practices may be deliberate, or done without adequate knowledge or understanding of the article.

FDA's Center for Devices and Radiological Health (CDRH) is responsible for ensuring that devices in the marketplace are safe and effective. Where possible, the Center takes action against products for which unrealistic and unsupported health claims are made. However, because of limited resources, the Center sets priorities in its health fraud activities based on the claims made, the seriousness of the health condition the device purports to treat, and the extent and prominence of promotion. Also considered high priority are fraudulent devices that target especially vulnerable populations, such as the elderly or the hearing impaired.

In a recent action, CDRH seized more than a million dollars worth of "Stimulators," a product widely promoted through infomercials and periodicals as being effective in treating back, joint and muscle pain, carpal tunnel syndrome, sinus problems, heartburn, headaches, stomach aches, allergies, swelling, and menstrual cramps. The product, a relabeled piezo-electric gas barbecue grill starter, was deemed an illegally marketed medical device based on these claims.

CDRH and 17 state attorneys general also took action against a distributor of an unapproved $19 hearing aid, "Whisper XL", that was nationally promoted without data to support its claims.

For more information on how to report fraudulent devices, contact the FDA office in your community or region, the Office of the State Attorney General in your area, or CDRH's Promotion and Advertising Policy Staff at (301) 594-4639.

REPORT SERIOUS ADVERSE EVENTS AND PRODUCT PROBLEMS TO MEDWATCH
1-800-FDA-1088

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