Regulatory Actions Related to EAV Devices

Stephen Barrett, M.D.

Thousands of practitioners use "electrodiagnostic" devices to help select their recommended treatment. These devices, which are fancy galvanometers, merely measure skin resistance to the passage of electrical current. However, many are claimed to determine the cause of any disease by detecting the "energy imbalance" causing the problem. Some are also claimed to detect whether someone is allergic or sensitive to foods, deficient in vitamins, or has defective teeth. Some operators claim to tell whether a disease, such as cancer or AIDS, is not present. The diagnostic procedure is most commonly to as Electroacupuncture according to Voll (EAV) or electrodermal screening (EDS). This article summarizes the EAV-related regulatory actions that have come to my attention.

Galvanic skin resistance has no proven or logical relationship to the diagnosis or treatment of any disease. The U.S. Food and Drug Administration classifies "devices that use resistance measurements to diagnose and treat various diseases" as Class III devices, which require FDA approval prior to marketing. No such device can be legally marketed in the United States for diagnostic or treatment purposes. A few companies have obtained 510(k) clearance (not approval) by telling the FDA that their devices will be used for biofeedback or to measure skin resistance, but this does not entitle them to market the devices for other purposes.

EAV devices are not biofeedback devices. Biofeedback is a relaxation technique that uses an electronic device that continuously signals pulse rate, muscle tension, or other body function by tone or visual signal. In biofeedback, the signal originates and is influenced by the patient. In EAV, the signal is influenced by how hard the operator presses the probe against the patient's skin. (Pressure makes the electric current flow more easily between the device to the patient's skin.)

The FDA has banned importation of EAV devices into the United States and warned or prosecuted a few marketers. Foreign and state regulatory agencies have also taken a few actions. However, no systematic effort has been made to drive them from the marketplace. As a result, these bogus devices are being used by many chiropractors, acupuncturists, dentists, "holistic" physicians, veterinarians, self-styled "nutritionists," and various unlicensed individuals. The most common use is for prescribing homeopathic products. They are also used to determine "allergies," detect "nutrient deficiencies," and locate alleged problems in teeth that contain amalgam fillings.

FDA Warnings

State Attorney General Civil Actions

Criminal Prosecutions

Professional Board Actions

Foreign Regulatory Agency Actions

For Additional Information

References

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This article was revised on September 8, 2013.