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Electrodermal Testing Part II: Legal and Regulatory Aspects

Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things.

Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require new approval — for biofeedback. It is illegal to use the devices for anything other than biofeedback. The FDA has prohibited their sale or importation for unapproved purposes like electrodermal testing; it has sent warnings to companies, raided clinics, and confiscated machines. States have prosecuted users for practicing medicine without a license. Medical boards have chastised licensed providers. The Quackwatch website lists these regulatory actions but points out that there has been no systematic effort to drive these devices from the marketplace.

Excuses, Excuses

One electrodermal testing website admits that what it is doing is illegal and tries to fight back with this specious disclaimer:

It is important to understand that the laws in the USA forbid me from being able to treat, diagnose, cure or prevent disease. The AMA has a patent on those words and only a licensed medical doctor can do that.  And although it is legal for a licensed medical doctor to violate the Hippocratic oath and prescribe toxic drugs that cause harm and sometimes even kill patients, it is illegal for me to claim you can be cured using natural, nontoxic remedies, even though thousands of people can testify how they have been healed using natural remedies.

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Posted in: Diagnostic tests & procedures, Energy Medicine, Legal

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Biofeedback and Laser for Allergies

AllergiCare Relief Centers are a chain of franchises started by a man called David Tucker who is not listed as having an MD or any other title. They offer diagnosis of allergies by biofeedback and treatment of allergies by laser acupuncture. They admit that the method is not backed by any science, and they claim that what they are doing is not medical treatment.

Responsible journalism might have investigated this as quackery or practicing medicine without a license. Instead, irresponsible journalism has helped promote these centers and has given them invaluable free advertising.

From one news story:

Tucker said the device works based on biofeedback. The allergy sufferer wears a sensing clip on his finger for testing, and the computer simulates the bio-frequency for 10,000 known allergens. As the body responds to those stimuli, the computer lists which substances are irritants. “This digitized allergen actually matches the harmonic frequency of the actual allergen, making the body believe it is in contact with the real substance,” Tucker said. “The body will react if it is allergic to the particular substance.” ….Once the allergens are identified, a laser stimulates biomeridian points on the body — the same points used in acupuncture and acupressure. Tucker said the idea is to strengthen organs to act properly the next time they encounter the allergen — that is, to treat them as harmless…So far, there is no science to prove the devices work, but Tucker claims a 70 percent positive response rate. (more…)

Posted in: Energy Medicine, Health Fraud, Medical devices, Science and the Media

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