Sale of Amalgameter Banned
FDA Consumer October 1989
It was called the "Amalgameter." Its promoted purpose was to reveal the presence of positively or negatively charged dental fillings that contained mercury, tin, silver, or other metals.
The dentist-inventor of the Amalgameter, Hal A. Huggins, of Colorado Springs, Cob., lectured and wrote that mercury vapor emitted from dental fillings could be a health hazard. He advocated that patients diagnosed as hypersensitive to mercury and other metals should have all metal dental work in their mouths progressively removed and replaced with gold or plastic. Huggins also developed and promoted "X-it" and "Eaters Digest," edible compounds that he claimed would help flush mercury vapors escaping from amalgam dental fillings out of the body, and otherwise promote better health and recovery from disease.
Huggins was a businessman, known to FDA through some of his other ventures. He had previously been warned by the agency about violating good manufacturing practices and marketing medical devices without FDA approval.
Literature accompanying the Amalgameter claimed there was "the possibility of carcinoma [cancer] resulting from nickel accumulation," and that mercury sensitivity "affected 22 percent of the U.S. population," with symptoms of headaches, fatigue, and "immune response and heart function." The claims were scientifically unsubstantiated.
Other literature packaged with the Amalgameter described "polarity centers" and an "Amalgam War" in the patient's mouth. Directions detailed locating high and low positive and negative current readings in fillings and recommended removing fillings in successive visits to the dentist, starting with the filling with highest negative current reading. Directions noted that if the patient "has a severe problem such as MS [multiple sclerosis], seizures, cardiac problems or suicidal problems, we recommend removing just.. . . one amalgam at the first appointment, then proceeding by quadrants."
Visiting Huggins in Colorado in July of 1985, FDA investigators obtained samples of the Amalgameter—a simple battery-powered ammeter that measured electrical current. In November 1985, the agency sent a regulatory letter to Huggins, informing him that the Amalgameter was misbranded in that its labeling recommended removal of dental fillings based on findings for which there was no scientific basis, and that it was promoted as a medical device for which there was no approval for manufacture or marketing.
At least two states (Iowa and Utah) have investigated dentists using the Amalgameter in their practices. The device also was the subject of a nationally syndicated television program, "Inside Edition," last February, which exposed the unsubstantiated claims of danger from mercury-emitting dental fillings. During the broadcast, a reporter was shown being examined by Huggins, who described the reporter's mouth as "corrosion soup" and as an "accident waiting for a place to happen." Another reporter was shown during an undercover visit to a New York dentist who used the Amalgameter to test her dental fillings and recommended removal and replacement of all of them.
FDA inspections in July of 1985 and again in the spring of 1989 confirmed that neither Huggins nor Tox Supply, Inc., the firm owned by Huggins that made the device, were any longer in the Amalgameter-making business. But records show that at least 100 units were produced and, as simple as the device is, many could be around to dupe unsuspecting dental patients for a long, long time.
Update by Stephen Barrett, M.D. (9/20/04)
This article was originally published in FDA Consumer 23(8):33-34, 1989, under the title "Dentist's Device." Huggins's license to practice dentistry was revoked in 1996, but he is marketing himself through seminars, telephone consultations, and the Internet. In December 2003, his Web site began offering a device called the "Rita Meter," which costs $610 and appears to be a reincarnation of his Amalgameter. His Web site states:
In 1986, the FDA classified the Amalgameter as a "Class III" medical device, which meant that it could not be legally marketed without FDA approval. Devices approved by the FDA for marketing are listed in the agency's 510K database. In September 2004, after finding no listing for "Rita Meter," I asked the FDA and the Colorado Attorney General to ban it.
This page was revised on September 20, 2004.