Regulatory Action against the Amalgameter

Stephen Barrett, M.D.

The Amalgameter was one of several devices rogue dentists have used to help persuade patients to have their amalgam fillings removed. It was developed and marketed during the 1980s by Hal A. Huggins, D.D.S., who falsely claimed that mercury vapor emitted from dental fillings was a health hazard. He also claimed that the order in which the amalgams were removed was critical and that those with the highest "negative current reading" should be removed first [1]. In 1996, Huggins's license to practice dentistry was revoked in 1996 after an Administrative Law Judge concluded that his treatments were "a sham, illusory and without scientific basis." [2]

The Amalgameter was a simple battery-powered ammeter that measured the flow of electrical current. A grounded component was held against the inside of the patient's cheek while a probe was held for a few seconds against the tooth to be tested [3]. Some ammeters have FDA approval, but Huggins's claims made the Amalgameter a medical device that required FDA approval before marketing. Huggins originally marketed it through a company called Tox Supply, which he owned. In 1984, he sold the company to Brickley Enterprises [4] but continued to promote the device. In 1985, the FDA notified both Brickley and Huggins that the marketing was illegal and ordered both of them to stop. Here are the warning letter to Huggins, his evasive reply, and the FDA's forceful response.

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Room 500 U.S. Customhouse
721 19th Street
Denver, Colorado 80202
303-844-4915

November 19, 1985

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Hal A. Huggins, D.D.S.
1715 Monterey Drive
Colorado Springs, CO 80901

REGULATORY LETTER

Dear Dr. Huggins:

The Food and Drug Administration has recently conducted an investigation into the promotion and distribution of the "Amalgameter" distributed by ToxSupply, Inc., of Greeley, Colorado. This investigation revealed serious violations of the Federal Food, Drug, and Cosmetic Act as follows:

Section Brief Description
502(a) The Amalgameter is misbranded in that the labeling, In a leaflet entitled "USE AND INTERPRETATION OF READINGS WITH THE AMALGAMETER” recommends the removal of dental fillings based on readings given by this device. This labeling  is false and misleading because there is no scientific basis for the removal of dental amalgams for the purposes claimed in the leaflet and this procedure has not been proven to be safe and effective for good oral health care.
502(f) (1) This device is misbranded since it fails to provide adequate directions for use for the purposes for which it is intended, since adequate directions cannot be written for use by a layman for such purposes, and the device is not exempt from the requirements of Section 502(f) (1) of the Act, under Regulation 21 CFR 801.109 (copy enclosed), because the label fails to bear the caution statement required by 801.109(b) (1), and the labeling fails to bear information for use regarding any relevant hazards and precautions under which practitioners licensed by law to administer this device can use this device safely and for the purposes for which they are intended as required by 21 CFR 801.109(c).

Our investigation determined that some or all of the promotional literature was generated by you when you were responsible for the firm ToxSupply. In addition, we have determined that you continue to promote the “Amalgameter” for use as a medical device.

Our review disclosed that there is no scientific basis for the removal of dental amalgams for the purpose of replacing them with other materials as described in your leaflet. Additionally, there is a possibility that his procedure as described in your leaflet, and further restorative operations may be detrimental to the patient's oral health, including the unnecessary loss of teeth. While our evaluation on this point is ongoing, you should be aware that we consider your device directly associated with, and an integral part of, a process which may have adverse health consequences when used for the purposes for which it is intended.

We request that you take prompt action to correct these violations. If such action is not taken, the Food and Drug Administration is prepared to invoke regulatory sanctions such as seizure and/or injunction. Please advise us within ten (10) days of the specific actions taken or intended to be taken to correct these violations.

Your response should be sent to the Food and Drug Administration, Denver District Office, 500 U.S. Customhouse, 721 19th Street, Denver, Colorado 80202, Attention: Shelly L. Maifarth, Compliance Officer.

Sincerely yours,

LeRoy M. Gomez
Director, Denver District


HAL A. HUGGINS. D.D.S.
P. O. Box 2581
Colorado Springs CO 80901
(303) 473-1703

December 2, 1985

Shelly L. Maifarth,
Compliance Officer
FDA, Denver District Office
500 U. S. Customhouse
721 19th Street
Denver, Colorado 80202

Dear Ms. Maifarth:

In attempting to answer your request posted November 19 and received on November 25, there are some areas that were not clarified in the letter. I am sure that you will agree that these are serious charges and that I need to be fully informed in order to respond properly. You could help me by expediting the following questions of clarification at your earliest convenience.

1. In regard to "this procedure" (removing amalgams I presume) "has not been proven to be safe and effective for good oral health." Could you expand on this allegation?

2. Could you explain in what context the amalgameter is used as a medical device?

3. You mention "we have determined that you continue to promote the amalgameter…" Does this mean that you want me to stop speaking about the use of the meter?

4. Could you cite your references that suggest there is no scientific basis for removal of amalgam?

5. In regard to "restorative operations may be detrimental to the patients oral health," please describe and cite the references (enclose copies if possible to expedite the matter) you have found in your review.

6. In regard to "adverse health consequences", could you be more specific, as neurologic, cardiovascular, etc., and provide the citations from which this allegation is based.

Your prompt attention to these requests will be appreciated. Also, you may be receiving a request for further clarifications from [redacted] He is familiar with your allegations and any material you can offer him would also help us in resolving this matter as quickly as possible.

Sincerely,

Hal A. Huggins, DDS


DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Room 500 U.S. Customhouse
721 19th Street
Denver, Colorado 80202
303-844-4915

May 30, 1986

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Hal A. Huggins, DDS
P.O. Box 2589
Colorado Springs, CO 80901

Dear Dr. Huggins:

This is in reply to your letter of December 2, 1985. Your response is inadequate in that you have presented questions instead of answers.

You ask in what context the amalgameter is used as a medical device. This product clearly falls within the definition of a medical device in that it is an instrument, apparatus, or machine, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man, which does not achieve. any of its principal intended purposes through chemical action in or on the body of man and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. [Food, Drug and Cosmetic Act, Section 201 (h), copy enclosed.]

You also asked if we wanted you to stop speaking about the use of the amalgameter. Any claims which you make about the intended use of this device, which are false and misleading, serve to misbrand the device. We advised you in our regulatory letter that misbranded devices are subject to seizure action; firms/individuals which cause devices to become misbranded are subject to injunction.

The remainder of your letter requests scientific references for specific statements made in our regulatory letter. Be advised that it is your responsibility to demonstrate to us that the device you are promoting is safe and effective for its intended purposes.

We have recently received a response from the Center for Devices and Radiological Health, Office of Device Evaluation regarding the classification status of the amalgameter. It has been classified as a Class III device, subject to premarket approval by FDA. As a Class III device, it cannot be legally marketed unless the provisions of the April 18, 1986 letter to Mr. Brickley are followed.

Sincerely,

Shelly L. Maifarth

To gain FDA approval, a device must be generally regarded by experts as safe and effective for its intended use. Intended use is determined by the context in which the device is used. Huggins's promotion made it clear to the FDA that the Amalgameter was intended to guide the removal of teeth as part of a treatment program that was completely irrational. To gain approval, the manufacturer must inform the FDA how they believe the device should be classified and what steps they have taken to comply with the rules for substantiation. The notice that is filed is commonly referred to as a "510k notification" or simply a "510k." Approved devices are listed in the agency's 510k database, which is readily accessible online. Although Brickley Enterprises applied for 510k clearance after it received the FDA's warning letter, the Amalgamater is not listed in the database, so I assume that approval was denied.

FDA inspections in July 1985 and the spring of 1989 determined that neither Huggins nor Brickley were still in the Amalgameter business [1]. However, in December 2003, Huggins's Web site began offering a device called the "Rita Meter," which costs $610 and appears to have the same purpose as the Amalgameter. According to the site:

The Rita Meter is used to test electrical current for sequential removal of amalgam dental materials. The Rita Meter has a 'ground' that touches the cheek or is placed under the tongue. The probe touches the dental restoration to be tested. . . . A video included with your order provides a visual demonstration of how to use the Rita Meter and details the concept of Sequential Removal.

 

 

In September 2004, after finding no 510k listing for "Rita Meter," I asked the FDA and the Colorado Attorney General to ban it. If you encounter any practitioner using this bogus device, please complain to your state attorney general and notify me also.

For Additional Information

References

  1. Dentist's device. FDA Consumer 23(8):33-34, 1989 (republished on Quackwatch).
  2. Connick N. Before the State Board of Dental Examiners, State Board of Colorado. Case No. 95-04. In the matter of the disciplinary proceedings regarding the license to practice dentistry in the State of Colorado of Hal A. Huggins, D.D.S., License No. 3057. Feb 29, 1996.
  3. Information sheet. Tox Supply, Inc., Nov 29, 1984.
  4. Brickley, Glen E. Letter to Shelley L. Maifarth, Nov 30, 1985.

This article was posted on September 21, 2004.

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