Mike Fleming DDS discusses the History of FDA’s Classification of Dental Amalgam Fillings

{slide=Views Expressed Do Not Represent FDA}

Views Expressed Do Not Represent FDA

Written by Dr. Michael Fleming

Tuesday, 25 August 2009

Dr. Fleming was recently honored to be appointed to a four year term as a Consultant to the Center for Devices and Radiologic Health of the Food and Drug Administration. His tasks include advising FDA on matters related to the safety and effectiveness of medical devices to include dental products. Dr. Fleming is the former Consumer Representative on the Dental Products Panel of the Food and Drug Administration (FDA). He has also served as the Acting Consumer Representative on the Circulatory System Devices Panel that advises FDA on matters related to products and devices utilized within the heart and blood vessels.*

Dr. Fleming’s new role as a Consultant requires him to periodically interface with the FDA and other designated stakeholders with respect to medical device review and regulation. His specific role as a Consultant or panel member is to impartially and objectively evaluate scientific data, clinical trial designs, risk assessments and other matters brought before an advisory panel to enhance FDA’s regulatory decision making process.

Dr. Fleming receives many inquiries regarding his opinion on such matters as water fluoridation, dental filling materials, root canals and other important matters affecting the health and well being of Americans. Dr. Fleming’s statements about these issues are his personal opinions only but reflect many years of scientific study and involvement in a number of different public venues. They do not necessarily reflect views held by the FDA or any other regulatory agency.

Dr. Fleming is a dental professional and, as such, cannot dispense medical advice with respect to any device, medical condition or procedure reviewed before any FDA advisory panel that is the purview of physicians.

Dr. Fleming’s ongoing challenge to consumers of dental and medical services is to become a conscious consumer. That is, patients need to be proactive in their own health care choices and be vigilant and knowledgeable about the services and products offered in today’s competitive and rapidly changing environment.

* CDRH advisory panels do not regulate but only advise the FDA on matters related to the reasonable assurance of safety and effectiveness of medical devices. Further information about Advisory Panels, Consultants and their functions can be found at www.fda.gov.{/slide}

The text below was taken from a 1994 citizens petition to the FDA. This reveals that even back then the FDA was doing everything they could not to properly classify dental amalgam.

The 1976 Medical Devices Act as amended requires that all medical devices be certified and placed in either classification I, II or III. In 1978 the FDA Commissioner refused to exclude mercury/silver fillings (amalgam) from the definition as an  implant. Federal Registry, vol. 43.146, July 28, 1978, page 32988.

In 1987 the FDA certified dental mercury (21 CFR 3700) in class I and amalgam alloy in class II. 

The FDA maintains that mercury/silver fillings are a reaction product over which it has no jurisdiction, despite the fact that it has classified a number of other reaction products. In January of 1993, the Public Health Service (PHS) presented the Final Report of the Committee to Coordinate Environmental Health and Related Programs (CCEHRP). This document was entitled “Dental Amalgam: A Scientific Review and Recommended Public Health

Service Strategy for Research, Education and Regulation”, and included recommendations from several sub-committees. The recommendations for regulation were prepared by the Regulatory Work Group (Appendix VI), consisting of five officials of the Food and Drug Administration (FDA).

The recommendation of the Regulatory Work Group on dental amalgam, stated on page V1-2, was: “The Regulatory Work Group recommends that the Food and Drug Administration view dental amalgam as a kit, in that both mercury and alloy must be used together to create dental amalgam restorative material. FDA considers the class of the kit to be that of the component of the kit assigned the highest classification. In this case the kit would be viewed as a Class II device because that is the classification of amalgam alloy. No reclassification action would be required.”

The full CCEHRP committee adopted this recommendation, as stated on page 19: “For this reason, a Regulatory Work Group (operating under the auspices of the Subcommittee on Risk Management) believes FDA should administratively combine dental mercury and amalgam alloys into a single product for regulatory purposes.”

Also on page 19, the CCEHRP report stated: “Federal regulatory of dental amalgam and elemental mercury as an amalgam component resides with the Food and Drug Administration. Both products are regulated under the mandate of the Medical Device Amendments of 1976 and the Safe Medical Devices Amendments of 1990.” The report further states: “Historically, FDA has regulated dental mercury and amalgam alloys separately, with mercury treated as a class I device and the alloy as a class II device.”

Administrative combination of dental mercury and amalgam alloy, viewed as a “kit” without further evaluation or “reclassification action” of the subsequent reaction product as a distinct dental device, is a clear violation of the Rules and Procedures of the Food and Drug Administration for Medical Devices. Any Class II device must be subjected to “Performance Standards” in order to satisfy requirements to ensure “safety and effectiveness”.