ADA urges caution in shaping new amalgam regulation

Washington鈥擳he Association urged the U.S. Food and Drug Administration to avoid “draconian regulatory action” in reclassifying dental amalgam as a regulated medical device.

The Association offered support July 28 for the reclassification first proposed in 2002 but told the FDA that any special controls or other steps related to the regulation of amalgam and its component parts “must be scientifically based.”

“Warnings and restrictions for dental amalgam would run counter to the best available science, and the consequences of any such action would be great,” said an extensive Association statement submitted for the FDA public docket on the proposed regulation, Dental Devices: Classification of Encapsulated Amalgam Alloy. The ADA statement includes a summary review of scientific literature published between Jan. 1, 2004, and May 2, 2008, and comments in response to five specific questions posed by the FDA.

The ADA comments were filed for FDA’s public docket on the proposed regulation, which is posted at the government Web site www.regulations.gov.

The FDA by Federal Register notice April 28, 2008, reopened the rulemaking procedure “to provide the public with an additional opportunity to comment and to request data and information that may have become available since publication (Feb. 20, 2002) of the proposed rule.” The FR notice invited comments and available data on five regulatory options for dental amalgam. The ADA statement offers comments responsive to all five questions.

“FDA has spent years evaluating the benefits and safety profile of dental mercury amalgam products,” the Association said. “Based upon this review, FDA will issue some form of final regulation, perhaps in the form of special controls.” Current scientific evidence does not support such controls as warnings or limitations on use of dental amalgam, said the ADA statement. “Rather, the best scientific evidence continues to support the safety of dental amalgam.”

Such controls would also have economic, legal and public health implications, the ADA said in urging “deliberate, nuanced decisions” by the FDA in shaping new amalgam regulation.

“Any action by FDA should have preemptive effect over state law,” the Association said. “If the FDA mandates certain warnings or information be provided to patients, the ADA believes it is imperative for the FDA to indicate clearly that the agency’s regulatory approach preempts conflicting state and local laws, and state-law product liability actions, against dentists who use amalgam products in their practices.”