ADA seeks clarification from FDA on amalgam comments

The ADA is expressing concern about recent statements from the FDA suggesting that the agency has already decided to mandate some form of special labeling for dental amalgam as a caution to groups purportedly sensitive to mercury.

The FDA is currently in the process of reviewing public comment on amalgam and possibly considering reclassifying it for regulatory purposes following the settlement of a lawsuit with consumer advocacy groups that had sought to have the material banned completely.

According to a press release from the ADA, a recent Associated Press article attributed this statement to FDA Deputy Commissioner Randall Lutter, Ph.D.: "What this says is there's a clear intent on our part on labeling for sensitive subpopulations."

The ADA does not believe that such action is supported by the best scientific studies published on this topic, and intends to seek clarification from FDA, including any scientific support for the agency's recent statements.

"People depend on the FDA and other government health agencies to help protect their health. It's critically important that public health recommendations are based on sound scientific evidence," states ADA President Mark J. Feldman, D.M.D. "The ADA will continue to advocate for the best oral health of the public as part of the FDA regulatory process."

Presently, FDA has different classifications for encapsulated amalgam and its component parts, dental mercury and amalgam alloy. The FDA's proposed reclassification, which the ADA has supported since 2002, would place encapsulated amalgam and its components under one classification.

Based on extensive studies and scientific reviews of dental amalgam by government and independent organizations worldwide, the ADA believes that dental amalgam remains a safe, affordable, and durable cavity filling choice for dental patients.

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