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FDA position on dental amalgam hasn't changed

January 28, 2015

By Craig Palmer

Washington — The U.S. Food and Drug Administration updated its consumer advisory on dental amalgam fillings Jan. 27, but "there is no change in our position," an agency spokeswoman told Association representatives.

The website update responds to just one of several citizen petition requests, the FDA spokeswoman said in a courtesy call to alert the ADA to new language in the consumer advisory. There are no changes in FDA's content for health professionals because "we don't think the information for health professionals is changing," she said.

"Our position on dental amalgam hasn't changed. There is some content that changes."

The FDA released letters denying three petitions to ban or restrict dental amalgam, telling one person, "FDA finds that the information you submitted, as well as other information that we have reviewed, does not support a finding that dental amalgam presents a substantial deception or an unreasonable and substantial risk of illness or injury." Letters to the three petitioners said in conclusion, "Even so, FDA continues to evaluate the safety of dental amalgam and will take any further actions that are warranted."

The consumer update advises patients to "discuss treatment options with your dentist."

Other language "clarifies" and "changes" descriptions and content in the answers to these questions, the FDA representative said:

  • What is dental amalgam?
  • What should I know before getting a dental amalgam filling?
  • Benefits.
  • Potential risks.
  • What is bioaccumulation?
  • Is the mercury in dental amalgam the same as the mercury in some types of fish?
  • If I am concerned about the mercury in dental amalgam, should I have my fillings removed?

The FDA concluded in 2009 that dental amalgam was a safe and effective restorative treatment and issued a final rule, which the Association supported, that reclassified dental mercury and amalgam components for regulatory purposes. The FDA has received petitions suggesting that "consumers should be better informed" about dental amalgam fillings, the agency spokeswoman said.