FDA sets 2009 deadline to reclassify dental amalgam
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Posted June 18, 2008 |
By Jennifer Garvin Washington—The U.S. Food and Drug Administration has set a deadline for its reclassification of dental amalgam as part of a settlement between the FDA and the consumer group Moms Against Mercury.
Beginning in July 2009, the FDA will issue a final regulation on how to classify encapsulated amalgam and its components. FDA's current proposal is to classify encapsulated amalgam and its components as class II devices with special controls (materials and labeling.) However, the precise nature of any special controls ultimately selected by FDA is unknown at this time. The FDA presently has different classifications for encapsulated amalgam and its component parts, dental mercury and amalgam alloy.
The ADA supports the FDA's decision to reclassify amalgam and reinforces this support in a news release stressing that the recent settlement agreement and FDA's Web site do not mean that FDA has changed its position on dental amalgam. Rather, FDA's final position will be determined through the on-going regulatory process and call for public comments on that issue.
"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," said Dr. Mark J. Feldman, ADA president. "The ADA will continue to advocate for the best oral health of the public as part of the FDA regulatory process."
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.
Two studies in the April 19, 2006, issue of The Journal of the American Medical Association concluded that children with dental amalgam fillings do not experience adverse effects related to neurobehavioral, neuropsychological (IQ) and kidney function, reinforcing the ADA's longstanding position on the safety of dental amalgam.
The ADA believes these independent studies support the existing scientific understanding that the minute amount of mercury released by amalgam does not adversely affect children's health. Additionally, both studies reinforce the substantial body of peer-reviewed scientific literature that supports the safety of dental amalgam.
The ADA intends to file comments with the FDA regarding the reclassification in July.
To read more about the ADA and 2002 comments regarding the reclassification of amalgam, visit www.ada.org/prof/resources/positions/statements/statements_amalgam_fda.pdf.
For comprehensive information about fillings and all other aspects of dental care and oral health, visit www.ada.org/prof/resources/topics/amalgam.asp.
Additionally, members are advised to direct patients seeking more information to www.ada.org/goto/fillings.
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