ADA Statement On The New FDA Panel Reviewing Amalgam Safety

Main Category: Dentistry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Jun 2010 - 9:00 PDT

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As a science-based organization, the American Dental Association (ADA) supports scientific inquiry that contributes to the growing body of knowledge about oral health and dental treatment. However, we regret the U.S. Food and Drug Administration's (FDA) decision to convene what appears to be a costly and redundant "advisory panel" to reexamine, yet again, the safety of dental amalgam.

Dental amalgam is a cavity filling material made by combining mercury with other metals such as silver, copper and tin. Numerous rigorously reviewed scientific studies have indicated that dental amalgam is a safe, effective option for treating dental decay.

Less than a year ago, the very same agency determined that amalgam is a safe and effective treatment option and should be a class II medical device, placing it in the same class as gold and tooth-colored composite fillings. We know of no new evidence to justify revisiting this decision.

The ADA has a long and proud history of supporting and advocating scientific inquiries that could benefit the quality of dental care and the health of dental patients. However, the FDA's decision to reopen its investigation appears to owe not to any new scientific evidence, but rather to political pressure from activist groups who refuse to accept the vast body of scientific knowledge that supports the safety and efficacy of amalgam. We know of no new evidence justifying the agency's action.

Source
American Dental Association

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