FDA requests comments on amalgam

Attention mercury skeptics! It is open season on dentistry's oldest bogeyman as the FDA has opened a 90-day comment period on its classification of amalgam alloy, encapsulated amalgam alloy, and dental mercury.

The FDA is considering whether the use of dental amalgam should be more tightly regulated. In 2006, the agency reached a preliminary finding that there was "insufficient evidence to support a correlation or causal relationship between exposure to dental amalgam and kidney or cognitive dysfunction; neurodegenerative disease (specifically Alzheimer's disease and Parkinson's disease); autoimmune disease (including multiple sclerosis); or adverse pregnancy outcomes."

But an FDA committee rejected that finding, leading to the agency's decision to invite further public comment.

"The agency is taking this action to provide the public with an additional opportunity to comment and to request data and information that may have become available since publication of the proposed rule," stated a FDA press release.

Following is an example of the kind of comments the FDA is looking for:

"How should labeling controls, if any, address the disclosure of composition, including mercury content?"

The deadline for submitting written or electronic comments is July 28, 2008.

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