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ADA Positions & Statements

American Dental Association's Comments on FDA's Proposed Rule and Special Control Guidance on Dental Amalgam Products

 

The ADA has submitted a statement to the FDA responding to "concerns" about the safe use of dental amalgam products with a study-by-study review of research related to dental mercury and amalgam, including recent and ongoing research.

The comments, available to download below, are in support of the Food and Drug Administration's ("FDA" or "the Agency") proposed rule on dental amalgam products and draft guidance document entitled "Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA" (hereinafter "Draft Guidance").

The proposed rule and notice of availability of the Draft Guidance were published in the Federal Register on February 20, 2002 (67 Fed. Reg. 34 (2002)).

Download the ADA's comments | PDF file/146k

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