A bipartisan letter authored by Rep. Diane Watson (D-CA) and Rep. Dan Burton (R-IN), and co-signed by congresswomen and men from twelve states, has been sent to the FDA urging them to require clear warnings about mercury toxicity to every dental patient, and to establish specific protections for children and young women.
For thirty years, FDA has failed to classify mercury dental amalgam, even though it is required to do so as a legal prerequisite to the sale of any implants. “Classifying” a product or device puts it in one of FDA’s three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The failure of the FDA to classify mercury amalgam is all the more questionable given the fact that in September 2006 a joint panel of FDA advisers rejected an FDA finding that amalgams are safe.
With the FDA under a court order to classify mercury amalgam by this July 28, the nineteen members of Congress wrote FDA Acting Commissioner Sharfstein to insist that;
- FDA require the industry to correctly label “silver” fillings to reflect their predominate component, mercury;
- require all parents of children under the age of 18 to sign a written consent form indicating that they are fully aware of the potential negative effects of mercury; and
require a verbal warning given by dentists to patients over 18 years noting the high toxicity of mercury and the potential of neurological problems.
The congressional letter reflects an in-depth understanding of the dangers of mercury fillings, noting that “vapors from mercury can traverse the placenta of pregnant women and threaten the development of the fetus. . . . Mercury is a known neurotoxin, the third most toxic element as listed by the CERLA Priority List of Hazardous Substances. . . . Dental amalgam is the predominant source of human exposure to mercury.”
Sen. Mike Enzi of Wyoming, the ranking Republican on the health committee, has promised to ask Dr. Hamburg in writing whether the FDA, consistent with its website warnings, will protect children and pregnant women from amalgam.