The U.S. Food and Drug Administration’s ( FDA) Center for Devices and Radiological Health (CDRH) is coming to Orlando on May 5, 2011 for a Town Hall Meeting at the Sheraton Orlando Downton Hotel between 8 a.m. and 12 noon. . Mercury poisoned consumers, dentists and healthcare professionals will confront the Center’s Director, Dr. Jeffrey Shuren, about FDA’s non-action to remove mercury fillings from dentistry. CDRH is the arm of the FDA that regulates amalgam fillings containing fifty percent mercury, a known neurotoxin. Supporting public demands is a new Norwegian peer-reviewed study indicating that the replacement of mercury amalgam fillings was associated with reductions in subjective health complaints, similar to a prior Norwegian study with a similar outcome.
Dr. Shuren signed off on the 2009 FDA Amalgam Rule proclaiming mercury amalgam dental fillings safe for all people, including the very young. In December 2010 an FDA scientific advisory panel criticized the rule, telling FDA to
1) Discontinue amalgam use, at least in pregnant women and children
2) Issue consumer labeling to educate the public about the risks of this mercury product.
For example, Dr. Suresh Kotogal, M.D. a pediatric neurologist said there is “no place for mercury in children.” (Transcript:.FDA 2010 Dental Products Panel)
The FDA’s failure to restrict amalgam use and issue new amalgam labels has not prevented the U.S. government from moving forward in order to protect children and educate consumers. In 2009, with U.S. leadership, the Governing Council of the United Nations Environmental Program agreed to develop a global treaty on mercury. In a recent submission by the U.S. Department of State to the United Nations “Mercury International Negotiation Committee,” the U.S. government: calls for “educating patients and parents [about mercury amalgam] in order to protect children and fetuses” and supports a “phase down, with the goal of eventual phase out by all Parties, of mercury amalgam.”
Consumer, dental, and amalgam victim groups applaud the U.S. government position, but continue to demand appropriate action from FDA, the federal agency responsible for ensuring that medical devices are safe and effective and that products are honestly, accurately and informatively represented to the public. .
Dr. James Hardy, DMD of Winter Park FL, a pioneer in non-mercury dentistry and author of “Mercury Free,” explains that “mercury fillings came to America during the civil war era. Mountains of research clearly demonstrate mercury is toxic to the brain and kidneys. Isn’t it about time dentistry stops using this poison in American teeth?”
According to Matt Young, DDS, president of the International Academy of Oral Medicine and Toxicology (IAOMT), “If Dr. Shuren were to abide by the science which IAOMT has clearly outlined in its Petition for Reconsideration, FDA would immediately eliminate mercury fillings from use.” Dr. Young further notes that, “as our Petition indicates, scientific documentation supports the causal link between mercury amalgam fillings and chronic illnesses such as autoimmune disorders, neurodegenerative diseases, birth defects, oral lesions, and mental disorders.
“The U.S. position marks the beginning of the end of mercury amalgam globally,” says Charlie Brown, national council of Consumers for Dental Choice. “The puzzling outlier is FDA, which still allows amalgam to be placed in pregnant women and small children – and even claims that increasing amalgam ‘is likely to result in positive public health outcomes.’ It’s time for FDA to recognize that neurological risks and dental mercury pollution are not ‘positive public health outcomes.’”
**The public is encouraged to attend the FDA Town Meeting to learn, listen and participate. Public comments are welcome during the Q&A from 10:00 a.m. to 12 noon.