Consumers Demand FDA Action as U.S. Calls For Mercury Amalgam ‘Phase Out’


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.j_oral_rehab

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)

unepThe 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?”

iaomtAccording 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.

“We have documentation of many thousands of cases,” Bernard Windham of Tallahassee, president of Dental Amalgam Mercury Solutions, elaborates. “In spite of the widespread harm to the public and to the environment – and unlike other countries with less special interest control, such as Sweden, Denmark and Norway that have banned the use of mercury fillings, – the U.S. FDA has not instituted a ban nor required limits nor health warnings on mercury amalgam use.” Other countries such as Canada, UK, Germany, Austria and other European countries have issued warnings for pregnant women and children and other vulnerable populations such as those with kidney disease.

consumers-for-dental-choice-01“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.

Significant Changes in health complaints after removal of amalgam fillings
FDA 2010 Dental Products Panel
The US Dental Amalgam Debate, 2010 Meeting of the FDA Dental Products Pane

About The Author

Freya advocates for informed consent for patients and banning the use of mercury amalgam dental fillings and is founder and President of the PA Coalition for Mercury-Free Dentistry, a grassroots organization dedicated to bringing public awareness about the health and environmental risks of mercury in dentistry.

1 Comment

    Bernard Windham

    Extremely important aspects of the amalgam issue documented at the FDA forum were not covered by the Orlando Sentinel article, such as

    1. the major widespread environmental effects affecting all in florida documented in the forum, since amalgam is documented to be the largest source of mercury in sewers and sewer sludge, and a major source in water bodies, the environment, fish, etc. Note that a Scientist there demonstrated that mercury proliferation from such use is increasing and affecting the environment, animals, people all over the world. (Sam Queen)(I have similar documentation)

    And this is a reason cited by some countries as a major factor in why their country banned amalgam use.

    2. the statement of the 4 mercury free dentists and a dental hygenists with documentation that there are better options than amalgam and that use of amalgam affects not only patients but dental staff and that there is as much as 90% difference in the mercury exposure of patients having amalgam work depending on the training and protocol of the dentist,


    3. the major connection to criminality and violent behavior of mercury and other toxic metals also noted by the last speaker at the forum (who was himself affected before amalgam replacement) and documented at the forum to be widespread by myself from peer-reviwed studies

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