FDA Opens Public Comment for Safety of Mercury in Dentistry (Action Alert)

Friday, May 23, 2008 by: Teri Lee Gruss
Tags: mercury fillings, health news, Natural News

(NewsTarget) Under intensifying consumer group pressure, the FDA has announced that it will open public comment regarding its proposed ruling on the classification of dental mercury amalgam materials. The more we learn about mercury amalgams the more we have to question why the ADA and most dentists still insist that mercury amalgams are safe to put in our mouths. The Center for Disease Control has gone so far as to say that mercury amalgams do emit small amounts of mercury vapors that are absorbed and the EPA has said that dental clinics are major environmental polluters via the release of amalgam laced waste waters.

What does this mean for the average person that has eight mercury amalgams in their mouths?

The EPA notes that the ongoing National Health and Nutrition Examination Survey (NHANES) found that, between 1999-2000, about 8% of 16-to-49 year old women had blood mercury concentrations greater than 5.8 ug/L . "Based on this prevalence for the overall U.S. population of women of reproductive age and the number of U.S. births each year, it is estimated that more than 300,000 newborns each year may have increased risk of learning disabilities associated with in utero exposure to methyl mercury."

Fish contains mercury in the form of methyl mercury. Dental amalgams contain elemental mercury, which can be methylated by microorganisms once inside the human body. The EPA has established a daily reference dose (RfD) of 0.1 µg/kg body weight/day of methyl mercury, "without recognized adverse effects". Methyl mercury is the most toxic form of mercury.

Dental amalgams are approximately 50% mercury and 50% a mix of silver, copper, zinc and tin. The higher the copper content the more hazardous the amalgam material becomes. Certain metals interact with one another in the mouth in a process called galvanism. Saliva bathing dissimilar metals, mercury and copper, produce an electric current and promote corrosion of the amalgam. Corrosion increases mercury vapors absorbed.

When the price of silver increased in the 1970's amalgam manufacturers, to keep costs down, increased the copper content of amalgams. These amalgams are called non-gamma-2 (high copper) and are even more toxic than prior mercury amalgam formulations. Ask your dentist if you and your children have high copper mercury amalgams in your mouths.

The EPA says that "improved substitute materials are now available" and that "amalgam use is in decline". Why use a metal known to be hazardous to the environment and to the human central nervous system when there are other, safer materials readily available? Isn't it time to ban mercury amalgams?

Several well organized consumer and professional groups including Consumers for Dental Choice and the International Academy of Oral Medicine and Toxicology (IAOMT) have requested that the FDA address the hazards of mercury amalgams (fillings) used in dentistry. The intensity of their request escalated back in 2002. These groups have been instrumental in lobbying and taking legal action against the FDA for its continued refusal to rule on the safety of dental mercury.

Mercury amalgams are currently classified by the FDA as Class II medical devices. The medical device classification system consists of three levels, Class I, which include bandages and tongue depressors, regulated by "general controls". Class II devices, subject to "special controls", include amalgams and powered wheel chairs. Class III devices require "pre-market approval" and include silicone breast implants and heart valve replacements.

Anti dental mercury groups would like to see amalgams placed in the latter group, Class III medical devices. This would place the burden of proof of safety on amalgam manufacturers. Prior to 2002 mercury amalgams were Class I medical devices, like bandages and tongue depressors.

After years of FDA inaction, in December 2007 a lawsuit was filed against the troubled agency for its failure to address mercury safety. Possibly this pressure has led to the agency announcement to reopen public comment on mercury amalgam safety.

For whatever reason, the FDA comment period is a real opportunity for all of us who are concerned about the known health risks of having this toxic heavy metal in our mouths and the mouths of our children. Cognitive dysfunction and neurodegenerative disorders including Alzheimer's, Parkinson's and MS have all been linked to mercury toxicity.

Norway, Sweden and Denmark have all recently banned mercury amalgams because of its toxicity to humans and the environment. According to Norway's Environmental Minister, Erik Solheim, "Mercury is among the most dangerous pollutants. Good alternatives to mercury exist already and it is therefore right to introduce this ban."

Sweden, Canada and the U.K. have banned the use of mercury amalgams in pregnant women and children. With safe alternatives available it doesn't make sense to keep putting a material in our mouths that is shipped and disposed of as a "hazardous material".

While we await a FDA ruling on dental mercury, shouldn't we, at the very least, insist that our dentists provide us with an "Informed Consent" form which lists possible risks of mercury amalgams and optional and safe materials available. This is really an issue of health freedom of choice.

To learn more about the hazards of mercury amalgams visit (http://www.toxicteeth.org/) and (http://iaomt.org/) .

Take this opportunity to let the FDA know how you feel about the dangers of mercury in dentistry. Public comment is open until July 28, 2008. Also consider sending a copy of your comments to your elected Congressional representatives.

Docket ID: FDA-2008-N-0163
Docket Title: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period

To file an electronic comment:
(http://www.regulations.gov) In the search box enter: FDA-2008-N-0163

To fax a written comment:
301.827.6870

To mail a comment:
Division of Dockets Management(HFA-305)
FDA
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Additional reading:

(http://www.fda.gov/ohrms/DOCKETS/dockets/05p...)

(http://www.fplc.edu/risk/vol2/spring/royal.h...)

About the author

Teri Lee Gruss, MS Human Nutrition