Last Updated on February 8, 2020

Jan. 17, 2012

By Dr. Mercola 

After enormous public pressure from scientists, dentists, health professionals, and consumers, the U.S. Food and Drug Administration (FDA) promised to make an announcement about dental amalgam by the end of 2011.

Dental amalgam, of course, is composed 50% of the dreadful neurotoxin mercury.

Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH, the branch of the FDA responsible for the approval and safety of all medical devises) said at a public hearing in September, in San Francisco, that FDA will make an “announcement” on a new amalgam policy  by the end of 2011. 

When questioned by a reporter at a major newspaper, FDA repeated that it would act in 2011.

As 2011 came to a close, the suspense grew as everyone speculated whether FDA would act or whether it would continue its decades of protecting the profits of pro-mercury dentists instead of protecting the health of American children. 

With just six minutes left in the work year, at 4:54 pm on Friday, December 30, FDA conceded that no announcement was forthcoming – not in 2011, and maybe not at all.

In that midnight statement, one FDA press person, one Karen Jackler, said that another FDA press person, Morgan Liscinsky, would answer questions about amalgam. 

So when the respected trade publication FDA Webview asked, Liscinsky said:  No announcement. 

And no target date for FDA to do anything on amalgam. 

Instead, FDA said what it said ten years ago: it will “continue to study the safety of amalgam.”

FDA has broken yet another promise on amalgam. 

Why Won’t the FDA Act to Protect You Against Toxic Mercury?

The FDA’s history of protecting dental amalgam is a long one.

For the past 32 years, the agency has refused to issue any public warning about its neurotoxic risks, and in 2009, the FDA declared it safe under Class 2 for adults and children over the age of 6 who are not allergic to mercury—despite the overwhelming evidence showing mercury to be highly toxic and easily released in the form of vapor each time you eat, drink, brush your teeth or otherwise stimulate your teeth.

These mercury vapors readily pass through cell membranes, across your blood-brain barrier, and into your central nervous system, where it can cause psychological, neurological, and immunological problems.

Children and fetuses, whose brains are still developing, are clearly most at risk, but anyone can be impacted, and the health risks get greater the longer you have your fillings.

According to Boyd Haley, retired professor emeritus at the University of Kentucky (where he headed the chemistry department), about 80 percent of the mercury vapor released from your fillings collect in your body tissues and can take months or years to eliminate. Needless to say, if your body keeps accumulating more mercury than it can eliminate, after many years of chronic exposure you may end up with quite a bit of accumulated mercury in your body. Studies on cadavers have confirmed that the more amalgam fillings a person has, the more mercury collects in their brain, for example.

World Health Organization Urges Phasing Out of Dental Amalgam

Many hoped that the FDA would reconsider this foolish stance after the World Health Organization called for the phasing-out of amalgam in their 2011 report: Future Use of Materials for Dental Restoration. In May 2011, the Council of Europe also issued a proclamation calling for restrictions and prohibitions of mercury fillings, which are already banned in Norway, Sweden, and Denmark. Health Canada also stopped endorsing amalgam for use in children, pregnant women, and people with impaired kidney function, all the way back in 1996!

The World Health Organization noted the following three reasons for its new position:

1. Amalgam releases a “significant amount of mercury” into the environment, including the atmosphere, surface water, groundwater, and soil. WHO reports:

    

    

   “When released from dental amalgam use into the environment through these pathways, mercury is transported globally and deposited. Mercury releases may then enter the human food chain especially via fish consumption.”

2. WHO determines that amalgam raises “general health concerns”:While the report acknowledges that a few dental trade groups still believe amalgam is safe for all, the WHO report reaches a very different conclusion: “Amalgam has been associated with general health concerns.” The report observes:

    

    

   “According to the Norwegian Dental Biomaterials Adverse Reaction Unit, the majority of cases of side-effects of dental filling materials are linked with dental amalgam.”

3. WHO concludes “materials alternative to dental amalgam are available”and cites studies indicating they are superior to amalgam. For example, WHO says “recent data suggest that RBCs [resin-based composites] perform equally well” as amalgam. And compomers have a higher survival rate, says WHO, citing a study finding that 95% of compomers and 92% of amalgams survive after 4 years.

    

    

   In particular, WHO explains that “Alternative restorative materials of sufficient quality are available for use in the deciduous [baby] dentition of children” – the population whose developing neurological systems are most susceptible to the neurotoxic effects of dental mercury. Perhaps more important than the survival of the filling, WHO asserts that:

    

   “Adhesive resin materials allow for less tooth destruction and, as a result, a longer survival of the tooth itself.”

The report also included mention of the known toxic effects of mercury exposure, stating that:

“Mercury is highly toxic and harmful to health. Approximately 80% of inhaled mercury vapor is absorbed in the blood through the lungs, causing damages to lungs, kidneys and the nervous, digestive, respiratory and immune systems. Health effects from excessive mercury exposure include tremors, impaired vision and hearing, paralysis, insomnia, emotional instability, developmental deficits during fetal development, and attention deficit and developmental delays during childhood.”

Why Does the FDA Ignore its Own Experts?

In December 2010, in response to the outrage over their 2009 ruling, the FDA asked an advisory panel to examine the latest science on amalgams. The panel recommended that the FDA promptly:

• Make sure that all consumers and all parents know that amalgam is mainly mercury
• Stop amalgam use for children and pregnant women

Still, the agency hesitated… Then, last year Shuren attended a series of town hall meetings around the US, where he heard so much criticism against the agency’s amalgam policy that he eventually started saying the agency would act on the petitions to reconsider its position. As recently as November 30, the FDA confirmed to the Chicago Tribune that it did indeed intend to address amalgam in 2011, stating that:

” … in response to concerns about its [2009] ruling, the FDA convened a panel last December to re-examine the issue and expects to make a new announcement by the end of this year.”

But, it didn’t… According to Charlie Brown, national counsel for Consumers for Dental Choice, and President of the World Alliance for Mercury-Free Dentistry:

“At Jeff Shuren’s Center for Devices, politics wins. Science loses. Thirteen months ago, FDA’s own advisory panel of handpicked scientists told FDA to stop amalgam use for children and pregnant women. But Shuren fails to heed the scientists — even though, since September, he repeatedly announced that he intended to act on amalgam in 2011. Every day that Shuren fails to act, more children are subjected to this mercury product, which — FDA’s own rule concedes — can have ‘neurotoxic effects’ on the ‘developing neurological systems’ of children and unborn babies.”

No One NEEDS Amalgam to Remain Available…

Dental amalgam is far from an essential dental product; it’s interchangeable with many other filling materials that do not have the toxic profile amalgam has. Just consider these disturbing facts:

• Amalgam is the MOST EXPENSIVE dental material when you count environmental costs and clean-up costs.
• Amalgam is the number one cause of mercury exposure for consumers, according to the Canadian government and other sources.
• Mercury from dental offices is the largest source of mercury in wastewater. According to an article by Michael Bender (co-founder of the Mercury Policy Project), at least 40 percent of mercury flowing into municipal water treatment plants begins in dentist offices. And those plants are not set up to remove it, so it ends up in your fish.
• Americans and Europeans have more mercury in their mouths than exists in all products combined—more than 1,000 tons.
• Amalgams of the dead pose a risk to the living. Emissions from the combustion of mercury fillings during cremation are a significant contaminator of air, waterways, soil, wildlife and food. Seven to nine metric tons of mercury per year escapes into the atmosphere during cremations, and it is estimated that, left unchecked, crematoria will be the largest single cause of mercury pollution by 2020.

Modern materials like resin composites and glass ionomers have rendered amalgam completely unnecessary for any clinical situation. In fact, the mercury-free alternatives are so advanced that entire nations, such as the Scandinavian countries, have stopped using amalgam altogether.

Already, about half of U.S. dentists are mercury-free and 77 percent of consumers who are told that amalgam contains mercury choose mercury-free alternatives. One of the most popular alternatives to amalgam is resin composite. Resin composites are made of a type of plastic reinforced with powdered glass. It is already common throughout the U.S. and the rest of the developed world, offering notable improvements over amalgam, as it:

• Is environmentally safe: Composite, which contains no mercury, does not pollute the environment. This saves taxpayers from paying the costs of cleaning up dental mercury pollution in our water, air, and land – and the costs of health problems associated with mercury pollution.
• Preserves healthy tooth structure, because, unlike amalgam, it does not require the removal of significant amounts of healthy tooth matter. Over the long term, composite preserves healthy tooth structure and actually strengthens teeth, leading to better oral health and less extensive dental work over the long-term.
• Is long-lasting: While some claim that amalgam fillings last longer than composite fillings, the science reveals this claim to be baseless. The latest studies show that composite not only lasts as long as amalgam, but actually has a higher overall survival rate.

A lesser-known alternative is increasingly making mercury-free dentistry possible even in the rural areas of developing countries. Atraumatic restorative treatment (also called alternative restorative treatment or ART) is a mercury-free restorative technique that has been demonstrated a success in a diverse array of countries around the world, including Tanzania, India, Brazil, Zimbabwe, Turkey, South Africa, Thailand, Canada, and a dozen others. ART relies on adhesive materials for the filling (instead of mercury) and uses only hand instruments to place the filling, making it particularly well-suited for rural areas of developing countries.

How You Can Help Protect Children Everywhere

It’s high time for the FDA start acting on the science and get on the bandwagon to protect the health of children and pregnant women across the U.S.

Your voice is needed in order to bring about permanent change in the fight for mercury-free dentistry. The FDA reneged on their stated intent to address dental amalgam by the end of 2011. We now need you to urge the FDA to heed the advice of its own scientists convened in December 2010 and the World Health Organization. To voice your opinion, please contact Dr. Shuren.This time, we think it best if you telephone or fax, and make your message more direct, rather than emailing Dr. Shuren:

Dr. Jeffrey Shuren, Director

Center for Devices, U.S. Food & Drug Administration

10903 New Hampshire Ave.

WO66-5431, Room 5442

Silver Spring, MD 20993-0002

Phone: 301-796-5900 or 301.796-5000

Fax: 301-847-8149 or 301-847-8109

If you can’t get through to Dr. Shuren via phone or fax, please write Anthony Watson, Director of the Division on Devices, [email protected].

Phone calls and faxes are especially important because Dr. Shuren cannot ignore them – keep calling and leaving messages until you get answers! Here are some recommended talking points when you call or write:

• Why is the FDA ignoring its own scientific advisory panel that told the FDA to stop the use of amalgam immediately for children, pregnant women, and hypersensitive adults (as a minimum) over a year ago? There is no excuse for endangering our children with dental mercury.
• Why is the FDA failing to warn every parent that amalgam is mercury, not silver? Every consumer should be told the truth about what’s going into their mouths and their children’s mouths.
• Why is the FDA so out-of-step with the World Health Organization? In its 2011 report, the World Health Organization calls on health authorities like FDA to take action against amalgam now: “Health authorities can play an active role in advocacy for use of dental materials alternative to amalgam.”

   

   

  It is time for the FDA to act now. An announcement that the FDA’s decision will be indefinitely postponed is unacceptable! We have irrefutable scientific evidence about the dangers of mercury amalgams. Your children are being subjected to harm now—they can’t wait another year.

It is time for the FDA to get out of the way of progress. Please join Charlie and me in keeping the pressure on them — let’s not allow them to manipulate their way into placing dental industry profiteering before of your children’s health.

I also urge you to tell your family, friends, and neighbors the truth about dental amalgams, and don’t let your dentist talk you into one for yourself or for your child. It’s not your dentist’s mouth—it’s YOUR mouth. And YOUR pocket book—which holds a great deal of buying power. If your dentist insists mercury is safe, you may want to seek a mercury-free dentist.

Last but not least, please consider making a contribution to Consumers for Dental Choice. I strongly believe in their mission and their commitment to the Campaign for Mercury-Free Dentistry. They rely on public donations to complete this important mission. (Consumers for Dental Choice is a 501(c)(3) non-profit organization dedicated to advocating mercury-free dentistry. Contributions are tax-deductible in the U.S.)

Donations can be made online or through the mail:

• Online donations here
• Checks can be mailed to:

Consumers for Dental Choice

316 F St., N.E.,

Suite 210

Washington DC 20002

Also, for timely updates and information, please join Consumers for Dental Choice on Facebook.

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