Why is the FDA Ignoring Its Own Scientists' Warnings About Amalgam?
March 06, 2012
By Dr. Mercola
The U.S. Food and Drug Administration (FDA) has 50 committees and panels that it depends on to obtain independent expert advice on scientific, technical and policy matters.
However, the FDA is NOT legally required to follow its committee's recommendations, and, unfortunately, the FDA has a long history of ignoring its panelists' advice if it doesn't uphold a pro-industry position -- even to the point of disagreeing with their own FDA scientific experts.
This is precisely the case with silver amalgam (mercury) fillings; the agency has repeatedly ignored its expert panels' advice to get mercury out of fillings for kids and pregnant women.
The ongoing saga has continued for far too long, with the FDA repeatedly defying the sound scientific and commonsense judgments of its own expert panel.
FDA Ignores its Own Experts… Again
In 2009, the FDA went against its expert panels' advice and ruled there will be no warnings to patients, not even young women and parents of young children, that the mercury in the fillings is a dangerous reproductive toxin and a neurotoxin.
They even gave the amalgam industry the green light to sell and use amalgam fillings (restorations) without disclosing to consumers that the fillings are mainly mercury, even though the agency is aware of the industry's long-time deceptive practice of marketing amalgam as "silver fillings."
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 all consumers and all parents know that amalgam is mainly mercury
- Stop amalgam use for children and pregnant women
Still, the agency hesitated, even though the scientists had made it very clear that amalgam use in children, pregnant women and certain hypersensitive adults needs to stop. As the Campaign for Mercury-Free Dentistry reported:
"Here's the FDA scientific advisory panel in its own words: Dr. Kotagal said there is "no place for mercury in children," Dr. Ismail said "children less than 6 years of age, I would restrict it significantly," Dr. Thompson said "definitely not in pregnant women and definitely not in those below 6 years of age," Dr. Fleming said we need contraindications for pregnant women, and Dr. Burbacher said, "why put amalgams in children if we know they're going to live with that for the rest of their lives? And we don't know what that's going to do."
Not a single panelist agreed with FDA's 2009 rule that permitted unrestricted amalgam use in children and pregnant women. FDA has heard that message before: in 2006 its advisory panel concluded – by a 13 to 7 vote – that amalgam is not generally safe for everybody. But FDA did nothing."
Then, in 2011 Jeffrey Shuren, director of the Center for Devices and Radiological Health, attended a series of town hall meetings around the United States, where he heard such a great upwelling of 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:i
"… in response to concerns about its  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."
2011 Deadline Passed by Unmet …
As 2011 came to a close, the suspense grew as everyone speculated whether FDA would act or whether it would continue its decades long practice 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. Instead, FDA said what it said 10 years ago: it will "continue to study the safety of amalgam."
FDA has broken yet another promise on amalgam. Now it's time to get Congress involved to force the FDA to explain itself. 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."
There's No Reason to Put Mercury in Your Mouth
Even if the FDA won't admit the facts, other health organizations are ready to turn the page and put the use of mercury in dentistry behind us. In its final report on dental amalgam, the World Health Organization (WHO) has taken a stance against the use of mercury in dentistry -- a move that could signal the beginning of the end for this toxic, outdated practice.
In their report, Future Use of Materials for Dental Restoration, WHO committed itself "to work for reduction of mercury and ... facilitate the work for a switch in use of dental materials."ii The report states that amalgam "has been associated with general health concerns" and releases a "significant amount of mercury" into the environment. It also notes that alternatives to amalgam are readily available.
The fact is, amalgam is the MOST EXPENSIVE dental material when you count environmental costs and clean-up costs. It is also the number one cause of mercury exposure for consumers, according to the Canadian government and other sources. And mercury from dental offices is the largest source of mercury in wastewater.
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. It's high time for the FDA to start acknowledging these facts and get on the bandwagon to at least protect the health of children and pregnant women across the United States.
IMPORTANT: Find a Good Biological Dentist
If you are convinced of the importance of removing your mercury let me caution you to avoid the mistake I made. After being convinced of the danger by watching the 60 Minutes program on the topic 20 years ago (you can see the video below).
I actually had over a dozen of my amalgam fillings removed. I saw a competent conventional dentist for this, who was absolutely clueless about the dangers of mercury. As a result I had large amounts of mercury liberated improperly and I believe it was largely responsible for damaging my kidneys.
SO PLEASE …
Avoid my mistake and see a biological dentist that is trained in properly removing mercury so it doesn't go into your body during the removal process. This typically involves the use of high-powered suction and rubber dams.
One simple strategy is to ask your friends or local health food stores who these dentists are in your community or you can also contact The International Academy of Biological Dentistry and Medicine, which is the organization that created the video above.
Tell Congress the FDA Needs to Listen to its Scientists!
There is 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. In the United States, children and pregnant women continue to have their health and the health of future generations put at risk because the FDA is failing to protect them.
It's time for Congress to step in and tell the FDA to listen to its scientists. It sometimes takes a couple of phone calls or a second email, but talking to Congress is an effective way to invoke real change.
You can find the name of your Member of Congress here, then phone Congress at 202-224-3121 and ask for your Member's office. Here are some talking points from the Campaign for Mercury-Free Dentistry:
- Over a year ago, the scientists on FDA's advisory panel told FDA that dental amalgam is not safe for children, pregnant women's unborn babies, and hypersensitive adults.
- Now FDA is refusing to protect these vulnerable populations. Dentists are still using amalgam even in children.
- Would the Congressman/Congresswoman please write FDA to find out why FDA is failing to protect our children -- in spite of warnings from its own scientists?
It is time for the FDA to get out of the way of progress. Please join us in keeping the pressure on them — let's not allow them to manipulate their way into placing dental industry profiteering before 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 pocketbook—which holds a great deal of buying power. If your dentist insists mercury is safe, you may want to seek out 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:
Also, for timely updates and information, please join Consumers for Dental Choice on Facebook.
Important Information Regarding Amalgam Removal
For those of you who have mercury fillings, I recommend that you have them removed … but avoid making the mistake I did nearly 20 years ago by having it done by a non-biological dentist. When you have these fillings removed you can be exposed to significant amounts of mercury vapors if the dentist doesn't know what he or she is doing. It's also for this reason that I strongly suggest you get healthy BEFORE having your fillings removed, as you want your detoxification mechanisms optimized prior to removal.
My struggles with my own teeth led me to learn about and embrace biological dentistry, also known as holistic or environmental dentistry. In a nutshell, biological dentistry views your teeth and gums as an integrated part of your entire body, and any medical treatments performed takes this fact into account. The primary aim of holistic dentistry is to resolve your dental problems while working in harmony with the rest of your body. Biological dentists are well aware of the dangers involved with toxic materials such as mercury fillings (aka amalgams). Some things that need to be done to keep you (and your dentist) safe during amalgam removal include:
- Providing you with an alternative air source and instructing you not to breathe through your mouth
- Using a cold-water spray to minimize mercury vapors
- Putting a rubber dam in your mouth so you don't swallow or inhale any toxins
- Using a high-volume evacuator near the tooth at all times to evacuate the mercury vapor
- Washing your mouth out immediately after the fillings have been removed (the dentist should also change gloves after the removal)
- Immediately cleaning your protective wear and face once the fillings are removed
- Using room air purifiers
How to Find a Qualified Biological Dentist
Knowledgeable biological dentists can be hard to come by, so start your search by asking a friend, relative, neighbor, or inquire at your local health food store. The following links can also help you to find a mercury-free, biological dentist: