09.12.02 - FDA's Mercury Ruling Defies ALL Scientific Reasoning
Summary: The U.S. FDA has issued a final regulation classifying dental amalgam without calling for stringent precautions for pregnant women and children -- even though last June a court settlement filed by the Consumers for Dental Choice required the FDA to withdraw claims of mercury amalgam's safety from its Web site and issue an advisory
 
 


In the video above I speak with Charles Brown, legal counsel for the Consumers for Dental Choice, which is a nonprofit corporation whose purpose is to educate the public about the health and environmental dangers of mercury fillings, and to ensure more effective government oversight on amalgam. Charles discusses the processes he's been undertaking for the last 10 years to get dangerous mercury fillings removed from the market, and brings you up to speed on where we are today with the FDA's most recent, atrocious ruling.

The U.S. FDA has issued a final regulation classifying dental amalgam without calling for stringent precautions for pregnant women and children -- even though last June a court settlement filed by the Consumers for Dental Choice required the FDA to withdraw claims of mercury amalgam's safety from its Web site and issue an advisory indicating:

"Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."

Instead, the FDA has classified the fillings as class II devices, meaning the agency is claiming that they are completely harmless. This stands in direct contradiction of the conclusions of the FDA's own panel of scientific experts, and the findings of the International Academy of Oral Medicine and Toxicology (IAOMT).

In fact, mercury dental fillings contribute 2 to 3 times as much mercury to the human body as all dietary and environmental sources combined. IAOMT is urging the FDA to change the ruling, ban dental amalgam from commerce and issue a mandatory recall on the product.

Charles Brown says:

"FDA broke its contract and broke its word that it would put warnings for children and unborn children for neurological damage. Bowing to the dental products industry, FDA for the first time in its history pulled a warning about neurological harm to children.”

“This contemptuous attitude toward children and the unborn will not go unanswered,” said Brown.  “We will see FDA in court."

Vapors from dental mercury go into the human body. Due to mercury waste, amalgam is also increasingly targeted by environmentalists. Amalgam has also become controversial because the middle-class has largely moved to non-toxic alternatives while the poor, minorities, and institutional recipients, such as soldiers and prisoners, still get mercury amalgam.

The Food and Drug Administration’s new regulation on mercury amalgam fillings is a disaster for consumers -- and a bonanza for those companies still selling, and those dentists still placing, this primitive 19th-century device.

FDA’s rule, published August 4, says there will be no warnings to patients, not even young women and parents of young children, that the mercury from the amalgam fillings is a reproductive toxin and a neurotoxin. 

FDA even gives the amalgam industry the green light to sell and place amalgam 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.”

As a further step to conceal the mercury and its risks, the FDA even pulled from its website a warning that dental mercury can cause neurological damage to children and fetuses -- despite signing a contract in 2008 with Consumers for Dental Choice, a nonprofit corporation whose purpose is to educate the public about the health and environmental dangers of mercury fillings, and to ensure more effective government oversight on amalgam.

Every scientist in the world knows that mercury is a virulent neurotoxin that can kill unborn children and cause permanent neurological harm to a child’s developing brain. But the FDA doesn’t want patients to know any of this.

Stung by consumer reaction to its new amalgam rule, the FDA immediately added a warning to its website stating:

“High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys."

But they failed to take the more important step of having the warning issued to dental patients and especially parents. The small change also still allows the nation’s #1 distributor of mercury amalgam, Henry Schein Inc., untrammeled rights to market amalgam for everyone, even pregnant women, without even disclosing the mercury to patients.

The FDA’s Web site also still fails to inform consumers that young children and unborn children are especially susceptible to the effects of mercury. The FDA does not want parents to know about this danger to children even though it admits that this information is true (buried deep in the labeling intended for dentists in the new rule’s special controls, the agency writes that “The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor”).

With the FDA already conceding that it made a mistake by not posting the risks of mercury on its website, speaking up against this outrageous rule might get results.

Deputy Commissioner Joshua Sharfstein is the FDA official in charge of the amalgam rulemaking. The corporate big-shots have his e-mail address, and so should you -- it’s JMSharf1@fda.hhs.gov . Or call him at 301.796-5000. Not speaking up now means the poisoning of another generation of American children. 

Why is the FDA Ignoring Its Own Scientists’ Recommendations?

The FDA’s new ruling is in direct contradiction to the conclusions of their own 2006 Joint Panel of FDA scientific experts, as well as the International Academy of Oral Medicine & Toxicology Scientific Advisory Board members who reviewed the same papers.

The ruling is even contradictory to the FDA’s own advisories that pregnant women should limit their intake of certain fish due to mercury content. Well, as IAOMT reports, mercury dental fillings contribute two to three times as much mercury to the human body than do dietary and environmental sources combined.

Well, eating contaminated seafood will expose you to about 2.3 micrograms of mercury a day, a single dental amalgam filling releases as much as 15 micrograms of mercury per day!

It appears the FDA has sided with big business once again, as its ruling will ensure Americans’ continue using and buying amalgam fillings … but at what expense to their health?

As Charles Brown, National Counsel for advocacy group Consumers for Dental Choice, stated:

"FDA remains alone in the world in failing to protect children and pregnant women from mercury fillings. Since 1996, Canadian dentists have been told not to put mercury amalgam in children or pregnant women. Since 1998, British dentists have been told the same for pregnant women. Norway and Sweden have banned amalgam altogether.

Regrettably, this rule should have meant the end of two-tiered dentistry: mercury for the poor and choice for the rest. Instead the FDA has failed to carry out its mission of protecting the public health.”

Now’s the Time to Look Out for Your Own Health

The FDA has gone back on their word and is now ruling dental amalgam as safe. What this means is that it’s up to you to make sure you do not have this toxic metal implanted into your, or your child’s, mouth.

It’s an ironic fact that the metallic mercury used by dentists to manufacture dental amalgam is shipped as a hazardous material to the dental office. Any amalgam leftover is also treated as hazardous and requires special precautions to dispose of.

Yet you can have those same toxic fillings put into your mouth just by asking (and paying the price, of course)!

Dental amalgam fillings are made from about 50 percent mercury and the rest an amalgam of silver, tin, copper, zinc and other metals.

Mercury is a potent toxin that can damage your brain, central nervous system and kidneys. Children and fetuses, whose brains are still developing, are most at risk, and that is why it’s especially dangerous for pregnant women to get an amalgam … but really anyone can be impacted. Again, those most at risk include:

  • Pregnant and nursing women
  • Children
  • Fetuses
  • People with already high levels of mercury bioburden
  • Those who are sensitive to mercury exposure

Help for Those Who Already Have Mercury Fillings

If your mouth is currently free of mercury fillings, good for you. Make sure you keep it that way by seeing a biological dentist who can recommend a truly inert material that will not harm your health in the event you do need a filling.

For those of you who have mercury fillings, I recommend that you have them removed … but avoid making the mistake I did 20 years ago by having it done by a non-biological  dentist. You see, 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 suggest you get healthy BEFORE having your fillings removed, as you want your detoxification mechanisms optimized prior to removal.

Once you’re ready to go ahead with it, do your research and seek out a highly qualified biological dentist. Some things that need to be done to keep you (and your dentist) safe during the procedure include:

  • Providing you with an alternative air source and instructing you not to breath 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

If you opt not to have your mercury fillings replaced, or if you’re concerned about the mercury burden in your body right now, I highly recommend reviewing my Mercury Detoxification Protocol, which details the things you can do right now to help detoxify your body of this toxic substance.

Please Let Your Voice Be Heard About This Important Issue

Consumers for Dental Choice is working to abolish mercury dental fillings, and you can join their fight!

As I said earlier, Deputy Commissioner Joshua Sharfstein is the FDA official in charge of the amalgam rulemaking. His e-mail address is Sharfstein@fda.hhs.gov or you can call him at (301)796-5000. 

Please contact Mr. Sharfstein and let him know how you feel about the FDA’s atrocious ruling on mercury fillings. Not speaking up now means the poisoning of another generation of American children.

Sources:

Medical News Today July 29, 2009

International Academy of Oral Medicine & Toxicology Press Release

International Academy of Oral Medicine & Toxicology Position Paper on Dental Amalgam

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