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In an astounding about-face to its previous stance, the FDA issued a warning that mercury fillings may adversely affect pregnant women, children and other susceptible individuals, and should be avoided by these groups.

The safety communication¹ was posted September 24, 2020, and with this, we have suddenly achieved an incredibly important goal that we’ve had our sights on for the last decade!

Goal Achieved: FDA Releases Amalgam Safety Communication

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Groups identified by the FDA as being at increased risk for harmful effects from dental mercury fillings include:

• Pregnant women and their developing fetuses
• Women who are planning to become pregnant
• Nursing women and their newborns and infants
  Children, especially those younger than 6
• People with pre-existing neurological disease such as multiple sclerosis, Alzheimer’s disease or Parkinson’s disease
• People with impaired kidney function
• People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam

FDA Admits Amalgam Dangers

After years of pressure from Consumers for Dental Choice and its allies, the FDA finally admits the unvarnished truth about amalgam, noting³ that “Dental amalgam is a mixture of mercury and a powdered alloy made up of silver, tin and copper” that “releases small amounts of mercury vapor over time.”

The agency also admits there are “uncertainties” and risks associated with this mercury vapor release, especially for the high-risk groups listed. In particular, there is “the potential for mercury in dental amalgam to convert to other mercury compounds in the body,” and mercury could potentially accumulate in body fluids and tissues, resulting in “unintended health outcomes.”

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While the FDA downplays the importance of its changed recommendation by stressing that the benefits of dental amalgam likely “outweigh their risks for most patients,” this update is nothing short of monumental, and opens the door, finally, for the elimination of dental mercury for all patients in the U.S., as has been done in many other countries already.

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Consumers for Dental Choice put an end to FDA’s negligence when, in 2008, this dynamic nonprofit organization assembled plaintiffs and sued FDA, demanding that amalgam be classified. The judge agreed and told FDA to sit down with Consumers for Dental Choice to determine a deadline. FDA was compelled to commit to classifying amalgam by July 2009.

But when July 2009 came around, it was clear the FDA had not considered the science — especially the evidence of harm amalgam can cause vulnerable populations like children, pregnant women and breastfeeding mothers.

Its abysmal rule reflected this shortcoming, as it did not restrict the use of amalgam for these most vulnerable individuals. The rule did not even require that patients be told that amalgam is made of mercury. Nonetheless, FDA’s 2009 rule did acknowledge that amalgam could be harmful, and that there was no proof of safety for the populations most susceptible to this toxin.

In response, Consumers for Dental Choice challenged FDA’s rule, while simultaneously pursuing other opportunities to advance mercury-free dentistry, like defeating pro-mercury state dental boards, fighting for amalgam fact sheet laws for patients at the state level, and getting amalgam into the Minamata Convention on Mercury.

As Consumers for Dental Choice racked up win after win — regaining licenses for mercury-free dentists persecuted by state boards, gaining fact sheets to protect dental patients, achieving an amalgam reduction requirement in the Minamata Convention — the FDA’s rule was looking increasingly archaic.

Decade-Long Wait Is Over

Nearly a decade after the FDA issued its flawed amalgam rule, Consumers for Dental Choice launched a nonstop campaign focused on getting the FDA to move on amalgam.

They assembled an accomplished team of experts to approach the FDA, and in 2018, unveiled the “Chicago Declaration to End Mercury Use in the Dental Industry” at the University of Illinois School of Public Health.

This declaration, signed by more than 50 heavy-hitter environmental groups, called on the FDA “to bring its policies in line with the Federal Government as a whole and with its responsibilities under the Minamata Convention and to publicly advise a phase down of the use of mercury amalgams with the goal of phasing out entirely.”

The declaration also called for the immediate ban on amalgam use in children, pregnant women and breastfeeding mothers. Working with key signatories to the “Chicago Declaration,” Consumers for Dental Choice were able to secure meetings with top officials at the FDA, during which they were able to submit scientific studies for the FDA to review.

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FDA Reverses Stance on Amalgam

Consumers for Dental Choice also organized a strong showing of public support from you. Its online petition, which had nearly 50,000 signatures, was presented to the FDA in person at its first meeting with the agency. Many of you also submitted public comments on patient preferences to the FDA.

FDA was also made aware of the changes to amalgam rules in other parts of the world, such as amalgam phase-out dates set by the Philippines, Ireland, Slovakia, Finland, Nepal, Moldova, Czech Republic and New Caledonia, and the bans on amalgam use in children issued by the European Union, Vietnam and Tanzania.

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Final Step Ahead

Now that the FDA has finally broken its silence on the dangers of mercury for pregnant and nursing mothers, children and people with certain underlying conditions, the final step — a full ban on amalgam for all — looms near.

The American Dental Association, which has long defended amalgam’s safety, is now running out of allies. For now, however, the ADA still maintains its contrarian view.

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In its September 24, 2020, safety communication on dental amalgam,⁷ the FDA specifically advises dentists against using the term “silver filling,” “as this may imply the filling is made solely from silver and does not accurately convey the mercury component of this restorative material.” The FDA also highlights this in its Dental Devices description page for amalgam, which received its last update September 29, 2020, noting that:⁸

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What’s Lurking in Your Silver Fillings?

That 50% to 60% of Americans don’t know amalgam fillings are half mercury is no accident. The American Dental Association, an amalgam patent-holder, popularized the deceptive term “silver fillings” so consumers would think amalgam is made mainly of silver when actually it has twice as much mercury as silver.

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Via https://articles.mercola.com/sites/articles/archive/2023/02/22/fda-dental-amalgam-warning