Mercury Use in Dentistry Is on Its Way Out

This Mercury-Free Dentistry Week, we celebrate the 20th anniversary of Consumers for Dental Choice, the nonprofit advocates moving mercury-free dentistry from dream to reality.

From protecting dentists' right to practice without mercury-laden dental amalgam fillings to obtaining mandated fact sheets to inform patients about amalgam's mercury content, to bans and restrictions on amalgam use around the world, Consumers for Dental Choice and its leader, former state Attorney General Charlie Brown, are making mercury-free dentistry more widely available than ever before.

And, that progress is starting to sway the U.S. Food and Drug Administration (FDA), the chief regulator of dental amalgam, at the federal level. Thanks to your donations, Consumers for Dental Choice has reopened the door for FDA action against amalgam.

I ask that you continue your support by donating at ToxicTeeth.org, and I will match all donations during Mercury-Free Dentistry Week (August 23 to 29, 2020) up to $150,000. So, double your impact today. Together, we can win the campaign for mercury-free dentistry at FDA that has come so far.

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Consumers for Dental Choice Sues the FDA — and Wins

The FDA is legally required to classify — that is, issue a rule for — all medical devices, including dental amalgam. But for 30 years, FDA dodged its legal duty to classify amalgam.

Consumers for Dental Choice put an end to FDA's negligence. 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 it, posing no restrictions on amalgam use to protect the public — or even requiring that patients be told that amalgam is made of mercury.

Nonetheless, FDA's rule acknowledged that amalgam could be harmful and that there was no proof of safety for the populations most susceptible to this toxin:

"The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor. Very limited to no clinical information is available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed."

Fortunately, Consumers for Dental Choice never puts all its eggs in one basket. So, Charlie and his team challenged FDA's rule while 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.

And 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 became more and more outdated and the U.S. slipped further and further behind.

Consumers for Dental Choice's Game-Changing Return to FDA

Almost a decade after the FDA issued its flawed amalgam rule, Consumers for Dental Choice launched a nonstop campaign focused on getting FDA moving again on amalgam. And that campaign is starting to bear fruit. To succeed, Consumers for Dental Choice brought a whole new ball game to the FDA, giving the agency even more reasons to act.

First, Consumers for Dental Choice assembled an accomplished team of experts to approach the FDA. In 2018, they 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 50-plus 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."

Furthermore, it recommended immediately ceasing amalgam use in children, pregnant women and breastfeeding mothers. Working with some key signatories to the Chicago Declaration, Consumers for Dental Choice sent the declaration to FDA — and their team got meetings with the top of the agency.

Second, Consumers for Dental Choice organized a strong showing of public support from you. Do you remember its online petition that almost 50,000 of you signed? Consumers for Dental Choice presented it to the FDA in person at its first meeting with the agency and has continued to make sure your voice is heard via such means as the public comments on patient preferences it asked you to submit to the FDA last spring.

As one article's headline described the result, "FDA Gets Mouthful on Mercury Dental Fillings After Requesting Public Comment on Device Regulation."¹ Third, Consumers for Dental Choice presented the FDA with new science showing amalgam's harmful effects.

FDA Flips Their Position on Amalgam

Having reached the top of the agency, Consumers for Dental Choice could submit scientific studies that someone at the FDA would read. As a result, FDA's most recent scientific review of amalgam flips FDA's position on a major issue.

FDA now recognizes evidence that shows once dental amalgam is implanted in the human body, its elemental mercury can convert to toxic methylmercury — the same type of mercury that the FDA warns about in fish.

Furthermore, FDA is starting to recognize the bioaccumulative effect of amalgam's mercury. With patients exposed to so many sources of mercury — from high-mercury fish in their diets, occupational exposures in their workplaces and waste incinerators emitting mercury in their neighborhoods — the mercury from amalgam could very well be the straw that breaks the camel's back.

Consumers for Dental Choice laid a track record of victories on the table at the FDA. Working with strong local partners, Consumers for Dental Choice has won amalgam phase-out set dates in the Philippines, Ireland, Slovakia, Finland, Nepal, Moldova, Czech Republic and New Caledonia.

Consumers for Dental Choice has also won — again partnering with a local partner — bans on amalgam use in children in the European Union, Vietnam and Tanzania, and public warnings about amalgam's mercury in Nigeria.

And, it let the FDA know about these victories because if other countries can do it, so can the U.S. Armed with this new support, Consumers for Dental Choice succeeded in persuading the FDA to reopen the amalgam issue, starting with a new FDA review and scientific advisory committee meeting.

Consumers for Dental Choice Convinces the FDA

In November 2019, the promised FDA scientific advisory committee met to discuss metal implants and specifically dental amalgam. First, the committee heard from the public, primarily Consumers for Dental Choice's team of 16 experts.

Consumers for Dental Choice executive director Charlie Brown testified alongside 15 heavy hitters from the Children's Environmental Health Network, Tuskegee University, International Indian Treaty Council, Organic & Natural Health Association and Connecticut Coalition for Environmental Justice, as well as city and county commissioners, a physician expert in environmental justice, a pharmacist specializing in toxicology and several attorneys — all speaking out for mercury-free dentistry.

You can see Consumers for Dental Choice's team and their colleagues in action in the video at the top of this article, which shares highlights of the advisory panel meeting. The FDA advisory committee members discussed amalgam among themselves. They recommended that the agency provide information to patients about the risks of dental amalgam, especially for vulnerable populations.

Committee members expressed particular concern about the disproportionate use of amalgam in disadvantaged populations, including communities of color and low-income communities that are already exposed to higher levels of toxins. And many committee members even called for an end to amalgam use:

• Dr. McDiarmid — "I'll speak for myself and say I think that the evidence is there because we can show an exposure and we know the behavior of these neurotoxicants in the developing brain of children. We really need to think about continuing to just bless this because the evidence isn't quite there."

• Dr. Connor — "But it seems like if a product came on the market today that said it's 50% made with a material we know is highly toxic and we're only going to use it predominantly in disadvantaged populations, we wouldn't be having a meeting, you know? FDA would not approve it without a meeting.

So, I mean, I'll leave that right there in terms of our discussion, but if this were coming on the market today saying it's 50% highly toxic material and we're predominantly going to use it in disadvantaged populations, it wouldn't even be a question."

• Dr. Weisman — "So given all that, my feeling is that mercury-containing amalgam should probably be on its way out."

• Mr. Lison — "I think everybody would agree that mercury in the body isn't a good thing. I see no reason why it shouldn't be phased out as quickly as possible."

Even the FDA advisory committee chair, Dr. Rao, agreed as he summed up the committee's conclusions to the FDA:

"And I think, generally, the Panel feels in response to Question Number 6 that the evidence that was presented and is available currently confirms what was previously known and tends to move the needle a little bit further along in the direction that there is some recognition and understanding of the risks associated with mercury-containing amalgams.

These risks are to the environment and also to the patient, and potentially, to the — and to the dental professionals involved in the insertion of these. I don't think there's been any clear understanding of a quantified increase in risk that is available currently.

But the trend seems to be that when there are alternatives available to the use of mercury, the general direction should be to move away from using mercury-containing amalgams and towards non-mercury-containing products to help with dental restorations."

So, the consensus of its own advisory committee is that FDA's silence on amalgam must end. But as executive director Charlie Brown explains:

"FDA has a history of not acting on advisory committee recommendations, so Consumers for Dental Choice is keeping them on the agency's plate. We've been following up with meetings, letters from experts and multiple memos answering specific questions raised at the committee meeting."

Now It's Your Turn to Act

Consumers for Dental Choice has brought a whole new ball game to FDA, and this time it looks like the FDA is ready to play ball. But you don't have to wait on the government; you can go to a mercury-free dentist now by checking out Consumers for Dental Choice's listing of mercury-free dentists.

With your continuing support, this effective advocacy organization can make the dream of mercury-free dentistry a reality at the FDA. Will you consider a donation to this 501(c)(3) nonprofit organization dedicated to advocating mercury-free dentistry?

If you donate during Mercury Awareness Week (August 23 to 29, 2020), I will double your money. I'll match you, dollar for dollar (up to $150,000). Donations are tax-deductible and can be made online at ToxicTeeth.org. Checks can be mailed to:

Consumers for Dental Choice
316 F St., N.E., Suite 210
Washington DC 20002

Thank you for helping make the dream of mercury-free dentistry into reality for all patients, everywhere.

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