United Nations -- The United States is lagging far behind its Western allies -- and perhaps most of the key developing countries -- in refusing to act decisively to end a longstanding health and environmental hazard: the use of mercury in dentistry.
The 28-member European Union (EU), with an estimated population of over 510 million people, recently announced its decision to ban amalgam use in children under age 15, pregnant women, and breastfeeding mothers. The ban comes into effect July 2018.
"In sharp contrast, the US government has done nothing to protect these vulnerable populations from exposure to amalgam's mercury," says a petition filed by Consumers for Dental Choice (CDC), which has been vigorously campaigning for mercury-free dentistry, since its founding back in 1996.
In Norway and Sweden, dental amalgam is no longer in use, while it is being phased out in Japan, Finland and the Netherlands. In Mauritius and EU nations, it is banned from use on children. Denmark uses dental amalgam for only 5% of restorations and Germany for 10% of restorations.
In Bangladesh, it is to be phased out in 2018, and in India, there is a dental school requirement of eliminating amalgam in favour of alternatives.
In Nigeria, the government has printed and distributed consumer-information brochures while the government of Canada has recommended that all dentists stop its use in children and pregnant women — and those with kidney disorders.
Dental amalgam has been described as a dental filling material used to fill cavities caused by tooth decay. And it is a mixture of metals, consisting of liquid (elemental) mercury and a powdered alloy composed of silver, tin, and copper.
In its petition, addressed to the FDA Commissioner, CDC says the United States -- the only developed nation with no warnings or restrictions on the use of dental amalgam in children -- is the outlier.
"Why are other countries protecting their children while the FDA lets American children be exposed to dental mercury? In order to catch up with other developed nations, the Commissioner must amend FDA's mercury amalgam rule," says the lengthy petition replete with facts and figures—and worthy of a research project.
The petition presents its case citing several sources, including the World Health Organization (WHO), the European Commission's Scientific Committee on Emerging and Newly-Identified Health Risks and the Pan American Health Organization (PAHO)
According to the Wall Street Journal last week, FDA Commissioner Dr Scott Gottlieb, in a sweeping regulatory overhaul of Big Tobacco, has cracked down on tobacco companies, demanding that all cigarettes should have such low levels of nicotine so they no longer are considered addictive.
But dental mercury apparently continues to get a free pass.
Charlie Brown, executive director of Consumers for Dental Choice, told IPS that with all the modern mercury-free dental fillings available today, it is inexcusable that FDA remains the world's chief defender of implanting neurotoxic mercury in children's mouths -- mere centimeters from their developing brains."
It's time for FDA to catch up to the European Union and ban amalgam use in children, pregnant women, and breastfeeding mothers," he added.
Michael Bender, Director, Mercury Policy Project in Vermont, USA, told IPS: "During negotiations, the US stated position was 'to achieve the phase down, with the goal, the eventual phase out' of dental amalgam. FDA should stop acting like a rogue agency and follow the US position."
In its petition, CDC urges the Commissioner to take three key measures to stop amalgam use in children under age 15, pregnant women, and breastfeeding mothers:
Firstly, issue a safety communication warning dentists, parents, and dental consumers against amalgam use in children, pregnant women, and breastfeeding mothers.
Secondly, require manufacturers to distribute patient-labeling that includes warnings against amalgam use in children, pregnant women, and breastfeeding mothers.
Thirdly, develop and implement a public information campaign (including FDA's website, social media, press releases, and a press conference) to warn dentists, dental associations, parents, and dental consumers against amalgam use in children, pregnant women, and breastfeeding mothers.
The petition also says the 2013 Minamata Convention on Mercury requires nations to "phase down the use of dental amalgam."
The US government signed and accepted the Minamata Convention on 6 November 2013. FDA's official support for "change towards use of dental amalgam" and its rejection of "any change away from use of dental amalgam" in its 2009 dental amalgam rule is contrary to the Minamata Convention's requirement that parties "phase down the use of dental amalgam."
FDA's push for phasing up amalgam use has raised major concerns in the international community, says the petition.
The Convention enters into force -- and becomes legally binding -- on 16 August. On 18 May the 50th nation ratified, and with that threshold reached, the Convention enters into force in 90 days -- namely, 16 August. Jamaica was the 71st nation to ratify the convention last week.
Asked for an FDA response, Stephanie Caccomo, Press Officer, Office of Media Affairs & Office of External Affairs, told IPS the FDA has neither promoted the use of dental amalgams nor supported an increase in their use.
FDA serves as the Department of Health and Human Services (HHS) lead representative to the Minamata Convention on Mercury and takes very seriously the Convention's objective of protecting human health from the possible adverse health effects of mercury exposure, she added.
"The US actively supported the Convention throughout its development and the FDA continues to work closely with the US Department of State on how the United States will implement the treaty obligations."
She pointed out that the US government is committed to complying with the Convention by taking at least two of the nine specific measures set forth in Part II of Annex A of the Convention with respect to dental amalgam.
Elaborating further, she said in an email message, that dental amalgam contains elemental mercury. It releases low levels of mercury in the form of a vapor that can be inhaled and absorbed by the lungs. High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys.
"FDA has reviewed the best available scientific evidence to determine whether the low levels of mercury vapor associated with dental amalgam fillings are a cause for concern. Based on this evidence, FDA considers dental amalgam fillings safe for adults and children ages 6 and above."
The weight of credible scientific evidence reviewed by FDA does not establish an association between dental amalgam use and adverse health effects in the general population. Clinical studies in adults and children ages 6 and above have found no link between dental amalgam fillings and health problems, she noted.
"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 data 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. Pregnant women and parents with children under six who are concerned about the absence of clinical data as to long-term health outcomes should talk to their dentist."
However, the estimated amount of mercury in breast milk attributable to dental amalgam is low and falls well below general levels for oral intake that the Environmental Protection Agency (EPA) considers safe, she added.
"Despite the limited clinical information, FDA concludes that the existing risk information supports a finding that infants are not at risk for adverse health effects from the mercury in breast milk of women exposed to mercury vapor from dental amalgam."
Some individuals have an allergy or sensitivity to mercury or the other components of dental amalgam (such as silver, copper, or tin). Dental amalgam might cause these individuals to develop oral lesions or other contact reactions.
"If you are allergic to any of the metals in dental amalgam, you should not get amalgam fillings. You can discuss other treatment options with your dentist," she advised.
To the extent there are any potential risks to health generally associated with the use of dental amalgam, FDA issued a final rule and related guidance document establishing special regulatory controls to mitigate any such risks.
"Moreover, while FDA does not believe additional action is warranted at this time, FDA continues to evaluate the literature on dental amalgam and any other new information it receives in light of the 2010 advisory panel recommendations and will take further action on dental amalgam as warranted," Caccomo added.
Asked for a response to the FDA statement, Charlie Brown said: "Consumers for Dental Choice's petition demands that FDA carry out its duty to provide American children the same protection from amalgam's mercury that the European Union does over there."
He pointed out that FDA admits repeatedly that no evidence exist that amalgam's mercury is safe for young children, yet FDA will not stop being the world's most stubborn defender of implanting mercury into children's mouths (and bodies).
"FDA must now fish or cut bait. With our petition in its lap, FDA must choose between, on the one hand, doing its duty as a federal agency, and, on the other hand, keeping in place its four-decade-long program of putting profits for pro-mercury dentists ahead of lives of American children," he declared.
Meanwhile, Consumers for Dental Choice says its campaign goal for Mercury-Free Dentistry is to phase out the use of amalgam, a 50% mercury product — worldwide. The recently concluded draft mercury treaty requires each signing nation to phase down its use of amalgam, and it provides a road map how.
"We aim to: educate consumers about the use of mercury in dentistry so they can make informed decisions; stop dental mercury pollution; protect consumers -- especially vulnerable populations such as children and the unborn -- from exposure to dental mercury; empower dental workers -- dental assistants and hygienists -- to protect themselves from mercury in the workplace; and promote access to mercury-free alternatives to amalgam.