Groundswell Pushing FDA to Stop Mercury Amalgam Use in Children: Op-Ed

FDA’s failed amalgam policy contrasts with other nations protecting children

By Charles G. Brown, Executive Director of Consumers for Dental Choice and president of the World Alliance for Mercury-Free Dentistry

July 10, 2019: The continued use of dental amalgam, a primitive pre-Civil War device that is 50% neurotoxic mercury, is in increasing disrepute, as health and environmental regulators push for its end in children, and in some cases for everyone.

By European Union law, all of its 28 member nations effectively ended the use of amalgam in children under 15, pregnant women, and breastfeeding women on July 1, 2018.[i]   Governments across Asia and Africa – Vietnam, Pakistan, Mauritius, Nigeria – are following suit.  Some European nations are going further – having ended amalgam use already (Sweden, Norway) or announcing an end date for amalgam use (Slovakia, Ireland, Finland).

The U.S. Food and Drug Administration, by contrast, does nothing even to protect children – this despite its own 2009 rule[ii] that concedes the need for action:

  • FDA admits that mercury exposures increase for a pregnant woman receiving an amalgam,[iii] hence putting the baby at direct risk of neurological harm;
  • FDA admits it lacks clinical studies determining the effect of amalgam’s mercury exposures to children under six.[iv]
  • FDA admits it has “very limited to no clinical information” for “long-term health outcomes” for pregnant women, developing fetuses, babies being breastfed, nor children under six.[v]

Because FDA does not know if amalgam is safe or not for children under six, nor for pregnant women nor fetuses nor suckling babies – and so admits in its amalgam rule –  FDA by law needs to stop use of the amalgam implant going into children, pregnant women, and breastfeeding women.  But FDA does not.  Even more puzzling, FDA does not even take the mild step of mandating warnings to parents, pregnant women, and breastfeeding women.

FDA’s lack of concern about amalgam use in children is at odds with growing concerns from American patients and parents.  FDA invited the public to comment about patient preferences regarding medical devices.  In the public docket that closed on July 2, approximately 94% of those comments addressed FDA’s failed amalgam policy – overwhelming the 6% covering all other devices combined.[vi]

Another sign of the growing public support for stopping amalgam use in children is the Chicago Declaration to End Dental Mercury Use, signed onto by more than 50 nonprofit groups, including such heavyweights as Sierra Club, Greenpeace, Health Care Without Harm, Organic Consumers Association, and Learning Disabilities Association of America.  The Chicago Declaration calls for the immediate end to “the placement of dental amalgam in children, pregnant women, and breastfeeding mothers.” [vii]

Of equal concern is the growing inequity caused by continuing amalgam use in low-income children and children of color, as illustrated by a commentary in the prestigious Journal of the National Medical Association entitled “Is Dental Amalgam Toxic to Children of Color?” [viii]  A team of two physicians, one a leading expert on environmental justice the other a former NMA president; a dentist who is a bioethics professor at Tuskegee Institute, and a research scientist from Harvard who conducted the New England Children’s Amalgam Trial called for action aimed at  “eliminating mercury exposure wherever possible for everyone, especially the most vulnerable.”[ix]

FDA’s unwillingness to protect American children is particularly disconcerting because a 2014 Zogby poll reveals that dentists are three times less likely to tell African-Americans than white Americans that amalgam is made mainly of mercury, and three times less likely to tell people of any race making under $50,000 a year compared to people making over $50,000/year.

A groundswell from the American public calls on FDA to end its failed amalgam policy – and end dental amalgam use for children, pregnant women, and breastfeeding women.

Charles G. Brown is Executive Director of Consumers for Dental Choice and president of the World Alliance for Mercury-Free Dentistry.

[i] Regulation of the European Parliament and of the Council on Mercury, and Repealing Regulation (EC) No 1102/2008 (17 May 2017), p. 25, http://data.consilium.europa.eu/doc/document/PE-4-2017-REV-1/en/pdf

[ii] Federal Register / Vol. 74, No. 148 / Aug. 4, 2009, pp. 38885 et seq. http://www.gpo.gov/fdsys/pkg/FR-2009-08-04/pdf/E9-18447.pdf

[iii] “Maternal exposures are likely to increase temporarily when new dental amalgams are inserted or existing dental amalgam restorations are removed.” Ibid. at p. 38691

[iv] “No clinical studies have evaluated the effects of mercury vapor exposure from dental amalgam in children under six years of age.”  Ibid. at p. 38692

[v]  “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.”  Ibid. at p. 38694;  repeated at p. 38707.

[vi] FDA Webview, “Amalgam Concerns Flood Patient Info Docket,” 6/14/2019

[vii] https://mercuryfreedentistry.files.wordpress.com/2018/04/chicago-declaration-to-end-dental-industry-mercury-use-4-14-17.pdf

[viii] Mitchell, Warren, Bellinger, & Browne, “Is Dental Amalgam Toxic to Children of Color?” Journal of the National Medical Association 2018, 110 (4): 414.

[ix] Ibid.

11 COMMENTS

  1. C’mon FDA, enough already! It is MADDENING that other countries care more about their kids and mamas. We can do better. What are we still doing over a hundred years later putting freakin’ mercury into the mouths of our most vulnerable populations?! Seriously, what 1st world country still thinks this is a good idea?! FDA, put your pride and nonsense aside and do the right thing–BAN mercury fillings, at least for those most vulnerable among us!

  2. Thank you, Charlie, for your tireless quest to bring this grave health threat to the attention of the public and to the authorities in position to make the necessary changes. More than 25 years ago in my training with healthcare professionals using the electrodermal testing I became aware of the many ways dental amalgam manifested in health issues. I brought these issues up to my dentist, requesting removal of all amalgam as a prophylactic measure. He complied all the while stating that no evidence existed connecting dental amalgam with health issues. I appreciate all the good work you are accomplishing.

  3. The battle over the use of mercury amalgam in dentistry represents a larger struggle between those who benefit from the economic status quo and the scientists who document the effects of that status quo on the long term sustainability of human civilization. It’s not a fair fight! The uncertainty inherent in the development of any scientific theory creates a vulnerability that is exploited by proponents of the status quo who can claim, with some degree of certainty, that changing medical practices (or energy consumption or food production or banking regulation) will cost someone money. That’s why the advocacy work of Consumers for Dental Choice and the dedication of Mr. Brown and his supporters is so important. It is only through the continuous presentation of arguments supported by a growing body of scientific evidence that policy makers will be convinced take the steps necessary to protect the public from the unnecessary use of a hazardous chemical like mercury in dentistry.

  4. Thank you Mr. Brown for your continued efforts on the behalf of all of us living in the U.S. A first baby step is definitely to ban amalgam in pregnant women and children who are at high risk for mercury toxicity. Let us also keep in mind the teenagers and young adults and older folks as well, who are diagnosed with myriad autoimmune disorders…or those suffering from symptoms without any diagnoses, who have amalgams. Many of those diagnoses and symptoms could be mitigated if such individuals could safely get their existing amalgams removed. Most of those who have them, are not financially able to pay to have them removed. The FDA commissioned a team of experts, to examine mercury exposure and the risks associated with the use of dental amalgam several years ago (Richardson et al. 2011). Using the most conservative metric, Richardson concluded that more than 67 million Americans exceed the mercury dose associated with the reference exposure level (REL) established by the US Environmental Protection Agency (EPA), which is so small already that it doesn’t seem as if it could pose a threat. The findings were used as a centerpiece at the FDA’s Expert Panel review in 2010. Dr. Richardson stated, “The proportion of the American population predicted to exceed the U.S. EPA reference exposure level (REL)-associated dose for Hg vapor due to dental amalgam is large, and would not be supported or permitted by regulation for other sources of exposure.” The FDA themselves commissioned Dr. Richardson and yet, they did not establish a lower REL and continue to allow the use of amalgam. Amalgam needs to be banned for all individuals. Teresa (Teri) Franklin, Ph.D., mercury4dummies.blogspot.com

  5. Great work Charlie!

    You have covered all the bases and successfully exposed FDA for their immoral and indefensible stance
    on this issue.

    It would be interesting to know how many members of FDA carry in their teeth the amalgam!

  6. Hi, I am not a politician or someone who is advocating for ceasing the use of mercury in dentistry. I am a mother of two small children and as I read this, I know how and what I have to do to protect my child from being injured in any way. Thank you for educating us on this subject. I have shared it with many of my friends and I hope that they will respond too.

  7. The FDA should use the precautionary principle and stop using amalgam in children, mothers. Especially breastfeeding mothers, until it has been proven safe by credible peer/reviewed scientific studies. Their own advisory panel advised not to use it 15 or more years agile, yet they haven’t stopped using it. The rest of the world is stopping it. We should follow their example.

  8. KUDOS to the author for insights into the background surrounding the FDA turning a blind eye to an issue that requiring their attention. FDA fiddles while nations around the world recognize the obsolescence of mercury amalgam as a dental restorative material for the 21st century by eliminating its use in women and children with plans for total elimination.

    Just as we have found in numerous other situations, substitution eliminates problems at so many levels. Mercury is recognized as one of those complex problems requiring action at every level by other federal agencies – EPA, ATSDR, NIEHS among them. Eliminating amalgam use prevents the requirements of mercury trade, transport, use and disposal. All of which create more mercury problems and costs.

    A 2016 study done at the University of Georgia used population-level numbers from the USA’s national health and nutrition studies (NHANES). Researchers found that the more amalgam fillings a person had, the greater the mercury in their blood (Ecotoxicology and Environmental Safety 134 (2016) 213–225). As Mr. Brown points out, subjecting mothers, children and others to this unnecessary mercury and the cascading impacts from those exposures, needs to be eliminated.

    FDA needs to open their eyes to the big picture and adopt rules to virtually eliminate all new amalgam use. We owe it to the children, the mothers and those forced to accept mercury amalgam because FDA continues their failure to respond to the weight of evidence, global actions and public demand.

  9. > FDA’s lack of concern about amalgam use in children is at odds with growing concerns from American patients and parents. FDA invited the public to comment about patient preferences regarding medical devices. In the public docket that closed on July 2, approximately 94% of those comments addressed FDA’s failed amalgam policy – overwhelming the 6% covering all other devices combined.[vi]

    Is there any other dental device possibly more dangerous than mercury amalgams!?!?! It’s time for this madness to end!

    Thank you for this excellent summary!

  10. It’s time FDA steps up to the plate to reduce mercury use in dentistry. Given the solid science, it’s time that FDA also does more to recognize that dental amalgam is an inferior product (more tooth tissue must be removed) that takes away from the longevity of the tooth. Finally, FDA never did an environmental impact statement on dental amalgam, although environmental releases of dental amalgam (resulting in secondary poisoning via fish consumption) are the main reason countries agreed to phase down dental amalgam under a new multi-lateral environmental treaty, the Minamata Convention on Mercury.
    –Michael Bender, Director, Mercury Policy Project, Montpelier, VT 05602

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