The news is concerning about the US Food and Drug Administration (FDA) these days. Last week FDA Commissioner Dr. Marty Makary, MD, resigned from his post, a step normally taken in order to avoid being officially fired. Makary was one of the most visible figures in reform in the Trump II administration and a visible ally of the reform-oriented Robert F Kennedy, Jr, the HHS Secretary. Just days ago another top FDA official, Dr. Tracy Hoeg, MD, was told she had to resign or be fired. Dr. Hoeg, who has been head of FDA’s Center for Drug Evaluation and Research (CDER) said she liked her job and didn’t want to resign. Hours later, she was fired. Another senior FDA official, Vinay Prasad, has also been terminated. The wave of departures has raised the troubling question: is reform at the FDA still on track or are the chances for reform being derailed under pressure from political forces, big media, and the forces of the vaccine industry, Big Pharma? Is the dental establishment bent on fending off another item on the reform agenda: banning dental amalgam mercury fillings in the United States just as they have been banned in the European Union?

FDA’s dismal classification of dental amalgam in 2009

Big dentistry, as exemplified by the American Dental Association (ADA), has always tended to have its way with the FDA, and, over the years, the FDA has been singing the same tune as the ADA, extolling the virtues and safety of dental amalgam fillings, even though they are half mercury and a major source of mercury exposure for those who have them. FDA’s Center for Radiological and Medical Devices has been the government’s sole regulator of dental material products and FDA has been the protector of the status quo when it comes to the dental mercury question. In 2009, FDA adopted a long-awaited rule on dental amalgam, classifying it in the “moderate risk” category (Class II) rather than in the most hazardous risk category, Class III, where it obviously belonged and which would require a manufacturer to prove safety of the product. No amalgam manufacturer is going to spend $5 million to try to prove that amalgams are safe when they are so obviously unsafe, so Class III would have spelled the end of amalgam mercury fillings in America.

What the science actually says about dental amalgam

Over the earlier decades, the ADA had claimed that mercury in amalgam fillings is stable, but that was just a big lie. In 1979, Gay and his team at the University of Iowa showed that there is a measurable release of mercury from amalgams and that much more mercury is released when the amalgam surfaces are stimulated by chewing, brushing, or hot beverages. In 1987, autopsy studies by Swedish researchers Nylander, Friberg, and Lind showed that mercury levels in the brain cortexes of people who died suddenly were strongly correlated with the number of amalgam fillings in the person’s mouth. In 1989, Nylander and Friberg did autopsy studies on dental professionals and found that mercury levels in the pituitary glands of dentists were about 40 times higher than found in the pituitaries of non-dentist controls.

In 1990, Vimy and Lorscheider at the University of Calgary School of Medicine did some animal studies that should have brought dental mercury to a crashing halt. They used amalgam filling that had radioactive mercury so that, when placed into the teeth of test animals, they could trace the migration, if any, into the test animal’s organs. After 29 days, they found that the mercury had migrated from the teeth into the vital organs–kidneys, pituitary, liver, GI tract, and even to the unborn fetus. Mercury from a mother’s amalgam filling is transferred by breast milk into the nursing infant (Vimy, 1997).  In 1994 Drasch et al. measured mercury levels in the kidney cortexes of children aged 1 day to 5 years and found that mercury levels in the children correlated with the number of amalgam fillings in the mother’s mouth.             

At the cellular level, mercury causes oxidative stress and lower glutathione levels such as are found in people with autism and other neurological disorders and in people with immune disorders such as rheumatoid arthritis (Haley, IAOMT conference, 2012). Chronic illnesses such as Parkinson’s disease, dementia, multiple sclerosis, and ALS have multiple causes, but mercury exposure would exacerbate, if not solely cause, every one of them.

Haley has evaluated the synergy of mercury with other toxicants, such as lead, cadmium, and aluminum, and has found that mercury’s toxic effects greatly magnifies the toxic effects of the other toxins.

Mercury is an often unrecognized underlying cause of disability and death

Mercury is a significant contributing cause to every leading cause of disability and death. It adversely affects every bodily system; the nervous system, the immune system, the endocrine system, and the circulatory system. Yet mercury status is rarely considered when a patient’s health status is routinely evaluated or when a chronic illness is presented. Most physicians do not know how to accurately and safely test for mercury toxicity and most dentists do not know how to safely remove amalgam fillings. This is tragic both for the dental patients and for the dentists removing the amalgam because unsafe amalgam removal often exacerbates mercury symptoms and also often gives rise to new mercury symptoms and disorders. It is a quagmire of mistakes arising from a large amount of dis-information. The ADA throws a lot of misinformation into the mix, the FDA tends to fall into alignment with the ADA, and the big media is often quite complicit in the scheme.

Is there a chance now to ban amalgam fillings?

But times may be changing, especially with the momentum that comes from the entire European Union banning dental amalgam at the beginning of 2025. The appointment of RFK Jr as Secretary of HHS has given an impetus for reform at least for the HHS sector of the federal government and that includes the FDA, which can perhaps now step up and ban amalgam fillings. Several formal petitions calling for the FDA to reconsider its 2009 amalgam rule were filed last summer. The first one was filed in July by activist researcher-writer Anita Vasquez Tibau. A second one was filed on behalf of two non-profits: the International Academy of Oral Medicine and Toxicology (IAOMT) and DAMS (Dental Amalgam Mercury Solutions). Both petitions cited a mountain of scientific evidence showing that amalgams are unsafe and were able to cite scientific research published after the FDA’s 2009 rule, indicating that the case against amalgam is even stronger today than ever. Riding along with these new petitions is the hope that a new, reformed FDA, operating under a newer, more reformed leadership, will welcome this opportunity to revisit the dental amalgam question and decide to put amalgam into the right category: Class III, requiring proof of safety.

Class III would be the death knell for amalgam mercury fillings and, probably, lead to a quicker end throughout the world. That would be a victory for reform in this administration and a victory for health and health freedom worldwide.

Leo Cashman is the Executive Director of DAMS; he is also a co-founder of National Health Freedom Coalition and National Health Freedom Action.