Will the FDA Follow the EU’s Mercury Dental Amalgam Ban?
On January 1, 2025, the European Union implemented a comprehensive ban on mercury dental amalgam, marking a decisive
shift away from the use of a known neurotoxin in dentistry. This action aligned the EU with the global objective of
reducing mercury exposure under the Minamata Convention on Mercury. In contrast, the United States continues to
permit the use of mercury dental amalgam, despite growing scientific, environmental, and ethical concerns.
Mercury dental amalgam—often misleadingly referred to as “silver fillings”—is composed of approximately 50 percent
elemental mercury. While this material has been used for over a century, its safety has never been established
through modern clinical testing standards. As scientific understanding of mercury toxicity has advanced, the
continued use of this material has come under increasing scrutiny.
The FDA’s Regulatory Position
The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety of medical devices, including
dental restorative materials. For decades, mercury dental amalgam was classified as a low-risk device, requiring
minimal oversight. Although the FDA later reclassified it as a moderate-risk device, this change did not result in
a ban, mandatory patient warnings, or a clear phase-out strategy.
The FDA has acknowledged that certain populations—including pregnant women, young children, individuals with
neurological or kidney conditions, and those with specific genetic traits—may be more vulnerable to mercury
exposure. Despite this recognition, the agency has stopped short of requiring dentists to disclose these risks to
patients or to prioritize mercury-free alternatives.
Health Risks Associated with Mercury Dental Amalgam
Mercury is a potent neurotoxin with well-documented effects on the nervous, immune, and renal systems. Dental
amalgam continuously releases mercury vapor, which can be inhaled and absorbed into the bloodstream. Everyday
activities such as chewing, brushing teeth, and consuming hot foods or beverages can increase mercury release.
Research has linked mercury exposure from dental amalgam to a range of adverse health outcomes, including
neurological impairment, immune dysfunction, respiratory issues, and chronic inflammatory conditions. Studies
have also shown that mercury can accumulate in organs such as the brain and kidneys, with higher levels observed
in individuals who have multiple amalgam fillings.
The Informed Consent Problem
A central concern surrounding mercury dental amalgam is the lack of informed consent. Patients are rarely told
that so-called “silver fillings” contain mercury, nor are they routinely informed of potential health risks or
safer alternatives. The terminology itself obscures the true composition of the material, creating a false sense
of safety.
Ethical medical practice depends on transparency and patient autonomy. Without clear disclosure, patients are
unable to make fully informed decisions about materials that are permanently implanted in their bodies.
Environmental Impact
Beyond individual health concerns, mercury dental amalgam contributes significantly to environmental pollution.
Dental clinics are a major source of mercury entering wastewater systems. Mercury released during placement,
removal, cremation, and burial can persist in the environment, bioaccumulate in ecosystems, and ultimately enter
the food chain.
Many countries have concluded that continued use of mercury in dentistry is incompatible with environmental
protection goals, leading to widespread bans or phase-outs.
Safer Alternatives Are Available
Advances in dental materials and techniques have made mercury-free restorations widely available. Composite
resins, glass ionomer cements, and atraumatic restorative techniques provide effective, durable, and
biocompatible alternatives without the risks associated with mercury exposure.
These alternatives are already in widespread use globally, undermining arguments that mercury dental amalgam is
necessary due to cost, durability, or access concerns.
A Question of Alignment
The European Union’s ban demonstrates that eliminating mercury dental amalgam is both feasible and practical.
As scientific evidence continues to mount and international standards evolve, the United States faces growing
pressure to reassess its position.
Whether the FDA will follow the EU’s lead remains an open question—but the trajectory of global health policy
suggests that mercury-free dentistry is not only the future, but a necessary step toward protecting both human
health and the environment.
