As we noted last week, the IAOMT and DAMS recently teamed up to petition the FDA. Their main ask is simple and straightforward: formally ban mercury fillings completely. This would align the US with more than 40 other countries – including all those in the European Union – that have already restricted the use of dental mercury.
As the petitioners argue, mercury amalgam presents an “unreasonable, direct and substantial danger to the health of people who have them, as well as the people who place [amalgam fillings].”
Because of this, the petition offers an alternative in case the FDA isn’t ready for an outright ban: reclassify mercury fillings from their current Class II status to Class III. To understand why this matters, it helps to know a little about how the FDA classifies medical devices.
Class I devices are considered low risk. Think of things like bandages and tongue depressors. Such devices don’t need a lot of regulatory oversight. Class II devices pose a moderate risk and so require some safety controls. Class III is reserved for the highest risk devices, including those posing a significant potential for harm. Although there are some exceptions, as a rule, long-term devices must be proven both safe and effective before receiving approval.
Mercury amalgam fillings were never tested for safety. They were grandfathering in based on their historical use. The FDA bought the ADA cliche that since dentists have been filling teeth with mercury for over a century, it must be safe.
Yet any device intended to remain in the human body for more than 30 days should automatically be designated Class III. Amalgam fillings are designed to stay in your teeth for decades. In fact, over the years, its defenders have made quite a big deal about amalgam’s longevity.
If mercury amalgam fillings were moved to Class III, those still making and selling amalgam would face a monumental challenge: They would have to actually prove, for the first time in history, that amalgam fillings are safe and effective. Considering how major suppliers have been getting out of the market in response to international bans and changing guidelines, and given the wealth of science already documenting mercury’s neurotoxic effects, this would be a nearly impossible task.
The petition also asks for specific restrictions on amalgam use in certain vulnerable populations if the FDA opts for reclassification instead of an outright ban:
- Children under 19.
- Women of childbearing age.
- People with compromised kidney, immune, or neurological function.
- Those with genetic susceptibilities to mercury toxicity.
As the petition states,
Neither “Class II controls” nor “Special Controls” can accomplish a reasonable assurance of safety for all sectors of our general population. Reasonable assurance of safety can only be achieved by abolishing the use [of] dental amalgam or by placing it into Class III. However, given that only 15% of Americans do not fall into the above categories of risk, banning its use is the only real solution.
While nearly half of American dentists have already moved away from amalgam – some due to health concerns; some, to patient demand – economic barriers still force many patients into accepting mercury fillings. Most dental insurance plans still consider amalgam the default option, offering minimal reimbursement for mercury-free alternatives. This means patients often face a choice between accepting mercury fillings or paying significant out-of-pocket costs for safer materials.
The situation is even starker for those whose dental care is funded by the government: veterans through the VA system, military personnel, Medicaid recipients, Native Americans through the Indian Health Service, and children in public health programs. All are still routinely given mercury fillings as the default option with no real choice at all.
Meantime, modern composites and ceramics have been successfully used for decades. They offer excellent durability and aesthetics without the risk of mercury toxicity.
For decades, the federal government has systematically phased out mercury from consumer products including paint, antiseptics, nasal sprays, ear drops, medications, and most recently, vaccines. Mercury fillings represent one of the last holdouts from an era when the toxic effects of mercury were less well understood.
The petition’s language underscores both the urgency and gravity of the situation. As the document states,
By continuing to allow and support amalgam use, we are forcing these vulnerable groups to receive the cheapest, and most toxic option, without choice.
The petition represents more than just another regulatory request. It’s a roadmap for bringing mainstream American dentistry in line with current scientific understanding and global health trends. It offers a clear path toward ensuring that all Americans have access to safe, mercury-free dental care.
