The FDA is currently considering taking certain oral fluoride supplements that are swallowed off the market, specifically tablets and lozenges. Toothpastes and mouth rinses that contain fluoride are not affected, though, as these are considered topical. So far, the FDA has opened a review, held a public hearing, and set an internal target of the 31st of October, 2025, to decide whether these products should stay or go. However, this move has many dentists concerned, especially for communities that don’t have access to fluoridated water.
Will the FDA Ban Fluoride Supplements
Ingestible prescription supplements for children are currently being scrutinized by the FDA. Even though they’ve already been used for decades, they have never been put through the full modern approval process as other FDA-approved drugs. The FDA feels it should have sufficient data that shows the proper dosing and benefits of the supplements before kids take them. Additionally, some scientists are asking whether swallowed fluoride can potentially affect developing systems such as the gut microbiome.
The conversation once again entered the public sphere in 2025, when a research review found that high levels of fluoride exposure were linked to a lower average IQ in kids. However, the majority of these studies came from places outside of the United States and involved levels that were much higher than those found in the United States. The authors themselves noted that the findings should not be over-interpreted for the United States context. Even so, the findings of the paper have prompted regulators to take another look at how fluoride affects children when swallowed.
Dentists Are Concerned with this Move
However, according to dentists and pediatricians, removing supplements would hit the kids who can least afford it. For those who live in areas without fluoridated water, these low-dose supplements are often the only way for them to have consistent access to cavity-fighting fluoride. The American Dental Association and other groups have warned that taking away these supplements without some sort of alternative in place only increases dental health risks. They have cited real-world examples where children’s cavity rates increased within a few years of stopping water fluoridation. For example, more dental treatments were required in Calgary, Canada, after they stopped fluoridation, forcing them to eventually bring it back. This is why so many dentists see it as an essential backup plan for those who do not have access to fluoride in their water.
The Stance of the FDA
According to the FDA, this is not about ideology, but evidence. Fluoride supplements that are swallowed were never formally approved by the agency. Therefore, they don’t have the typical pediatric trials that reveal the risks and benefits of their use. They are also responding to growing concerns from some of the public that it can potentially stunt the development of children. However, most of their concern seems to be based on data from places where the levels of fluoride far exceed those found in US water supplies. Another thing to keep in mind is that this isn’t necessarily an outright ban of the products. Manufacturers could still run the necessary studies and come back through the proper approval pathway once their findings are confirmed.
This current move is part of a larger country-wide shift in the approach to fluoridation. For example, several states and cities have recently been rethinking their views on water fluoridation. For example, in 2025, Utah passed a law that prohibits any addition of fluoride into the public water supply, with Florida following suit in July. Without fluoridation in their water, however, how will families make sure they get any at all, especially with a ban on supplements? If those also disappear, the ways to prevent cavities grow even smaller. This ultimately affects the poorest communities and those who live in rural areas.
The Bottom Line
At the moment, nothing has really changed regarding your child’s fluoride toothpaste and dentist-applied fluoride. The FDA’s review is all about making sure that anything your children ingest meets today’s standards. While dentists agree that high-quality research is important, they have still voiced their concerns about how those in poor and rural areas will be affected by this move. In many areas where there is no fluoridated water, the community relies on some sort of fluoride substitute to prevent the formation of cavities.
Without those supplements, many will potentially require dental procedures to treat their teeth. Many states are also now removing fluoride from their water supply, so make sure that you still use toothpaste and other products that contain fluoride to help protect your teeth from decay. Brush regularly, floss daily, and visit your dentist often for a check-up! That is the best way to keep your teeth healthy until more is known about the benefits and risks of ingestible fluoride supplements.
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