FDA Takes Action to Restrict Fluoride Supplements for Children

• Fluoride prescription drugs have been used for decades without FDA approval — Unlike toothpaste or fluoride rinses, ingestible fluoride prescription drugs are swallowed and ingested in the form of tablets or drops. These have been used for decades without FDA approval for safety, quality, or effectiveness. Single-ingredient sodium fluoride drugs are currently sold in doses from 0.25 to 1 milligram (mg) per day.

According to existing unapproved labeling, they were intended to supplement fluoride for children in areas where water fluoride levels do not exceed 0.6 parts per million (ppm). Drops are typically recommended for infants and toddlers from 6 months to 3 years, while tablets are marketed for older children through adolescence.⁸

• The FDA launched a full safety review in May 2025 — Following the MAHA directive, the agency began evaluating ingestible fluoride prescription drugs for children early this year. Commissioner Marty Makary, M.D., M.P.H., explained the agency’s approach, stating:

“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health.

I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”⁹

• The FDA moved to impose new federal restrictions on ingestible fluoride drugs — After the FDA reached its target date of October 31 for completing its scientific review and public comment period, the agency announced decisive steps regarding the future of ingestible fluoride products. It determined that unapproved fluoride prescription drugs marketed for children would face new federal restrictions. In its news release, the agency stated:

“The FDA sent notices to four companies outlining the agency’s intention to take enforcement action against those marketing unapproved fluoride-containing ingestible drugs labeled for use in children under age 3 or older children at low or moderate risk for tooth decay.”¹⁰

• New guidance and national initiatives accompanied the enforcement action — The FDA sent a detailed advisory letter directing clinicians away from ingestible fluoride in children who are not at high risk of cavities.¹¹ In partnership with the National Institutes of Health (NIH) and HHS, the agency also announced development of a fluoride research agenda and a national oral health strategy to address research gaps and improve prevention of childhood dental disease.

• Kennedy described the decision as long overdue — He thanked Makary for his leadership, emphasizing that the action “directly safeguards the health and development of our children”¹² and advances the administration’s broader MAHA goal of strengthening protections for young patients.

“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” Kennedy commented. “It’s scary that these products have been used for decades without approval. Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again.”¹³

• Ingestible fluoride and supplement use remains widespread — In 2024, 1.2 million prescriptions were dispensed for ingestible fluoride drug products and fluoride-containing dietary supplements combined. Of these, 700,000 were supplements. Among drug products alone, 0.5 mg chewable tablets accounted for 33% of prescriptions, 1 mg tablets for 31%, and 0.5 mg/mL oral drops for 24%. Pediatricians issued 43% of these prescriptions, and dentists wrote 29%.

• Evidence shows benefits only for permanent teeth — CDER’s review found that systemic fluoride delivers measurable protection only to developing permanent teeth. Studies from the 1950s through the 1990s, summarized in the 2011 Cochrane Review and a 2008 Journal of the American Dental Association (JADA) review, reported reductions of 6.2% to 70% in decayed, missing, and filled permanent surfaces, depending on study design and population.

By contrast, five trials focused on primary teeth produced inconsistent findings, with multiple studies showing no meaningful benefit. The agency concluded that ingestible fluoride aids permanent tooth development but does not offer clear advantages for primary teeth.

• Dental fluorosis is the most established adverse effect — The evaluation confirmed that excessive systemic fluoride exposure can permanently damage tooth enamel. Fluorosis ranges from mild white streaking to brown discoloration and surface pitting. The risk is highest between 22 and 27 months of age, when permanent incisors and molars are forming.

• Other safety signals require further study — The review examined additional concerns raised in international research, including possible links between fluoride exposure and neurocognitive changes, thyroid hormone alterations, gut microbiome disruption, and weight gain. The FDA classified these findings as “hypothesis-generating.”

One meta-analysis reported an inverse relationship between urinary fluoride and IQ, estimating a 1.14-point decrease per 1 mg/L increase in urinary fluoride.¹⁵ The agency noted that U.S. urinary fluoride levels (median 0.619 mg/L) fall below the exposure range evaluated in that research.

• The FDA recommends limiting use to high-risk children aged 3 and older — After reviewing all available data, the agency concluded that ingestible fluoride offers limited benefits and carries clearly documented risks. It advised restricting use to children at high risk for tooth decay, such as those with previous caries or no access to fluoridated water, and delaying use until age 3 to avoid the most vulnerable window of enamel development.

The report emphasized that shared decision-making between parents and clinicians should guide fluoride use, taking into account water source, total fluoride exposure, diet, and dental hygiene habits.

• New research is needed to resolve major evidence gaps — The agency called for updated studies on cumulative fluoride exposure, weight-based dosing, and direct comparisons between systemic and topical fluoride delivery. Until stronger data are available, the FDA advised that topical fluoride from brushing and professional applications remains the safer and more effective method for preventing cavities in children.

• Children in fluoridated areas showed fewer affected teeth, but results varied widely — Across the included studies, fluoridated communities reported fewer decayed, missing, and filled teeth and surfaces compared to non-fluoridated areas. The size of these differences, however, ranged dramatically.

Because of this variability, the certainty ratings — a measure of how confident the researchers are that the effect they observed is real and not the result of bias, poor study design, missing data, or chance — spanned from low to very low. These inconsistencies immediately raised questions about how reliably the findings apply across diverse communities.

• A major issue highlighted by the authors is the lack of data on caries increments — This measurement shows how cavities form and worsen over time. Most studies reported only overall counts, not changes, which limits how well fluoride’s long-term protective effect can be understood.

The review also pointed out that almost no studies reported outcomes related to quality of life, dental symptoms, or the financial impact of fluoridation programs. Without these broader measures, the evidence remains narrow and focused on tooth counts rather than full health or real-world cost-effectiveness.

• Many studies came from populations with already low decay levels — A substantial portion of the research involved communities with minimal baseline decay, making it difficult to determine whether fluoride offered any additional benefit. Population differences, socioeconomic factors, and unequal access to dental care affected the results as well.

These variations made it challenging to determine how much of the observed benefit could be attributed to fluoridation alone. This uncertainty has fueled ongoing discussion about how applicable the findings are to today’s communities, where dental care and dietary patterns differ significantly from the older studies included.

• Most available data centered on school-aged children, with major gaps for adults — Eleven studies involving between 4,591 and 25,282 children formed the core of the evidence base. These consistently showed fewer cavities in fluoridated areas, but the certainty ratings again ranged from high to very low.

Nearly no data existed for adults, and no suitable evidence addressed fluoride’s effects on root decay or cavity prevention later in life. This gap matters because adults and older adults face different dental risks than children, yet the evidence base for these groups remains thin.

• Adult trials offered limited insight due to overlapping exposures — Three cluster-randomized trials involving adults were included, but these tested fluoride toothpaste in communities with varying fluoride levels in the water. Because the trials combined exposure from toothpaste and fluoridated water, they did not allow the researchers to isolate the effect of water fluoridation alone. As a result, the review could not draw conclusions about adult outcomes or root caries.

• The review reopened debate by illustrating both the findings and the uncertainties — The reductions in tooth decay observed in some studies stand alongside substantial gaps in long-term outcomes, limited adult data, and inconsistent study quality. By outlining what is known and what remains unknown, the Cochrane review reopened the debate on how much confidence you should place in fluoridation as a preventive strategy.

• IQ loss in children — A 2023 meta-analysis involving 12,263 children from seven countries found an average IQ reduction of 5.6 points in groups with higher fluoride exposure. The decline followed a dose-response pattern, meaning the IQ drop became more pronounced as fluoride levels increased.

Children with urinary fluoride concentrations of only 0.28 mg/L, which are levels consistent with fluoridated water intake, already showed measurable cognitive impairment.¹⁸ Learn more about fluoride’s impact on children’s neurodevelopment in “Fluoride’s Hidden Danger — Lower IQ in Children Exposed.”

• Permanent neurodevelopmental harm — The National Toxicology Program’s 2024 report concluded with “moderate confidence” that fluoride exposure, even around the current U.S. target of 0.7 mg/L, reduces cognitive performance in children. The developing brain is especially vulnerable during pregnancy and early childhood, and the studies reviewed showed consistent effects across different populations and research methods.¹⁹

• Hormonal disruption affecting early brain development — Research shows that prenatal fluoride exposure is linked to poorer executive function in children and higher rates of ADHD-related symptoms. These outcomes are closely tied to interference with thyroid hormones, which guide fetal brain development. Florida Surgeon General Joseph A. Ladapo highlighted these findings when calling for an end to statewide water fluoridation.²⁰

• Risks to fetal organs and blood function — A 2024 study in Environmental Health found that rising maternal fluoride levels were associated with adverse effects on fetal kidney and liver function. These organs handle detoxification and are known to store more fluoride than most other tissues.

The researchers also observed decreases in proteins involved in the complement cascade — a key part of immune development — and changes in blood-clotting proteins, suggesting that fluoride exposure may disrupt normal blood and immune processes during gestation.²¹

• Skeletal fluorosis — When fluoride accumulates in bone over many years, it can lead to stiff joints, calcified ligaments, and reduced mobility. In regions with moderate to high intake, these changes progress into skeletal fluorosis, a severe and irreversible condition. Early symptoms often resemble arthritis, which delays diagnosis until the damage becomes permanent.^22,23

• Altered calcium balance and higher fracture rates — Fluoride affects the activity of the cells that build and break down bone, which weakens structural integrity over time. Studies examining communities with chronic fluoride exposure have documented elevated rates of hip and wrist fractures.^24,25,26

• Endocrine disruption beyond the thyroid — Long-term fluoride intake has been associated with impaired glucose control and shifts in insulin sensitivity, raising concerns about metabolic health. Research also points to fluoride’s influence on the pineal gland, where it may reduce melatonin output and interfere with natural sleep rhythms.²⁷

• Progressive muscle loss — A 2022 study found that extended fluoride exposure triggers the breakdown of essential muscle proteins, leading to shrinking muscle fibers and increasing weakness. This decline was linked to the activation of a molecular pathway involved in muscle wasting.²⁸

• The ADA continues to support systemic fluoride even as federal agencies reassess its safety — The association pointed out that states discontinuing community water fluoridation may turn more heavily to fluoride supplements and varnish programs to manage dental decay. This stance maintains routine systemic fluoride use at a time when federal health agencies are reexamining its risks for young children.

• Concerns about outdated guidance have been raised directly to the ADA — In May 2025, I wrote an open letter urging the organization to review its support for water fluoridation.

That letter summarized research associating fluoride exposure with reduced IQ, increased ADHD-related symptoms, and disrupted thyroid function, and argued that modern evidence no longer supports prolonged systemic intake. My concern remains that this continued endorsement does not reflect today’s scientific understanding.

• Other countries demonstrate that fluoridation is not required for strong dental outcomes — Many Western nations that discontinued fluoridation now rely on improved nutrition, public education, and fluoride-free oral care, and report dental health outcomes comparable to those in the U.S. These approaches show that safer alternatives are viable.

1. Install a filtration system designed to remove fluoride — Basic carbon filters like Brita or PUR, along with common water softeners, do not take fluoride out of drinking water. If you want to reduce fluoride in the water you use for drinking and cooking, choose a system specifically engineered for that purpose.

Reverse osmosis remains a widely used option, but consider its drawbacks, including wasting water and removing beneficial minerals along with contaminants. Bone-char systems also exist, though they work best when water is more acidic. It’s also worth filtering the water you use for bathing. Fluoride is absorbed through the skin, so placing filters on showers and other household water sources offers broader protection.

2. Use fluoride-free water when preparing infant formula — Babies who consume formula mixed with fluoridated tap water take in far more fluoride than breastfed infants, which raises concerns for their developing brain and nervous system. If breastfeeding is not possible, prepare formula with filtered, fluoride-free water to keep exposure as low as possible.

3. Choose fluoride-free toothpaste and oral care products — Toothpaste and mouth rinses are major contributors to everyday fluoride intake. Switching to fluoride-free versions is an easy way to lower total exposure. Read labels carefully; many conventional formulas also contain ingredients you may want to avoid, including triclosan, sodium lauryl sulfate, propylene glycol, diethanolamine, parabens, and plastic microbeads.

You can also make your own toothpaste with simple ingredients such as organic coconut oil, baking soda, a small amount of Himalayan salt, and a drop of peppermint essential oil for a clean, familiar flavor.

4. Be proactive about fluoride prescriptions — Asking your clinician to explain why your child would qualify as “high risk” for cavities helps avoid unnecessary prescriptions. You can also request non-fluoride approaches, such as improved oral hygiene routines and diet-based strategies, that work directly on the teeth rather than through ingestion.

If your clinician recommends fluoride tablets without checking the fluoride level in your local water supply, request that information before deciding. Reviewing any prescription before filling it ensures you understand exactly what your child will be taking.

5. Pay attention to hidden fluoride in foods and beverages — Products made with fluoridated water often retain some of that fluoride, and this includes many packaged foods and drinks. Tea is another source, since tea plants naturally absorb fluoride from the soil. If you drink tea regularly, white tea tends to contain lower levels than black or green varieties.

6. Participate in local water policy decisions — Community involvement plays a significant role in shaping water treatment practices. Staying informed, sharing research with neighbors and local leaders, and taking part in discussions about water fluoridation help bring greater awareness to the issue. More than 200 million Americans still rely on fluoridated water without explicit consent, and local engagement is often the first step toward meaningful change.