FDA Takes Action to Restrict Fluoride Supplements for Children
Since the 1940s, one substance has been added to the water supply of nearly three-quarters of Americans without their explicit consent.
STORY AT-A-GLANCE
The FDA announced new federal restrictions on ingestible fluoride drugs for children. This marks a major policy shift that limits their use, introduces enforcement actions, and directs clinicians toward safer, risk-based prevention
The agency has sent formal notices to four companies stating its intention to take enforcement action against unapproved fluoride-containing ingestible drugs marketed for young children and those at low or moderate cavity risk
The FDA’s scientific review found limited dental benefits from ingestible fluoride, no measurable advantage for primary teeth, and documented risks including fluorosis and microbiome disruption
Modern research has also linked fluoride exposure to a number of health concerns, including reduced IQ in children, altered thyroid hormones, skeletal changes, and progressive muscle loss
You can lower your family’s fluoride exposure by filtering drinking and bathing water, choosing fluoride-free oral care, reviewing prescriptions carefully, and staying engaged in local water policy decisions
Fluoridated water has shaped U.S. dental policy since the 1940s, when officials began adding fluoride to public water supplies in an effort to reduce childhood cavities.1 As of 2022, the U.S. Centers for Disease Control and Prevention (CDC) reported that 72.3% of Americans on community water systems (about 62.8% of the entire population) received fluoridated water,2 making systemic exposure nearly unavoidable.
Mounting evidence now shows that fluoride offers little measurable benefit for dental health while introducing significant risks, particularly for children. Many countries, including Germany, Sweden, and the Netherlands, have already abandoned water fluoridation.3 In the U.S., Utah and Florida recently became the first states to ban the practice, and similar bills are emerging elsewhere.4
However, in places where fluoride is not added to tap water, fluoride supplements are prescribed for infants and children. Recently, the U.S. Food and Drug Administration (FDA) announced it is taking action to restrict the use of these prescription fluoride supplements, following a directive from the Make America Healthy Again (MAHA) Commission to reassess their safety and effectiveness.5
FDA Moves to Restrict Unapproved Fluoride Drugs for Children
Federal attention on ingestible fluoride intensified in early 2025 after the MAHA Commission, led by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., directed health agencies to reassess long-standing exposures that affect children’s development. This directive led to a full federal review of fluoride products administered to infants and young children.6 7
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
For you as a parent or clinician, this marks a significant change in how fluoride is regulated and prescribed. Products that once appeared as routine pediatric supplements now face strict federal oversight. This decision signals a turning point in U.S. dental policy, aligning long-standing practices with the latest evidence and a renewed focus on children’s safety.
What the FDA’s Scientific Evaluation of Pediatric Fluoride Supplements Revealed
Alongside its enforcement action, the FDA released its scientific assessment of unapproved fluoride tablets and drops prescribed to children. Conducted by the Center for Drug Evaluation and Research (CDER), the evaluation reviewed clinical studies alongside real-world exposure data to determine whether the dental effects of ingestible fluoride justify continued use.14
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.
While the FDA’s scientific review moves the conversation in the right direction, its recommendation to continue systemic fluoride for select children stops short of what the evidence now shows. This remains a public health tradeoff American families should not be asked to accept. As you’ll see in the sections ahead, the growing body of research on fluoride’s biological effects makes it clear that ongoing exposure poses serious concerns.
A New Cochrane Review Reignites Debate on Fluoride Exposure
A Cochrane review released in October 2024 brought renewed national attention to water fluoridation by examining the strength and limitations of the evidence supporting its dental benefits.16 The researchers assessed measures commonly used in dental research, such as the number of decayed, missing, and filled teeth and tooth surfaces in fluoridated versus non-fluoridated communities, to determine whether fluoride meaningfully improves dental health in real populations.17
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.
Other Health Risks Linked to Long-Term Fluoride Exposure
Fluoride is a bioaccumulative substance, which means your body absorbs it faster than it eliminates it. As toxicology research has expanded, scientists have documented a wide range of health concerns that extend well beyond the teeth, including:
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
Despite these documented hazards, powerful interests with deep ties to fluoridation are lobbying for its continued use. Read “How Lobbyists Are Blocking Local Efforts to End Water Fluoridation“ to learn how that influence shapes decisions in your community.
The American Dental Association (ADA) Holds Its Line on Chronic Fluoride Use
Following the FDA’s announcement, the American Dental Association reiterated its long-standing position that daily fluoride tablets or drops remain “safe and effective” for children deemed at high risk for tooth decay. The organization emphasized clinician judgment in prescribing decisions and reiterated its dosing guidance from infancy through adolescence, adjusted according to local water fluoride levels.29
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.
You have the ability to make informed choices long before national organizations reconsider their positions, and small changes in your home and daily habits can meaningfully reduce fluoride exposure for you and your family.
6 Steps to Reduce Your Family’s Fluoride Exposure
With more research linking fluoride exposure to significant health concerns, especially during early development, it’s now more important than ever to lower the amount you and your family encounter each day. Here are strategies I recommend:
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.
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.
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.
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.
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.
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.
Frequently Asked Questions (FAQs) About Fluoride Supplements
Q: Am I putting my child at risk by giving them fluoride supplements?
A: Fluoride tablets and drops expose your child to systemic fluoride that affects their entire body, not just their teeth. The FDA’s recent review shows that benefits are limited, and the risks include fluorosis during crucial windows of tooth development. Modern studies also link chronic fluoride intake to measurable impacts on cognition, thyroid hormones, and early neurodevelopment.
Q: If fluoride helps prevent cavities, why should I rethink its use?
A: Many of the studies showing cavity reduction come from older research with limitations the latest Cochrane review highlights, including low certainty ratings and inconsistent reporting. Fluoride also accumulates in your body over time, and long-term exposure has been linked to neurological changes, thyroid disruption, skeletal effects, and impacts on fetal organ development. Your family deserves a dental strategy that supports oral health without these systemic risks.
Q: Should I filter my tap water if my community fluoridates its supply?
A: Using a filtration system that specifically targets fluoride lowers your exposure substantially. Standard carbon filters do not remove fluoride, so choosing a system engineered for this purpose helps reduce what you drink and cook with each day. Adding filtration to showers and bath water further limits absorption through your skin.
Q: How do I know if my child really needs fluoride for their teeth?
A: Clinicians often rely on standard dosing charts rather than a full review of a child’s actual risk factors. Before agreeing to a supplement, ask your clinician to explain their reasoning, confirm your local water fluoride level, and discuss alternatives such as dietary changes and improved brushing routines. These approaches support oral health without systemic exposure.
Q: What should I do if my dentist insists fluoride is safe?
A: You have the right to review evidence and make informed decisions for yourself and your family. Asking your dentist to explain the specific benefit they expect from chronic fluoride use and requesting alternatives encourages a more individualized approach. Pointing to updated federal assessments and recent research often opens the door to a more balanced discussion.
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The sugar and pharmaceutical industries have always been united to increase their corrupt business. More sugar, more fluoride; more fluoride and sugar, more chronic diseases. One of the studies that evaluated the effects of fluoride was conducted by the most famous scientist at the National Cancer Institute, Dr. Dean Burk. Dr. Burk conducted the largest study in the history of medical science resulting from fluoride-induced cancer deaths in 10 major U.S. cities. He told Congress that fluoridation "socially imposed large-scale mass murder involving unexpectedly tens of thousands of American cancer deaths each year."
https://www.youtube.com/watch?v=r7CxjCHf4R8&feature=youtu.be
Chronic fluoride exposure has been linked to a wide variety of human diseases, such as bone and dental fluorosis, diabetes, atherosclerosis, cardiovascular disease, and hyperkeratosis. More than 500 million people live in areas endemic for fluorosis, with high levels of fluoride in their drinking water and biosphere, facing public health challenges. Symptoms of fluorosis include dental and skeletal fluorosis, hypothyroidism, sleep disorders, inflammation, IQ deficits, and autism.
Fluoride inhibits the function of the immune system, bone cells, fibroblasts, and lung cells, liver metabolism, neurotransmission processes, and brain functions, including cognition and mental acuity. It also contributes to the development of other pulmonary and respiratory diseases. Fluoride has implications for endothelial dysfunction and vascular disorders associated with atherosclerosis, as well as cognitive and thyroid function.
https://www.mdpi.com/2076-3417/10/20/7100 (2020).---
https://www.sciencedirect.com/science/article/pii/S001393512302563X (2024).---
The high prevalence of autism spectrum disorder (ASD) in countries with community water fluoridation (CWF), as well as in countries with endemic fluorosis, was highlighted during the second day of testimony in a landmark fluoride trial. Expert witnesses presented evidence that fluoride exposure is associated with lower IQ in children and that it poses risks to pregnant mothers.
https://childrenshealthdefense.org/defender/fluoride-trial-day-2-risks-pregnant-mothers/ (2024).—