The U.S. Food and Drug Administration (FDA) announced sweeping new restrictions on the use of fluoride supplements for children on October 31, 2025, marking a pivotal moment in the ongoing debate over the safety and efficacy of this long-standing dental health intervention. The agency’s decision, which comes after months of scientific review and public comment, signals a significant shift in federal health guidance and is already sparking discussion among dental professionals, parents, and public health experts nationwide.
Under the new guidelines, the FDA no longer recommends fluoride supplements for children younger than three years old and advises against their use for older children unless they are at high risk for tooth decay. This is a marked departure from previous practices, where pediatricians and dentists often prescribed fluoride tablets or drops for children as young as six months—especially in communities without access to fluoridated water.
The FDA’s move follows a directive from the Make American Healthy Again (MAHA) Commission, led by Health Secretary Robert F. Kennedy Jr., to assess the risks and benefits of fluoride products. According to CNN, the agency notified four companies, warning them not to market or sell unapproved fluoride-containing ingestible drugs for children under three or for older children not at serious risk of cavities. Similar letters were sent to healthcare professionals, urging them to refrain from prescribing these supplements outside the new limits.
Fluoride, a mineral that occurs naturally in some foods and groundwater, has been a mainstay of dental care in the United States for decades. Its ability to strengthen tooth enamel and help prevent decay was first harnessed on a national scale in 1945, when the practice of adding fluoride to public water supplies began. The Centers for Disease Control and Prevention (CDC) has called water fluoridation one of the ten greatest public health interventions of the 20th century, alongside vaccination and family planning.
As of 2022, most Americans live in communities where the water supply contains fluoride. However, in states like Utah and Florida, recent legislation has banned water fluoridation, leaving families to rely more heavily on prescription supplements. As reported by the Associated Press, dentists warn that new restrictions could result in more cavities and dental problems, particularly in rural areas where access to fluoridated water is limited.
The FDA’s decision was informed by a new scientific analysis, which concluded that fluoride supplements offer limited dental benefits and may be linked to emerging safety concerns. These include potential impacts on the gut microbiome, weight gain, and cognitive development. In its statement, the agency explained, “For the same reason fluoride may work to kill bacteria on teeth, it may also alter the gut microbiome, which may have broader health implications.”
Preliminary—but potentially concerning—data also suggest that high levels of fluoride exposure could affect children’s intellectual development. A recent meta-analysis cited by the FDA found a correlation between increased fluoride levels and lower IQ scores, although some experts have noted that the analysis focused on fluoride concentrations much higher than those typically found in U.S. water supplies. The FDA’s press release emphasized, “According to scientific findings, there are better ways to protect children’s teeth than using unproven fluoride supplements, which are now recognized for their impact on the gut microbiome. The microbiome is increasingly seen as a key factor in children’s health and development.”
Not everyone agrees with the FDA’s assessment. The American Dental Association (ADA) disputes claims of significant health problems associated with fluoride at prescribed levels. The ADA maintains that, when used as directed, fluoride is safe and effective—though it does acknowledge that excessive exposure can cause spotting or discoloration of the teeth. As the ADA has stated, “There are no significant health problems associated with fluoride when used at the levels prescribed by dentists.”
Some oral health advocates see the FDA’s decision as a reasonable compromise, since it stops short of banning fluoride supplements outright. Dr. James Bekker, a pediatric dentist from Utah who has spoken publicly on the issue, told CNN, “We are actually quite pleased about this decision, because fluoride supplements remain available and will continue to be a benefit to oral health.” He added, “Providers can prescribe according to their consultation with parents and patients at recommended levels. We still recommend starting fluoride supplements at age 6 months in non-fluoridated water communities and will rely on knowledgeable health professionals to follow the documented science as they consider appropriate ages and dosages.”
The FDA’s action does not affect fluoride-containing toothpastes, mouthwashes, or professional treatments used by adults or in dental offices. These products remain widely available and are still considered effective tools for cavity prevention. The agency’s focus is squarely on ingestible supplements intended for children—a segment where the balance between potential benefits and emerging risks appears to be shifting.
Behind the scenes, broader political and regulatory currents are also shaping the fluoride debate. In April, the Department of Health and Human Services and the Environmental Protection Agency announced plans to review the latest science on fluoride and propose new guidelines. Health Secretary Robert F. Kennedy Jr., a longtime critic of water fluoridation, has signaled his intention to recommend that the CDC stop endorsing community water fluoridation altogether. Kennedy, a former environmental lawyer, has called fluoride a “dangerous neurotoxin” and has advocated for its removal from public water systems nationwide.
As water fluoridation is rolled back in some states, demand for prescription fluoride supplements has surged. Utah’s legislation banning water fluoridation, for instance, included provisions to expand access to prescription fluoride, and local health departments have reported a spike in prescriptions since the law took effect. Supporters of the FDA’s latest move argue that keeping supplements available—albeit with tighter restrictions—preserves options for families in areas without fluoridated water.
The debate over fluoride is far from settled. As the FDA’s new guidelines take effect, parents, dentists, and policymakers alike are weighing the best path forward for children’s dental health. The agency’s decision, rooted in a careful review of scientific evidence and public input, underscores the complexity of balancing public health benefits with emerging concerns about safety and long-term impact.
For now, one thing is clear: the conversation about fluoride’s role in protecting children’s teeth—and its potential risks—will continue to evolve as new research and regulatory decisions come to light.
