In a sweeping new directive, the US Food and Drug Administration (FDA) has announced plans to remove ingestible fluoride supplements for children from the market, raising concerns and debate among dental health professionals, policymakers, and parents worldwide. The move is driven by new scrutiny over the potential impact of systemic fluoride on children’s gut health and overall development, but it contradicts decades of dental best practices and global recommendations for caries prevention. As Thailand continues to battle high rates of childhood dental decay, this decision has important implications for local public health strategies.
The FDA’s announcement, issued on May 13, 2025, states that prescription fluoride tablets and drops—mainly intended for children in non-fluoridated water areas—will be subject to removal following a comprehensive safety review and a period for public comment to conclude by October 31. According to the FDA, concerns about ingested fluoride altering the gut microbiome, and cited associations with thyroid disorders, weight gain, and possible decreases in intelligence, have prompted a reevaluation of these prescription products—despite their widespread use for more than half a century (FDA announcement, CNN, NPR).
Fluoride has long been hailed as a cornerstone of dental caries prevention, particularly in children. It acts by strengthening dental enamel, making teeth more resistant to acid attacks from bacteria and sugars, as established in extensive reviews of the scientific literature (PubMed Review, 2024). Water fluoridation began in the United States in the 1940s, and the Centers for Disease Control and Prevention (CDC) credit it with reducing cavities in children and adults by up to 25%. In areas without sufficient fluoride in drinking water, health professionals have typically prescribed fluoride supplements—drops and tablets—for children considered at high risk for dental decay (CDC guidance).
However, opposition to ingestible (as opposed to topical) fluoride has grown in recent years, spurred by research suggesting possible systemic health concerns. The FDA’s recent release referenced studies indicating that ingesting fluoride could disrupt children’s developing gut microbiome and highlighted tenuous links to endocrine and neurological outcomes. Notably, the FDA emphasized that these ingestible fluoride supplements have never received formal FDA approval, intensifying calls for an updated assessment of their safety and efficacy.
Professionals and medical authorities have voiced strong objections to the FDA’s position, warning of potential rises in childhood dental decay if supplements are withdrawn without viable alternatives. According to the chief policy officer of the American Academy of Pediatric Dentistry, “This removes a choice… ban[ning] a treatment that is in the best interest of a patient, as determined by a trained, licensed health professional.” Supporting this view, organizations such as the American Academy of Pediatrics and the American Dental Association have long advocated for targeted fluoride supplementation for children living in non-fluoridated communities, stressing its critical role in the fight against caries. Both organizations recommend an appropriate amount of fluoridated toothpaste, regular dental visits starting at age one, and, where indicated, fluoride varnish treatments to bolster oral health in young children (AAP guidance).
The FDA’s decision also follows political trends in the United States, with key states such as Utah and Florida recently banning water fluoridation and prompting renewed interest in supplements among healthcare providers. The US Health and Human Services Secretary, referencing the new policy, expressed gratitude for efforts to “safeguard the health and development of our children.” This marks a distinct departure from the prevailing view in countries where water fluoridation is still common, such as New Zealand, Australia, and much of the UK, and particularly from Southeast Asia, where oral health challenges are severe (NPR).
For Thailand, a country where childhood dental caries rates are among the highest in the ASEAN region, the U.S. development raises pressing questions about future strategies. According to the latest national oral health survey by the Ministry of Public Health, over 50% of Thai children under the age of six have experienced tooth decay, and in rural areas the rate is even higher. Nationwide efforts have sought to expand access to fluoride through community water fluoridation in select municipalities and through the promotion of fluoridated toothpaste in schools, as recommended by the World Health Organization (WHO fact sheet).
Yet wide disparities remain between urban and rural communities, with many remote and mountainous villages lacking access to fluoridated water entirely. In these settings, local dental clinics and public health offices have distributed fluoride supplements to children for decades. Should Thai policymakers heed the FDA move and restrict or discontinue these supplements, significant increases in untreated dental decay and subsequent health complications could result, local dental experts caution.
Emerging data on fluoride’s systemic effects are complex and often contradictory. Recent PubMed reviews note that while very high levels of fluoride can lead to dental and skeletal fluorosis, controlled use in recommended doses is widely considered safe and effective for caries prevention (PubMed review, 2024). Standalone studies cited by the FDA, suggesting adverse health impacts, often involve fluoride concentrations much higher than those used in supplements or are confounded by other environmental and dietary risk factors. The two reviews highlighted in the FDA’s statement both concluded that while fluoride can impact the microbiome, the clinical significance at recommended doses is uncertain and may even be beneficial for oral health—directly contradicting the justification for the ban.
Cultural attitudes toward dental care in Thailand further complicate the issue. Sweetened snacks and beverages are widely consumed by Thai children, exacerbating caries risk. Oral hygiene education, while improving, is not yet universal—particularly in under-resourced areas. The successful school-based fluoride mouthrinse program of the 1990s, which contributed to measurable declines in caries, has seen reduced coverage in recent years because of funding constraints and shifting health priorities. Many Thai parents, especially in areas where tap water is not reliably safe to drink, perceive bottled or rainwater as healthier, but these sources are typically not fluoridated and may leave children unprotected if fluoride supplements are abandoned.
Debate and concern among Thai health leaders are intensifying as they watch the US response unfold. According to a leading official at the Department of Health’s Dental Health Division, “Any policy change that impacts the availability of fluoride for high-risk children has to be weighed very carefully in our context. Without effective, accessible prevention, we risk reversing decades of oral health gains.”
Looking forward, several scenarios are possible for Thailand. If the FDA’s decision prompts international regulatory shifts, Thailand may need to step up investment in alternative caries prevention methods such as school dental sealant programs, broader distribution of fluoridated toothpaste, or even a reconsideration of mass water fluoridation where feasible. Policymakers may also leverage the FDA’s findings to review the safety profile of fluoride supplements, updating guidelines based on the most robust evidence while maintaining essential protections for children’s oral health.
Global researchers agree that ongoing, large-scale studies are necessary to clarify the full effects of systemic fluoride exposure in childhood, especially regarding the gut microbiome and neurodevelopment. Meanwhile, clinicians and parents are advised to prioritize regular brushing with fluoridated toothpaste, limit children’s sugar intake, and maintain routine dental check-ups as the most reliable, evidence-based methods to safeguard dental health.
For Thai families, the most practical recommendation is consistent oral hygiene at home and vigilance in seeking proven dental care for children. For national leaders, the challenge is to remain informed of emerging science and ensure any regulatory shifts reflect Thailand’s unique oral health landscape and risks.
As this complex issue continues to evolve on the global stage, Thai dental professionals, educators, and policymakers will need to work closely together to ensure that all children—regardless of where they live—retain access to safe and effective caries prevention. Ongoing communication from public health officials and clear, evidence-based policy guidance are paramount as Thailand navigates this changing landscape.