New FDA action reshapes paediatric fluoride policy in the US

Dental Tribune International

Wed. 19 November 2025

save

SILVER SPRING, Md., US: The US Food and Drug Administration (FDA) has announced new enforcement actions to restrict the sale of ingestible fluoride drug products for children. This step is intended to direct manufacturers to stop marketing products labelled for use in children under 3 years and in older children who are not at high risk of dental caries. The decision follows a formal scientific evaluation of fluoride supplements used in the paediatric population and months of public consultation. It marks a significant shift in federal oversight of products that have been prescribed for decades without having undergone full FDA review for safety, efficacy or manufacturing quality.

Ingestible single-ingredient prescription fluoride products—typically supplied as oral drops or chewable tablets with daily doses of between 0.25 mg and 1.0 mg—have been used in the US since the 1940s, particularly for children living in areas without optimally fluoridated water. However, based on its latest review, the only one of its kind since the 1940s, the FDA concluded that these supplements should not be used in children under the age of 3 and should be limited to older children who are at high risk for caries. Enforcement letters have been issued to companies that do not follow these guidelines.

Limited benefit for primary teeth, concern about health risks

The FDA’s scientific evaluation and cited independent reviews report that existing clinical trials provide little or no evidence that ingestible fluoride supplements reduce caries in primary teeth, although they indicate some benefit in permanent teeth. Additionally, the findings show that fluoride supplement use in very young children increases the risk of dental fluorosis and that susceptibility peaks in the second year of life.

The FDA also noted concerns drawn from recent studies suggesting potential effects of higher fluoride exposure on neurodevelopmental outcomes and possible alteration of the gut microbiome and emphasised that although this data is preliminary it warrants caution. On this basis, the agency believes that the potential harms of unapproved ingestible fluoride products for young children may outweigh their documented benefits.

Professional and advocacy responses

The FDA’s move intersects with long-standing guidance from professional bodies that have supported systemic fluoride supplementation for children in non-fluoridated areas. The American Dental Association, in an initial response, reaffirmed support for evidence-based fluoride use and stressed that clinicians should retain flexibility to prescribe supplements for appropriately selected high-risk patients.

“A doctor’s clinical judgement, not a new warning label, should remain the guiding factor in determining appropriate fluoride use for children, ensuring both safety and access to essential oral healthcare,” Dr Richard J. Rosato, president of the American Dental Association, said in a press release. At the same time, some oral health advocates have warned that tighter controls on supplements, combined with reductions in community water fluoridation in parts of the US, may exacerbate existing issues in paediatric oral health if not accompanied by expanded access to alternative preventive care.

Global and policy context

Internationally, community water fluoridation policies remain heterogeneous. Several European countries rely on alternative strategies such as salt fluoridation or comprehensive public dental programmes, while the World Health Organization currently recommends a fluoride concentration of up to 1.5 mg/l in drinking water, and around 0.7 mg/l is often cited as effective for caries prevention.

Recent legislative developments in the US, including statewide bans on community water fluoridation in Utah and Florida, have further intensified debate about systemic fluoride exposure and the need for robust, equitable preventive strategies for children.

Next steps for research and practice

The FDA, together with the National Institutes of Health and the Department of Health and Human Services, plans to implement a targeted research agenda and a broader national oral health strategy to address evidence gaps surrounding fluoride exposure and paediatric outcomes. Its action signals a recalibration of systemic fluoride use in early childhood and underscores the importance of aligning long-standing preventive practices with current evidence and regulatory standards. Dental professionals will play a central role in interpreting recommendations as they evolve and safeguarding access to effective, science-based caries prevention for the children most in need.

Topics:

Tags:

Childhood dental caries Dental fluorosis Dental policy Dental research Fluoride Food and Drug Administration Paediatric dentistry Primary teeth

To post a reply please login or register

FDA finalises guidance on animal studies for dental bone grafting devices

SILVER SPRING, Md., US: The US Food and Drug Administration (FDA) has finalised guidance on animal studies for dental bone grafting material devices, aiming...

“Our goal is to make oral synbiotics an accessible preventive tool for childhood caries”

In many parts of the world, unequal access to oral health professionals and facilities makes it difficult for communities to receive adequate care. This ...

New protein-based gel shows promise for natural enamel regeneration in dentistry

NOTTINGHAM, England: The use of advanced biomaterials in dentistry continues to gain momentum, offering new ways to repair and protect teeth without relying...

Health experts lament removal of fluoride from Queensland water supplies

GYMPIE, Australia: Despite water fluoridation being recognised as one of the twentieth century’s greatest public health achievements, an increasing number...

Zinc compound offers non-staining alternative to silver diamine fluoride

NEW YORK, US: Although silver diamine fluoride remains an effective non-invasive option for treating caries, its characteristic black staining is a major ...