FDA Restricts Use of Fluoride Supplements for Children - New Perspective on Health Risks

Fluoride Supplements for Children "Not Recommended for Under 3s" — FDA's New Policy Extends Debate to "Water Fluoridation"

October 31, 2025 (U.S. Time), the U.S. Food and Drug Administration (FDA) announced new recommendations significantly restricting the use of fluoride (fluoride) oral supplements (drops and tablets) for children. The new policy states that use for children under 3 years old is not recommended, and also not recommended for children who are not at high risk of dental caries. Warning letters were sent to four manufacturers to ensure they do not sell or label products outside the new standards. Although this measure is not a ban (complete removal), it is certain to have a strong impact on prescription practices.mymotherlode.com

Simultaneously, the FDA released a scientific evaluation document of about 30 pages. It confirmed that while oral fluoride preparations have been used since the 1940s, no products have been approved by the FDA (for efficacy and safety), and that the number of prescriptions in 2024 had decreased to about 500,000. It concluded that benefits are limited to permanent teeth (adult teeth), with no consistent effects on baby teeth, while dental fluorosis is a known risk. Furthermore, it noted that "newly emerging safety signals" such as changes in gut microbiota, weight gain, and cognitive function are at a hypothesis-generating level, requiring further research. Based on the precautionary principle, the FDA suggested considering use only for "children over 3" and "at high risk".U.S. Food and Drug Administration

On the other hand, this measure does not affect the use of "topical" fluoride such as toothpaste, mouthwash, and dental office topcoats. According to the FDA, the scope of impact is limited to prescription drugs that are ingested orally.mymotherlode.com

Background: From "Market Withdrawal" Indication in May to "Limited Restrictions"

In May 2025, the FDA announced the initiation of procedures for the market withdrawal of oral fluoride supplements for children, forecasting a safety review and public comment period until October 31. Ultimately, the decision settled on strict usage restrictions and warnings to manufacturers rather than a complete withdrawal.U.S. Food and Drug Administration　hhs.gov

In terms of policy, Health Secretary Robert F. Kennedy Jr. has shown a critical stance towards community water fluoridation (CWF), suggesting a review of CDC recommendations. The restriction on supplements may prompt a reorganization of the overall fluoride policy, in line with this trend.PBS

Scientific Highlights: What is Known and What is "Still Uncertain"

• Effectiveness: Oral supplements are suggested to have some effect on preventing caries in permanent teeth, but are inconsistent for baby teeth. Routine brushing (with fluoride toothpaste) and other topical approaches are considered basic measures effective for all children.U.S. Food and Drug Administration

• Known Risks: Dental fluorosis (mottling and discoloration). Especially around age 2, as it relates to the formation of permanent teeth, the FDA organized that avoiding use under 3 years helps reduce risks.U.S. Food and Drug Administration

• "New" Concerns: Issues like gut microbiota, cognition, thyroid, and weight have some studies suggesting a connection, but evidence is limited. Currently, these are at a hypothesis stage, requiring further research.U.S. Food and Drug Administration

Meanwhile, the CDC continues to support the Public Health Service (PHS) guideline that sets the optimal fluoride concentration in water at 0.7 mg/L, stating that CWF is a core strategy for caries prevention. It is important to note that the recommendation for CWF and the restriction on supplements are debated in different policy layers.CDC

Reactions: Dental Community Concerns Over "Excessive Restrictions," Mixed Opinions on Social Media

The American Dental Association (ADA) has stated that "no significant health damage has been shown at concentrations prescribed by doctors and dentists", maintaining an oppositional stance since the May announcement of withdrawal plans. In their October 31 statement, they emphasized the appropriate use for high-risk children and reiterated that complete withdrawal is excessive.ada.org

On social media, there were mixed opinions (summary and abstracts, comments summarized by the editorial team):

• Dental professional accounts: "CWF and supplements serve different roles. In rural or non-fluoridated areas, supplements can be the last safety net" (citing local U.S. stations and dentists' posts).X (formerly Twitter)

• Public health organizations: "The FDA's correction of the treatment of unapproved drugs is commendable. However, ensuring access for high-risk children is the next issue" (summary of official posts on X).X (formerly Twitter)

• Anti-fluoride accounts: "Finally, a first step towards the elimination of neurotoxins. The fluoride in water should also be reconsidered" (summary of activist posts).X (formerly Twitter)

• General users: "If the discussion extends to 'gut microbiota', it's natural to be cautious with children", "But won't cavities increase?" showing mixed reactions (from threads of shared news posts).X (formerly Twitter)

• On Reddit, the focus of discussion on public health and health boards was on **"the uncertainty of scientific consensus" and "regional disparities"**.Reddit

What's Changing? "Operational Points" for Parents and Healthcare Providers

• Do not use for children under 3 years old as a principle. For those over 3 years old, consider use if at high risk of caries or if the local water is non-fluoridated, and consult with healthcare providers.U.S. Food and Drug Administration

• Topical fluoride (toothpaste, mouthwash, dental office applications) remains useful. Not subject to the current restrictions.mymotherlode.com

• Correction of Display and Promotion: The FDA issued warnings to four companies. Parents should check if online and in-store displays comply with the latest recommendations.mymotherlode.com

• Evidence is Being Updated: Issues like gut microbiota and cognition are at a hypothesis stage. Instead of making ##