FDA advises against fluoride supplements to “protect” children under three years old

On October 31, 2025, the Food and Drug Administration (FDA) announced it will restrict the sale of unapproved ingestible fluoride drugs for infants and young children. This comes after the Trump administration's request to evaluate fluoride products initiated back in September.¹

According to the FDA website, their decision was informed by a long-running scientific investigation on the risks, efficacy, and safety of those fluoride products, with input from various parents, clinicians, and federal partners. Prior to this investigation, ingestible fluoride drug products had not been reviewed since the 1940s.¹

CareQuest responds to FDA announcement

CareQuest Institute for Oral Health responded to this announcement with tentative support in a press release earlier this week. The health-care nonprofit "encourages continued collaboration with health professionals to ensure that decisions around fluoride are guided by the best available science and evidence," but points out the FDA's decision dovetails with the American Academy of Pediatrics and American Dental Association's stance on fluoride consumption for infants and young children.²

Melissa Burroughs, senior director of policy and advocacy for CareQuest, said: "While this action is not nearly as restrictive as the FDA's early proposals, we remain concerned that these recommendations would reduce access to an important preventive tool-especially for families in communities without fluoridated drinking water."

Conversely, Health and Human Services Secretary RFK Jr. lauds this decision, stating that: "The FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride ... Today's action raises public awareness, informs medical professionals, and builds on President Trump's commitment to Make Our Children Healthy Again."¹

Pediatric oral health is in decline

Moving forward, manufacturers can no longer market ingestible fluoride supplements for toddlers and infants who are not considered "high risk." This may make young children more susceptible to caries as a lack of fluoride leaves them without protection against harmful oral bacteria.²

The question remains as to whether the FDA's decision will worsen the current state of pediatric oral health, which is in steady decline. According to CareQuest data, medical visits for children 14 and under for preventable dental problems rose by nearly 60% from 2019 to 2022, placing visits from this age group above prepandemic levels.2

This may only be exacerbated by the threat of fluoridated water bans spreading across the country. As of right now, 16 states have introduced legislatures to ban fluoridated water, with bills passing in Utah and Florida.³

Earlier this year, a study published by the Journal of the American Medical Association (JAMA) concluded that proliferating of statewide fluoride bans directly correlates with an increase in dental diseases and treatment costs. In 2024, 12.1% of children aged one to 17 had cavities or decayed teeth.⁴

Despite this data, the FDA noted that while evidence indicates fluoride reduces the risk of dental caries in older children, an independent analysis of multiple scientific studies showed that fluoride did not reduce dental caries in baby teeth.1

References

1. FDA acts to protect children from unapproved fluoride drugs. Food and Drug Administration. October 31, 2025. https://www.fda.gov/news-events/press-announcements/fda-acts-protect-children-unapproved-fluoride-drug-products

2. CareQuest Institute reacts to new FDA action on children's fluoride supplements and urges continued focus on prevention and access. CareQuest Institute for Oral Health. November 4, 2025. Press release.

3. Jennemann A. Get the facts: what states have considered fluoride bans? WBALTV. May 23, 2025. https://www.wbaltv.com/article/what-states-have-considered-fluoride-bans/64855417

4. Butkovic S. New study projects economic and oral health effects of fluoride removal. DentistryIQ. September 19, 2025. https://www.dentistryiq.com/dentistry/research-and-news/news/55317314/new-study-projects-economic-and-oral-health-effects-of-fluoride-removal