Tejal Somvanshi
The Food and Drug Administration announced Tuesday it’s starting the process to remove prescription fluoride supplements for children from the market. These include fluoride drops, tablets, and lozenges that dentists prescribe to kids who don’t have fluorinated water.
FDA Commissioner Dr. Marty Makary said the agency will complete a safety review and public comment period by October 31. “When it comes to children, we should err on the side of safety,” Makary stated.
Health and Human Services Secretary Robert F. Kennedy Jr. strongly supports this action. “Ending the use of ingestible fluoride is long overdue,” Kennedy said. He called it part of the Trump administration’s “Make America Healthy Again” initiative.
What These Products Are
These prescription fluoride supplements are different from fluoride toothpaste or mouth rinses. Children swallow the drops, tablets, and lozenges completely. Dentists typically prescribe them for kids at high risk of cavities who live in areas without fluorinated water.
Dr. Meg Lochary, a pediatric dentist in Union County, North Carolina, said she’s been prescribing these supplements since county commissioners voted to stop adding fluoride to its water supply last year. “This is really going to hamper our goal of providing kids with fluoride,” Lochary said.
The FDA noted these products were never formally approved by the agency for ingestion.
Health Concerns Raised
The FDA cited several health concerns about ingested fluoride. The agency said studies show ingested fluoride can alter the gut microbiome in children. During early childhood, the gut microbiome plays a crucial role in digestion, immunity, and other bodily functions.
“For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” Makary explained.
The FDA also referenced studies suggesting links between fluoride intake and thyroid disorders, weight gain, and potentially decreased IQ in children. However, many of these studies involved much higher fluoride levels than what’s typically found in U.S. drinking water.
A recent review published in JAMA Pediatrics found connections between higher fluoride exposure and lower IQ scores in children. But most studies in this analysis came from countries with much higher fluoride levels than the United States. The majority of these studies were also rated as poor quality.
Dental Community Pushes Back
Major dental and medical organizations oppose the FDA’s action. The American Dental Association, American Academy of Pediatrics, American Academy of Pediatric Dentistry, and the Centers for Disease Control and Prevention all support fluoride supplements for certain children.
The CDC says drinking fluorinated water reduces cavities by about 25% in children and adults. These organizations have long recommended low-dose fluoride supplements specifically for children living in non-fluorinated areas who are at high risk for tooth decay.
“This removes a choice,” said Dr. Paul Casamassimo, chief policy officer for the American Academy of Pediatric Dentistry. “It bans a treatment that is in the best interest of a patient, as determined by a trained, licensed health professional.”
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The American Dental Association maintains that rigorous reviews have found no credible evidence linking fluoride at recommended levels to health problems. Dental professionals worry this action eliminates an important tool for preventing tooth decay in vulnerable children.
How Fluoride Works
Fluoride helps prevent cavities by strengthening tooth enamel. It makes teeth more resistant to acid attacks from bacteria, plaque, and sugars in the mouth. Fluoride can even help repair early signs of tooth decay through a process called remineralization.
The United States began adding fluoride to public water systems in 1945. The CDC has called water fluoridation one of the ten great public health achievements of the 20th century.
Alternative Prevention Methods
The FDA emphasized that preventing cavities should focus on reducing sugar intake and maintaining good dental hygiene rather than altering children’s gut bacteria. Makary said these are the most effective ways to prevent tooth decay.
Children can still use fluoride toothpaste and receive fluoride varnish treatments from dental professionals. Dentists also apply dental sealants to protect teeth. However, these topical treatments differ from the systemic exposure provided by ingested supplements.
State-Level Changes
Several states have recently taken action regarding fluoride. Utah became the first state to ban fluoride from public drinking water systems. Florida lawmakers passed a similar ban, and other states are considering comparable moves.
In Utah, state health officials released guidance encouraging residents to learn about fluoride supplements after municipal water systems could no longer add fluoride to water. The state passed a law allowing pharmacists to provide oral fluoride without a prescription.
Dr. Stacey Bank from Utah’s Department of Health and Human Services explained the challenge: “People are going to have to be proactive about getting their fluoride. This will no longer be delivered to them passively.”
Scientific Evidence Questions
The FDA cited two literature reviews to support concerns about fluoride’s effect on the gut microbiome. However, both studies reached more nuanced conclusions than the FDA statement suggests.
One review from Irish researchers found that fluoride-containing oral hygiene products “may have beneficial effects on the oral microbiome regarding caries prevention.” The other review, by UK researchers, concluded that while high doses of fluoride might harm the microbiome, low doses had either harmless or even positive effects.
Both research teams emphasized that evidence remains limited and more studies are needed.
Impact on Access to Care
Dental professionals express particular concern about how removing these supplements affects children in underserved communities. Kids in low-income and rural areas often face barriers to regular dental care and may not have access to fluorinated water.
Professor Margherita Fontana from the University of Michigan, who chairs the department of cariology, restorative sciences and endodontics, warned about potential consequences. “If we start removing them, we’re going to be where our grandparents or great-grandparents were, with dentures at young ages.”
The American Academy of Pediatric Dentistry notes that removing fluoride supplements eliminates a valuable preventive tool, especially for patients in areas without fluorinated water or those at high risk for cavities.
Timeline and Next Steps
The FDA plans to complete its safety review and public comment period by October 31. The agency will then take what it calls “appropriate action” to remove these products from the market.
Initially, the FDA is asking manufacturers to voluntarily withdraw the products. A formal ban through rulemaking could take much longer if manufacturers don’t comply voluntarily.
The Department of Health and Human Services also plans to release new best practices for dental hygiene in children that don’t involve altering gut health.
This action represents a significant shift in federal policy on fluoride. For decades, health agencies have supported fluoride use for cavity prevention. Kennedy’s broader campaign against fluoride extends beyond these supplements to community water fluoridation itself, which he has directed the CDC to reevaluate.
The coming months will likely bring continued debate as the FDA reviews evidence and stakeholders submit public comments. The outcome will significantly influence how pediatric dental care is practiced in the United States and could affect oral health outcomes for millions of children.
