BCHC urges FDA to affirm safety and importance of fluoride for children’s oral health
July 2025
BCHC submitted public comment to the FDA affirming that fluoride is a safe, evidence-based tool for preventing tooth decay in children. As the agency reviews the use of ingestible fluoride products, BCHC urges it to uphold the science and protect access to this essential public health intervention.
Big Cities Health Coalition (BCHC) provided comment in response to the request by the Food and Drug Administration (FDA) [Docket No. FDA-2025-N-1557] for information on the clinical use and safety concerns associated with the use of orally ingestible prescription drug products containing fluoride in the pediatric population.
Tooth decay remains an endemic disease. Also known as dental caries, it is the most common chronic disease in children, with over a third of U.S. children suffering from this condition before age 5.
Tooth decay results in children missing school, having toothaches, and developing facial abscesses and the need for expensive treatment that in very young or medically compromised children can involve sedation and/or general anesthesia.
Children consuming fluoridated water have the benefit of frequent, low-dose fluoride exposures that act both systemically and topically to provide optimal caries prevention with maximum safety. Children consuming water deficient in fluoride results in a daily total fluoride intake that is suboptimal and does not aid in the prevention of dental caries.
A child’s exposure to fluoride comes from a variety of sources, including food, beverages, and dental preventive products. Studies have suggested that a total daily fluoride intake of 0.05 to 0.07 mg F/kg body weight is protective against developing tooth decay without safety issues or the development of dental fluorosis.
The convergence of evidence, assessing a variety of experimental models, indicates that systemic fluoride consumption at the concentrations used for community water fluoridation and fluoride supplements are safe for children.
Fluoride is known to have a preventive effect on tooth decay, and the mechanisms for this are well-studied and understood. Exposure of developing
teeth to fluorides from dietary fluoride supplements or drinking water is sufficient to provide this protective health benefit that results in a substantial decrease in tooth decay for the population.
Neurobehavioral effects of fluoride have been studied extensively over the past decade using a variety of models. One of the more recent reviews was developed as part of the National Toxicology Program to help inform on the state of science related to fluoride and neurodevelopment. This study reviewed 74 studies and concluded there was no association between fluoride exposure below 1.5 ppm F in drinking water (more than twice the currently recommended community water recommendation in the United States) and outcomes such as IQ related to neurodevelopment of children.
The use of fluoride supplements has declined over recent decades due to the widespread access to community water fluoridation (CWF) across the United States (over 70% of the US population). This trend is now changing as states are removing the autonomy for municipalities to choose CWF. The result of de-fluoridating will be an increase in dental caries, days children miss school, increased health care costs, increased emergency room visits, increased oral health disparities, and an overall decrease in health and quality of life for the children of the US.
In closing, it is important to remember that fluoride supplements have been used since the late 1940s and have been proven to be an effective tool for helping control the highly prevalent global disease, dental caries. Concerns over the safety related to fluorides have been discussed and investigated since the element was first discovered and isolated in the late 1800s.
Given the consequences of unchecked tooth decay for a child and the discomfort and expense of treatment, the FDA is urged to recognize and
recommend the continued availability and use of systemic fluorides in this, our most deserving population.
