CHICAGO, May 13, 2025 — Today, the U.S. Food and Drug Administration (FDA) announced that it intends to remove fluoride supplements from the market effective October 2025 once a safety review is completed. According to the FDA, this safety review applies to “ingestible fluoride prescription drug products” – not toothpaste, mouth rinses or other topical products containing fluoride.
“Proposals like this stand to hurt rural America, not make them healthier,” said Brett Kessler, D.D.S., president of the American Dental Association. “More than ever, at this critical time in American health care policy, it is vital that we slow down to properly study the full implications of actions like this on the health of the nation.”
Fluoride supplements have been shown to be effective at reducing tooth decay and are one method for maintaining oral health when utilized daily in compliance with the proper dose. A review of the studies offered as referenced by U.S. Department of Health and Human Services (HHS) do not in fact demonstrate any harmful effects for the concentrations of fluoride prescribed by physicians and dentists. There is limited research on the studies of microbiome composition and fluoride association.
“In non-fluoridated communities, especially rural areas, fluoride supplements are the only chance for individuals to get the appropriate amount of fluoride to prevent tooth decay,” said Dr. Kessler. "This is true even when other sources of fluoride are available, like fluoride-containing toothpastes and mouth rinses.”
Fluoride is a naturally occurring mineral. If community water fluoridation programs are terminated, without appropriate fluoride supplementation, children and adults are unlikely to get an adequate amount of fluoride needed to safely prevent dental cavities. The recommended fluoride intake will likely not be met if fluoride supplements or tablets are banned because few over-the-counter dietary supplements contain fluoride, and many multivitamins only contain trace minerals.
“In places like Utah and Florida with fluoride bans, if the recommended level of fluoride for community water systems at 0.7 mg/L is reduced or terminated, health experts will need to look to other public prevention programs to offset tooth decay and mitigate factors impeding dental care treatment options in communities. If prescription and over the counter fluoride supplements are also banned, then there are fewer prevention methods of tooth decay available,” said Dr. Kessler. “This is not ideal for our patients, but it will be particularly harmful to the most vulnerable and those who lack access to care. Today’s announcement stands to harm states like Utah disproportionately since they recently banned community water fluoridation while their own health department recommended fluoride supplements as a sound alternative to help prevent decay.”
Water fluoridation is one of the safest ways we can prevent cavities for children and adults. Around 70 percent of the U.S. population receives fluoridated community water. Optimal levels of water fluoridation prevent cavities by providing frequent and consistent contact with low levels of fluoride, reducing tooth decay by 25 percent in children and adults. Fluoride in plaque and saliva is recharged by frequent sips of water and inhibits the demineralization of enamel while enhancing the remineralization of tooth surfaces. While community water fluoridation is the most efficient method to deliver this preventive benefit, the substitution of alternative decay prevention like fluoride tablets or supplements are recommended to glean the proven systemic benefits fluoride provides.
Where community water fluoridation is not delivered, there has been increased incidence of dental decay, particularly among children and low-income populations. For example, in Calgary, Canada; Juneau, Alaska; and Israel, tooth decay levels and dental treatment costs rose even though brushing did not stop.
For more information on community water fluoridation and ADA advocacy, visit ADA.org/fluoride.