October 31, 2025

 

Today the Food and Drug Administration (FDA) issued a warning against the use of fluoride supplements (“orally ingestible drug products”) for children under the age of 3 years. This action is part of a broader effort to weaken preventive fluoride treatments in water, supplements, and toothpaste. Collectively, these efforts will have a drastic effect on caries prevention, and we will experience a rise in tooth decay.

 

We welcome the FDA’s acknowledgement that fluoride supplements can be a useful caries prevention tool for children with high caries risk but are concerned by the advice to limit use to those 3 and older. Fluoride supplementation can have a substantial benefit in the early childhood years (under age 3) on the mineralization of the permanent dentition, particularly for children with very low fluoride exposure.

 

In May, the FDA announced plans of intent to remove ingestible fluoride prescription products for children from the market. In July, the Reagan-Udall Foundation, on behalf of the FDA, hosted a public meeting to discuss safety concerns for fluoride supplements. Representatives from the AAPD, AAP, and ADA were all present for that meeting.

 

The AAPD, along with the AAP and ADA, affirms that the use of fluoride in prevention of caries is safe and effective. The AAPD continues to support the established fluoride supplement recommendations, prescribed only after a caries risk assessment and evaluation of total fluoride exposure. We strongly support fluoride supplementation as a method to prevent caries, particularly in communities without fluoridated water and for all children with high caries risk.

 

Many aspects of FDA’s rationale – including that fluoride supplementation does not improve outcomes in the primary dentition and harms the gut microbiome – are not well supported scientifically. As pediatric dentists and all dentists understand well, mineralization of the primary dentition occurs primarily in utero and is not the target of fluoride supplementation. Fluoride supplements have systemic and topical benefits, strengthening and remineralizing the enamel and repressing caries-causing bacteria on both primary and permanent teeth. Exposure to fluoride supplements at the recommended levels does not cause unhealthy changes in the oral or gut microbiome in children. 

 

The FDA’s warning regarding single-ingredient fluoride supplements could lead to their removal from the market. The FDA does not have regulatory authority over traditional supplements, like multivitamins. These types of products containing fluoride will remain available.

 

The AAPD will continue to advocate for the protection and availability of fluoride products to ensure that providers and families maintain multiple avenues for preventing tooth decay. Members can access additional resources at the links below: 

 

 

The AAPD will continue to update members as additional information becomes available. Thank you for your ongoing service to children and families.