The Food and Drug Administration on Oct. 31 published a report containing a warning against the use of orally ingestible fluoride supplements for children under the age of 3 or at low or moderate risk of dental caries. Fluoride supplements are still recommended to children over age 3 and at high risk of dental caries.
According to the American Academy of Pediatrics, children with high risk for dental caries include individuals with low exposure to fluoride concentration (less than 0.7 mg/L) in their drinking water or who have active carious lesions. Fluoride supplements are still an effective method to reduce tooth decay for children in communities without optimal fluoride in drinking water.
Professional oral health organizations respond, affirm fluoride as safe and effective
The American Academy of Pediatric Dentistry and American Dental Association responded to FDA’s announcement by reaffirming the importance of access to ingestible fluoride supplementation.
AAPD’s press release called the FDA’s action “part of a broader effort to weaken preventive fluoride treatments in water, supplements, and toothpaste,” adding that “collectively, these efforts will have a drastic effect on caries prevention, and we will experience a rise in tooth decay.”
ADA President Dr. Richard J. Rosato said, in ADA’s statement about the safety of fluoride supplementation:
“The research shows that daily use of fluoride tablets or drops at home are a safe and effective way to strengthen teeth and prevent cavities in children who are at high risk for tooth decay and whose water is deficient in fluoride. A doctor’s clinical judgment, not a new warning label, should remain the guiding factor in determining appropriate fluoride use for children, ensuring both safety and access to essential oral health care.”
CDA, alongside the AAPD, ADA, and AAP, affirm the use of fluoride as a safe and effective prevention practice. CDA continues to support the recommendation of fluoride supplements as a method to prevent caries in communities without fluoridated water and for children with high caries risk.
FDA action not an outright ban on fluoridated prescription products
CDA in July sent a letter to the FDA expressing strong concern over FDA’s proposal to remove orally ingestible fluoride prescription drug products for children from the market:
“These prescription products are safe to use and supported by decades of clinical best practices as recommended by the American Dental Association and the U.S. Preventive Services Task Force. Although the FDA has cited emerging safety concerns, studies that found associations between thyroid hormones, changes to the microbiome, and decreased IQ were all at fluoride levels significantly higher than U.S. prescription products, lack methodological rigor, or have inconclusive findings.”
While FDA’s warning could limit access to single-ingredient ingestible fluoride supplements on the market, many fluoridated prescription products will remain available for appropriate prescription use.
Safety of ingestible fluoride supplement prescriptions
The FDA report cited chronically high concentrations of fluoride, more than double the recommended levels for community water fluoridation and fluoride supplementation. However, the National Toxicology Program’s review and supporting studies did not establish a link between fluoride exposure and negative health outcomes at levels used in community water fluoridation or fluoride supplementation, further reinforcing the importance of evidence-based decision-making. The 2025 systematic review in Nutrition Reviews journal found no harmful effects of fluoride on gut microbiome at or less than 2 mg/L.
The FDA announcement also emphasizes that fluoride-containing ingestible drugs are “unapproved.”
Dr. Susan Fisher-Owens, pediatrician and fluoridation consultant to the California Department of Public Health, addressed the FDA’s emphasis on unapproved, stating that “Over 70% of prescriptions used in pediatric settings are ‘unapproved’ or ‘off-label’ due to not having been studied in children or being legacy (in use prior to the FDA’s review processes).”
Fisher-Owens added of dentists, “We follow nationally recognized prescription practices to appropriately prevent and address disease in our patients, individually.”
Resources from CDA, other experts, support oral health
Visit CDA’s Fluoride and Fluoridation webpage for more materials that support patient health and local advocacy:
- Water fluoridation: It’s beneficial, safe and saves money (printable flyer, CDA, CDA Foundation)
- Water fluoridation “key facts” sheet and Q&A one-pager on topical and systemic fluorides as public health strategies (CDA, CDA Foundation)
- “Truth Decay and Tooth Decay: The Role of Dental Teams in Sharing the Science of Community Water Fluoridation” (CDA Journal article)
- California Fluoridation Manual (California Oral Health Technical Assistance Center)
- Fluoridation Facts: 2025 e-book (ADA)
- Campaign for Dental Health (American Academy of Pediatrics)
- On-demand webinar: Tooth Truth: Advocacy Skills for Fluoride Champions
- On-demand webinar: Fluoride Facts, Myths & Meaningful Conversations: Communicating Effectively with Patients