Fluoride Fight: We Want To Hear From YOU!
The FDA has announced its intent to remove prescription fluoride supplements—including drops, tablets, and lozenges used in children—from the U.S. market by October 31, 2025. The decision, rooted in regulatory and safety concerns, has triggered serious conversation within the dental community—especially for independent dentists serving rural or non-fluoridated populations.
As this is a clinical and regulatory development that could impact how preventive care is delivered to high-risk children in underserved areas, we want your feedback to feature in next week’s newsletter. Email your thoughts and be heard!
What the FDA Is Proposing—and Why
According to its May 2025 statement, the U.S. Food & Drug Administration (FDA) plans to eliminate ingestible fluoride supplements because:
These products were never formally approved through the FDA’s New Drug Application (NDA) process.
The agency classifies them as “unapproved new drugs.”
Cited concerns include potential—but not conclusive—risks to the thyroid, gut microbiome, and neurodevelopment, based largely on animal studies or high-level exposures not reflective of typical pediatric prescriptions.
“This action is not based on fluoride’s well-established benefits in preventing tooth decay through topical exposure. It’s focused on unapproved ingestible forms.”
— FDA Press Release, May 13, 2025
This proposal does not affect water fluoridation programs or professionally applied topical fluoride products like varnish, gels, or toothpaste.
Source: FDA.gov – May 13, 2025, Press Announcement
ADA and Pediatric Dentistry Organizations Respond
The American Dental Association (ADA), American Academy of Pediatric Dentistry (AAPD), and other clinical organizations have responded firmly, urging the FDA to reconsider:
Ingestible fluoride supplements are not universally prescribed. They are only recommended for children at high risk for caries who do not have access to fluoridated water.
The ADA’s evidence-based clinical guidelines, in place since 2010, provide precise age- and dosage-based recommendations for systemic fluoride use.
A blanket removal of these supplements may increase dental disease risk for children in non-fluoridated or underserved regions—including rural areas and communities that have opted out of water fluoridation.
“The science has long shown that fluoride, when used appropriately, is safe and effective. Removing this option could unintentionally widen health disparities.”
— Dr. Brett Kessler, ADA President
Source: ADA News – May 2025 Update
What Clinically Remains the Standard of Care
Independent dentist-owners should be reassured that fluoride continues to be a core clinical tool. Specifically:
Topical fluoride treatments (varnishes, toothpaste, rinses) are not impacted and remain central to preventive care.
Water fluoridation is still fully endorsed by national public health agencies.
These positions are supported by:
The Centers for Disease Control and Prevention (CDC)
The American Dental Association (ADA)
The U.S. Preventive Services Task Force (USPSTF)—an independent panel of national experts in prevention and evidence-based medicine.
The USPSTF specifically recommends:
Topical fluoride varnish for all children under 5 as soon as teeth erupt.
Oral fluoride supplements only for children at high risk of dental caries who do not have access to fluoridated drinking water.
These are evidence-based, non-partisan clinical recommendations that guide best practices in pediatric dental prevention.
Source: USPSTF Recommendation on Dental Caries Prevention
How Dentist-Owners Can Prepare
If your practice serves children who rely on fluoride supplements—or if your community lacks fluoridated water—consider these next steps:
1. Assess Your Patient Population
Identify which patients may be affected and track their caries risk and preventive needs.
2. Strengthen Topical Fluoride Protocols
Increase frequency of in-office fluoride varnish applications.
Recommend fluoride toothpaste or prescription-strength rinses for high-risk patients.
3. Communicate with Parents and Caregivers
Clarify the distinction between systemic and topical fluoride.
Reinforce oral hygiene, diet, and routine recall visits.
4. Monitor Regulatory Developments
The FDA plans a final determination by October 2025. The ADA and others are actively submitting clinical commentary.
5. Advocate for Science-Based Access
Participate in public comment periods and ADA grassroots advocacy if you believe patients in your region will be negatively impacted.
We Want to Hear from You
How many of your patients rely on fluoride supplements?
How is your team adjusting care recommendations?
Are parents asking more questions about fluoride safety or alternatives?
📧 Email us directly—we’ll feature your insights, strategies, or concerns in next week’s edition of Practice Pulse.
