The US Food and Drug Administration (FDA) under the leadership of Health Secretary Robert F. Kennedy Jr., has announced plans to phase out ingestable fluoride supplements intended for children.
These products, including tablets, lozenges or drops, and are generally prescribed to children at risk of tooth decay due to low fluoride levels in their local water supply.
The FDA aims to conduct a scienctific review by late October 2025 and encourage manufacturers to voluntarily remove thee supplement from the market, marking a significant shift in dental care policy.
FDA Concerns About Fluoride Supplements
FDA Commissioner Marty Makary expressed concerns that ingestible fluoride supplements may disrupt the healthy gut microbiome in children, which is vital for digestion, immunity and other bodily functions.
He cited studies that indicate possible links between excesss fluoride intake and adverse effects such as decreased IQ and thyroid dysfunction.
The agency emphasized prioritizing safety and recommended that early tooth decay prevention should focus on eating less sugar and maintaining proper dental hygiene as better cavity prevention methods.
Products Targeted and Their Usage
The supplements targeted by the FDA are intended largely for children and teenagers who are at greater risk for cavities due to insufficient fluoride in drinking water. These include chewable or swallowable tablets, lozenges, and fluoride drops for infants.
These products are not topical fluoride contained within products like toothpaste or mouth rinses but are instead swallowed, and add to the safety issues raised by the FDA.
FDA Regulatory Status and Review Process
These fluoride supplements are not approved by the FDA as medical products. The planned review is a public process that includes a comment period, and is intended to conclude by October 31, 2025.
The agency’s approach involves requesting voluntary withdrawal by manufacturers rather than immediately imposing a formal ban, a process that could take years through rulemaking.
Opposition from Dental and Health Organizations
The American Dental Association (ADA) and other professional organizations have critized the FDA’s move, stating that existing studies do not demonstrate harmful effects of flouride at recommended levels.
ADA president Dr. Brett Kessler also warned that by removing these supplements could negatively impact vulnerable populations, especially those in rural areas with limited access to fluoridated water and dental care.
Context of Fluoride Use in Public Health
Fluoride has been widely used for decades to prevent tooth decay by strengthening tooth enamel. Since 1962, the Centers for Disease Control and Prevention (CDC) established guidelines for water fluoridation and fluoride is found in many dental products.
Fluoride supplements are also recommended for children residing in non-fluoridated areas to prevent cavities, especially for those at high-risk.
RFK’s Role and Views
Health Secreatry Robert F. Kennedy Jr., a former environmental lawyer, has been a vocal critic of fluoride, which he has called a “dangerous neurotoxin.”
He has also launched a task force to review the use of fluoride and has challenged CDC recommendations for adding flouride to public water. Kennedy described the FDA’s decision as a step toward fulfilling a promise to improve public health.
Science Evidence and Controversies
A 2024 report by the National Toxicology Program linked high fluoride exposure in drinking water to lower IQ in children, based on international studies.
However, many dental and public health experts argue that fluoride at recommended levels is both safe and beneficial. The controversy rages on as the FDA continues to review amid conflicting interepretations of the data.
Legal and Market Implications
Recent weeks have seen increased legal scrutiny of flouride-containing products. For example, the Texas Attorney General launched an investigation into the marketing practices of major toothpaste manufacturers, accusing them of misleading claims about flouride safety. The FDA’s action may further influence regulatory and market dynamics for flouride products.
Next Steps for Dental Care
The FDA’s decision to remove ingestible fluoride supplements for children marks a significant policy change influenced by health concerns over flouride’s systemic effects.
While the agency emphasizes safety and gut health, dental organizations caution against removing a proven cavity prevention tool. The debate underscores ongoimng tensions between emerging scientific findings, public health practices, and regulatory decisions in dental care.
Discover more DIY hacks and style inspo- Follow us to keep the glow-up coming to your feed!
Love content like this? Tap Follow at the top of the page to stay in the loop with the latest beauty trends, DIY tips, and style inspo. Don’t forget to share your thoughts in the comments — we love hearing from you!