FDA’s Action on Ingestible Fluoride Supplements: Legal, Regulatory, and Public Health Perspectives for the Oral Care Industry

In May 2025, the U.S. Food and Drug Administration (FDA) announced its intention to remove ingestible fluoride prescription drug products such as tablets and drops for children from the market, pending the completion of a safety review by October 2025. This action, which has ignited a nationwide debate, is rooted in concerns about possible harm to the gut microbiome and potential associations with thyroid disorders, weight gain, and decreased IQ in children. The FDA’s move is particularly significant for the oral care industry, dental professionals, and families in rural and underserved communities.

NOTE: A main concern I continue to hear is how this will affect oral care products such as toothpastes. As mentioned in more detail below, this Announcement has no impact on oral care products such as toothpaste and mouthrinses.

Understanding the FDA’s Rationale

The FDA’s decision is based on a growing body of research that raises questions about the safety of systemic fluoride exposure in children. The agency points to studies suggesting that ingesting fluoride may alter the gut microbiome, bacteria essential for health, especially during early childhood development. Additional research cited by the FDA links systemic fluoride exposure to thyroid dysfunction, metabolic changes, and possible cognitive effects. Notably, these prescription products have never been formally approved by the FDA for cavity prevention, despite decades of use.

FDA Commissioner Dr. Marty Makary emphasized a precautionary approach, stating, “The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health”. The agency has set a goal of October 31, 2025, to complete its safety review and public comment period before taking final action.

Industry and Professional Pushback

The FDA’s move has been met with strong opposition from leading dental and medical organizations, including the American Dental Association (ADA), the American Academy of Pediatrics, and the American Academy of Pediatric Dentistry. These groups argue that the evidence cited by the FDA does not demonstrate significant harm at the low, prescribed doses used in fluoride supplements. The ADA, for example, points to decades of research and real-world experience showing that fluoride supplements are effective at reducing tooth decay and are safe when used as directed.

ADA President Dr. Brett Kessler has been outspoken, warning, “Proposals like this stand to hurt rural America, not make them healthier. 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”. The ADA and other professional groups emphasize that in non-fluoridated communities, especially rural areas, fluoride supplements are often the only practical way for children to receive adequate fluoride for cavity prevention.

What About Topical Fluoride?

It’s important to clarify that the FDA’s action does not affect topical fluoride products such as toothpaste or mouth rinses. These products remain widely recommended and are considered safe and effective by both dental professionals and public health authorities. The focus of the FDA’s review is solely on products that are swallowed and absorbed into the body.

Legal and Regulatory Context: The FD&C Act

The FDA’s authority to regulate and remove drug products from the market is grounded in the Federal Food, Drug, and Cosmetic (FD&C) Act. Under this law, the agency can take action if new evidence emerges suggesting a product is unsafe or ineffective. In this case, the FDA notes ingestible fluoride prescription products have never received formal approval for cavity prevention, and the agency is responding to emerging research and public health concerns.

This situation raises important questions about how the FDA weighs scientific evidence, such as preventive products with a long history of use, and how it balances potential risks with well-established public health benefits. Critics argue that the agency should consider the totality of evidence, including decades of safe use, while supporters of the FDA’s move believe that erring on the side of caution is justified when children’s health is at stake.

Public Health Implications: Focus on Rural and Underserved Communities

A central concern raised by the ADA and other organizations is the potential impact on rural and underserved communities. In many parts of the United States, community water fluoridation is not available, and fluoride supplements are the only way for children to receive the proven benefits of fluoride for cavity prevention. Oral health disparities are already a significant issue, with children in rural, low-income, and minority communities experiencing higher rates of tooth decay and less access to dental care.

Removing fluoride supplements could exacerbate these disparities, leaving vulnerable children at greater risk for untreated dental disease, pain, infection, and long-term health problems. The ADA warns that without access to fluoride supplements or tablets, the recommended fluoride intake of 0.7 mg/L will likely not be met for many children, as few over-the-counter supplements contain fluoride and most multivitamins include only trace amounts.

Industry Response and Future Directions

For manufacturers of fluoride supplements, the FDA’s action could mean halting production, recalling products, and shifting focus to topical fluoride products or other preventive dental solutions. The broader oral care industry is closely monitoring the situation, as this decision could influence product demand, marketing strategies, and innovation in preventive dental care.

Industry leaders and dental professionals are also concerned about the precedent this sets for how the FDA evaluates long-standing preventive products. Many are urging the agency to carefully consider the full body of scientific evidence and the real-world impact of removing these products, especially for vulnerable populations.

The Broader Policy Landscape

This FDA action comes amid ongoing debates about fluoride in water and oral care products. Some states have moved to reduce or eliminate water fluoridation, often citing safety concerns or individual choice. In Europe and many other countries, fluoride is not added to drinking water at all. These policy trends make fluoride supplements even more important for children at risk of cavities in non-fluoridated areas.

Simultaneously, there is growing interest in expanding access to oral care products through insurance coverage, flexible spending accounts, and public health programs. The oral care industry and dental professionals are likely to play a key role in shaping these policies and ensuring that preventive care remains accessible to all.

What’s Next?

The FDA is currently conducting a safety review and accepting public comments, with a target date of October 31, 2025, for a final decision. During this period, dental professionals, industry stakeholders, and the public are encouraged to provide input. The Department of Health and Human Services also plans to release new best practices for children’s dental hygiene that are effective and do not affect gut health.

If the FDA finalizes its decision to remove ingestible fluoride supplements, dental professionals will need to explore alternative strategies for cavity prevention in at-risk children, such as increased use of topical fluoride, school-based dental programs, or renewed efforts to expand water fluoridation. Families in affected communities should consult with their dental providers to ensure children continue to receive effective preventive care.

The FDA’s move to remove ingestible fluoride supplements marks a pivotal moment in the intersection of regulatory policy, dental health, and public health equity. While the agency’s concerns about the gut microbiome and other potential risks are driving the review, a substantial body of evidence and decades of clinical experience support the safety and effectiveness of fluoride supplements when used as prescribed. The outcome of this regulatory process will have far-reaching implications for the oral care industry, dental professionals, and especially for children in rural and underserved communities.

As the debate continues, it is essential for all stakeholders to stay informed, participate in the public comment process, and advocate for solutions that protect both safety and access to proven preventive care.

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