What just happened, and why you're hearing about it
In the past two years, fluoride has become one of the most contested ingredients in everyday household products. State legislatures have banned it from public water systems. Federal agencies have withdrawn longstanding safety endorsements for one category of fluoride products. A major "natural" toothpaste brand received an FDA warning letter that raised questions about credibility across the natural oral care segment. And a growing body of research on hydroxyapatite has given consumers an evidence-backed fluoride-free option for the first time with mainstream visibility.
None of this has changed the status of fluoride toothpaste. That is worth stating plainly at the start, because news coverage has not been consistent about which fluoride, in which product, is under scrutiny.
The FDA action: ingestible supplements, not toothpaste
In November 2024, the FDA published a proposed rule to withdraw fluoride drops and tablets for children from the list of drugs that can be marketed over the counter without agency approval. These are the products parents add to water or give directly to children in areas where drinking water is not fluoridated.
The withdrawal is not a ban. It means manufacturers would need to submit a new drug application demonstrating safety and efficacy if they want to continue selling these products through OTC channels. The FDA cited a 2020 JAMA Pediatrics cohort study linking prenatal fluoride exposure to modest reductions in child IQ scores as part of its rationale for reexamining the prior safety conclusion.
That study's findings are real. They are also disputed within the epidemiological literature, and the FDA's own position is that the evidence warrants a formal review rather than an immediate prohibition. The key phrase in the proposed rule is "not generally recognized as safe and effective for this use at this time." It is a process opening, not a verdict.
Fluoride toothpaste is a separate regulatory category. The FDA classifies it as an OTC drug governed by a different monograph, finalized in 2020. No regulatory action in 2024 or 2025 touched that monograph. The ADA and the FDA are aligned on this point.
State water fluoridation bans
Utah became the first state to prohibit fluoride in public water supplies when Governor Spencer Cox signed HB 81 in January 2024, effective May 1. Florida followed in May 2024, when Governor Ron DeSantis signed HB 1267 into law, effective July 1, 2024. Both laws prohibit municipalities from adding fluoride to drinking water regardless of CDC guidance.
These are political decisions, not scientific ones. The CDC and the American Dental Association still recommend water fluoridation at 0.7 milligrams per liter as a population-level public health measure. Decades of epidemiological data support a modest reduction in tooth decay rates in fluoridated communities.
The state bans will likely increase tooth decay rates in low-income populations who rely on public water and cannot afford regular dental care or fluoride supplements. That is the consensus prediction from dental public health researchers. It is a real public health concern that coexists alongside the legitimate questions about systemic fluoride exposure in early childhood.
ADA position
The American Dental Association has not moved its position. As of August 2026, the ADA endorses fluoride toothpaste for everyone over age two (a pea-sized amount for children two to six), community water fluoridation at 0.7 mg/L, and professional fluoride treatments for high-risk patients.
The ADA has explicitly stated that the FDA's 2024 action on fluoride supplements does not change its recommendations for fluoride toothpaste. Consumers looking for authoritative dental guidance should read ADA statements directly rather than inferring the organization's position from news coverage of the supplement ruling.
Hydroxyapatite: the evidence-backed alternative
Hydroxyapatite (HAp) is the mineral that makes up approximately 97% of tooth enamel. HAp toothpaste works by depositing calcium phosphate directly onto the enamel surface, filling in early demineralization the same way fluoride does, without the fluoride ion.
Japan approved nano-hydroxyapatite as an anti-caries agent in 1993. A 2019 systematic review published in the Journal of Dentistry found HAp toothpaste comparable to fluoride toothpaste in remineralizing early enamel lesions in controlled clinical studies. HAp does not carry the same neurodevelopmental concerns because it is not systemically absorbed.
In the United States, HAp toothpaste is sold as a cosmetic rather than an OTC drug because the FDA has not yet approved it as an anti-caries agent. Brands cannot legally claim their HAp toothpaste "prevents cavities" under current US rules. What they can claim is remineralization and enamel strengthening, which is what the ingredient does in the evidence.
This distinction matters when reading ingredient labels. A HAp toothpaste sold in the US as a cosmetic is not a fringe product; it is a well-studied ingredient operating under a regulatory category that simply has not extended its anti-caries approval to HAp yet. Several HAp toothpastes are in our companion guide to non-toxic toothpaste.
The Tom's of Maine subplot
Tom's of Maine occupies a specific position in the oral care market. Founded in 1970 on a commitment to natural ingredients, it built a loyal following among consumers trying to avoid conventional personal care formulations. Colgate-Palmolive acquired it in 2006.
In 2023, the FDA sent Tom's of Maine a warning letter citing impermissible drug claims for some of its toothpaste products. The issue was marketing language around plaque and gingivitis benefits on products that had not completed the OTC drug review process required to make those claims legally. This is a compliance matter, not a safety recall, but the letter circulated widely in natural health communities as evidence that "natural" toothpaste brands could not be taken at face value.
The concern this raised is legitimate, though many write-ups framed it misleadingly. The problem was not that the toothpaste was unsafe. The problem was that the brand was making drug-class claims without the regulatory filing to support them. For consumers who use ingredient transparency as a guide, the episode is a reminder that marketing credibility and regulatory compliance are independent variables, and the former consistently outpaces the latter in CPG categories. Tom's of Maine toothpaste, for what it is worth, contains fluoride. The natural positioning and the fluoride formulation have coexisted in the brand since its early days.
What to do with your toothpaste
The regulatory activity of 2024 to 2026 does not require you to change your toothpaste. If you are using a fluoride toothpaste and find it effective, the evidence does not provide a strong case for switching. The ADA, the CDC, and the regulatory framework governing OTC drugs all support continued use of fluoride toothpaste as directed.
If you prefer to avoid fluoride, the evidence base for HAp toothpaste is now solid enough to make it a reasonable choice for adults. Children under two should use toothpaste without fluoride in any case, per ADA guidelines, because swallowing risk at that age is real regardless of formulation.
What does require attention is the broader category of claims in oral care marketing. "Natural" is not a regulated term in the US. Ingredient lists matter more than brand positioning. The FDA warning letter to Tom's of Maine illustrates that brand trust and OTC drug compliance are different things and worth evaluating separately.
Our guide to non-toxic toothpaste covers specific products across both fluoride and fluoride-free formulations, with ingredient transparency as the primary screen. The fluoride debate is background context. The guide is the practical answer.
Photo via Pexels (Pexels License). Source.

