The U.S. Food and Drug Administration says it will begin removing concentrated, ingestible fluoride prescription drug products for children from the U.S. market.
In a statement Tuesday, the agency said these products, offered for children aged six months to 16 years, have never been approved by the FDA. The agency has set Oct. 31 as the deadline to complete a safety review and public comment period, after which it will take appropriate action to remove the products.
“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.” FDA Commissioner Dr. Marty Makary.
The FDA said it is concerned about potential risks of systemic fluoride exposure in children, including impacts on the gut microbiome — which it called a “magnified concern” for young patients — as well as possible associations with thyroid disorders, weight gain and decreased IQ.
“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,” said FDA Commissioner Dr. Marty Makary in the statement.
Makary said the agency’s Center for Drug Evaluation and Research will evaluate the evidence to better inform parents and health-care providers.
“For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” he added. “When it comes to children, we should err on the side of safety.”
For more: How Utah dentists are preparing patients for the first statewide fluoride ban
Promoting best dental practices
The U.S. Department of Health and Human Services said it plans to promote best practices for children’s dental hygiene that are effective, feasible and do not affect gut health.
Health Secretary Robert F. Kennedy Jr. praised the move, calling it “vital” and saying he is grateful for the commissioner’s leadership.
“This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again,” Kennedy said.
Kennedy has previously criticized fluoride use, and Utah recently became the first U.S. state to ban fluoride in public drinking water — a move opposed by dentists and health organizations who argue it could worsen oral health and disproportionately affect low-income communities. Florida is expected to follow.
On April 23, Kennedy called sugar “poison,” the same day the International Dairy Foods Association (IDFA) announced a voluntary commitment to eliminate certified artificial colours — such as Red 3, Yellow 5 and Blue 1 — from milk, cheese and yogurt sold in U.S. K-12 schools for the National School Lunch and Breakfast Programs by July 2026.
For more: U.S. health secretary calls sugar ‘poison’ weeks after dental association urges cutbacks
ADA reacts: ‘Proposals like this stand to hurt rural America’
The nation’s leading dental group said Tuesday the studies “do not in fact demonstrate any harmful effects” from fluoride at the levels used by dentists.
“Proposals like this stand to hurt rural America, not make them healthier,” American Dental Association President Dr. Brett Kessler said. “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.”
Officials in Utah recently made fluoride supplements available without a prescription. As more state and local governments begin removing fluoride from their water, the need for supplemental fluoride is expected to grow.
A 2010 paper from the ADA recommended supplemental fluoride for children up to 16 years old who are at high risk of cavities. The recommendation was based on a review of studies across different age groups. The most common side effect associated with the products is spotting or discoloration of the teeth, caused by extra fluoride.
ADA’s Kessler said the FDA’s plan “will be particularly harmful to the most vulnerable and those who lack access to care.”
The FDA regulates most dental products, including fluoride-containing toothpastes, supplements, mouthwashes and rinses. But in Tuesday’s press release, the FDA said the ingestible products targeted by the agency have “never been approved.” The agency’s plan wouldn’t affect toothpastes, mouthwash or fluoride treatments used by adults or those offered in dentists’ offices.
In recent weeks fluoride-containing products have increasingly been targeted with lawsuits and legal actions.
Texas Attorney General Ken Paxton announced an investigation early this month into the marketing of fluoride toothpastes by Colgate-Palmolive and Proctor and Gamble. A press release from his office described the companies’ promotions as “misleading, deceptive and dangerous.”
(With files from the Associated Press)
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