FDA targets prescription fluoride tablets for children

The Food and Drug Administration said Tuesday it is seeking to remove prescription fluoride for children from the market, escalating the Trump administration’s campaign against the cavity-fighting mineral.

The agency cast fluoride pills long prescribed by dentists to improve oral health as a potential health hazard to children. It set an Oct. 31 deadline to complete a safety review of “concentrated ingestible fluoride prescription drug products” and take “appropriate action” to remove them from the market.

“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,” FDA Commissioner Marty Makary said in a statement. “When it comes to children, we should err on the side of safety.”

An official with the Department of Health and Human Services, who spoke on the condition of anonymity to describe the process, said the FDA will issue a letter to manufacturers asking them to first voluntarily remove the products from the market. The official could not provide an immediate timeline for when the letters would be sent.

In advice on its website, the American Dental Association says fluoride supplements can be prescribed to children between the ages of 6 months and 16 years who are at high risk of tooth decay and rely on drinking water with low concentrations of fluoride. Doses vary from 0.25 mg to 1 mg in a tablet or lozenge. Doctors and dentists consider how much fluoride is in a patient’s water before deciding which dose to prescribe.

The ADA says the primary side effect of ingesting excess fluoride is mild dental fluorosis, an aesthetic issue of stained or discolored teeth.

HHS Secretary Robert F. Kennedy Jr. has made targeting fluoride one of his signature issues. The agency he leads said it would convene a task force to study water fluoridation and make a new recommendation.

“Ending the use of ingestible fluoride is long overdue,” Kennedy said in a statement.

The announcement is the latest move from the FDA to align with Kennedy’s Make America Healthy Again agenda. The agency recently announced an intent to phase out the use of artificial synthetic dyes in the nation’s food supply by the end of 2026 and is seeking voluntary compliance from the food industry. It also announced steps Tuesday to initiate a review of nutrients in infant formula.

The FDA announcement comes as the Trump administration also targets the fluoridation of drinking water, a long-standing practice credited with saving generations of children from preventable tooth decay. Earlier this month, Utah became the first state to enact a ban on water fluoridation, and Florida Gov. Ron DeSantis (R) recently said he would sign legislation making his state the second.

Fluoride strengthens teeth, but research has suggested it is not as beneficial as it used to be with the widespread addition of fluoride to toothpaste and mouthwash. Studies have also shown associations between high concentrations of fluoride in drinking water - above the levels recommended in the United States - and negative health effects for children, including lower IQ.

The scientific paper the FDA cited to suggest that ingested fluoride can be harmful to a child’s gut health has limitations.

Most of the underlying research in that report involved studies on animals using doses of fluoride far above the levels considered safe for humans. It did not find that fluoride at low levels affects gut bacteria. The paper concluded that more studies are needed to determine the ideal concentration of fluoride supplements over extended periods.

“It’s just such weak evidence to propose a change in public health or pharmaceutical practice,” said Scott Tomar, a professor and associate dean at the University of Illinois at Chicago’s College of Dentistry who has served on professional boards that advise on fluoride safety.

Supporters of water fluoridation bans have said there are other ways for children to receive the mineral’s benefits, including in toothpaste, through topical fluoride treatments, at the dentist’s office and via supplements.

“They talk about patients having the right to choose and then they turn around and eliminate one of the choices that they have,” said Jeff Ottley, president of the Florida Dental Association.

In Utah, the authors of the bill that bans water fluoridation sought to address concerns about access to oral health care by allowing pharmacists to provide fluoride tablets.

Dentists in Utah said a crackdown on prescription fluoride would make it even more difficult to protect children from cavities.

“It’s giving the public an idea that this is a poison, and I had a lot of parents come into the office and refuse fluoride even in a topical form,” said Darren Chamberlain, a dentist in Springville, Utah, who frequently prescribes fluoride in a community where it is not added to the water.

He added: “We are going to be overwhelmed by the number of cavities we are going to see in the near future.”