FDA and RFK Jr. aim to remove ingestible fluoride products used to
protect kids' teeth
[May 14, 2025]
By MATTHEW PERRONE
WASHINGTON (AP) — U.S. health regulators announced an effort Tuesday to
phase out ingestible fluoride supplements sometimes used to strengthen
children’s teeth, opening a new front in Health Secretary Robert F.
Kennedy Jr.’s effort against a mainstay of dental care.
The Food and Drug Administration said it will conduct a scientific
review of the children's products by late October with the aim of
removing them from the market. Formally withdrawing medical products
requires a lengthy rulemaking process that can take years. Instead, the
FDA will ask manufacturers to voluntarily pull their products, according
to an administration official.
Fluoride tablets and lozenges are sometimes recommended for children and
teens at increased risk of tooth decay or cavities because of low
fluoride in their local drinking water. Companies also sell drops for
babies.
FDA Commissioner Marty Makary said the products pose a risk when
swallowed because they may interfere with healthy gut bacteria that are
critical to digestion, immunity and other key bodily functions. He also
referenced studies showing possible associations between excess fluoride
intake and other problems, including decreased IQ.
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 — the first U.S. state to ban fluoride from drinking
water — 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.
Fluoride strengthens teeth and reduces cavities by replacing minerals
lost during normal wear and tear, according to the Centers for Disease
Control and Prevention. In 1962, the agency set guidelines for how much
should be added to water.
Kennedy, a former environmental lawyer, has called fluoride a “dangerous
neurotoxin” tied to a range of health dangers. Last month, he announced
a task force to scrutinize fluoride's use, while at the same time saying
he would order the CDC to stop recommending that it be added to tap
water.
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A child shows off her teeth after a dental exam in Concord, N.H.,
Wednesday, Feb. 21, 2024. (AP Photo/Robert F. Bukaty, file)
 A report last year by the federal
government’s National Toxicology Program concluded that drinking
water with more than twice the CDC’s recommended level was
associated with lower IQs in kids. The study was based on research
conducted in Canada, China, India, Iran, Pakistan and Mexico.
“Ending the use of ingestible fluoride is long overdue,” Kennedy
said in a statement Tuesday. "This decision brings us one step
closer to delivering on President Trump’s promise to Make America
Healthy Again.”
An influential government health panel recommends fluoride
supplements for children between the ages of six months and 5 years
if they live in areas with low fluoridation levels. The U.S.
Preventative Services Task Forces judged the recommendation to have
“high certainty," based on the available evidence.
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.”
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