FDA restricts use of kids' fluoride supplements citing emerging health
risks
[November 01, 2025]
By MATTHEW PERRONE
WASHINGTON (AP) — The Food and Drug Administration on Friday moved to
limit the use of fluoride supplements used to strengthen children's
teeth, the latest action by Health Secretary Robert F. Kennedy Jr. and
his deputies against a chemical that is a mainstay of dental care.
The FDA said that the products are no longer recommended for children
younger than 3 and those who are older but don't face serious risks of
tooth decay. Previously, the products have been prescribed for children
as young as six months.
The action stopped short of FDA statements in May suggesting regulators
would seek the removal of the products from the market. Instead, the
agency sent letters to four companies warning them not to market their
products outside the new limits.
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.
The FDA released a new scientific analysis Friday, concluding that
fluoride supplements have limited benefits for children's teeth and may
be linked to emerging safety concerns, including gut issues, weight gain
and cognition.
“For the same reason fluoride may work to kill bacteria on teeth, it may
also alter the gut microbiome, which may have broader health
implications,” the agency said in a statement.
The agency also sent a form letter to dentists and other health
providers warning about the risks of the products.
Those claims have been disputed by the American Dental Association,
which has said there are no significant health problems associated with
fluoride when used at the levels prescribed by dentists. The supplements
can cause spotting or discoloration of teeth due to the extra fluoride,
a downside the FDA also noted.
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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)
 Dentists have warned that
restricting fluoride supplements may result in more cavities and
dental problems in rural communities, which are less likely to have
fluoridated water. Kennedy is also seeking to end the practice of
adding fluoride to drinking water throughout the U.S.
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.
The FDA regulates most dental products, including
fluoride-containing toothpastes, supplements, mouthwashes and
rinses. The agency’s actions don't affect toothpastes, mouthwash or
fluoride treatments used by adults or those offered in dentists’
offices.
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