FDA moves to ban widely used kids’ supplements over brain damage risk
By Reda Wigle
The Food and Drug Administration has initiated the process of banning oral fluoride supplements for children.
The Centers for Disease Control and Prevention recommends these tablets and lozenges for children with a high risk of tooth decay or for those whose local drinking water is low in fluoride, a naturally occurring mineral found in soil, water, plants and many foods.
Fluoride has been shown to strengthen teeth and reduce cavities by about 25% in children and adults.
But unlike fluoride toothpaste or mouthwash, oral fluoride supplements — which are not approved by the FDA — are ingested.
And there are some concerns that fluoride acts as a neurotoxin, including from Secretary of the Department of Health and Human Services Robert F. Kennedy Jr.
Illustration of U.S. flag, FDA logo, a syringe and a vial from May 13, 2025
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The FDA said the evaluation of fluoride tablets and lozenges should be completed by October 31.
REUTERS
In a news release on Tuesday, the FDA recommended combating tooth decay in children by limiting sugar consumption and increasing hygiene, asserting that ingested fluoride can dangerously alter the gut microbiome.
They cited studies that suggest a link between fluoride and thyroid disorders, weight gain and possibly decreased IQ.
“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 Dr. Marty Makary said.
The FDA said the evaluation of fluoride tablets and lozenges should be completed by Oct. 31.
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Can fluoride cause brain damage?
RFK Jr. has been leading the charge against fluoride in recent months.
“Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease,” he wrote in a post on X in November.
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A study by scientists at the National Institute of Environmental Health Sciences published in JAMA Pediatrics on Jan. 6 found a “statistically significant association” between higher fluoride exposure and lower children’s IQ scores.
In addition, a meta-analysis study published recently in the Annual Review of Public Health found fluoride to be “toxic to early brain development.”
In August, the federal National Toxicology Program released a report that concluded with “moderate confidence” that higher levels of fluoride are associated with lower IQ in children.
However, the American Dental Association pointed out that the studies on which the report was based were flawed because they primarily focused on countries with far higher levels of fluoride than what is considered safe in the US.
Pills on a white background
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The CDC recommends one milligram tablets for children between the ages of 4 to 8.
StudioLOWERLOOPs – stock.adobe.com
A study they conducted in 2010 recommended supplemental fluoride for children up to 16 years of age who are at high risk of cavities and whose drinking water is deemed fluoride deficient.
The comprehensive review identified the most common side effect of fluoride supplementation as spotting and/or discoloration of the teeth caused by excess fluoride.
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Fluoride
Fluoride in drinking water at twice the recommended limit is linked to lower IQ in kids: US government report
What happens if these products are banned?
If these supplements are removed from the market, children will be left with only fluoridated toothpaste and mouthwash to help strengthen developing teeth.
There is no clear documentation on the number of US children who are given fluoride tablets, which are commonly sold under the brand names Luride, Fluoritab and Pediaflor.
The CDC recommends 1 milligram tablets for children between the ages of 4 to 8, 2 milligrams for children 9 to 13 years old and 3 milligrams for teenagers between 14 and 18 years old.
A small child in a hospital bed with an adult holding his hand
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If fluoride supplements are removed from the market, children will be left with only fluoridated toothpaste and mouthwash to help strengthen developing teeth.
pingpao – stock.adobe.com
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What are the benefits of fluoride in drinking water?
The practice of adding fluoride to US drinking water began in Grand Rapids, Michigan, in 1945 as an effort to reduce tooth decay. After 10 years, local dentists reported a jaw-dropping 60% reduction in cavities among children.
About a third of US community water systems serve more than 60% of the population with fluoridated water, according to the CDC. In some areas, fluoride naturally occurs at levels high enough to fight cavities.
State and local governments currently decide whether to fluoridate water and, if so, how much, so long as it doesn’t exceed a maximum set by the EPA.
According to the EPA, drinking water should not contain more than 2 milligrams per liter of fluoride. If levels exceed this amount, water systems are required to alert customers.
Health Secretary Robert F. Kennedy Jr. speaking at the 2025 Rx and Illicit Drug Summit Nashville, Tennessee.
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Health Secretary Robert F. Kennedy Jr. speaking at the 2025 Rx and Illicit Drug Summit Nashville, Tennessee.
Nicole Hester / The Tennessean / USA TODAY NETWORK via Imagn Images
When it’s over 4 milligrams per liter or higher, the CDC suggests using a “filter that removes fluoride from water.” Long term, that level of fluoride can lead to skeletal fluorosis, causing risks of weaker bones in the elderly, joint stiffness and more.
Since 2010, more than 170 communities across the country have chosen to remove fluoride from their drinking water, including places like Oneida, New York, Portland, Oregon, and Bucks County, Pennsylvania, according to the Fluoride Action Network, which opposes the practice of adding fluoride to public water supplies.
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This year, Utah made history by becoming the first US state to outlaw the addition of fluoride to public drinking water despite warnings from dentists and national health organizations that the restriction could cause medical problems.
Antifluoridation bills have also been introduced in North Dakota, Tennessee and Montana.
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While RFK Jr. cannot order communities to stop fluoridation, he can order the CDC to cease its recommendation and work with the EPA to alter the amount permitted.
The FDA said their latest move to ban fluoride tablets is consistent with “Secretary Kennedy’s Make America Healthy Again effort to ensure children grow up in a healthy environment.”
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