FDA Cracks Down on Unapproved Fluoride Supplements for Kids

Written by Brenda Baletti PhD on November 6, 2025. Posted in Current News

The U.S. Food and Drug Administration (FDA) warned four companies last week that it may take action against them for selling unapproved prescription fluoride supplements for use by children under age three or older children at low or moderate risk of tooth decay

The move is part of a broader push by the agency to remove unapproved fluoride products from the market. The FDA did not name the four companies.

“The FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” U.S. Health Secretary Robert F. Kennedy Jr. said in a press release. “It’s scary that these products have been used for decades without approval. Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again.”

Stuart Cooper, executive director for the Fluoride Action Network (FAN), told The Defender:

“FAN petitioned the FDA a decade ago to end the sale of fluoride supplements for use in children, and we were part of the FDA’s latest review, which led to this decision. While not the full prohibition we had hoped for, this is still a major victory and a significant step in the right direction.”

The FDA never approved fluoride supplements, which come in tablet or lozenge form. However, doctors have routinely prescribed them for decades — even to babies as young as 6 months old — to prevent cavities.

For more than two decades, research has shown that fluoride helps teeth only when applied topically — as with toothpaste — not when ingested.

The supplements can cause dental fluorosis, a tooth discoloration that signals fluoride overexposure. Overwhelming evidence now shows that swallowing fluoride can lower children’s IQ and contribute to neurobehavioral issues and thyroid problems.

‘Formal FDA restriction of fluoride supplements is long overdue’

In January, top government scientists published a review in JAMA Pediatrics showing that early fluoride exposure was linked to lower IQ scores in children.

In response, the FDA moved to ban fluoride supplements. FDA Commissioner Marty Makary announced in May that the FDA Center for Drug Evaluation and Research would evaluate the risks of fluoride exposure from the supplements.

In July, the agency held a public meeting to gather scientific input and public comment on the issue.

The agency’s scientific evaluation, published online Oct. 31, showed that the most rigorous analyses found that the ingestible drugs offer limited benefits. The drugs also pose risks, including dental fluorosis and potential effects on cognition, thyroid function, gut microbiome and weight gain.

“Given these findings, out of an abundance of caution, our overall recommendation is that the evidence supports limiting use of ingestible fluoride drug products to children aged three years and older who are at high risk of tooth decay,” the report concluded. It also called for “new and better evidence” on the issue.

Dr. Griffin Cole, an expert who presented at the July meeting and is on the board of directors of the International Academy of Oral Medicine and Toxicology, told The Defender, “This formal FDA restriction of fluoride supplements is long overdue, but greatly appreciated.”

In its letter last week, the FDA said it will take compliance action against any company that markets fluoride drugs for use by children under age three or does not restrict them to older children at high risk for dental caries.

The stipulation that the supplements shouldn’t be given to children under age 3 “may be the most significant aspect of this decision,” Cooper said.

It means “that the FDA has officially acknowledged that children under 3 ought not to ingest supplemental fluoride at the exact same level experienced from water fluoridation,” Cooper said. Fluoride supplements are used as a proxy for fluoridation and currently affect “hundreds of thousands of children in the U.S.” who are already at risk because they’re drinking fluoridated water.

The FDA asked the companies to report to the agency within 30 days on how they plan to address the safety concerns. The FDA also said it may issue additional notices as it continues reviewing the safety of ingesting fluoride.

Fluoride drugs were grandfathered in — without FDA-regulated safety testing

In last week’s letter, the FDA publicly acknowledged that the agency has never reviewed or confirmed the safety and efficacy of ingesting fluoride.

“This flies in the face of claims by proponents of fluoride ingestion, like the American Dental Association [ADA], who have made it their policy to prescribe fluoride to children as young as 6 months of age,” Cooper said.

Manufacturers launched fluoride supplements in the 1940s and later effectively grandfathered them into the regulatory process. The supplements never underwent the safety and effectiveness testing that FDA-regulated drugs typically require, and the agency never formally approved them.

Before 1938, dentists did not use sodium fluoride. Instead, people commonly used it to poison roaches and rodents.

In 2016, FAN filed a citizen petition demanding the removal of “unapproved, unsafe, unnecessary, and ineffective sodium fluoride-containing” supplements from the market.

The petition cited a letter the FDA sent to Kirkman Labs, a fluoride supplement manufacturer, informing the company that it couldn’t sell its products because they were unapproved drugs and didn’t meet the “generally recognized as safe” classification.

The petition argued that the FDA should apply its decision on Kirkman to all supplement manufacturers.

The FDA didn’t disagree, but said it made decisions on a case-by-case basis, largely dependent on whether the U.S. attorney decided to file a lawsuit, Cooper said.

A 2011 Cochrane review on fluoride supplements found no studies examining adverse effects other than dental fluorosis, and it identified only one study on that effect.

The Cochrane review concluded that the risk-benefit ratio of fluoride supplements was unknown for young children.

The study also found that supplements had only a minimal effect on cavities, and then only in children who did not use any topical fluoride, such as toothpaste. It concluded that today, fluoride supplements provide little, if any, dental benefits.

However, organizations like the ADA and the American Academy of Pediatrics continue to recommend the supplements for children ages 6 months to 17 years old who don’t have access to fluoridated drinking water.

Canada’s Pediatric and Dental Association said the supplements should not be given to children under the age of three.

See more here childrenshealthdefense.org

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