FDA moves to restrict fluoride supplements as part of MAHA agenda
The FDA says fluoride supplements “should not be used in children under age 3 or by older children who are not at high risk of tooth decay.”
By Deidre McPhillips, CNN
(CNN) — The US Food and Drug Administration said Friday that it is taking action to restrict the use of prescription fluoride supplements, following a directive from the government’s Make American Healthy Again Commission to assess the risks and benefits of the products.
The FDA says it sent notices to four companies “outlining the agency’s intention to take enforcement action against those marketing unapproved fluoride-containing ingestible drugs labeled for use in children under age 3 or older children at low or moderate risk for tooth decay.” The agency also sent letters to health care professionals recommending against the use of fluoride supplements for these groups.
Fluoride has faced heavy scrutiny from the Trump administration after recent research reignited debate about the health risks associated with exposure to high levels of fluoride. But experts broadly emphasize the safety and benefits of fluoride.
Fluoride is a mineral that can be found naturally in some foods and groundwater. It can help prevent tooth decay by strengthening the protective outer layer of enamel that can be worn away by acids formed by bacteria, plaque and sugars in the mouth.
The practice of adding fluoride to public water systems started in the United States in 1945 to help improve oral health in a cost-effective and equitable way. The CDC named fluoridation of drinking water one of the 10 greatest health interventions in America in the 20th century alongside vaccination, family planning and safer workplaces.
Most US residents live in a community where fluoride is added to public drinking water, according to federal data from 2022. In places where fluoride is not in the water, fluoride tablets or drops may be prescribed for babies and children to reduce the risk of tooth decay — and reliance on fluoride supplements could become more common, as Utah and Florida became the first states to ban the practice of adding fluoride to drinking water and similar legislation has been introduced in several other states.
In April, the US Department of Health and Human Services and the US Environmental Protection Agency Administration announced that they would study the science to make a new recommendation on fluoride. HHS Secretary Robert F. Kennedy Jr. has also said he will tell the US Centers for Disease Control and Prevention to stop recommending fluoridation for drinking water in communities.
The FDA launched a ”safety review and public comment period” on the issue in ​May, and a strategy report from the MAHA Commission – with an agenda spearheaded by Kennedy – specifically named fluoride supplements as an issue to investigate, along with vaccine injuries and exposures to pesticides and microplastics.
In the resulting scientific evaluation, published Friday, the agency concluded that fluoride supplements “should not be used in children under age 3 or by older children who are not at high risk of tooth decay.”
“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 news release.
“There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome. The microbiome is increasingly recognized to be central to a child’s health and development,” FDA Commissioner Dr. Marty Makary said in the release.
The FDA on Friday also referenced “preliminary but potentially concerning” data about the risks that fluoride can have for children’s intellectual development. A meta-analysis published earlier this year, which would become the basis for further federal investigation, concluded that IQ drops as fluoride levels rise. But some experts have raised concerns about biases in the analysis and emphasized that it focused on levels of fluoride that are far higher than most people are exposed to.
As water fluoridation starts to roll back in some communities, experts say that protecting the option to use prescription supplements is key. In fact, the legislation in Utah that banned the addition of fluoride to the public drinking water included provisions to expand access to prescription fluoride — and prescriptions spiked after the change.
For some oral health advocates, the latest action from the FDA is a win simply because it is not an outright ban.
“We are actually quite pleased about this decision, because fluoride supplements remain available and will continue to be a benefit to oral health,” said Dr. James Bekker, a pediatric dentist from Utah who spoke at public meeting to discuss the risks and benefits of the prescription fluoride supplements in July.
“We feel that the decision of the FDA to continue making fluoride supplements available is an indication that all of the input generated from health professionals was heard and considered in their decision,” Bekker said in an email to CNN on Friday. “Providers can prescribe according to their consultation with parents and patients at recommended levels. We still recommend starting fluoride supplements at age 6 months in non-fluoridated water communities and will rely on knowledgeable health professionals to follow the documented science as they consider appropriate ages and dosages.”
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