FDA restricts prescription fluoride supplements after assessment
The US Food and Drug Administration (FDA) announced 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, reports BritPanorama.
The FDA’s announcement included notices sent to four companies outlining its intention to enforce regulations against those marketing unapproved fluoride-containing ingestible drugs for children under the age of three, as well as older children at low or moderate risk for tooth decay. Additionally, the agency has recommended that healthcare professionals refrain from prescribing fluoride supplements for these groups.
The scrutiny surrounding fluoride intensified during the Trump administration after recent research reignited debates over the health risks of high fluoride exposure. However, many experts have continued to emphasize the mineral’s safety and benefits in oral health.
Fluoride, found naturally in certain foods and groundwater, helps prevent tooth decay by strengthening enamel, which can be compromised by acids from bacteria and sugars in the mouth. The practice of fluoridating public water systems began in the US in 1945 as a means to improve oral health affordably and equitably. The Centers for Disease Control and Prevention (CDC) has traditionally regarded fluoridation as one of the 10 greatest public health achievements of the 20th century.
Currently, the majority of US residents live in areas where fluoride is incorporated into public drinking water. In regions without such measures, fluoride tablets or drops may be prescribed, particularly for infants and children, to mitigate the risk of decay. Following legislation in Utah and Florida banning the addition of fluoride to water supplies, a spike in prescriptions for fluoride supplements was noted.
In April, the US Department of Health and Human Services (HHS) and the US Environmental Protection Agency (EPA) announced they would explore the scientific basis for fluoride recommendations. HHS Secretary Robert F. Kennedy Jr. stated that he would direct the CDC to cease endorsing fluoridation practices in communities.
This month, the FDA launched a public comment period and safety review regarding fluoride. A strategy report from the MAHA Commission, headed by Kennedy, identified fluoride supplements for investigation alongside concerns about vaccines and pesticide exposure.
In its scientific evaluation published Friday, the FDA 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.” The agency cautioned that while fluoride can kill harmful bacteria on teeth, it may also impact the gut microbiome, suggesting potential broader health implications.
“There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome,” said FDA Commissioner Dr. Marty Makary in a statement. The agency also referred to “preliminary but potentially concerning” data indicating that fluoride could adversely affect children’s intellectual development, although some experts questioned biases in the studies due to their focus on fluoride levels significantly higher than typical exposure.
As communities begin to reverse water fluoridation, many experts believe maintaining access to prescription supplements is vital. Notably, Utah’s ban included provisions for enhanced access to these prescriptions.
For some oral health advocates, the FDA’s latest decision is seen as a positive development since it does not constitute an outright ban. Dr. James Bekker, a pediatric dentist from Utah, expressed satisfaction with the outcome, emphasizing that fluoride supplements continue to be a valuable resource for oral health.
“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 reflected. He reiterated the recommendation to start prescribing fluoride supplements at six months in non-fluoridated water communities, relying on providers to follow documented scientific guidelines as they determine appropriate dosages.
The evolving conversation around fluoride highlights ongoing tensions between public health recommendations and individual communities’ choices, a discourse likely to continue as more states take decisive actions regarding fluoride policies.
