FDA restricts fluoride supplements for children over health concerns

The U.S. Food and Drug Administration (FDA) has moved to restrict the use of fluoride supplements for children, particularly those under three years old and older children at low to moderate risk of cavities. This action, part of President Donald Trump's "Make Our Children Healthy Again Strategy," involves enforcement notices to companies marketing unapproved fluoride-containing drugs and warnings to healthcare providers against their use in these groups. The FDA's decision is based on a new scientific review highlighting limited effectiveness of fluoride supplements in preventing dental decay and potential health risks, including impacts on the gut microbiome that could affect immunity and cognitive development. While fluoride has long been recognized for its role in dental health through water fluoridation, these ingestible products have never been formally approved for safety or efficacy. The American Dental Association disputes significant health risks at prescribed levels, but the FDA emphasizes emerging concerns and the availability of safer alternatives for dental health protection. This represents the first major federal reassessment of fluoride safety since the 1940s and reflects growing scrutiny of fluoride use amid changing public health policies.