FDA Moves to Remove Ingestible Fluoride Prescriptions for Children Amid Safety Concerns
The Food and Drug Administration (FDA) has announced a significant step towards reassessing outdated practices concerning children’s health by initiating the removal of ingestible fluoride prescription drug products intended for young children from the market. This decision, framed as a proactive measure to safeguard the well-being of American children, follows growing concerns regarding the potential risks associated with these unapproved medications.
Andrew Nixon, a spokesperson for the Department of Health and Human Services (HHS), conveyed the urgency and gravity of the situation, emphasizing that the action is not merely a public health matter but also a moral imperative. According to Nixon, these fluoride prescription drug products, commonly administered to infants and toddlers, have never undergone FDA approval and present potential hazards to developing children, including disruptions to the gut microbiome, potential thyroid dysfunction, weight gain, and even reduced IQ.
The FDA’s decision represents a tangible step towards fulfilling the promise of "Making America Healthy Again" by prioritizing evidence-based practices and placing the highest standards of scientific scrutiny at the center of children’s healthcare.
Dr. Marty Makary, a leading voice within the FDA, highlighted the inherent differences between ingestible fluoride and other fluoride products, such as toothpaste. Ingestible fluoride, typically prescribed in tablet form to children at high risk for cavities, is swallowed and absorbed systemically, potentially leading to broader impacts on the body. Makary cited emerging evidence suggesting that ingestible fluoride can alter the gut microbiome, an ecosystem of microorganisms crucial for overall health, and may be linked to thyroid disorders, weight gain, and potentially decreased IQ.
Makary emphasized that alternative strategies, such as limiting sugar intake and practicing good dental hygiene, should be prioritized over systemic fluoride exposure to prevent cavities in children. He argued that the potential risks associated with altering a child’s microbiome outweigh the benefits of ingestible fluoride, particularly given the availability of safer alternatives.
The FDA plans to conduct a thorough safety review of FDA-regulated pediatric ingestible fluoride prescription drug products, encouraging public participation to ensure transparency and informed decision-making. The goal is to provide parents and the medical community with the most accurate and up-to-date information regarding the risks of systemic fluoride exposure.
HHS Secretary Robert F. Kennedy Jr. lauded the FDA’s decision, calling the elimination of ingestible fluoride "long overdue." He thanked Commissioner Makary for his leadership on this vital issue, which Kennedy believes directly protects the health and development of children.
Kennedy further expressed his support for President Trump’s promise to "Make America Healthy Again," aligning the FDA’s action with broader efforts to prioritize preventative healthcare and address potential environmental toxins. Kennedy has previously advocated for removing fluoride from public water systems, citing concerns about its potential health effects.
Concerns surrounding fluoride exposure have been growing in recent years, with some studies suggesting a link between higher fluoride levels and lower IQ scores in children. Fluoride has also been identified as an industrial waste product associated with various health problems, including arthritis, bone fractures, bone cancer, neurodevelopmental disorders, and thyroid disease.
Utah has already taken the step of banning fluoride from public water systems, while Florida Governor Ron DeSantis recently signed a bill prohibiting fluoride additives in the state’s public water supply. DeSantis characterized the addition of fluoride to water as "forced medication," arguing that individuals deserve informed consent regarding their exposure to such substances.
These actions reflect a growing movement against the widespread fluoridation of water supplies, with critics arguing that it infringes on individual liberties and poses potential health risks. Local dentists and proponents of water fluoridation argue that such measures will harm residents who rely on fluoride to maintain good dental health.
The FDA’s decision to remove ingestible fluoride prescriptions for children marks a significant turning point in the ongoing debate over fluoride exposure. By prioritizing safety and transparency, the agency is signaling a commitment to evidence-based decision-making and a willingness to reassess long-standing practices in light of new scientific evidence. The move is likely to spark further discussion and debate about the role of fluoride in public health and the best strategies for promoting dental health in children.
