Feds crack down on children's fluoride pills, citing gut harm and lack of benefit
By isabelle // 2025-11-03
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  • The FDA will remove unapproved prescription fluoride supplements for children.
  • These ingestible products have been used for decades without formal FDA review.
  • The agency cites emerging risks to the gut microbiome and overall child health.
  • The move prioritizes caution and modern science over long-standing public health dogma.
  • Officials warn the benefits for most young children do not justify the potential risks.
Federal regulators are finally taking action against unapproved and potentially risky prescription fluoride products that have been given to children for decades. The U.S. Food and Drug Administration warned companies on October 31 that it plans to crack down on the sale of these ingestible fluoride drugs, signaling a major shift in the official stance on fluoride supplementation. This decisive action, driven by Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary, aims to pull outdated and unvetted medical practices into the light of modern science. The move prioritizes caution and biological integrity over a long-standing public health dogma, directly challenging a status quo that has gone unquestioned for too long.

New scrutiny on old science

The target of the FDA’s action is a class of prescription drugs including chewable tablets and drops that have been used since the 1940s without ever being formally reviewed or approved by the agency for safety or effectiveness. An FDA analysis concluded these products appear to reduce tooth decay in permanent teeth but not in the teeth of younger children. The agency now recommends limiting the use of ingestible fluoride to children aged three years and older who are at high risk of tooth decay, such as those with a history of decay and a lack of access to fluoridated water. For the broader population of young children, the purported benefits simply do not justify the potential risks. The FDA’s review identified several concerning side effects. These include tooth discoloration and, more significantly, emerging concerns about fluoride's effects on the delicate gut microbiome. This internal ecosystem of bacteria is now understood to be central to a child’s overall health and development.

Protecting the vulnerable

The agency’s warning letters put companies on notice that enforcement action is coming, giving them time to assess their products and take corrective actions. This formal process underscores the seriousness of the FDA's findings and its commitment to removing these products from the market. Health Secretary Robert F. Kennedy Jr., a long-time critic of non-essential fluoride exposure, celebrated the move. “This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” Kennedy said. “It’s scary that these products have been used for decades without approval.” FDA Commissioner Dr. Marty Makary provided the scientific rationale for the crackdown, pointing to the delicate balance of the human gut. “There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome,” Makary stated. “The microbiome is increasingly recognized to be central to a child’s health and development.” This policy change aligns with the broader "Make Our Children Healthy Again" initiative, which has directed a re-evaluation of fluoride products. The decision follows a months-long safety review and public comment period that began earlier in the year. The FDA’s analysis referenced a Cochrane review, considered the gold standard for evaluating evidence, which found no clear benefit for these supplements in protecting baby teeth. The agency also noted that the very mechanism that makes fluoride effective at killing bacteria on teeth may be what causes disruption to gut health when it is swallowed. This federal action represents a significant step toward reevaluating the role of systemic fluoride in public health. It marks a pivot toward a more cautious, evidence-based approach that prioritizes a child's overall biological health, acknowledging that what happens in the gut does not stay in the gut. For parents, it is a long-overdue correction and a warning to take a closer look at even the most common medical advice. Sources for this article include: TheEpochTimes.com USNews.com DailyMail.co.uk
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