FDA initiates removal of children’s ingestible fluoride products

Published 13/05/2025, 17:34
FDA initiates removal of children’s ingestible fluoride products

Investing.com -- The U.S. Food and Drug Administration (FDA) has announced it is taking steps to remove ingestible fluoride prescription drug products for children from the market. Unlike fluoride toothpaste or rinses, these products are swallowed by infants and toddlers. The FDA has not approved these products. Studies have shown that ingested fluoride can alter gut microbiome, which is particularly concerning considering the early development of the gut microbiome in childhood. Research has suggested links between fluoride and thyroid disorders, weight gain, and possibly decreased IQ.

The FDA Commissioner, Marty Makary, M.D., M.P.H., stated that the best way to prevent cavities in children is not by altering a child’s microbiome but through limiting sugar intake and maintaining good dental hygiene. He explained that fluoride might kill intestinal bacteria important for a child’s health in the same way it kills bacteria on teeth. Makary has directed the FDA’s Center for Drug Evaluation and Research to assess the risks of systemic fluoride exposure from these pediatric ingestible fluoride prescription drug products. The aim is to better inform parents and the medical community about this emerging issue. Makary emphasized the need to prioritize children’s safety.

The FDA has set a goal to complete a safety review and public comment period, and take appropriate action regarding the removal of these products from the market by October 31. As part of this evaluation, the U.S. Department of Health and Human Services (HHS) plans to share best practices for children’s dental hygiene that are effective, feasible, and do not affect gut health.

HHS Secretary Robert F. Kennedy, Jr. expressed gratitude to Commissioner Makary for his leadership on this vital issue. He said this decision is a step toward fulfilling President Trump’s promise to Make America Healthy Again. Several states have already taken action to stop the fluoridation of drinking water. Fluoride is not added to drinking water in most of Europe or other countries worldwide. The FDA’s action aligns with Secretary Kennedy’s Make American Healthy Again effort to ensure a healthy environment for children’s growth.

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