HQ Team
May 14, 2025: The US regulator is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market, a move that drew ire from dental experts.
Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers, according to a statement from the US Food and Drug Administration (FDA).
“They have also never been approved by the FDA.”
Ingested fluoride has been shown to alter the gut microbiome, which is of concern given the early development of the gut microbiome in childhood, the agency stated.
Other studies have suggested an association between fluoride and thyroid disorders, weight gain, and possibly decreased intelligence quotient.
‘Avoid excessive sugar’
“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome,” said FDA Commissioner Marty Makary, MD, MPH.
“For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,”
The FDA has instructed its Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area.
“When it comes to children, we should err on the side of safety.”
The agency has set a goal date of October 31 for completing a safety review and public comment period and for taking appropriate action regarding the removal of these products from the market.
‘Long overdue’
In conjunction with this evaluation, the U.S. Department of Health and Human Services (HHS) plans to disseminate best practices for dental hygiene in children that are feasible, effective and do not alter gut health.
“Ending the use of ingestible fluoride is long overdue,” said HHS Secretary Robert F. Kennedy Jr. “This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
Several states have taken action to stop fluoridation of drinking water, and fluoride is not added to drinking water in most of Europe or other countries of the world.
Water fluoridation is one of the safest ways we can prevent cavities in children and adults. Around 70% of the US population receives fluoridated community water, according to the American Dental Association.
The body is the country’s largest dental association, representing 159,000 dentist members.
‘Hurt rural America’
Optimal levels of water fluoridation prevent cavities by providing frequent and consistent contact with low levels of fluoride, reducing tooth decay by 25% in children and adults, it stated.
“Proposals like this stand to hurt rural America, not make them healthier,” said Brett Kessler, DDS, president of the American Dental Association.
“More than ever, at this critical time in American health care policy, it is vital that we slow down to properly study the full implications of actions like this on the health of the nation.”
Fluoride supplements are effective at reducing tooth decay and are one method for maintaining oral health when utilised daily in compliance with the proper dose, according to the association.
No harmful effects
A review of the studies offered as referenced by the US Department of Health and Human Services does not demonstrate any harmful effects from the concentrations of fluoride prescribed by physicians and dentists.
There is limited research on the studies of microbiome composition and fluoride association.
“In non-fluoridated communities, especially rural areas, fluoride supplements are the only chance for individuals to get the appropriate amount of fluoride to prevent tooth decay,” said Dr Kessler.
“This is true even when other sources of fluoride are available, like fluoride-containing toothpastes and mouth rinses.”
