In brief: FDA aims to remove prescription drug products with fluoride, antibiotic prescription patterns call for more stewardship

FDA's effort to remove fluoride prescription drugs for children

Earlier this week, the Food and Drug Administration (FDA) announced its plans to remove ingestible fluoride prescription drugs for children from the market. This begets an effort to reduce caries in infants and toddlers; ingested fluoride can disrupt the gut microbiome, which may negatively impact the development of this ecosystem in children.¹

And unlike standard fluoride toothpaste or rinses, these drugs have never been approved by the FDA.

In a recent press release, FDA commissioner Marty Makary said: "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. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child's health."¹

RFK Jr. head of Health and Human Services (HHS) approves of this decision, noting that it is a step in the right direction to "make America healthy again."

The FDA's Center for Drug Evaluation and Research will examine the possible risks fluoride exposure from FDA-regulated ingestible prescription drugs may have on children to protect their health and keep parents-as well as the medical community-better informed.¹

The topic of fluoride consumption and its impact on both oral and overall health has been a hot-button issue over the past couple of months, with many citing studies linking high levels of fluoride and decreased intelligence scores in children and others, including the ADHA, asserting safe levels of fluoride can effectively support public health.²

You can learn more about this plan to remove prescription drug products with fluoride here.

Push for greater antibiotic stewardship

Recently released key findings and highlights from The Journal of the American Dental Association (JADA) revealed that antibiotic prescription patterns plateaued from 2018 to 2022, despite new guidelines to limit antibiotic use for dental infections.³

JADA found that 24.65 million antibiotics were prescribed in 2018 and 25.17 million were prescribed 2022, resulting in 75.5 prescriptions per 1,000 people for both years.

This news is not surprising; another study from 2023 noted that provider-based prescribing rate for all antibiotics was 142,155 per 1,000 dentists per year. Overall, dentists prescribe 10% of all outpatient antibiotics in the US, which amounted to roughly 216 million antibiotic prescriptions from 2012 to 2019.⁴

Overall, these findings highlight the need for stronger antibiotic stewardship and the elimination of unnecessary antibiotic use. You can learn more about JADA's study here.

References

1. FDA begins action to remove ingestible fluoride prescription drug products for children from the market. Food and Drug Administration. May 13, 2025. https://www.fda.gov/news-events/press-announcements/fda-begins-action-remove-ingestible-fluoride-prescription-drug-products-children-market

2. The American Dental Hygienists' Association maintains its strong support of community water fluoridation as a safe, effective and equitable public health measure. American Dental Hygienists' Association. 2024. https://www.adha.org/wp-content/uploads/2024/12/ADHA_PositionStatement_2024-12-18_Community-Water-Fluoridation.pdf

3. Huynh CT, Gouin KA, Hicks LA, et al. Outpatient antibiotic prescribing by general dentists in the United States from 2018 through 2022. J Am Dent Assoc. 2025 May;156(5):382-389.e2. doi: 10.1016/j.adaj.2024.

4. Leaver ES. Dental antibiotic prescribing rate "unchanged" in US. DentistryIQ. September 13, 2023. https://www.dentistryiq.com/dentistry/article/14298918/dental-antibiotic-prescribing-rate-unchanged-in-us