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Food and Drug Administration, HHS.
Notice of public meeting; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled “Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population.” The purpose of the hybrid public meeting is to seek public input on the clinical use and safety concerns associated with the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population. The public meeting will be facilitated by the Reagan-Udall Foundation for the FDA. ( printed page 25330) FDA is establishing a docket for public comment on this topic.
The public meeting will be held in person and virtually on July 23, 2025, from 9:30 a.m. to 4:00 p.m. Eastern Time. Either electronic or written comments on this public meeting must be submitted by July 16, 2025. See the SUPPLEMENTARY INFORMATION section for registration date and information.
The public meeting will be held in person at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. #1503), Silver Spring, MD 20993-0002 and virtually via webinar. Participants must be REAL ID compliant to access federal facilities. For additional information regarding REAL ID, refer to https://www.dhs.gov/real-id/real-id-faqs. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/about-fda/visitor-information.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 16, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2025-N-1557 for “Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Regarding the meeting: Lea Ann Browning-McNee, Director of Communication and Stakeholder Engagement, Reagan-Udall Foundation for the FDA, 202-849-2075, fluoride@reaganudall.org.
Regarding the docket: Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, 855-543-3784, fluoridemeeting@fda.hhs.gov.
Prescription fluoride drops and tablets for ingestion were first marketed in the United States in the 1940s to prevent dental caries, particularly in children who lived in areas with low or no water fluoridation. Although these products are still prescribed today, none have been reviewed and approved by FDA for safety, effectiveness, or quality. FDA has previously not taken action to remove such unapproved drug products from the market. Over the years, numerous medical and dental organizations in the United States have recommended the use of ingestible fluoride products for individuals for whom regular topical treatment is difficult to achieve and those for whom topical fluoride only is insufficient to avoid dental decay.
However, FDA continuously monitors the safety of drug products sold in the United States, including marketed unapproved prescription drug products, and is aware of recent scientific research on the safety of ingestible fluoride. While the safety concerns presented in the scientific literature have generally focused on fluoride levels greater than those found in prescription drug products marketed in the United States, given that these products are predominantly used in young children, FDA is undertaking a review of their safety. Some studies suggest an association between ingestible fluoride and several health effects, including on ( printed page 25331) thyroid hormones, changes to the microbiome, and possibly decreased IQ. These safety findings are not conclusive, but they warrant continued research and discussion.
Toward that end, FDA is collaborating with the Reagan-Udall Foundation for the FDA to convene a public meeting to seek input on the clinical use and safety concerns associated with orally ingestible unapproved prescription drug products containing fluoride for use in the pediatric population. The purpose of this meeting is to facilitate an exchange of perspectives from subject matter experts and patients on the benefits and risks of using these drug products in the pediatric population.
The Reagan-Udall Foundation for the FDA will facilitate the public meeting. The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development; accelerate innovation; and enhance product safety.
FDA seeks public input from clinical, patient, public health, and research communities on the clinical use of and safety concerns associated with orally ingestible unapproved prescription drug products containing fluoride for prevention of tooth decay in the pediatric population.[1] In particular, comments are sought on the following topics:
1. Please comment on the evidence supporting the current clinical uses of orally ingestible unapproved prescription drug products containing fluoride for tooth decay prevention in the pediatric population. What factors do clinicians consider when prescribing such drug products for the pediatric population?
2. Please comment on the safety concerns associated with these drug products, taking into account the amount of fluoride they provide when used as directed for prevention of tooth decay prevention in the pediatric population.
3. Based on the totality of the data available today, please comment on the continued use of these drug products for tooth decay prevention in the pediatric population considering the additional sources of fluoride available.
4. From the perspective of patients and clinicians, what are the potential impacts of removing these drug products from the market? Are there alternatives to use of these ingestible drug products to achieve these ends?
Registration: To register for the public meeting, please visit the following website: https://reaganudall.org/news-and-events/events/use-orally-ingestible-unapproved-prescription-drug-products-fluoride. Please indicate either in-person or virtual attendance and provide complete contact information for each attendee.
Registration is free and based on space availability, with priority for in-person attendance given to early registrants. Persons interested in attending this public meeting in person must register online by July 22, 2025, at 5:00 p.m. Eastern Time. Early registration for in-person attendance is recommended because seating is limited; therefore, the number of participants from a single organization may be limited. While there is no deadline for persons interested in attending this public meeting virtually, they must register online to receive the link. Registrants will receive registration confirmation via email.
If you need special accommodations due to a disability, please contact Lea Ann Browning-McNee, Director of Communication and Stakeholder Engagement, Reagan-Udall Foundation for the FDA, 202-849-2075, fluoride@reaganudall.org, no later than July 16, 2025, at 5:00 p.m. Eastern Time.
Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. The deadline to request a public comment slot is 5:00 p.m. Eastern Time on July 9, 2025. Following the July 9 deadline, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. Selected participants will be notified the week of July 14, 2025, and provided with instructions regarding submission of a single slide in PowerPoint format. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.
Streaming Webcast of the Public Meeting: This public workshop will also be available via webinar to virtual attendees who register at https://reaganudall.org/news-and-events/events/use-orally-ingestible-unapproved-prescription-drug-products-fluoride.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: June 11, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
1. Although the Agency is aware that there are other fluoride-containing products on the market, including dietary supplements, this public meeting is focused only on orally ingestible unapproved prescription drug products containing fluoride.
Back to Citation[FR Doc. 2025-10943 Filed 6-13-25; 8:45 am]
BILLING CODE 4164-01-P
4,604 comments have been received at Regulations.gov.
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