[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25329-25331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10943]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1557]
Use of Orally Ingestible Unapproved Prescription Drug Products
Containing Fluoride in the Pediatric Population; Public Meeting;
Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; establishment of a public docket;
request for comments.
-----------------------------------------------------------------------
SUMMARY: 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.
[[Page 25330]]
FDA is establishing a docket for public comment on this topic.
DATES: 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.
ADDRESSES: 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.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
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.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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.
FOR FURTHER INFORMATION CONTACT:
Regarding the meeting: Lea Ann Browning-McNee, Director of
Communication and Stakeholder Engagement, Reagan-Udall Foundation for
the FDA, 202-849-2075, [email protected].
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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
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
[[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.
II. Topics for Discussion at the Public Meeting
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\ 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.
---------------------------------------------------------------------------
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?
III. Participating in the Public Meeting
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, [email protected], 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.
[FR Doc. 2025-10943 Filed 6-13-25; 8:45 am]
BILLING CODE 4164-01-P