Notice2025-20768
Tobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC or the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues related to tobacco products. The meeting will be open to the public. FDA is establishing a docket for public comments related to the TPSAC meeting.
Full Text
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<title>Federal Register, Volume 90 Issue 224 (Monday, November 24, 2025)</title>
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[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52969-52971]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20768]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0835]
Tobacco Products Scientific Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Tobacco Products Scientific
Advisory Committee (TPSAC or the Committee). The general function of
the Committee is to provide advice and recommendations to FDA on
regulatory issues related to tobacco products. The meeting will be open
to the public. FDA is establishing a docket for public comments related
to the TPSAC meeting.
DATES: The meeting will be held on January 22, 2026, from 9:00 a.m. to
4:30 p.m. Eastern Time (ET).
ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online video
conferencing platform. Answers to commonly asked questions about FDA
advisory committee meetings may be
[[Page 52970]]
accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
The online video conference meeting will be available at the
following link on the day of the meeting at: <a href="https://youtube.com/live/yrYtTTjlv8A?feature=share">https://youtube.com/live/yrYtTTjlv8A?feature=share</a>.
FDA has established a docket for public comment on this meeting.
The docket number is FDA-2025-N-0835. The docket will close on January
21, 2026. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will
accept comments on this advisory committee meeting until 11:59 p.m. ET
at the end of January 21, 2026. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
Comments received on or before January 7, 2026, will be provided to
the Committee. Comments received after that date will be taken into
consideration by FDA but will not be considered by the Committee. FDA
also reminds the public that comments directed to the application may
be submitted to Docket No. FDA-2025-N-0835,\1\ established on June 18,
2025.
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\1\ On June 18, 2025, FDA established a docket, Docket No. FDA-
2025-N-0835, for comments related to the same applications subject
to this TPSAC meeting. See Federal Register:: Modified Risk Tobacco
Product Application: Applications for ZYN Products Submitted by
Swedish Match U.S.A., Inc. The closing date for the comment period
for Docket No. FDA-2025-N-0835 will be no earlier than 180 days from
the date of the Federal Register notice and at least 30 days from
the date FDA posts the last group of application materials.
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You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-0835 for ``Tobacco Products Scientific Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments.'' Received comments on the advisory committee meeting, those
filed in a timely manner, will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as written/paper submissions. 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.'' FDA 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information 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 the 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Rachel Jang, PharmD, DFO, Center for
Tobacco Products, Food and Drug Administration, Document Control
Center, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-
0002, 1-877-287-1373, <a href="/cdn-cgi/l/email-protection#7e2a2e2d3f3d3e181a1f5016160d50191108"><span class="__cf_email__" data-cfemail="e3b7b3b0a2a0a3858782cd8b8b90cd848c95">[email protected]</span></a>, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On January 22, 2026, the Center for Tobacco Products' TPSAC
will convene for one open session, during which the Committee will
discuss modified risk tobacco product applications submitted by Swedish
Match USA, Inc. for the following products:
<bullet> MR0000268.PD1: ZYN Cool Mint 3 mg
<bullet> MR0000268.PD2: ZYN Cool Mint 6 mg
<bullet> MR0000268.PD3: ZYN Peppermint 3 mg
<bullet> MR0000268.PD4: ZYN Peppermint 6 mg
<bullet> MR0000268.PD5: ZYN Spearmint 3 mg
<bullet> MR0000268.PD6: ZYN Spearmint 6 mg
<bullet> MR0000268.PD7: ZYN Wintergreen 3 mg
<bullet> MR0000268.PD8: ZYN Wintergreen 6 mg
<bullet> MR0000268.PD9: ZYN Citrus 3 mg
<bullet> MR0000268.PD10: ZYN Citrus 6 mg
<bullet> MR0000268.PD11: ZYN Coffee 3 mg
<bullet> MR0000268.PD12: ZYN Coffee 6 mg
<bullet> MR0000268.PD13: ZYN Cinnamon 3 mg
[[Page 52971]]
<bullet> MR0000268.PD14: ZYN Cinnamon 6 mg
<bullet> MR0000268.PD15: ZYN Smooth 3 mg \2\
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\2\ Swedish Match might also market this product as ZYN Original
3 mg.
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<bullet> MR0000268.PD16: ZYN Smooth 6 mg \3\
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\3\ Swedish Match might also market this product as ZYN Original
6 mg.
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<bullet> MR0000268.PD17: ZYN Chill 3 mg \4\
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\4\ Swedish Match might also market this product as ZYN Classic
3 mg.
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<bullet> MR0000268.PD18: ZYN Chill 6 mg \5\
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\5\ Swedish Match might also market this product as ZYN Classic
6 mg.
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<bullet> MR0000268.PD19: ZYN Menthol 3 mg \6\
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\6\ Swedish Match might also market this product as ZYN Fresh 3
mg.
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<bullet> MR0000268.PD20: ZYN Menthol 6 mg \7\
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\7\ Swedish Match might also market this product as ZYN Fresh 6
mg.
Discussion generally will focus on evidence related to the relative
health risks of the products, consumer understanding and perceptions of
the applicant's proposed modified risk claim, and the potential public
health impact of a modified risk marketing order.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the time of the
advisory committee meeting and be posted on FDA's website after the
meeting. Background material and the link to the online video
conference meeting will be available at <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll down to the appropriate
advisory committee meeting link.
The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. ET on January 22, 2026. Those
individuals interested in making formal oral presentations should
notify the contact person (see FOR FURTHER INFORMATION CONTACT) and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, along with their names, phone numbers,
and email addresses of proposed participants, on or before 12 p.m. ET
on December 31, 2025. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by January
5, 2026.
For press inquiries, please contact the FDA Newsroom at
<a href="http://www.fda.gov/news-events/fda-newsroom">www.fda.gov/news-events/fda-newsroom</a>.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Rachel Jang, PharmD, DFO (see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform in conjunction with the physical
meeting room (see location). This waiver is in the interest of allowing
greater transparency and opportunities for public participation, in
addition to convenience for advisory committee members, speakers, and
guest speakers. The conditions for issuance of a waiver under 21 CFR
10.19 are met.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-20768 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P
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