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Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
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.
The meeting will be held on January 22, 2026, from 9:00 a.m. to 4:30 p.m. Eastern Time (ET).
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 ( printed page 52970) accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm.
The online video conference meeting will be available at the following link on the day of the meeting at: https://youtube.com/live/yrYtTTjlv8A?feature=share.
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 https://www.regulations.gov 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.
You may submit comments as follows:
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-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 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.
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, TPSAC@fda.hhs.gov, 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 https://www.fda.gov/AdvisoryCommittees/default.htm 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.
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:
MR0000268.PD13: ZYN Cinnamon 3 mg ( printed page 52971)
MR0000268.PD15: ZYN Smooth 3 mg [2]
MR0000268.PD16: ZYN Smooth 6 mg [3]
MR0000268.PD17: ZYN Chill 3 mg [4]
MR0000268.PD18: ZYN Chill 6 mg [5]
MR0000268.PD19: ZYN Menthol 3 mg [6]
MR0000268.PD20: ZYN Menthol 6 mg [7]
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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 www.fda.gov/news-events/fda-newsroom.
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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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.
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.
Back to Citation2. Swedish Match might also market this product as ZYN Original 3 mg.
Back to Citation3. Swedish Match might also market this product as ZYN Original 6 mg.
Back to Citation4. Swedish Match might also market this product as ZYN Classic 3 mg.
Back to Citation5. Swedish Match might also market this product as ZYN Classic 6 mg.
Back to Citation6. Swedish Match might also market this product as ZYN Fresh 3 mg.
Back to Citation7. Swedish Match might also market this product as ZYN Fresh 6 mg.
Back to Citation[FR Doc. 2025-20768 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P
13 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.