Tobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-0835]</DEPDOC> <SUBJECT>Tobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice; establishment of a public docket; request for comments. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The meeting will be held on January 22, 2026, from 9:00 a.m. to 4:30 p.m. Eastern Time (ET). </DATES> <HD SOURCE="HED">ADDRESSES:</HD> 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 accessed at: <E T="03">https://www.fda.gov/AdvisoryCommittees/default.htm.</E> The online video conference meeting will be available at the following link on the day of the meeting at: <E T="03">https://youtube.com/live/yrYtTTjlv8A?feature=share.</E> 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 <E T="03">https://www.regulations.gov</E> 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, <SU>1</SU> <FTREF/> established on June 18, 2025. <FTNT> <SU>1</SU>  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. <E T="03">See</E> <E T="04">Federal Register</E> :: 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 <E T="04">Federal Register</E> notice and at least 30 days from the date FDA posts the last group of application materials. </FTNT> You may submit comments as follows: <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> • 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”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> 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.” <E T="03">Instructions:</E> 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 <E T="03">https://www.regulations.gov</E> 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 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 <E T="03">https://www.regulations.gov.</E> 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: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT: </HD> 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, <E T="03">TPSAC@fda.hhs.gov,</E> or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the <E T="04">Federal Register</E> 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 <E T="03">https://www.fda.gov/AdvisoryCommittees/default.htm</E> 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. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Agenda:</E> 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: <FP SOURCE="FP-1">• MR0000268.PD1: ZYN Cool Mint 3 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD2: ZYN Cool Mint 6 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD3: ZYN Peppermint 3 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD4: ZYN Peppermint 6 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD5: ZYN Spearmint 3 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD6: ZYN Spearmint 6 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD7: ZYN Wintergreen 3 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD8: ZYN Wintergreen 6 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD9: ZYN Citrus 3 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD10: ZYN Citrus 6 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD11: ZYN Coffee 3 mg</FP> <FP SOURCE="FP-1">• MR0000268.PD12: ZYN Coffee 6 mg</FP> <FP SOURCE="FP-1"> • MR0000268.PD13: ZYN Cinnamon 3 mg </FP> <FP SOURCE="FP-1">• MR0000268.PD14: ZYN Cinnamon 6 mg</FP> <FP SOURCE="FP-1"> • MR0000268.PD15: ZYN Smooth 3 mg   Swedish Match might also market this product as ZYN Original 3 mg. </FTNT> <FP SOURCE="FP-1"> • MR0000268.PD16: ZYN Smooth 6 mg   Swedish Match might also market this product as ZYN Original 6 mg. </FTNT> <FP SOURCE="FP-1"> • MR0000268.PD17: ZYN Chill 3 mg   Swedish Match might also market this product as ZYN Classic 3 mg. </FTNT> <FP SOURCE="FP-1"> • MR0000268.PD18: ZYN Chill 6 mg   Swedish Match might also market this product as ZYN Classic 6 mg. </FTNT> <FP SOURCE="FP-1"> • MR0000268.PD19: ZYN Menthol 3 mg   Swedish Match might also market this product as ZYN Fresh 3 mg. </FTNT> <FP SOURCE="FP-1"> • MR0 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. 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