Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 1160</CFR> <DEPDOC>[Docket No. FDA-2024-N-5471]</DEPDOC> <RIN>RIN 0910-AI76</RIN> <SUBJECT>Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the proposed rule must be submitted by September 15, 2025. Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by September 15, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 15, 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. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: 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-2024-N-5471 for “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), 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 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 <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 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: <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. Go to the Federal eRulemaking Portal at <E T="03">https://www.regulations.gov</E> for access to the rulemaking docket, including any background documents and the plain-language summary of the proposed rule of not more than 100 words in length required by the Providing Accountability Through Transparency Act of 2023. Submit comments on the information collection under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) at <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E> Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The title of this proposed collection is “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products.” <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">With regard to the proposed rule:</E> Nate Mease or Dhanya John, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, <E T="03">CTPRegulations@fda.hhs.gov.</E> <E T="03">With regard to the information collection:</E> JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED"> SUPPLEMENTARY INFORMATION: </HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Proposed Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Proposed Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP> <FP SOURCE="FP-2">III. Background</FP> <FP SOURCE="FP1-2">A. Need for the Regulation</FP> <FP SOURCE="FP1-2">B. Relevant Regulatory History</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP-2">IV. Nicotine in Cigarettes and Other Combusted Tobacco Products: Addiction, Initiation, Dependence, Cessation, Relapse, Health Effects, and Consumer Perceptions</FP> <FP SOURCE="FP1-2">A. Nicotine Is Addictive</FP> <FP SOURCE="FP1-2">B. The Developing Brain's Vulnerability to the Effects of Nicotine Leads to Progression to Regular Cigarette Use Among Youth and Young Adults Who Experiment</FP> <FP SOURCE="FP1-2">C. Youth and Adult Cigarette Smoking Cessation and Relapse</FP> <FP SOURCE="FP1-2">D. Smoking Cigarettes and Other Combusted Tobacco Products Causes Serious Negative Health Effects</FP> <FP SOURCE="FP1-2">E. Tobacco Product Marketing Has Contributed to Disparities in Use and Health Outcomes</FP> <FP SOURCE="FP1-2">F. Consumer Knowledge, Attitudes, Beliefs, and Perceptions About Nicotine</FP> <FP SOURCE="FP-2">V. History and Perceptions of VLNC Cigarettes</FP> <FP SOURCE="FP1-2">A. History of LNC and VLNC Cigarettes</FP> <FP SOURCE="FP1-2">B. Consumer Knowledge, Attitudes, Beliefs, and Perceptions Regarding VLNC Cigarettes and Regulation of Levels of Nicotine in Tobacco</FP> <FP SOURCE="FP-2">VI. Rationale for Products Covered by the Proposed Product Standard</FP> <FP SOURCE="FP1-2">A. Prevalence and Abuse Potential of Cigarettes and Other Combusted Tobacco Products</FP> <FP SOURCE="FP1-2">B. Potential for Tobacco Product Switching</FP> <FP SOURCE="FP-2">VII. Discussion of Nicotine-Related Topics</FP> <FP SOURCE="FP1-2">A. Approach To Limiting User Exposure to Nicotine</FP> <FP SOURCE="FP1-2">B. Scientific Evidence Supports the Target Level of Nicotine</FP> <FP SOURCE="FP1-2">C. An Immediate Nicotine Reduction Approach Is Strongly Supported by Scientific Evidence</FP> <FP SOURCE="FP1-2">D. Scientific Evidence Supports the Use of an Analytical Test Method To Determine Nicotine Level</FP> <FP SOURCE="FP1-2">E. Scientific Evidence Supports the Technical Achievab ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 889k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━