United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2018_register executive 2018-03-16 article Part II Proposed Rules D09002ee1c7ea547a D09002ee1c7ea5749 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health. FDA is using the term "nonaddictive" in this document specifically in the context of a potentially nonaddictive cigarette. We acknowledge the highly addictive potential of nicotine itself depending upon the route of delivery. As discussed elsewhere in this document, questions remain with respect to the precise level of nicotine in cigarettes that might render them either minimally addictive or nonaddictive for specific members or segments of the population. We envision the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers. The scope of products covered by any potential product standard will be one issue for comment in the ANPRM. Any additional scientific data and research relevant to the empirical basis for regulatory decisions related to a nicotine tobacco product standard is another issue for comment in the ANPRM. 83 FR 11818 https://www.govinfo.gov/app/details/FR-2018-03-16/2018-05345 2018-05345 fr16mr18-19 RIN 0910-AH86 4164-01-P Docket No. FDA-2017-N-6189 https://www.govinfo.gov/app/details/FR-2018-03-16/2018-05345 https://www.govinfo.gov/content/pkg/FR-2018-03-16/html/2018-05345.htm https://www.govinfo.gov/content/pkg/FR-2018-03-16/pdf/2018-05345.pdf 26 p. 11818 11843 83 FR 11818 Title 21 Part 1130 21 CFR Part 1130 RIN 0910-AH86 Tobacco Product Standard for Nicotine Level of Combusted Cigarettes; Federal Register Vol. 83, Issue PRORULE 2018-05345 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-06-14 Docket No. FDA-2017-N-6189 4164-01-P 2018-05345 Advance notice of proposed rulemaking.

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health. FDA is using the term "nonaddictive" in this document specifically in the context of a potentially nonaddictive cigarette. We acknowledge the highly addictive potential of nicotine itself depending upon the route of delivery. As discussed elsewhere in this document, questions remain with respect to the precise level of nicotine in cigarettes that might render them either minimally addictive or nonaddictive for specific members or segments of the population. We envision the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers. The scope of products covered by any potential product standard will be one issue for comment in the ANPRM. Any additional scientific data and research relevant to the empirical basis for regulatory decisions related to a nicotine tobacco product standard is another issue for comment in the ANPRM.

Submit either electronic or written comments on the ANPRM by June 14, 2018. Gerie Voss, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-CTP-1373, gerie.voss@fda.hhs.gov. Tobacco Product Standard for Nicotine Level of Combusted Cigarettes , gerie.voss@fda.hhs.gov http://legacy.library.ucsf.edu/tid/aqu29d00 http://legacy.library.ucsf.edu/tid/bjx60f00 http://legacy.library.ucsf.edu/tid/cyo59d00 http://legacy.library.ucsf.edu/tid/ehf51e00 http://legacy.library.ucsf.edu/tid/eia65d00 http://legacy.library.ucsf.edu/tid/fgn84e00 http://legacy.library.ucsf.edu/tid/fgx81b00 http://legacy.library.ucsf.edu/tid/fqx81b00 http://legacy.library.ucsf.edu/tid/gpx86a99 http://legacy.library.ucsf.edu/tid/gqq00f00 http://legacy.library.ucsf.edu/tid/hdz54a99 http://legacy.library.ucsf.edu/tid/hgq09c00 http://legacy.library.ucsf.edu/tid/jlw84a99 http://legacy.library.ucsf.edu/tid/omd76b00 http://legacy.library.ucsf.edu/tid/pgo68e00 http://legacy.library.ucsf.edu/tid/qdb84a99 http://legacy.library.ucsf.edu/tid/rng84a99 http://legacy.library.ucsf.edu/tid/rnr94a99 http://legacy.library.ucsf.edu/tid/rsy55c00 http://legacy.library.ucsf.edu/tid/rum47a99 http://legacy.library.ucsf.edu/tid/smu97e00 http://legacy.library.ucsf.edu/tid/ucg52i00 http://legacy.library.ucsf.edu/tid/ung84a99 http://legacy.library.ucsf.edu/tid/uvu54f00 http://legacy.library.ucsf.edu/tid/vrk59d00 http://legacy.library.ucsf.edu/tid/wyr92d00 http://legacy.library.ucsf.edu/tid/xsk53d00 http://legacy.library.ucsf.edu/tid/zel13e00 http://legacy.library.ucsf.edu/tid/zit31e00 http://legacy.library.ucsf.edu/tid/zjt31e00 http://legacy.library.ucsf.edu/tid/zpn64e00 http://legacy.library.ucsf.edu/tid/zso05a99 http://nationalacademies.org/hmd/reports/2007/ending-the-tobacco-problem-a-blueprint-for-the-nation.aspx http://ntr.oxfordjournals.org/content/15/6/1113.long#T4 http://tobaccodocuments.org/youth/NcPdBWC19630918.Lt.html http://www.usaid.gov/policy/ads/200/tobacco.pdf http://www.who.int/tobacco/publications/prod_regulation/789241503907/en/ http://www.who.int/tobacco/quitting/en_tfi_quitting_fact_sheet.pdf http://www.xxiicentury.com/home/files/PM%20Alkaloid%20Reduced%20Tobacco%20Program.pdf https://cancercontrol.cancer.gov/tcrb/monographs/9/m9_complete.PDF https://doi.org/10.1371/journal.pone.0121008 https://grants.nih.gov/grants/guide/notice-files/NOT-DA-14-004.html https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2672576 https://legacy.library.ucsf.edu/tid/srm73d00 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5844a2.htm https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5708a1.htm https://www.cdc.gov/nchs/nhis/data-questionnaires-documentation.htm https://www.cdc.gov/tobacco/data_statistics/surveys/nyts/index.htm https://www.coresta.org/determination-nicotine-tobacco-and-tobacco-products-gas-chromatographic-analysis-29185.html https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/#id=sljb0079 https://www.iso.org/standard/56744.html https://www.lens.org/lens/patent/US_8791329_B2 https://www.nap.edu/catalog/19016/understanding-the-us-illicit-tobacco-market-characteristics-policy-context-and https://www.regulations.gov https://www.surgeongeneral.gov/library/reports/ https://www.surgeongeneral.gov/library/secondhandsmoke/report/ https://www.surgeongeneral.gov/library/smokingconsequences/index.html https://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf https://wwws.cdc.gov/tobacco/quit_smoking/how_to_quit/benefits/ Vol. 83, no. 52 Office of the Federal Register, National Archives and Records Administration 2018-03-16 continuing daily deposited born digital 221 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-03-16 P0b002ee199a54a25 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16mr18 https://www.govinfo.gov/app/details/FR-2018-03-16 https://www.govinfo.gov/content/pkg/FR-2018-03-16/pdf/FR-2018-03-16.pdf https://www.govinfo.gov/content/pkg/FR-2018-03-16/xml/FR-2018-03-16.xml fdlp 11633 11843 DGPO 2018-03-16 2024-06-01 FR-2018-03-16 machine generated eng FR FR-2018-03-16 83 52