{"abstract":"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.","action":"Advance notice of proposed rulemaking.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2018/03/16/2018-05345.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1130,"title":21}],"citation":"83 FR 11818","comment_url":null,"comments_close_on":"2018-06-14","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the ANPRM by June 14, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-6189"],"dockets":[{"supporting_documents":[{"title":"Reference 94_Gross_1997_Nicotine Containing Versus De Nicotinized Cigarettes Effects on Craving and Withdrawal","document_id":"FDA-2017-N-6189-0184"},{"title":"Reference 90_Eid_2005_Placebo cigarettes in a spaced smoking paradigm","document_id":"FDA-2017-N-6189-0182"},{"title":"Reference 84_Sof rev_2012_The reinforcement threshold for nicotine as a target for tobacco control","document_id":"FDA-2017-N-6189-0176"},{"title":"Reference 78_NIH_Notice of Availability of Nicotine Research Cigarettes Through NIDA’s Drug Supply Program","document_id":"FDA-2017-N-6189-0166"},{"title":"Reference 93_Perkins_2008_Mood Influences on Acute Smoking Responses Are Independent of Nicotine Intake and Dose Expectancy","document_id":"FDA-2017-N-6189-0158"},{"title":"Reference 168_Geiss_1972_Bw Process I  Reductions of Tobacco Nicotine Using Selected Bacteria","document_id":"FDA-2017-N-6189-0131"},{"title":"Reference 169_Geiss 75_Bw Process VI  Metabolism of Nicotine and Other Biochemistry of the Bw Process","document_id":"FDA-2017-N-6189-0130"},{"title":"Reference 136_Borriston_1984_.  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