Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

This Proposed Rule document was issued by the Food and Drug Administration (FDA)

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Reference 1 Counotte et al Development of the motivational system during adolescence and its sensitivity to disruption by nicotine

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Reference 2 Arrazola et al Patterns of Current Use of Tobacco Products Among US High School Students

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Reference 3 Pepper and Brewer, Electronic Nicotine Delivery System Awareness Use Reactions and Beliefs

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Reference 4 Corey et al Electronic Cigarette Use Among Middle and High School Students

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Reference 5 CDC Tobacco use among middle and high school students

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Reference 6 Goniewicz et al Nicotine Levels in E Cigs

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Reference 7 Ayers et al Tracking the Rise in E cigs

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Reference 8 Richter et al Young adult smoker risk perceptions

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Reference 9 Cobb et al Waterpipe tobacco smoking An emerging health crisis in the United States

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Reference 10 Knishkowy et al Water pipe smoking an emerging health risk behavior

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Reference 11 Eissenberg et al Waterpipe tobacco smoking

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Reference 12 Romito et al Retail promotions and perceptions

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Reference 13 Mejia et al Tobacco industry consumer research on smokeless

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Reference 14 Morrison et al Under the radar

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Reference 15 Alpert et al Free nicotine content

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Reference 16 Tomar et al Patterns of Dual Use of Cigarettes and Smokeless Tobacco Among U S Males Findings From National Surveys

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Reference 17 Villanti et alFlavored Tobacco Product Use Among US Young Adults

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Reference 18 Johnston et al Young Smokers Prevalence Trends Implications and Related Demographic Trends

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Reference 19 Bullen et al Electronic Cigarettes for Smoking Cessatio A randomized Controlled Trial

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Reference 20 Delnevo and Hrywna A Whole Nother Smoke or a Cigarette in Disguise How RJ Reynolds Reframed the Image of Little...

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Reference 21 Delnevo Smokers Choice What Explains the Steady Growth of Cigar Use in the U S

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Reference 22 CDC Consumption of Cigarettes and Combustible Tobacco

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Reference 23 Pearson et al e Cigarette Awareness Use and Harm Perception in U S Adults

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Reference 24 King et alAwareness and Ever Use of Electronic Cigarettes Among U S Adults

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Reference 25 Regan et al Electronic Nicotine Delivery Systems Adult Use and Awareness of the e Cigarette in the USA

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Reference 26 IOM of the National Academies Growing Up Tobacco Free Preventing Nicotine Addication in Children and Youths

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Reference 27 FDA letter to Stakeholders

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Reference 28 NCI Cigars Health Effects and Trends NCI Smoking and Tobacco Control Monograph 9

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Reference 29 Borawski et al Adult Use of Cigars Little Cigars and Cigarillos in Cuyahoga County Ohio A Cross Sectional Study

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Reference 30 Baker et al Health Risks Associated With Cigar Smoking

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Reference 31 American Cancer Society Cigar Smoking

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Reference 32 Rodriguez et al The Association of Pipe and Cigar Use With Cotinine Levels Lung Function and Airflow Obstruction

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Reference 33 Iribarren et al Effect of Cigar Smoking on the Risk of Cardiovascular Disease Chronic Obstructive Pulmonary Disease...

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Reference 34 Coleman et al Use of Flavored Cigars Cigarillos and Little Filtered Cigar

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Reference 35 OIG Youth Use of Cigars Patterns of Use and Perceptions of Risk

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Reference 36 Adkinson et al Electronic Nicotine Delivery Systems International Tobacco Control Four Country Survey

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Reference 37 CDC Centers for Disease Control and Prevention Tobacco Product Use Among Middle and High School Students United...

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Reference 38 Sutfin et al Electronic Cigarette Use by College Students Drug and Alcohol Dependence

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Reference 39 Nides et al Nicotine Blood Levels and Short-term Smoking Reduction With an Electronic Nicotine Delivery System

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Reference 40 Polosa et al A Fresh Look at Tobacco Harm Reduction the case for the Electronic Cigarette

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Reference 41 Cahn et al Electronic Cigarettes as a Harm Reduction Strategy for Tobacco Control

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Reference 42 Polosa et al Effectiveness and tolerability of electronic cigarettes in real life

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Reference 43 Popova and Ling Alternative Tobacco Product Use and Smoking Cessation

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Reference 44 Vickerman K A et al Use of Electronic Cigarettes Among State Tobacco Cessation Quitline Callers

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Reference 45 Caponnetto et al efficiency and safety of an electronic cigarette as tobacco substitute

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Reference 46 Vansickel Electronic Cigaretes Effective Nicotine Delivery After Acute Administration

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Reference 47 Goniewicz et al Levels of Selected Carcinogens and Toxicants in Vapour From Electronic Cigarettes

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Reference 48 NIH State of the Science Conference on Tobacco Use Prevention Cessation and Control Final Panel Statement

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Reference 49 Department of Health and Human Services The Health Consequences of Smoking Nicotine Addiction

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Reference 50 Department of Health and Human Services How Tobacco Smoke Causes Disease The Biology and Behavioral Basis for Smoking...

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Reference 51 HHS Youth and Tobacco Preventing Tobacco Use Among Young People

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Reference 52 SAMHSA Results From the 2008 National Survey on Drug Use and Health National Findings

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Reference 53 Prabbhat and Chaloupka Curbing the Epidemic Governments and the Economics of Tobacco Control

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Reference 54 HHS Preventing Tobacco Use Among Youth and Young Adults

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Reference 55 Poorthuis et al Nicotinic Actions on Neuronal Networks for Cognition General Principles and Long Term Consequences

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Reference 56 Levin et al Adolescent vs Adult Onset Nicotine Self Administration in Male Rats Duration of Effect and...

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Reference 57 Presidents Cancer Panel Promoting Healthy Lifestyles

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Reference 58 Institute of Medicine of the National Academies Ending the tobacco problem

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Reference 59 Barr R and D Pizzagalli A Single Dose of Nicotine Enhances Reward Responsiveness in Nonsmokers Implications for...

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Reference 60 Torres Tejeda et al Enhanced Vulnerability to the Rewarding Effects of Nicotine During the Adolescent Period of...

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Reference 61 Schochet et al The Dendritically Targeted Protein Dendrin Is Induced by Acute Nicotine in Cortical Regions of...

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Reference 62 Slotkin, Adolescent NicotineTreatment Changes the Response of acetylcholine systems to subsequent nicotine...

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Reference 63 Rubenstein Smoking Related CueInduced Brain Activation in Adolescent Light Smokers

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Reference 64 Fabian et al Ad lib Smoking of Black and Mild Cigarillos and Cigarettes

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Reference 65 Terchek et al Measuring Cigar Use in Adolescents Inclusion of a Brand Specific Item

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Reference 66 Nasim et al Cigar Use Misreporting Among Youth Data From the 2009 Youth Tobacco Survey Virginia

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Reference 67 Griffiths M A T R Harmon et al Hubble Bubble Trouble The Need for Education About and Regulation of Hookah Smoking

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Reference 68 Mishina et al Clinical Pharmacology Research Strategy for Dissolvable Tobacco Products 2013

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Reference 69 Washam, Can Cigarette Alternatives Deliver a Safer Fix

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Reference 70 Rainey et al Chemical Characterization of Dissolvable Tobacco Products Promoted to Reduce Harm

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Reference 71 Addictive Define Addictive at Dictionary com

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Reference 72 Benowitz N Pharmacologic Aspects of Cigarette Smoking and Nicotine Addiction

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Reference 73 Stolerman, The neurobiology of tobacco addiction

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Reference 74 Watkins et al Neural Mechanisms Underlying Nicotine Addiction Acute Positive Reinforcement and Withdrawal

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Reference 75 Dani et al Synaptic Plasticity and Nicotine Addiction

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Reference 76 Benowitz Nicotine addiction 2010

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Reference 77 NIDA INFO FACTS Cigarettes and other Tobacco Products 2010

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Reference 78 Cokkinides et al Tobacco Control in the United States Recent Progress and Opportunities

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Reference 79 Connolly, Richter, et al Unintentional Child Poisonings Through Ingestion of Conventional and Novel Tobacco Products

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Reference 80 SAMHSA Results from the 2010 National Survey on Drug Use and Health

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Reference 81 Results From the 2011 National Survey of Drug Use and Health Summary of National Findings Table 4 10A

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Reference 82 Substance Abuse and Mental Health Services Administration Results From the 2010 National Survey on Drug Use and...

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Reference 83 Johnston et al Monitoring the Future National Results on Adolescent Drug Use Overview of Key Findings 2010

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Reference 84 Johnston et al Monitoring the Future National Results on Adolescent Drug Use Overview of Key Findings 2011

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Reference 85 Henley et al Association Between Exclusive Pipe Smoking and Mortality From Cancer and Other Diseases

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Reference 86 HHS Reducing the Health Consequence of Smoking

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Reference 87 Tverdal Bjartveit Health Consequences of Pipe Versus Cigarette moking

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Reference 88 CDC Fact Sheet moking and Tobacco Use Hookahs

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Reference 89 Monn et al Ultrafine particle emissions from waterpipes 2007

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Reference 90 Smith Determinants of Hookah Use among High School Students

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Reference 91 Prignot et al Alternative forms of tobacco use 2008

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Reference 92 Cobb et al Acute Toxicant Exposure and Cardiac Autonomic Dysfunction From Smoking a Single Narghile Waterpipe With...

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Reference 93 Maziak W The Global Epidemic of Waterpipe Smoking

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Reference 94 Akl et al The Effects of Waterpipe Tobacco Smoking on Health Outcomes 2010

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Reference 95 Maziak W The Waterpipe An Emerging Global Risk for Cancer

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Reference 96 Septedjian et al Measurement of 16 Polycyclic Aromatic Hydrocarbons in Narghile Waterpipe Tobacco Smoke

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Reference 97 Schubert et al Mainstream Smoke of the Waterpipe Does This Environmental Matrix Reveal as Significant Source of...

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Reference 98 Jacob III et al Nicotine Carbon Monoxide and Carcinogen Exposure After a Single Use of a Water Pipe

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Reference 99 American Lung Association Tobacco Policy Trend Alert 2007

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Reference 100 Schep L et al Diethylene Glycol Poisoning

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Reference 101 Henningfield J E Zaatari G S Electronic Nicotine Delivery Systems Emerging Science Foundation for Policy

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Reference 102 FDA E Cigarettes at Public Health Focus

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Reference 103 Cobb and Abrams E Cigarette or Drug Delivery Device Regulating Novel Nicotine Products 2011

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Reference 104 Cobb et al Novel Nicotine Delivery Systems and Public Health The Rise of the E Cigarette

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Reference 105 Williams et al Metal and Silicate Particles Including Nanoparticles Are Present in Electronic Cigarette Cartomizer...

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Reference 106 Schrober W et al Use of Electronic Cigarettes Impairs Indoor Air Quality and Increases FeNO Levels of E Cigarette...

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Reference 107 Schripp T et al Does E Cigarette Consumption Cause Passive Vaping

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Reference 108 Memorandum from B J Westenberger to Michael Levy Re Evaluation of E cigarettes

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Reference 109 Trehy et all Analysis of Electronic Cigarette Cartridges Refill Solutions and Smoke for Nicotine and Nicotine...

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Reference 110 Kim et al Determination of Tobacco Specific Nitrosamines in Replacement Liquids of Electronic Cigarettes by Liquid...

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Reference 111 Etter J E Zather and S Svensson Analysis of Refill Liquids for Electronic Cigarettes

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Reference 112 American Cancer Society Electronic Cigarettes 2014

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Reference 113 American Academy of Pediatrics E cigarettes Easy to Buy Can Hook Kids on Nicotine

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Reference 114 Bolario Candy Flavors Put E Cigarettes on Kids Menu National Public Radio

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Reference 115 Chatham Stephens K Taylor et al Notes from the Field Calls to Poison Centers for Exposures to Electronic...

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Reference 116 Malone et al Cigar Risk Perception in Focus Groups of Urban African American Youth

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Reference 117 Brooks et al Cigars Cigarettes and Adolescents

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Reference 118 Nyman et al Trends in Cigar Smoking and Perceptions of Health Risks Among Massachusetts Adults

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Reference 119 Smith et al Harm Perception of Nicotine Products in College Freshmen

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Reference 120 Krosnick et al The Effects of Beliefs About the Health Consequences of Cigarette Smoking on Smoking Onset 2006

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Reference 121 Song Perceptions of Smoking Related Risks and Benefits as Predictors of Adolescence 2009

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Reference 122 Steinberg Cognitive and affective development in adolescence 2005

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Reference 123 Slovic, What does it mean to know a cumulative risk 2000

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Reference 124 Bombard et al Monitoring Polytobacco Use Among Adolescents Do Cigarette Smokers Use Other Forms of Tobacco

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Reference 125 Tomar et al Is Use of Smokeless Tobacco a Risk Factor for Cigarette Smoking The U S Experience

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Reference 126 Haddock et al Evidence That Smokeless Tobacco Use Is a Gateway for Smoking Initiation in Young Adult Males

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Reference 127 Sterlingand Mermelstein Examining Hookah Smoking Among a Cohort of Adolescent Ever Smokers

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Reference 128 Primack et al Waterpipe smoking among U S university students 2013

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Reference 129 Scragg et al Diminished Autonomy Over Tobacco Can Appear With the First Cigarettes 2008

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Reference 130 Hampson et al Smoking Trajectories Across High School Sensation Seeking and Hookah Use

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Reference 131 Heinz et al A Comprehensive Examination of Hookah Smoking in College Students 2013

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Reference 132 State Prevention Advancement and Support Center for Substance Abuse Prevention Best Practices for Responsible...

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Reference 133 Altman et al The Relationship Between Tobacco Access and Use Among Adolescents 1999

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Reference 134 DiFranza Reducing Youth Access to Tobacco

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Reference 135 Sundh et al Does a minimum age law for purchasing tobacco 2006

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Reference 136 Glanz et al Reducing Minors Access to Tobacco 8 Years Experience in Hawaii

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Reference 137 Forster et al The Effects of Community Policies to Reduce Youth Access to Tobacco

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Reference 138 DiFranza Which Interventions Against the Sale of Tobacco to Minors Can Be Expected to Reduce Smoking

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Reference 139 Jason et al Active Enforcement of Cigarette Control Laws in the Prevention of Cigarette Sales to Minors

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Reference 140 Hinds Impact of a Local Ordinance Banning Tobacco Sales to Minors

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Reference 141 Cumming et al Is the Prevalence of Youth Smoking Affected by Efforts to Increase Retailer Compliance With a Minors...

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Reference 142 Rigotti et al The Effect of Enforcing Tobacco Sales Laws on Adolescents Access to Tobacco and Smoking Behavior

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Reference 143 Fichtenberg et al Youth Access Interventions Do Not Affect Youth Smoking

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Reference 144 Ross et al Youth Smoking Uptake Progress Price and Public Policy Effects

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Reference 145 Doubeni et al Perceived Accessibility as a Predictor of Youth Smoking

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Reference 146 Levy and Friend Strategies for Reducing Youth Access to Tobacco A Framework for Understanding Empirical Findings on...

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Reference 147 Schneider et al Implementation of Electronic Locking Devices for Adolescents at German Tobacco Vending Machines

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Reference 148 Census Product Lines Statistics by Kind of Business for the US and states 2007

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Reference 149 Song et al When Health Policy and Empirical Evidence Collide The Case of Cigarette Package Warning Labels and...

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Reference 150 elliott&shannahan Literature Review Evaluation of the Effectiveness of Graphic Health Warnings on Tobacco Product...

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Reference 151 European Health Research Partnership and Centre for Tobacco Control Research, Research Into the Labeling of Tobacco...

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Reference 152 Portillo et al Information Disclosure and Smoking Risk Perceptions Potential Short Term Impact on Spanish Students...

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Reference 153 Hammond Effectiveness of Cigarette Warning Labels in Information Smokers About the Risks of Smoking Findings From...

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Reference 154 Fischer P M et al Recall and Eye Tracking Study of Adolescents Viewing Tobacco Advertisements

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Reference 154A Krugman et al Do Adolescents Attend to Warnings in Cigarette Advertising An Eye Tracking Approach

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Reference 155 Brubaker and S K Mitby Health Risk Warning Labels on Smokeless Tobacco Products Are They Effective

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Reference 156 Truitt Recall of Health Warnings in Smokeless Tobacco Ads

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Reference 157 MacKinnon D and Fenaughty A Substance Use and Memory for Health Warning Labels

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Reference 158 Les Etudes de Marche Createc Canada Health Warning Messages on Smokeless Tobacco Cigars and Pipe Products 2003

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Reference 159 Tobacco Product Information Regulations P C 2000 1039 June 2 2000

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Reference 160 Kozlowski et al Cigar Cigarillo Surveillance Limitations of the U S Department of Agriculture System

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Reference 161 Yerger et al When Is a Cigar Not a Cigar African American Youths Understanding of Cigar Use

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Reference 162 Cullen et al Seven Year Patterns in U S Cigar Use Epidemiology Among Young Adults Aged 18 25 Years A Focus on Race...

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Reference 163 Jolly Exploring the use of little cigars by students at a historically black university 2008

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Reference 164 American Cancer Society Cancer Facts and Figures 2011

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Reference 165 Delnevo et al Trading Tobacco Are Youths Choosing Cigars Over Cigarettes

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Reference 166 Substance Abuse and Mental Health Services Administration Department of Health and Human Services 2001 National...

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Reference 167 Centers for Disease Control and Prevention Youth Risk Behavior Surveillance United States 2009

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Reference 168 Cigar and Pipe Smoking and Cancer Risk in the European Prospective Investigation Into Cancer and Nutrition EPIC

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Reference 169 Internationl Agency for Research on Cancer Tobacco Smoke and Involuntary Smoking IARC Monographs on the Evaluation...

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Reference 170 Shapiro et al Cigar Smoking in Men and Risk of Death From Tobacco-Related Cancers

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Reference 171 HHS The Health Consequences to Involuntary Exposure to Tobacco Smoke

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Reference 172 IOM on Secondhand Smoke Exposure and Acute Coronary Events Secondhand Smoke Exposure and Cardiovascular Effects

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Reference 173 Rose Nicotine and Nonnicotine Factors in Cigarette Addiction

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Reference 174 Baker et al The Effect of Tobacco Ingredients on Smoke Chemistry Part I Flavourings and Additives

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Reference 175 Gaworski et al Toxicologic Evaluation of Flavor Ingredients Added to Cigarette Tobacco Skin Painting Bioassay of...

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Reference 176 Fowler et al Inhibition of Monoamine Oxidase B in the Brains of Smokers

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Reference 177 Fowler et al Brain Monoamine Oxidase A Inhibition in Cigarette Smokers

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Reference 178 Berlin et al A Reversible Monoamine Oxidase A Inhibitor Moclobemide Facilitates Smoking Cessation and Abstinence in...

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Reference 179 George et al A Preliminary Placebo Controlled Trial of Selegiline Hydrochloride for Smoking Cessation

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Reference 180 Green et al Contributory Role for Nornicotine in Nicotine Neuropharmacology Nornicotine Evoked Dopamine Overflow...

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Reference 181 Dwoskin et al S Nornicotine Increases Dopamine Release in a Calcium Dependent Manner From Superfused Rat Striatal...

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Reference 182 Balfour et al The Neurobiology of Tobacco Dependence A Preclinical Perspective on the Role of the Dopamine...

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Reference 183 Deadwyler Electrophysiological Correlates of Abused Drugs Relation to Natural Rewards

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Reference 184 Bardo et al Nornicotine Partially Substitutes for Amphetamine in a Drug Discrimination Paradigm in Rats Pharmacology...

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Reference 185 Jackson et al Role of alpha 5 Nicotinic Acetylcholine Receptors in Pharmacological and Behavioral Effects of...

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Reference 186 Desai et al Dopaminergic and Cholinergic Involvement in the Discriminative Stimulus Effects of Nicotine and Cocaine...

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Reference 187 Goldberg et al Nicotine and Some Related Compounds Effects on Schedule Controlled Behaviour and Discriminative...

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Reference 188 Myers et al Intravenous Self Administration of Acetaldehyde in the Rat as a Function of Schedule Food Deprivation...

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Reference 189 Amit et al Possible Involvement of Acetaldehyde Norepinephrine and Their Tetrahydroisoquinoline Derivatives in the...

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Reference 190 Rodd Henricks et al The Reinforcing Effects of Acetaldehyde in the Posterior Ventral Tegmental Area of Alcohol...

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Reference 191 Risinger et al NIcotine induced conditioned place preference and conditioned place aversion in mice 1995

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Reference 192 Dwoskin et al Minor Alkaloids of Tobacco Release 3H Dopamine From Superfused Rat Striatal Slices

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Reference 193 Perelman Cigar Cyclopedia Basics

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Reference 194 Deeming Tobacco Products To Be Subject to the Federal Food, Drug and Cosmetic Act as Amended by the Family Smoking...

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Comment Period Closed
Jul 9 2014, at 11:59 PM ET
ID: FDA-2014-N-0189-0001

Document Information

Date Posted: Apr 25, 2014
RIN: 0910-AG38
CFR: 21 CFR Parts 1100, 1140, and 1143
Federal Register Number: 2014-09491
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Please do not pass this ruling. The Food and Drug Administration (FDA) Proposed Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and...
My comment pertains specifically to the portion of the definition of a premium cigar that stipulates the premium cigar has a minimum cost of $10. I understand...

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