Taxation of Emerging Tobacco Products
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Other Tobacco Products (OTP) Are Products Including Smokeless and “Non-Cigarette” Materials
Other tobacco products (OTP) are products including smokeless and “non-cigarette” materials. For more information on smoking and how to quit using tobacco products, check out our page on tobacco. A tobacco user may actually absorb more nicotine from chewing tobacco or snuff than they do from a cigarette (Mayo Clinic). The health consequences of smokeless tobacco use include oral, throat and pancreatic cancer, tooth loss, gum disease and increased risk of heart disease, heart attack and stroke. (American Cancer Society, “Smokeless Tobacco” 2010) Smokeless tobacco products contain at least 28 cancer-causing agents. The risk of certain types of cancer increases with smokeless tobacco: Esophageal cancer, oral cancer (cancer of the mouth, throat, cheek, gums, lips, tongue). Other Tobacco Products (OTP) Include: Chewing/Spit Tobacco A smokeless tobacco product consumed by placing a portion of the tobacco between the cheek and gum or upper lip teeth and chewing. Must be manually crushed with the teeth to release flavor and nicotine. Spitting is required to get rid of the unwanted juices. Loose Tobacco Loose (pipe) tobacco is made of cured and dried leaves; often a mix of various types of leaves (including spiced leaves), with sweeteners and flavorings added to create an "aromatic" flavor. The tobacco used resembles cigarette tobacco, but is more moist and cut more coarsely. Pipe smoke is usually held in the mouth and then exhaled without inhaling into the lungs. Blunt Wraps Blunt wraps are hollowed out tobacco leaf to be filled by the consumer with tobacco (or other drugs) and comes in different flavors. Flavors are added to create aromas and flavors. -
Study Protocol – 24 March 2020
An Open-Label, Parallel Study to Assess Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-Day SwitcH to mybluTM e-Cigarettes in Adult Smokers NCT# 04019626 Study Protocol – 24 March 2020 An Open-Label, Parallel Study to Assess Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-Day Switch to my blu™ e-Cigarettes in Adult Smokers Sponsor Project No.: NER 01/001 Project No.: CA22747 Final Protocol: 28JAN2019 Protocol Amendment 1: 23APR2019 Protocol Amendment 2: 17MAY2019 Protocol Amendment 3: 24MAR2020 GCP Statement This study is to be performed in full compliance with the protocol, Good Clinical Practices (GCP), and applicable regulatory requirements. All required study documentation will be archived as required by regulatory authorities. Confidentiality Statement This document is confidential. It contains proprietary information of Nerudia Ltd. Any viewing or disclosure of such information that is not authorized in writing by Nerudia Ltd. is strictly prohibited. Such information may be used solely for the purpose of reviewing or performing this study. Page 1 CA22747_PROTOCOL AMENDMENT 3_24MAR2020 my blu Safety/Tolerability Study Project No.: CA22747 Nerudia Ltd. PRINCIPAL INVESTIGATOR SIGNATURE PAGE An Open-Label, Parallel Study to Assess Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-Day Switch to my ™ blu e-Cigarettes in Adult Smokers Principal Investigator: Printed Name: Site Name: Address: Tel.: Fax: E-mail: __________________________________ _________ Signature Date Page 7 CA22747_PROTOCOL AMENDMENT 3_24MAR2020 my blu Safety/Tolerability Study Project No.: CA22747 Nerudia Ltd. SYNOPSIS Study Objectives Primary: 1. -
Nicotine Flavoring Other Chemicals to Help with the Aerosolization Process
Professor Rounds WHITEY SEVEY, MD PGY-1 What is this? What is a Juul? E-cigarettes Juul Juul labs produces: Juul device (w/charger) Disposable Juul pods How do e-cigarettes work? Produce an aerosol by heating a liquid Liquid usually contains: Nicotine Flavoring Other chemicals to help with the aerosolization process What makes Juuling different? The Juul pods contain: 0.7mL “e-liquid” with 5% nicotine by weight What makes Juuling different? The Juul pods contain: 0.7mL “e-liquid” with 5% nicotine by weight It’s the Nicotine. Amount of Nicotine Type of Nicotine Typical e-cigarettes contain between 6-30mg nicotine per 1mL of e-liquid Most e- Freebase 1 juul pod contains 59mg cigarettes nicotine Nicotine Juul salts Freebase Nicotine Vs. Nicotine Salt 81.5% of current youth users state they use “BECAUSE IT COMES IN FLAVORS I LIKE” 63% of 15-24 year-old Juul users DO NOT KNOW that the product ALWAYS CONTAINS NICOTINE Why does it matter? Why does it matter? Why does it matter? Marketing Marketing Marketing Marketing Marketing Marketing Backlash Juul’s ads changed Now about current smokers Backlash Juul’s ads changed Now about current smokers Backlash Juul’s ads changed Now about current smokers New warnings In ads Backlash Juul’s ads changed Now about current smokers New warnings In ads On packaging But… Even with the changes to advertising SOCIAL MEDIA has helped fuel Juul’s popularity Company Instagram, Twitter, and Facebook accounts #Hashtags Risks Tobacco use if the leading cause of preventable disease and -
Frequency of Tobacco Use Among Middle and High School Students — United States, 2014
Morbidity and Mortality Weekly Report Weekly / Vol. 64 / No. 38 October 2, 2015 Frequency of Tobacco Use Among Middle and High School Students — United States, 2014 Linda J. Neff, PhD1; René A. Arrazola, MPH1; Ralph S. Caraballo, PhD1; Catherine G. Corey, MSPH2; Shanna Cox, MSPH1; Brian A. King, PhD1; Conrad J. Choiniere, PhD2; Corinne G. Husten, MD2 The use of tobacco products during adolescence increases evidence-based interventions to prevent and reduce all forms the risk for adverse health effects and lifelong nicotine addic- of tobacco use among youths (2). tion (1,2). In 2014, an estimated 4.6 million middle and high NYTS is a cross-sectional, school-based, pencil-and-paper school students were current users of any tobacco product, of questionnaire administered to U.S. middle school and high whom an estimated 2.2 million were current users of two or school students. Information is collected to monitor the more types of tobacco products (3). Symptoms of nicotine impact of comprehensive tobacco control policies and strate- dependence are increased for multiple tobacco product users gies and to inform FDA’s regulatory actions (6). A three-stage compared with single-product users (4,5). CDC and the Food cluster sampling procedure was used to generate a nation- and Drug Administration (FDA) analyzed data from the 2014 ally representative sample of U.S. students in grades 6–12 National Youth Tobacco Survey (NYTS) to determine how who attend public and private schools. Of the 258 schools frequently (the number of days in the preceding 30 days) U.S. middle school (grades 6–8) and high school (grades 9–12) students used cigarettes, e-cigarettes, cigars, and smokeless INSIDE tobacco products. -
Juul and Other High Nicotine E-Cigarettes Are Addicting a New Generation of Youth
JUUL AND OTHER HIGH NICOTINE E-CIGARETTES ARE ADDICTING A NEW GENERATION OF YOUTH Launched in 2015, JUUL quickly disrupted the e-cigarette marketplace, popularizing e-cigarette devices that are sleek, discreet and have sweet flavors and a powerful nicotine hit. Nicotine is highly addictive, can negatively impact the development of the adolescent brain, and can harm the cardiovascular system.1 Youth e-cigarette use in the United States has skyrocketed to what the U.S. Surgeon General and the FDA have called “epidemic” levels, with 3.6 million middle and high school students using e- cigarettes. 2 Former FDA Commissioner Scott Gottlieb has stated, “There’s no question the Juul product drove a lot of the youth use.”3 The Surgeon General has called for “aggressive steps to protect our children from these highly potent products that risk exposing a new generation of young people to nicotine.”4 Use of Nicotine Salts Makes it Easier for New Users to Try E-Cigarettes Just like the tobacco industry has used additives and design changes to make cigarettes more addictive and appealing to new users (particularly youth),5 JUUL pioneered a new e-liquid formulation that delivers nicotine more effectively and with less irritation than earlier e-cigarette models. According to the company, the nicotine in JUUL is made from “nicotine salts found in leaf tobacco, rather than free-base nicotine,” in order to “accommodate cigarette-like strength nicotine levels.”6 JUUL’s original patent stated that, “certain nicotine salt formulations provide satisfaction in an individual superior to that of free base nicotine, and more comparable to the satisfaction in an individual smoking a traditional cigarette. -
Pass the Salt. Why Nicotine Salts Make Vaping Products More Addictive. February 2020
Why nicotine salts make vaping products more addictive Pass the salt Nicotine salts are a chemical form of nicotine that is easier to inhale Chemically speaking, a salt is a substance that is produced by the reaction of an acid with a base. Nicotine, as extracted from tobacco or created synthetically, is a base (pH greater than 7). In this form, it is sometimes called freebase nicotine. Freebase nicotine is harsh to the taste and hard to inhale. Exposing freebase nicotine to an acid converts the nicotine to a salted form. The nicotine molecule picks up a hydrogen proton, making it similar to the protonated nicotine found in cigarettes. This form has lower pH and produces a smoother sensation when being inhaled. E-cigarette companies treat nicotine with an organic acid to produce nicotine salts. JUUL uses benzoic acid; Vype uses lactic Figure 1 courtesy of Dr. Arit Harvanko, UCSF acid. Other brands use levulinic acid, or a combination of organic acids. E-cigarettes that are not treated with organic acids to create nicotine salts would have a pH of about 7.5- 8.0. Like cigars, they would be harsh to the taste and hard to inhale. Canadian cigarettes, which are smoother to the taste than American-blend cigarettes, have a slightly lower pH in the range of 5 to 6.1 2 Tobacco companies studied nicotine salts but used other ways to control pH in cigarette smoke. The tobacco industry has long known that organic acids could be used to create nicotine salts and that this would reduce harshness and make cigarettes more inhalable, and their studies of these methods began in the 1950s and continued until the 1990s.3 Cigarette manufacturers, however, chose other methods to produce smooth-tasting cigarettes with low pH. -
Effect of Free-Base and Protonated Nicotine on Nicotine Yield From
www.nature.com/scientificreports OPEN Efect of free‑base and protonated nicotine on nicotine yield from electronic cigarettes with varying power and liquid vehicle Soha Talih1,3, Rola Salman1,3, Rachel El‑Hage2,3, Nareg Karaoghlanian1,3, Ahmad El‑Hellani2,3, Najat Saliba2,3 & Alan Shihadeh1,3* Nicotine in electronic cigarette (ECIG) liquids can exist in a free‑base or protonated (or “salt”) form. Protonated nicotine is less aversive upon inhalation than free‑base nicotine, and many ECIG manufacturers have begun marketing protonated nicotine products, often with high nicotine concentrations. Regulations intended to control ECIG nicotine delivery limit nicotine concentration but do not consider nicotine form. In this study, we systematically examined the efect of nicotine form on nicotine yield for varying powers and liquid vehicles. A Kanger Subox Mini‑C tank ECIG (0.5 Ω) was used to generate aerosols at varying powers (5–45 W) from liquid solutions that contained either free‑base or protonated nicotine at 15 mg/g concentration, with a liquid vehicle consisting of either propylene glycol (PG) or vegetable glycerin (VG), resulting in four diferent solutions (free‑base/ PG, free‑base/VG, protonated/PG, and protonated/VG). Nicotine yield was quantifed using gas chromatography‑mass spectrometry. Nicotine yields were not infuenced by nicotine form under any condition investigated. At each power level, PG‑based liquids resulted in approximately double the nicotine yield of VG‑based liquids. Nicotine concentrations in the aerosols matched those of the parent liquids for both the PG and VG conditions. Increasing power led to greater nicotine yield across all conditions. -
Complete Annual Report
Philip Morris International 2016 Annual Report THIS CHANGES EVERYTHING 2016 Philip Morris Annual Report_LCC/ANC Review Copy February 22 - Layout 2 We’ve built the world’s most successful cigarette company with the world’s most popular and iconic brands. Now we’ve made a dramatic decision. We’ve started building PMI’s future on breakthrough smoke-free products that are a much better choice than cigarette smoking. We’re investing to make these products the Philip Morris icons of the future. In these changing times, we’ve set a new course for the company. We’re going to lead a full-scale effort to ensure that smoke- free products replace cigarettes to the benefit of adult smokers, society, our company and our shareholders. Reduced-Risk Products - Our Product Platforms Heated Tobacco Products Products Without Tobacco Platform Platform 1 3 IQOS, using the consumables Platform 3 is based on HeatSticks or HEETS, acquired technology that features an electronic holder uses a chemical process to that heats tobacco rather Platform create a nicotine-containing than burning it, thereby 2 vapor. We are exploring two Platform creating a nicotine-containing routes for this platform: one 4 vapor with significantly fewer TEEPS uses a pressed with electronics and one harmful toxicants compared to carbon heat source that, once without. A city launch of the Products under this platform cigarette smoke. ignited, heats the tobacco product is planned in 2017. are e-vapor products – without burning it, to generate battery-powered devices a nicotine-containing vapor that produce an aerosol by with a reduction in harmful vaporizing a nicotine solution. -
Cell-Specific Toxicity of Short-Term JUUL Aerosol Exposure to Human
Pinkston et al. Respir Res (2020) 21:269 https://doi.org/10.1186/s12931-020-01539-1 RESEARCH Open Access Cell-specifc toxicity of short-term JUUL aerosol exposure to human bronchial epithelial cells and murine macrophages exposed at the air–liquid interface Rakeysha Pinkston1,2, Hasan Zaman2, Ekhtear Hossain2, Arthur L. Penn2 and Alexandra Noël2* Abstract Backgroud: JUUL, an electronic nicotine delivery system (ENDS), which frst appeared on the US market in 2015, controled more than 75% of the US ENDS sales in 2018. JUUL-type devices are currently the most commonly used form of ENDS among youth in the US. In contrast to free-base nicotine contained in cigarettes and other ENDS, JUUL contains high levels of nicotine salt (35 or 59 mg/mL), whose cellular and molecular efects on lung cells are largely unknown. In the present study, we evaluated the in vitro toxicity of JUUL crème brûlée-favored aerosols on 2 types of human bronchial epithelial cell lines (BEAS-2B, H292) and a murine macrophage cell line (RAW 264.7). Methods: Human lung epithelial cells and murine macrophages were exposed to JUUL crème brûlée-favored aerosols at the air–liquid interface (ALI) for 1-h followed by a 24-h recovery period. Membrane integrity, cytotoxicity, extracellular release of nitrogen species and reactive oxygen species, cellular morphology and gene expression were assessed. Results: Crème brûlée-favored aerosol contained elevated concentrations of benzoic acid (86.9 μg/puf), a well- established respiratory irritant. In BEAS-2B cells, crème brûlée-favored aerosol decreased cell viability ( 50%) and increased nitric oxide (NO) production ( 30%), as well as iNOS gene expression. -
Carbohydrates—Key Players in Tobacco Aroma Formation and Quality Determination
molecules Review Carbohydrates—Key Players in Tobacco Aroma Formation and Quality Determination Marija Banoži´c 1, Stela Joki´c 1,* , Đurđica Aˇckar 1 , Marijana Blaži´c 2 and Drago Šubari´c 1 1 Faculty of Food Technology Osijek, Josip Juraj Strossmayer University of Osijek, Franje Kuhaˇca20, 31000 Osijek, Croatia; [email protected] (M.B.); [email protected] (Đ.A.); [email protected] (D.Š.) 2 Karlovac University of Applied Sciences, Josip Juraj Strossmayer Square 9, 47000 Karlovac, Croatia; [email protected] * Correspondence: [email protected]; Tel.: +385-31-224-333 Received: 11 March 2020; Accepted: 9 April 2020; Published: 9 April 2020 Abstract: Carbohydrates are important compounds in natural products where they primarily serve as a source of energy, but they have important secondary roles as precursors of aroma or bioactive compounds. They are present in fresh and dried (cured) tobacco leaves as well. The sugar content of tobacco depends on the tobacco variety, harvesting, and primarily on the curing conditions (temperature, time and moisture). If the process of curing employs high temperatures (flue-curing and sun-curing), final sugar content is high. In contrast, when air curing has a lower temperature, at the end of the process, sugar level is low. Beside simple sugars, other carbohydrates reported in tobacco are oligosaccharides, cellulose, starch, and pectin. Degradation of polysaccharides results in a higher yield of simple sugars, but at the same time reduces sugars oxidization and transfer into carbon dioxide and water. Loss of sugar producers will compensate with added sugars, to cover undesirable aroma properties and achieve a better, pleasant taste during smoking. -
Nicotine Delivery and Relief of Craving After Consumption of European
www.nature.com/scientificreports OPEN Nicotine delivery and relief of craving after consumption of European JUUL e‑cigarettes prior and after pod modifcation Nadja Mallock1,2,4*, Andrea Rabenstein3,4, Solveig Gernun3, Peter Laux1, Christoph Hutzler1, Susanne Karch3, Gabriele Koller3, Frank Henkler‑Stephani1, Maria Kristina Parr2, Oliver Pogarell3, Andreas Luch1,2 & Tobias Rüther3 The emergence of e‑cigarettes on the consumer market led to a tremendous rise in e‑cigarette consumption among adolescents in the United States. The success of JUUL and other pod systems was linked to its high nicotine delivery capacity. In compliance with the European Tobacco Product directive, liquid nicotine contents in the European JUUL variants are limited to 20 mg/mL or below. A short time after launching the initial version in Europe, JUUL pods have been modifed in terms of the wick material used. This modifcation has been demonstrated previously to lead to an elevated aerosol generation, consequently, to a larger amount of nicotine per puf generated. The present study was designed to assess whether the mentioned diferences between the “initial” and “modifed” JUUL versions may cause a signifcant diference during consumption, and how nicotine delivery compares with tobacco cigarettes. In this single‑center three‑arm study, nicotine pharmacokinetics and infuence on urge to smoke/vape were compared for tobacco cigarettes, the “initial” version of the European JUUL, and the “modifed” version of the European JUUL. Participants, 15 active smokers and 17 active e‑cigarette users, were instructed to consume their study product according to a pre‑ directed pufng protocol. Venous blood was sampled for nicotine analysis to cover the acute phase and the frst 30 min after starting. -
EU Tobacco Products Directive 2014/40/EC
29.4.2014 EN Official Journal of the European Union L 127/1 I (Legislative acts) DIRECTIVES DIRECTIVE 2014/40/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 53(1), 62 and 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee ( 1 ), Having regard to the opinion of the Committee of the Regions ( 2), Acting in accordance with the ordinary legislative procedure ( 3 ), Whereas: (1) Directive 2001/37/EC of the European Parliament and of the Council ( 4) lays down rules at Union level concerning tobacco products. In order to reflect scientific, market and international developments, substantial changes to that Directive would be needed and it should therefore be repealed and replaced by a new Directive. (2) In its reports of 2005 and 2007 on the application of Directive 2001/37/EC the Commission identified areas in which further action was considered useful for the smooth functioning of the internal market. In 2008 and 2010 the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) provided scientific advice to the Commission on smokeless tobacco products and tobacco additives.