E-Cigarettes in Canada
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Surveillance of U.S. Corporate Filings Provides a Proactive Approach to Inform Tobacco Regulatory Research Strategy
Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 25 January 2021 doi:10.20944/preprints202101.0472.v1 Article Surveillance of U.S. corporate filings provides a proactive approach to inform tobacco regulatory research strategy S. Emma Sarles 1, Edward C. Hensel 2* and Risa J. Robinson 3 1 PhD in Engineering Student, Rochester Institute of Technology, Rochester NY, USA; [email protected], https://orcid.org/0000-0003-4890-1820 2 Department of Mechanical Engineering, Rochester Institute of Technology, Rochester NY, USA; [email protected], https://orcid.org/0000-0002-2682-0766 3 Department of Mechanical Engineering, Rochester Institute of Technology, Rochester NY, USA; [email protected], https://orcid.org/0000-0001-8488-5448 * Correspondence: [email protected] Abstract: The popularity of electronic cigarettes in the United States and around the world has led to a startling rise in youth nicotine use. The Juul e-cigarette was introduced in the U.S. market in 2015 and had captured approximately 13% of the U.S. market by 2017. Unlike many other contemporary electronic cigarette companies, the founders behind the Juul® e-cigarette approached their product launch like a traditional high-tech start-up company, not like a tobacco company. This article presents a case study of Juul’s corporate and product development history in the context of US regulatory actions. The objective of this article is to demonstrate the value of government- curated archives as leading indicators which can (a) provide insight into emergent technologies and (b) inform emergent regulatory science research questions. A variety of sources were used to gather data about the Juul e-cigarette and the corporations that surround it. -
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 -
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. -
Emerging Issues in Tobacco Control: the Rise of Electronic Products and Implications for Policy, Planning, and Practice
Emerging Issues in Tobacco Control: The Rise of Electronic Products and Implications for Policy, Planning, and Practice B R I A N A. KING, PHD, MPH DEPUTY DIRECTOR FOR RESEARCH TRANSLATION OFFICE ON SMOKING AND HEALTH State of Alaska Tobacco Prevention and Control Grantee Training Meeting ● November 14, 2018 1 What Are They? Why Are They 2 Popular? Who’s Using 3 Them? 4 Are They Safe? What Can We 5 Do About it? 1 What Are They? Why Are They 2 Popular? Who’s Using 3 Them? 4 Are They Safe? What Can We 5 Do About it? The Good News: Cigarette Smoking Is Down 40 35 30 25 smoking prevalence smoking 20 15 Cigarette Cigarette 10 5 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Adults 18+ High School Students Source: Adult cigarette smoking prevalence data are from the National Health Interview Survey (NHIS). High school cigarette smoking prevalence data are from the National Youth Risk Behavior Survey. The Bad News: The Landscape Is Evolving Cigars, Cigarillos Cigarettes Little Cigars Smokeless Pipes Tobacco Snus Hookah Bidis Dissolvables Kreteks E-cigarettes Heated Tobacco Products E-cigarettes: A Rapidly Diversifying Class The E-cigarette Landscape is Volatile Source: King, BA, Gammon DG, Marynak KL, Rogers T. Electronic Cigarette Sales in the United States, 2013-2017. JAMA October 2018;Volume 320:Number 13. The Rise of JUUL What Are “Heat Not Burn” Products? Contain Tobacco Throat Hit Similar to Cigarettes Pending FDA Pre-Market Approval A scientific advisory committee met to discuss the MRTP application in January 2018. -
Heated Tobacco Products (Htps) Information Sheet May 2018 WHO/NMH/PND/17.6
HEATED TOBACCO PRODUCTS (HTPS) INFORMATION SHEET MAY 2018 WHO/NMH/PND/17.6 What is a heated tobacco product? Heated tobacco products are tobacco products that produce aerosols containing nicotine and other chemicals, which are inhaled by users, through the mouth. They contain the highly addictive substance nicotine (contained in the tobacco), which makes HTPs addictive. They also contain non-tobacco additives, and are often flavoured. HTPs mimic the behaviour of smoking conventional cigarettes, and some make use of specifically designed cigarettes to contain the tobacco for heating. What are some examples of HTPs? Where are HTPs marketed? There are a number of these tobacco products HTPs are marketed or planned to be marketed in available on several markets. Examples include close to forty countries as of September 2017*, iQOS from Philip Morris International, Ploom and based on the current trend, it is likely that TECH from Japan Tobacco International, Glo these tobacco products will be introduced in from British American Tobacco, and PAX from more countries. PAX Labs. Are HTPs electronic-cigarettes? How do HTPs work? No, HTPs are not e-cigarettes. HTPs heat tobacco In order to produce the nicotine-infused vapor, to generate nicotine. E-cigarettes heat e-liquid, HTPs heat tobacco up to 350°C (lower than 600°C which may or may not contain nicotine and in as in conventional cigarettes) using battery- most cases do not contain tobacco. powered heating-systems. The heating-system enclosed in a device, can be an external heat source to aerosolize nicotine from specially designed cigarettes (e.g. iQOS and Glo), or a heated sealed chamber to aerosolize nicotine directly from tobacco leaf (ex. -
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. -
Action Needed: E-Cigarettes
ACTION NEEDED: E-CIGARETTES Since their introduction in 2008, e-cigarettes have become both ubiquitous and an increasing source of public policy concern and debate. This concern stems primarily from drastic increases in youth e-cigarette use. The most recent data show that 27.5% of high schoolers are using these products — a rate of youth tobacco product use not seen in nearly two decades. The public health community, parents and educators are shocked and worried to find their children and students using these products at home and even in class. Young people are reporting severe signs of dependence, E-cigarettes are now threatening including using e-cigarettes when they first wake up, inability to concentrate in the classroom without to undo all the progress that the using an e-cigarette, and even waking in the night public health community and to get a nicotine fix. government have made over decades We have known for decades that youth in particular to reduce cigarette smoking should not be exposed to nicotine because it changes brain chemistry to create a stronger addiction, can lead to memory and concentration Current generation of e-cigarettes problems, and can make youth who use it more susceptible to addiction to other substances. Research also suggests that young people who use e-cigarettes are four times more likely to go on to smoke combustible cigarettes. E-cigarettes are now threatening to undo all the progress that the public health community and JUUL government have made over decades to reduce cigarette smoking. Indeed, the surgeon general raised the alarm by issuing an advisory declaring a youth e-cigarette epidemic in December 2018.