Trends in Use of E-Cigarette Device Types and Heated Tobacco Products
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Electronic (E-) Cigarettes and Secondhand Aerosol
Defending your right to breathe smokefree air since 1976 Electronic (e-) Cigarettes and Secondhand Aerosol “If you are around somebody who is using e-cigarettes, you are breathing an aerosol of exhaled nicotine, ultra-fine particles, volatile organic compounds, and other toxins,” Dr. Stanton Glantz, Director for the Center for Tobacco Control Research and Education at the University of California, San Francisco. Current Legislative Landscape As of January 2, 2014, 108 municipalities and three states include e-cigarettes as products that are prohibited from use in smokefree environments. Constituents of Secondhand Aerosol E-cigarettes do not just emit “harmless water vapor.” Secondhand e-cigarette aerosol (incorrectly called vapor by the industry) contains nicotine, ultrafine particles and low levels of toxins that are known to cause cancer. E-cigarette aerosol is made up of a high concentration of ultrafine particles, and the particle concentration is higher than in conventional tobacco cigarette smoke.1 Exposure to fine and ultrafine particles may exacerbate respiratory ailments like asthma, and constrict arteries which could trigger a heart attack.2 At least 10 chemicals identified in e-cigarette aerosol are on California’s Proposition 65 list of carcinogens and reproductive toxins, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986. The compounds that have already been identified in mainstream (MS) or secondhand (SS) e-cigarette aerosol include: Acetaldehyde (MS), Benzene (SS), Cadmium (MS), Formaldehyde (MS,SS), Isoprene (SS), Lead (MS), Nickel (MS), Nicotine (MS, SS), N-Nitrosonornicotine (MS, SS), Toluene (MS, SS).3,4 E-cigarettes contain and emit propylene glycol, a chemical that is used as a base in e- cigarette solution and is one of the primary components in the aerosol emitted by e-cigarettes. -
BRFSS Brief Electronic Cigarette
BRFSS Brief Number 2020-01 The Behavioral Risk Factor Surveillance System (BRFSS) is an annual statewide telephone survey of adults developed by the Centers for Disease Control and Prevention (CDC) and administered by the New York State Department of Health. The BRFSS is designed to provide information on behaviors, risk factors, and utilization of preventive services related to the leading causes of chronic and infectious diseases, disability, injury, and death among the noninstitutionalized, civilian population aged 18 years and older. Electronic Cigarette Use New York State Adults, 2017 Introduction and Key Findings Electronic cigarettes (e-cigarettes) are battery-powered devices that heat a solution of liquid nicotine, flavorings, and other chemicals creating an aerosol that is inhaled by the user. E-cigarettes are known by many different names including e-cigs, vapes, vape pens, e-hookahs, and electronic nicotine delivery systems (ENDS). Using an e-cigarette is called vaping. E-cigarettes are not a United States (US) Food and Drug Administration (FDA) approved smoking cessation aid and their usefulness as a cessation aid is unproven. With or without nicotine, e-cigarettes are not hazard-free and e- cigarette aerosol is not simply water vapor; the aerosol may contain heavy metals, volatile organic compounds, ultrafine particles, and other toxins.1 In addition, e-cigarette use can undermine social norms about tobacco, delay cessation among cigarette smokers, and increase the risk of ever using combustible tobacco cigarettes among youth and young adults.1 The long-term health risks of e-cigarettes will not be known for decades. The FDA has extended regulatory authority to all tobacco products including e-cigarettes.2 But the FDA approach to regulation of e-cigarettes is being phased in over time, may be delayed by litigation, and effective regulation may be years away. -
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. -
The Teen Vaping Crisis
The Teen Vaping Crisis Carolina, Cindy, and Jay Problem ● JUUL, the leading company in electronic cigarettes, has sold 16.2 million e-cigarettes in 2017 ● 38% of high school students in the U.S. have tried vaping ● 10% of high school students in the U.S. have smoked ● The legal age to buy vapes in the U.S. is 18 ● Electronic cigarettes are too easily accessible for teens, despite its deadly consequences Why is this a problem? ● The nicotine content of JUUL pods is 5% or 50 mg/ml ● One JUUL pod has the same amount of nicotine as 20 cigarettes ● Leads to cancer and harms all organs ● Teens are too easily becoming addicted to nicotine 7 in 10 teens Are exposed to e-cig advertising Past Legislation ● Little regulation in packaging and distribution in USA at a national level ○ In Erie county, NY Governor Andrew Cuomo attached vaping legislation to his budget ■ Would ban companies from displaying vaping devices where children are allowed ■ Will also raise age to 21 ● Boxes have the warning “This product contains nicotine. Nicotine is an addictive chemical” ● Warning letters to companies who made the packaging look like candy ● Banned the sale of e-cigs to children under 18 ● Countries have plain packaging on normal cigarettes; saw 10% reduction in use in one year Constituents ● Government is working on regulating e-cigs ● Not much done with packaging Non-users ● Public opinion (STAT Harvard poll with 1014 people): Vapers Nearly 100% of users and non users agree that Total packaging should have warnings Solution ● More transparent/simple packaging -
Heated Cigarettes: How States Can Avoid Getting Burned
HEATED CIGARETTES: HOW STATES CAN AVOID GETTING BURNED 8/30/18 1 HEATED CIGARETTES HOW STATES CAN AVOID GETTING BURNED 8/30/18 2 THE PUBLIC HEALTH LAW CENTER 8/30/18 3 8/30/18 4 LEGAL TECHNICAL ASSISTANCE Legal Research Policy Development, Implementation, Defense Publications Trainings Direct Representation Lobby 8/30/18 5 HEATED CIGARETTES HOW STATES CAN AVOID GETTING BURNED • Presenters: – Kristy Marynak, MPP, Public Health Analyst, Centers for Disease Control and Prevention – Hudson Kingston, JD, LLM, Staff Attorney, Tobacco Control Legal Consortium at the Public Health Law Center 8/30/18 6 HEATED CIGARETTES HOW STATES CAN AVOID GETTING BURNED • Heated cigarettes on the global market • Distinguishing features 1. Heating at a temperature lower than conventional cigarettes that produce an inhalable aerosol • Heated Cigarettes: 450-700° F (generally) • Conventional cigarettes: 1250 – 1300 °F, • (max: 1500 °F) 2. Processed, commercial tobacco leaf is the nicotine source, flavor source, or both 8/30/18 7 HEATED CIGARETTES HOW STATES CAN AVOID GETTING BURNED Federal Regulation • Pre-Market Review • Modified Risk Tobacco Product Application • Vapeleaf 8/30/18 8 Heated Tobacco Products: Considerations for Public Health Policy and Practice KRISTY MARYNAK, MPP LEAD PUBLIC HEALTH ANALYST CDC OFFICE ON SMOKING AND HEALTH TOBACCO CONTROL LEGAL CONSORTIUM WEBINAR AUGUST 2018 8/30/18 9 What’s the public health importance of this topic? The landscape of tobacco products is continually changing By being proactive and anticipating new products, we can -
Robert K. Jackler Testimony.Pdf
Brief Biography of Robert K. Jackler, MD: Dr. Jackler is a professor at the Stanford University School of Medicine and is a practicing surgeon. He is the founder and principal investigator of an interdisciplinary research group (Stanford Research Into The Impact of Tobacco Advertising or SRITA) which conducts research into the promotional activities of the tobacco industry. SRITA collected 56,600 original tobacco advertisements which were donated to the National Museum of American History of the Smithsonian Institution. A public exhibit at NMAH drawn from this collection opened in April 2019. SRITA maintains an extensive online tobacco advertising research database (tobacco.stanford.edu) which has over 813,000 unique users. As an academic research program, SRITA scholars conduct a wide spectrum of research into the promotional behaviors of the tobacco industry. SRITA focuses upon original scholarship utilizing the unique resource of our advertising collection. Our early academic focus was primarily an historical study of advertisements from the 20th century. In recent years, our research has focused upon the design and marketing of emerging tobacco products such as e-cigarettes (e.g. JUUL), heated tobacco (e.g. IQOS), and novel nicotine delivery systems. Our research is primarily designed to provide scientific data and analysis to inform regulators and legislators. SYNOPSIS OF OPINIONS: Today’s Tobacco Advertising Conveys the Same Messages as it Did in the 1950s: I suspect that most Americans think that the worst excesses of tobacco marketing lay in the 20th century when countless ads glorified smoking as glamorous and sexy and a worried public was reassured that “More Doctors Smoke Camels.” While the tobacco industry loudly claims they advertise ethically today, my in-depth study of tobacco advertising makes it clear that they still convey the same messages as during the earlier era. -
Banning Flavored E-Cigarettes
CONTENTS Executive Summary 1 Introduction 2 The Potential for Unintended Harms 3 Predicting Response to a Flavor Ban 3 Impacts of a Flavor Ban on Harm Reduction 5 Other Impacts of a Flavor Ban 7 Lost Revenue and the Potential Public Health Tradeoff 8 Conclusion 8 About the Author 9 sation efforts and the growth of counterfeit and contraband products; and harm to communities via lost funding for broader health resources. A limited number of studies have looked at people’s actual and presumptive responses to flavor bans. This small body of research suggests that the policy could reduce vaping in R STREET POLICY STUDY NO. 222 general, but that it may drive some current vapers to resume March 2021 or increase their use of combustible cigarettes and others to seek out their preferred e-cigarette flavors through illicit markets and hard-to-regulate online retailers. As such, both potential sets of behavior changes could tip the net public health impact of flavor bans toward harmful. BANNING FLAVORED Because ENDS users inhale a nicotine-infused vapor rath- E-CIGARETTES COULD HAVE er than toxin-laden tobacco smoke, vaping is considered a safer alternative to smoking combustible cigarettes. In fact, UNINTENDED PUBLIC HEALTH both the U.S. Centers for Disease and Prevention and Public CONSEQUENCES Health England have stated (albeit to varying degrees) that smokers would benefit from switching to e-cigarettes, and By Stacey A. McKenna the devices are gaining traction as cessation tools. Further- more, research shows that flavors may aid individuals who are using e-cigarettes to quit or reduce smoking. -
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. -
Juul Factsheet 2
HEALTH PROMOTION & ADVOCACY CENTER Juuls, Vapes, and E-Cigs Everything You Need to Know More than 20% of high school seniors report vaping regularly or occasionally The Risks of Juuling Many of the of the long-term consequences of Juuls, e-cigarettes, People who vape and vapes are unknown. A study at Johns Hopkins found some e- are more than 4x more likely to start cigarettes contain potentially toxic levels of lead, chromium and smoking nickel- in addition to nicotine absorbed at inhalation. cigarettes! Nicotine is a neurotoxin which can permanently alter brain structure in users under the age of 26, and has consequential cardiovascular affects. 1 2 3 59 MG 92% 2.8 MILLION There are over 15,500 completely The concentration of of vaporizer products The number of adults unregulated flavor nicotine per mL in devices contain diacetyl, a 18-24 in the United States options for e- like Juul- far more than in flavoring linked to severe who vape cigarettes/vapes cigarettes respiratory infection Primack, A.B., et al. “Initation of traditional cigarette smoking after electronic cigarette use” American Journal of Medicine (2017) Stanford University, “Tobacco Prevention Toolkit,” (2018) Rule, A.M., et al. “Metal concentrations in e-cigarette liquid and aerosol 1 samples” Environmental Health Perspectives (2018) HEALTH PROMOTION & ADVOCACY CENTER Nicotine In The Body A stimulant, nicotine is an extremely addictive drug which alters the pleasure pathway of the brain. The human brain can develop such a strong dependence on the drug that a user may no longer control their desire or smoking behaviors- especially problematic with subtle and more easily concealed devices such as Juul.