E-Cigarettes & Electronic Nicotine Delivery Systems
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E-Cigarettes & Electronic Nicotine Delivery Systems Michael V. Burke EdD Program Director Mayo Clinic Nicotine Dependence Center ©2016 MFMER | slide-‹#› Learning Objectives • At the end of the presentation the participants should be able to • Describe the history and patterns of use of ENDS • Summarize literature on health and safety concerns • Discuss current regulatory and policy status and impact on tobacco control ©2016 MFMER | slide-2 What are E-Cigarettes? ©2016 MFMER | slide-‹#› History • Current iteration developed by Chinese pharmacist ‘Hon Lik; • marketed by ‘Ruyan’ in May 2004 • ‘resembling smoke’ • However, basic idea with similar structure/function researched by Big Tobacco going back at least 50 years • First patent in US 1965 • ‘Vaping’ described in a paper in 1979 ©2016 MFMER | slide-4 “Vaping” To inhale vapor from an e-cigarette ©2016 MFMER | slide-5 Electronic Nicotine Delivery System (ENDS): Basic structure A battery-powered device that provides inhaled doses of vaporized nicotine solution (usually) along with flavorants and solvents ©2016 MFMER | slide-6 Difficulty classifying as “one product” Over 466 brands Replete with differences • 7764 unique flavors • Nicotine amounts • Cartridge capacity • Toxicants in vapor • Heating element/battery Shu-Hong Zhu, et. al, Tob. Control 2014;23:iii3-iii9 doi:10.1136/tobaccocontrol-2014-05167 ©2016 MFMER | slide-7 First Generation ECs (‘cigalikes’) • Disposable • Re-chargeable with pre-filled cartridges ©2016 MFMER | slide-8 Avg. Price: ~$7 - $15 ©2016 MFMER | slide-9 Second Generation ECs Refillable with liquids Starter Kits ~ $40 - $180 Dawkins, L. E-Cigarette Summit, Royal Society UK Nov. 2013 ©2016 MFMER | slide-10 Third Generation Vapor Tanks (“Mods)” ©2016 MFMER | slide-11 Big Business • Silicon Valley investors • Vapor CEO say “a generation from now, people may forget what a machine-rolled cigarette looks like.” • “Consumption of e-cigs may overtake traditional cigarettes in the next decade” – Bonnie Herzog, Wells Fargo analyst ©2016 MFMER | slide-12 Family Smoking Prevention and Tobacco Control Act • Became law on June 22, 2009, first time tobacco regulated Gives the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health, including • Restricts tobacco advertising and sales to minors • Requires warning labels on tobacco (*challenged in court) • Manufacturing of products, including changes to reduce harm (cannot ban tobacco or nicotine completely) • New FDA Center that regulates and funds research • Does not regulate tobacco treatment (IND issues) • As a result of a court case, ENDS are considered ‘tobacco products’ even though they do not contain tobacco • FDA has indicated that they intend to regulate ENDS ©2016 MFMER | slide-13 ©2014 MFMER | slide-14 ©2016 MFMER | slide-14 Expected 2015 Vapor Market Expected 2015 Vapor Market Size: $3.5 Billion Vapors/Tanks/Mods & E-Cigarettes: $1.5B Personal Vaporizers: $2.0B C-store, Food, C-Store, Food, Online and Other Online and Other Drug, Mass Drug, Mass Vape Shops: retail Channels: retail channels: Retail Channels: Retail Channels: $1.2B $800M $400M $700M $400M *Other non-tracked outlets, e.g. tobacco-only outlets, etc. Online: $400M Other*: $400M Herzog B, et al. Tobacco Talk: More Bullish Than Retailers-Suggesting Vapor Growth Remains Robust. Wells Fargo Securities Equity Research. Jan 23 2015. ©2016 MFMER | slide-15 ©2016 MFMER | slide-16 U.S. TOBACCO COMPANIES JOIN THE MARKET ©2016 MFMER | slide-17 Lorillard: Blu ©2016 MFMER | slide-18 RJR Reynolds ©2016 MFMER | slide-19 Altria – (Philip Morris USA) ©2016 MFMER | slide-20 BAT – Voke – Medically approved quitting aid ©2016 MFMER | slide-21 How are ENDS Advertised? • ENDS advertising expenditures across media channels tripled from $6.4 million in 2011 to $18.3 million in 20121 • Blu ENDS: spent $12.4 million on advertising in the first quarter of Image from nytimes.com 20132 • Companies spent more than $15 million on television ads between Jan-Sept 20133 Image from facebook.com/gGreenSmokeRacing References: 1) Kim, et al. 2014. 2) Elliot S, 2013, 3) Esterl M, 2014 ©2016 MFMER | slide-22 Vape Shops Clockwise from left: Yahoonews, Nytimes, Theweek ©2016 MFMER | slide-23 Exposure to advertising • 7 in 10 middle and high school youth exposed to e-cigarette ads in 2014 • 1 in 2 exposed in retail stores • 2 in 5 saw e-cigarette ads on line ©2016 MFMER | slide-24 Use of Electronic Cigarettes ©2016 MFMER | slide-‹#› 2014 National Health Interview Survey % Ever tried e- cigarettes % Current use e- cigarettes ©2016 MFMER | slide-26 Prevalence of e-cigarette use in USA • Past 30 day use increased 9 fold among HS students • 1.5% in 2011 • 13.4% in 2014 • Middle school • 0.6% in 2011 • 3.9% in 2014 • In 2013 263,000 middle and high school students who had never smoked a cigarette and used an e-cigarette ©2016 MFMER | slide-27 E-Cigarettes: A Gateway Drug? • Leading form of nicotine use in adolescents (CDC,2014) • E-Cigarette use influences intention to use and progression toward combustible tobacco use • E-Cigarette using youth almost twice as likely to have intentions to smoke conventional cigarettes (CDC,2014) • Over one year, use of e-cigarettes at baseline was significantly associated with progression along the trajectory to cigarette (Primack, et al., 2015. JAMA Pediatr). ©2016 MFMER | slide-28 What is in an E-Cigarette: Safety Considerations ©2016 MFMER | slide-‹#› E-Liquid Solution Composition • Propylene glycol and/or vegetable glycerol • U. S. Food and Drug Administration • “Generally recognized as safe" (GRAS) for use as a direct food additive • Vapor that carries nicotine into body • Nicotine • Varying amounts – Ex. 12 mg/ml same as 1.2% • Flavoring & coloring agents • Impurities & Additives ©2016 MFMER | slide-30 FDA - Center for Drug Evaluation, Division of Pharmaceutical Analysis (DPA) 2009 • Analyzed content of two leading e-cigarette brands • 18 varying types - flavoring, nicotine concentrations, and 0 mg/ml nicotine cartridges • Nicotine inhaler (control) www.fda.gov ©2016 MFMER | slide-31 DPA's analysis: • Diethylene glycol in one cartridge @ 1% • Tobacco-specific nitrosamines (TSNA’s) in 1/2 of samples • As nicotine concentration increased, the number and concentration of TSNA’s increased. (Laugesen 2008, Health New Zealand Ltd.) • Tobacco-specific impurities detected in a majority of the samples tested • Anabasine • Myosmine • β-nicotyrine www.fda.gov ©2016 MFMER | slide-32 Nicotine Delivery • “No nicotine” E-Cigarettes • Low levels of nicotine present in all cartridges tested, except one. • Three cartridges with same label • Markedly different amount of nicotine with each puff. • Range: from 26.8 to 43.2 mcg nicotine/100 mL puff • One high-nicotine cartridge delivered 2 x as much nicotine as the nicotine inhaler www.fda.gov ©2016 MFMER | slide-33 Comparing nicotine between brands (Goniewicz et al. 2013, Nicotine Tob Res) • Selected 16 brands • Total nicotine level in 20 series of 15 puffs (300 total) • Nicotine delivered ranged from 0.5 to 15.4 mg • Effectively delivered nicotine in first 150 puffs • 50-60% of cartridge vaporized ©2016 MFMER | slide-34 Brand Model Labeled Nicotine in Nicotine in nicotine cartridge vapor (150 conc. (mg) puffs, mg) Trendy 808 18 16 3 Collins Age 18 11 4.7 Skycig Skycig 12 12 2.3 Liberro Black 18 19 6.1 Njoy Npro 18 16 5.0 Typical requires 12 x 46ml to deliver 1.5-2.6 mg cigarette puffs Most brand cartridges contained less nicotine than labeled (18 of 35) Seven brands contained more nicotine than labeled ©2016 MFMER | slide-35 Levels of selected carcinogens and toxicants in vapour (Goniewicz et al. 2013) • 12 brands of e-cigarettes tested • Compared with tobacco smoke and medicinal nicotine inhaler (10 sessions/15 puffs) • E cigarettes contained some cytotoxins & carcinogens • Carbonyls • VOC • PAH Levels 9–450 times lower than in cigarette smoke ©2016 MFMER | slide-36 TSNAs Levels in 105 Ecigarette Replacement Liquids Hyun-Ji Kim , et al. Journal of Chromatography A Volume 1291 2013 48 – 55. ©2016 MFMER | slide-37 Systematic Review of Health Effects of Electronic Cigarettes (Pisinger & Døssing, 2014) • High nicotine variability • Inter- and intra-brand • Inaccurate labels, ineffective delivery, etc. • Cytoxicity & carcinogens • Found in flavorants • TSNAs present in most samples (9-450 times lower than conventional cigarettes) • Metals & Particles • Particles of lead, tin, chromium, nickel and aluminum found in varying levels ©2016 MFMER | slide-38 Additional Health Concerns • High levels of formaldehyde (Varlat, et al. 2015) • Formaldehyde within mixtures • Released when heated at high temperature (voltage) • E-cigarettes associated with a significant increase in airway resistance (Vardavas, et al. 2011) • Potential to induce inflammation in airway cells (Tartell, 2015) • Harmful effects similar to those observed in COPD ©2016 MFMER | slide-39 Nicotine Poisoning Cases on the Rise • Dec 2014 death of NY toddler who ingested liquid nicotine1 • 2014 CDC study found a dramatic increase in ENDS-related calls to poison centers from 2011-early 20142 1) ABC News, 2014 2) Chatham-Stephens K, et al. 2014 ©2016 MFMER | slide-40 Other Risk Concerns • Secondhand Exposure to ‘Vapor’ • Nicotine? • Other toxicants (recent press on formaldehyde)? • Long Term Impact of Propylene Glycol and other substances (eg Popcorn Lung?) • Flavorings (youth uptake risk?) • Lithium Ion batteries that can ignite/explode • No current standards for ingredients