1. Electronic Cigarettes: Hype Versus Science (an update)
Audrey Darville, PhD, APRN, CTTS, FAANP
Certified Tobacco Treatment Specialist,
UK HealthCare
Co-Director, Tobacco Prevention &
Treatment Division, BREATHE
March 2, 2017

2. Learning Objectives
Describe the current state of electronic smoking products
Identify current use patterns of electronic smoking products
Explore cardiovascular concerns associated with the use of electronic smoking devices

3. What is an Electronic Smoking Device?
Developed in China in 2003; introduced in Europe and the US in and banned for sale/distribution in many countries; tested by the FDA in 2009 where inconsistencies were found in labeling versus actual ingredients and the product was refused approval in the U.S.

4. The Tobacco Control Act gives the FDA jurisdiction to regulate tobacco products (e-cigs, cigars, pipe tobacco, and hookah), and as of August, 2016 they have been deemed tobacco products
The deeming rule extends several provisions of the federal Tobacco Control Act to these new tobacco products. For example, these products would now be subject to the federal prohibition on sales to minors, the federal prohibition on free sampling, federal warning label requirements, and the requirement that tobacco manufacturers register with the FDA and seek the agency’s review of new tobacco products.

5. Why the Initial Concern?
Cessation treatment claims led FDA to initially pursue regulation as a drug delivery device
FDA testing found nicotine levels varied widely
Toxins (di-ethylene glycol=antifreeze) was found in one sample and ingredients were variable in others
Early reports raised concern for potential harmful effects to the lungs

6. Over 400 types of Devices
Range from “cig-alike” designs to large tank-style devices with adjustable voltage batteries
Designed & marketed with youth appeal

7. Heat Not Burn Devices
Initially developed in late 1980’s by tobacco companies; use tobacco not e-juice
No real market appeal until recently
Provide “hit” effect of conventional cigarette that is lacking in electronic cigarettes
Recent market expanding as e-cigarette market is slowing
Industry looking to have them regulated as “reduced-risk” products

8. From PMI: “These data alone do not imply or represent a claim of reduced risk or reduced exposure…”(pmiscience.com)
“Reduced-Risk Products (“RRPs”) is the term PMI uses to refer to products with the potential to reduce individual risk and population harm in comparison to smoking cigarettes.”

9. Use Patterns
Primarily users are current or former smokers, many with intent to reduce smoking
Experimentation in non-smokers
No current evidence that long term quit rates are significantly higher than “cold turkey”
Dual/multiple product use is common
Devices are modified for use with substances/drugs other than nicotine
Growing evidence that use may deter cessation

10. Constituents Nicotine: Concentrations can vary widely
Overall, significantly fewer chemicals than in combustible cigarettes (40-60 versus 7000)
Propylene glycol: Principle ingredient in vapor; known lung irritant
Some flavorings associated with known health risks
Formaldehyde: A by-product of heating and oxidation
Aerosolized Particulates: tin, silver, iron, and aluminum. Concentrations of nickel are higher than conventional cigarettes
Oxidizing chemicals

11. Health Concerns
Lung Effects: Immediate effects on lung function and nitric oxide levels variable but somewhat consistent with conventional cigarettes. Lipoid pneumonia attributed to e-cig use in a young woman
Cardiovascular Concerns: Arrhythmias and hypertension with e-cigarette use have been reported
Cytotoxic/teratogenic Effects: Uncertain at this time but concerns have been raised

12. Benowitz (2003) Progress in Cardiovascular Diseases 46 (1), 91-111.
Nicotine effects are dose dependent; high peak levels with initial hit cause catecholamine release. Lower, sustained levels have less impact.
Benowitz (2003) Progress in Cardiovascular Diseases 46 (1),

13. Cardiovascular Effect “Red Flags”
Oxidative stress markers are elevated with even short term use (Carnevale, et al, 2016, Chest DOI:
Chronic use is associated with persistent increases in oxidative stress and sympathetic stimulation in young, healthy subjects (Moheimani, et al, 2017; JAMA Cardiol. doi: /jamacardio )
Particulates and carbonyls such as formaldehyde, acetaldehyde, acetone, acrolein, and butanol in e-cigarettes are associated with impaired regulation of blood pressure, increased clotting, and accelerated formation of atherosclerotic lesions (Bhatnagar, 2016, doi: /s )

14. The Harm Reduction Debate
Current controversy in tobacco control and public health communities
Perceived as less harmful, but harms are largely untested with controlled studies
Multiple studies are ongoing
Many devices developed/marketed by the tobacco industry
Long range impact on tobacco prevalence & cessation rates is debated and largely unknown

15. Impact on Youth Initiation
5.6 million Americans aged <18 years who are alive today are projected to die prematurely from smoking-related disease
Are e-cigarettes a “gateway product”?
Estimated percentage of high school students who currently use (past 30 day) any tobacco products, ≥2 tobacco products, and select tobacco products— National Youth Tobacco Survey 2011–2015

16. In Summary
Safety regulations and standards regarding electronic cigarettes and vaping devices are pending: Product use is not “risk free” but “risk unknown” at this time
Nicotine is highly addictive and has been found in e-juices claiming to be nicotine free
There is increasing concern that e-cigarettes are a gateway to other forms of tobacco use in youth
There is no solid evidence that e-cigarettes help people quit smoking and growing evidence that they may be deterring cessation in certain cases
The tobacco industry is investing heavily in “Reduced-Risk Products”

17. Association for the Treatment of Tobacco Use and Dependence
An organization of providers dedicated to the promotion of and increased access to evidence-based tobacco treatment for the tobacco user.

18. BREATHE Tobacco Treatment Specialist Training Program: An Intensive Evidence-Based Training Program for Health Professionals
Teaches the core competencies for tobacco treatment specialists developed by the Association for the Treatment of Tobacco Use and Dependence
The online course with approximately twenty-five hours of instruction time, which is broken down into five sequential modules
Currently piloting/applying for accreditation but will re-open registration in late spring/early summer
Contact Audrey Darville for more information

19. If interested in clinical case studies see:
Clinical Case Conference Electronic cigarettes: a review of safety and clinical issues
Michael Weaver, MD, FASAM, Alison Breland, PhD, Tory Spindle, BS, & Thomas Eissenberg, PhD
NIH Public Access Manuscript:
J Addict Med. 2014; 8(4): 234–240. doi: /ADM

20. Selected References:
Bhatnagar A. E-cigarettes and cardiovascular disease risk: evaluation of evidence, policy implications, and recommendations. Curr Cardiovasc Risk Rep. 2016;10:1-10. Benowitz, N. L., & Goniewicz, M. L. (2013). The Regulatory Challenge of Electronic Cigarettes. JAMA. doi: /jama Bullen, C., et al. (2013). Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. doi: /S (13) Carnevale R, Sciarretta S, Violi F, Nocella C, Loffredo L, Perri L, Peruzzi M, Marullo AGM, De Falco E, Chimenti I, Valenti V, Biondi-Zoccai G, Frati G, Acute impact of tobacco versus electronic cigarette smoking on oxidative stress and vascular function, CHEST (2016), doi: /j.chest England LJ, et al. (2015) Nicotine and the Developing Human: A Neglected Element in the Electronic Cigarette Debate. Am J Prev Med. 2015;doi /j.amepre Goniewicz, M. L., et al. (2013). Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. doi: /tobaccocontrol Grana R, et al. (2014) E-Cigarettes: A Scientific Review. Circulation;129(19): Hajek P, et al. (2014) Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit. Addiction;109(11): McRobbie H, et al. (2015). Electronic cigarettes for smoking cessation and reduction. Cochrane Database Syst Rev. 2015;12:CD Moheimani RS, Bhetraratana M, Yin F, et al. Increased cardiac sympathetic activity and oxidative stres in habitual electronic cigarette users: implications for cardiovascular risk [published online February 1, 2017]. JAMA Cardiol. doi: /jamacardio Vardavas CI, et al. Acute pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance and exhaled nitric oxide. Chest. 2012;141(6): Williams, M., et al. (2013). Metal and Silicate Particles Including Nanoparticles Are Present in Electronic Cigarette Cartomizer Fluid and Aerosol. PLoS One, 8(3), e doi: /journal.pone Zarwertailo, L., Pavlov, D., Ivanova, A., Ng, G., Baliunas, D., Selby, P., (2017). Concurrent e-cigarette use during tobacco dependence treatment in primary care settings: Association with smoking cessation at 3- and 6-months.NTR19(2): Zhu SH, et al. (2014). Four hundred and sixty brands of e-cigarettes and counting: implications for product regulation. Tob Control;23(Suppl 3):iii3-9.