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E-cigarettes and colored potions E-cigarettes and colored potions

Developing and testing e-cigarette health warning labels targeting young people

In this project, using a mixed methods approach, we will combine a Delphi study to generate the first set of candidate health warning labels, conduct focus group sessions with ENDS users to adapt the health warning labels to our target population, and conduct a controlled clinical lab experiment to test the effect of health warning labels on a myriad of subjective and objective outcomes (e.g. harm perception, intention to quit, exposure toxicants).

E-Cigarette Use is an Important Public Health Problem in the United States

The most prevalent form of nicotine product amongst middle and high school students in the United States are e-cigarettes. E- cigarettes are battery powered devices that include nicotine and other additives in the form of an aerosol.1 E-cigarettes are different from cigarettes in that they come in different sizes and shapes and are comprised of multiple components (e.g., juice, device, battery). E-cigarette marketing claims (e.g. of product safety) are important drivers of e-cigarette uptake and use among young people.2, 3 E-cigarettes emit toxic substances, and their use leads to nicotine dependence and increased risk of cigarette smoking initiation among young people.4 As a result, the FDA Commissioner declared in 2018 that e- cigarette use among youth reached “nothing short of an epidemic proportion of growth”.5

According to the National Youth Tobacco Survey in 2016, the most common reasons for e- cigarette use amongst youth include the assumptions that e-cigarettes are less harmful than cigarettes, the variety and availability of flavors, and the social exposure to e-cigarettes from friends and family.6 https://tobaccocontrol.bmj.com/content/24/Suppl_1/i31.short  The National Youth Tobacco Survey (NYTS) assessed self-reported reasons for e-cigarette use among middle and high school students in the US. The most commonly selected reasons for US middle and high school students who reported having used e-cigarettes during the past 30 days were used by “friend or family member” (39%), availability of “flavors such as mint, candy, fruit, or chocolate” (31.0%) and the belief that “they are less harmful than other forms of tobacco such as cigarettes” (17.1%).4 During 2017-2018, e-cigarette use increased considerably among U.S middle and high school students.

The Importance of Communicating the Health Risks of E-Cigarette Use

Less evidence exists on the health risks of e-cigarettes, as it is a relatively new product that has emerged in recent years. Nonetheless, recent studies suggest that the use of e- cigarettes may have a negative impact on cardiovascular health.7 E-cigarettes are now the leading tobacco/nicotine product among young people in the US, where 27.5% of high school students in 2019 and 9.2% of young adults (18-24 years) in 2016 were current e-cigarette users.8, 9 According to national surveillance systems, between 2017 to 2018, E-cigarette use has increased by 46.2% among young adults, and 78% among high school students.10, 11 Young people are particularly prone to e-cigarettes due to their novelty, social acceptability, flavors, misperceptions of safety, and targeted industry marketing.12, 13

Flavorings on e-cigarette products are a largely unrecognized potential hazard that contain respiratory toxins. They create ultrafine aerosols that are inhaled deeply into the lungs, increasing the risk of developing lung disease.14 The liquid found in e-cigarettes contains nicotine, an addictive chemical, that can affect the development of the hippocampus a cerebral cortex among adolescents.15 Accumulating evidence shows that e-cigarette use is associated with nicotine dependence, acute respiratory symptoms, and increased risk of cigarette smoking initiation among young people.16, 4

Accordingly, there is an urgent need to respond to the e-cigarette epidemic among US youth, with communicating e-cigarette risks to young people being a cornerstone of such response. Communicating the health risks associated with e-cigarettes is important in order to reduce tobacco related harms and the overall use of e-cigarettes amongst youth and has been endorsed by leading health organizations.4, 8 In order to assess the health warning labels developed for our project, the message impact framework will be utilized. The message impact framework, a successful model used in cigarette health warning labels research assumes that features on health warning labels can lead to behavioral change and a chain of psychological events such as attracting users, influencing emotions (e.g attention, fear), affecting cognitive reactions such as thinking about the risk (harm perception), inducing intention to change the behavior (intention to quit), and ultimately behavior change (e.g reducing or quitting use).17

References
  1. Zhu, S. H., Sun, J. Y., Bonnevie, E., Cummins, S. E., Gamst, A., Yin, L., & Lee, M. (2014). Four hundred and sixty brands of e-cigarettes and counting: implications for product regulation. Tobacco control, 23 Suppl 3(Suppl 3), iii3–iii9. https://doi.org/10.1136/tobaccocontrol-2014-051670
  2. Li, W., Vargas-Rivera, M., Ebrahimi Kalan, M., Ben Taleb, Z., Asfar, T., Osibogun, O., Noar, S. M., & Maziak, W. (2022). The Effect of Graphic Health Warning Labels Placed on the ENDS Device on Young Adult Users' Experience, Exposure and Intention to Use: A Pilot Study. Health communication, 37(7), 842–849. https://doi.org/10.1080/10410236.2021.1872158
  3. Wang, T. W., Gentzke, A., Sharapova, S., Cullen, K. A., Ambrose, B. K., & Jamal, A. (2018). Tobacco Product Use Among Middle and High School Students - United States, 2011-2017. MMWR. Morbidity and mortality weekly report, 67(22), 629–633. https://doi.org/10.15585/mmwr.mm6722a3
  4. National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. E- Cigarette Use Among Youth and Young Adults: A Report of the Surgeon General. Centers for Disease Control and Prevention (US), 2016.
  5. Printz C. (2018). Food and drug administration takes steps to curb teen vaping. Cancer, 124(23), 4431. https://doi.org/10.1002/cncr.31868
  6. Tsai, J., Walton, K., Coleman, B. N., Sharapova, S. R., Johnson, S. E., Kennedy, S. M., & Caraballo, R. S. (2018). Reasons for Electronic Cigarette Use Among Middle and High School Students - National Youth Tobacco Survey, United States, 2016. MMWR. Morbidity and mortality weekly report, 67(6), 196–200. https://doi.org/10.15585/mmwr.mm6706a5
  7. Lippi, G., Favaloro, E. J., Meschi, T., Mattiuzzi, C., Borghi, L., & Cervellin, G. (2014). E-cigarettes and cardiovascular risk: beyond science and mysticism. Seminars in thrombosis and hemostasis, 40(1), 60–65. https://doi.org/10.1055/s-0033-1363468
  8. FDA (2019). " FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illness." From https://www.fda.gov/news-events/congressional-testimony/fda-regulation-electronic-nicotine-delivery-systems-and-investigation-vaping-illnesses-09252019
  9. Mirbolouk, M., Charkhchi, P., Kianoush, S., Uddin, S. M. I., Orimoloye, O. A., Jaber, R., Bhatnagar, A., Benjamin, E. J., Hall, M. E., DeFilippis, A. P., Maziak, W., Nasir, K., & Blaha, M. J. (2018). Prevalence and Distribution of E-Cigarette Use Among U.S. Adults: Behavioral Risk Factor Surveillance System, 2016. Annals of internal medicine, 169(7), 429–438. https://doi.org/10.7326/M17-3440
  10. Dai, H., & Leventhal, A. M. (2019). Association of electronic cigarette vaping and subsequent smoking relapse among former smokers. Drug and alcohol dependence, 199, 10–17. https://doi.org/10.1016/j.drugalcdep.2019.01.043
  11. Gentzke, A. S., Creamer, M., Cullen, K. A., Ambrose, B. K., Willis, G., Jamal, A., & King, B. A. (2019). Vital Signs: Tobacco Product Use Among Middle and High School Students - United States, 2011-2018. MMWR. Morbidity and mortality weekly report, 68(6), 157–164. https://doi.org/10.15585/mmwr.mm6806e1
  12. Soule, E. K., Rosas, S. R., & Nasim, A. (2016). Reasons for electronic cigarette use beyond cigarette smoking cessation: A concept mapping approach. Addictive behaviors, 56, 41–50. https://doi.org/10.1016/j.addbeh.2016.01.008
  13. Keamy-Minor, E., McQuoid, J., & Ling, P. M. (2019). Young adult perceptions of JUUL and other pod electronic cigarette devices in California: a qualitative study. BMJ open, 9(4), e026306. https://doi.org/10.1136/bmjopen-2018-026306
  14. Barrington-Trimis, J. L., Samet, J. M., & McConnell, R. (2014). Flavorings in electronic cigarettes: an unrecognized respiratory health hazard?. JAMA, 312(23), 2493–2494. https://doi.org/10.1001/jama.2014.14830
  15. England, L. J., Bunnell, R. E., Pechacek, T. F., Tong, V. T., & McAfee, T. A. (2015). Nicotine and the Developing Human: A Neglected Element in the Electronic Cigarette Debate. American journal of preventive medicine, 49(2), 286–293. https://doi.org/10.1016/j.amepre.2015.01.015
  16. Lee, M. S., Rees, V. W., Koutrakis, P., Wolfson, J. M., Son, Y. S., Lawrence, J., & Christiani, D. C. (2019). Cardiac Autonomic Effects of Secondhand Exposure to Nicotine from Electronic Cigarettes: An Exploratory Study. Environmental epidemiology (Philadelphia, Pa.), 3(1), e033. https://doi.org/10.1097/EE9.0000000000000033
  17. Noar, S. M., Hall, M. G., Francis, D. B., Ribisl, K. M., Pepper, J. K., & Brewer, N. T. (2016). Pictorial cigarette pack warnings: a meta-analysis of experimental studies. Tobacco control, 25(3), 341–354. https://doi.org/10.1136/tobaccocontrol-2014-051978

This grant is funded by the National Institutes of Health (NIH) R01, award R01DA051836, in collaboration with Florida International University (FIU) and the University of Memphis.

Collaborators

Portrait of Taghrid Asfar

Taghrid Asfar, M.D., M.S.P.H.

Principal Investigator
Associate Professor, Department of Public Health Sciences
Member, Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine

tasfar@miami.edu

(305) 243-3826

Dr. Asfar has extensive experience in tobacco control research nationally and internationally. Since 2001, her tobacco control work has been funded continuously by the NIH and conducted both in the United States and the Eastern Mediterranean Region, including Syria, Lebanon, and Tunisia. This work involves epidemiological and qualitative studies of tobacco use, randomized clinical trials of smoking cessation interventions, and tobacco regulatory research in health communication approaches targeting emerging tobacco products such as e-cigarettes and hookahs. She has two overarching aims in her research: (1) improving smoking cessation treatment among socially disadvantaged and high-risk populations (i.e., low-income adults, ethnic minorities, HIV patients, cancer survivors); and (2) preventing tobacco use among youth and young adults by advancing health communication strategies, such as health warning labels. She has more than 60 peer-reviewed publications (Asfar T - Search Results - PubMed) and many of these are in leading, high impact journals in this field (i.e., Tobacco Control; Nicotine and Tobacco Research; Addiction; and the Cochrane Tobacco Addiction Group). Dr. Asfar has currently five active grants as PI including:

  • 1R01DA051836: Developing and testing health warning labels on the ENDS (electronic cigarette) device
  • 20K10 James and Esther King Biomedical Research Program: Developing and testing waterpipe-specific health warning labels targeting young people in Florida
  • R01TW010654-01: Translating Evidence and Building Capacity to Support Waterpipe Control in the Eastern Mediterranean
  • CFAR Pilot Award P30AI07396: “Mind2Quit” Developing A Mindfulness Smartphone App for Smoking Cessation for People Living with HIV
  • Sylvester Cancer Center Pilot Award P30CA240139: Smartphone Application versus In-Person Mindfulness-Based Smoking Cessation Intervention for Young Cancer Survivors: Reach versus Effectiveness
Portrait of Wasim Maziak

Wasim Maziak, M.D., Ph.D.

Co-Investigator of the James & Esther King Hookah Health Warning Labels Study and National Institutes of Health E-cigarette Health Warning Labels Study
Robert Stempel College of Public Health and Social Work, Florida International University

wmaziak@fiu.edu

Dr. Wasim Maziak is a professor of Epidemiology, Director of the Clinical Research Lab for Tobacco Smoking at Florida International University, and Founder of the Syrian Center for Tobacco Studies. Dr. Maziak has extensive experience in tobacco control research and has published over 200 peer-reviewed scientific reports, including contributions in Science, Nature, Lancet, and British Medical Journal. His focus has been on emerging tobacco products such as e-cigarettes and hookah (Waterpipe), especially risk communication strategies targeting young users. He has been continuously funded by NIH since 2001 for tobacco control research.

Dr. Maziak’s Clinical Research Laboratory is located at the Academic Health Center 4 at FIU MMC campus. This state-of-the-art facility is fully equipped with five computer stations, blood drawing and specimen processing areas, fully furnished physical examination station, real-time monitoring equipment for vital signs, subjective measures assessment capability, and the latest in smoking topography technology (i.e., puff count, puff volume, average flow, puff duration, interpuff interval). This laboratory is devoted to assessing the impact of emerging tobacco products among young people such as waterpipe (hookah) and electronic nicotine delivery systems (i.e., ENDS, e-cigarettes). The research team is the first to evaluate this highly addictive and misperceived tobacco use method in a clinical lab setting, as its popularity grows statewide and nationally—especially among youth.

Portrait of Michael Schmidt

Michael Schmidt, Ph.D., M.G.D.

Collaborator/Graphic Designer in the James & Esther King Hookah Health Warning Labels Study and National Institutes of Health E-cigarette Health Warning Labels Study
Graphic Designer, Associate Professor, School of Public Health, The University of Memphis

mschmidt@memphis.edu

Dr. Michael Schmidt is a social and behavioral research scientist in the field of public health, graphic designer, associate professor of design in the Department of Art, and affiliate faculty member in the School of Public Health at the University of Memphis. Dr. Schmidt's research areas include substance use disorders, intimate partner violence, and child and family wellbeing. Dr. Schmidt serves as graphic designer on this project, assisting with conceptual development and providing photo editing, typography, and layout design for the health warning labels.

Consultants

Portrait of Thomas Eissenberg

Thomas Eissenberg, Ph.D.

Consultant in the James & Esther King Hookah Health Warning Labels Study and National Institutes of Health E-cigarette Health Warning Labels Study

teissenb@vcu.edu

Dr. Eissenberg’s primary area of research involves developing and demonstrating methods to evaluate modified risk and other novel tobacco/nicotine products. He has authored or co-authored more than 200 peer-reviewed publications and served as principal investigator on numerous NIH grants.

Portrait of Seth Noar

Seth Noar, M.A., Ph.D.

Consultant in the James & Esther King Hookah Health Warning Labels Study and National Institutes of Health E-cigarette Health Warning Labels Study

noar@email.unc.edu

Seth M Noar is a member of UNC’s Lineberger Comprehensive Cancer Center. Dr. Noar’s research interests are focused on health communication particularly how to harness traditional and new media to promote healthy behavioral changes among individuals and communities. For more than a decade, much of Dr. Noar’s research was focused HIV/AIDS. He has worked on National Institutes of Health (NIH) projects on developing and evaluating televised media campaigns to increase safer sexual behavior and has been a principal investigator on a National Institute of Mental Health funded project. Dr. Noar is also conducting significant research on anti-tobacco messages, including graphic warning labels on cigarette packs. He is the co-director of the Communication Core for the UNC Center for Regulatory Research on Tobacco Communication, funded by an FDA/NIH grant from 2013-2018. Much of his research today also focuses on cancer prevention.

Portrait of Eric N. Lindblom

Eric N. Lindblom, J.D.

Consultant in the James & Esther King Hookah Health Warning Labels Study and National Institutes of Health E-cigarette Health Warning Labels Study

enl27@law.georgetown.edu

Eric N. Lindblom, JD, is a policy expert that will guide the project team on the legal aspects of applying electronic nicotine delivery systems health warning labels consistent with FDA’s deeming rule, its statutory authority, and state and local governments’ constraints. Mr. Lindblom is a Senior Scholar and formerly the Director for Tobacco Control and Food and Drug Law at the O’Neil Institute for National and Global Health Law. Mr. Lindblom works on both domestic and international tobacco control matters and works with other regulatory and public health researchers to help make their research more policy relevant. Mr. Lindblom has previously worked on the full range of FDA tobacco control activities, specifically focusing on the economic analysis, legal, and policy of existing and proposed Center for Tobacco Products activities. Mr. Lindblom has also served as the Director for Policy Research and General Counsel for Tobacco- Free Kids, where he focused on legal and economic tobacco control issues.

  • Asfar, T., Schmidt, M., Oluwole, O. J., Casas, A., Friedman, L., Ferdous, T., Noar, S. M., Eissenberg, T., & Maziak, W. (2024). Building consensus on a set of ENDS-specific pictorial health warnings: a Delphi study among a tobacco control expert panel. Tobacco control, tc-2023-058384. Advance online publication. https://doi.org/10.1136/tc-2023-058384
  • Edwards K, Manoharan A, Asfar T, Kareff S, Lopes G, Rodriguez E, Olazagasti C. (2024). Disparities in Electronic Cigarette Use by Underserved Minorities. Critical Reviews in Oncogenesis, 29(3):91 – 98.
  • Asfar, T., Oluwole, O. J., Pan, Y., Casas, A., Hernandez Garayua, A. M., Schmidt, M., & Noar, S. M. (2023). Youth Exposure and Response to the FDA Health Warning Label on Electronic Cigarettes Packaging: Policy Implications. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, ntad175. Advance online publication. https://doi.org/10.1093/ntr/ntad175
  • Asfar T, Jebai R, Li W, Oluwole O J, Ferdous T, Gautam P, Schmidt M, Noar S M, Lindblom E N, Eissenberg T, Bursac Z, Vallone D, & Maziak W. (2022). The risk and safety profile of electronic nicotine delivery systems (ENDS) is an umbrella review to inform ENDS health communication strategies. Tobacco control, tobaccocontrol-2022-057495. Advance online publication. https://doi.org/10.1136/tc-2022-057495 Impact Factor = 6.953
  • Li, W., Vargas-Rivera, M., Ebrahimi Kalan, M., Ben Taleb, Z., Asfar, T., Osibogun, O., ... & Maziak, W. (2021). The Effect of Graphic Health Warning Labels Placed on the ENDS Device on Young Adult Users’ Experience, Exposure and Intention to Use: A Pilot Study. Health Communication, 1-8. https://doi.org/10.1080/10410236.2021.1872158
  • Chand, H. S., Muthumalage, T., Maziak, W., & Rahman, I. (2020). Pulmonary Toxicity and the Pathophysiology of Electronic Cigarette, or Vaping Product, Use Associated Lung Injury. Frontiers in pharmacology, 10, 1619. https://doi.org/10.3389/fphar.2019.01619
  • Eissenberg, T., & Maziak, W. (2020). Are Electronic Cigarette Users at Risk for Lipid-mediated Lung Injury?. American journal of respiratory and critical care medicine, 201(8), 1012–1013. https://doi.org/10.1164/rccm.201910-2082LE
  • Maziak W. (2020). E-cigarettes: harm reduction or rehabilitation of the tobacco industry?. International journal of public health, 65(2), 159–161. https://doi.org/10.1007/s00038-019-01316-y
  • Osibogun, O., Bursac, Z., & Maziak, W. (2020). E-Cigarette Use and Regular Cigarette Smoking Among Youth: Population Assessment of Tobacco and Health Study (2013-2016). American journal of preventive medicine, 58(5), 657–665. https://doi.org/10.1016/j.amepre.2020.01.003

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