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Peer-reviewed

Research Article

Use of tobacco during COVID-19: A qualitative study among medically underserved individuals

Roles Formal analysis, Methodology, Supervision, Writing – original draft, Writing – review & editing

* E-mail: [email protected]

Affiliation Palliative and Advanced Illness Research Center, University of Pennsylvania, Philadelphia, PA, United States of America

Roles Writing – review & editing

Roles Data curation, Project administration, Writing – review & editing

Roles Data curation, Formal analysis, Project administration, Writing – review & editing

Roles Formal analysis, Methodology, Writing – review & editing

Roles Data curation, Formal analysis, Project administration

Affiliation CHDI Foundation, New York, NY, United States of America

Roles Conceptualization, Writing – review & editing

Affiliation Tobacco Policy and Control Program, Philadelphia Department of Public Health, Philadelphia, PA, United States of America

Roles Conceptualization, Formal analysis, Funding acquisition, Investigation, Supervision, Writing – review & editing

• Tamar Klaiman, 
• Nsenga Farrell, 
• Dorothy Sheu, 
• Aerielle Belk, 
• Jasmine Silvestri, 
• Jannie Kim, 
• Ryan Coffman, 
• Joanna Hart

• Published: August 19, 2024
• https://doi.org/10.1371/journal.pone.0308966
• Peer Review
• Reader Comments

The COVID-19 pandemic produced stress for people around the world. The perception that tobacco can be a coping tool for stress relief suggests that the conditions during the COVID-19 pandemic can provide insight into the relationship between stress and tobacco use patterns, particularly among those most at risk for severe COVID-19 disease. The goal was to identify the impacts of the COVID-19 pandemic on tobacco use and preparedness for smoking cessation among individuals who smoke and are older and medically underserved. We conducted in-depth interviews with 39 patients to learn about individuals’ smoking behavior during the COVID-19 pandemic. We used a modified grounded theory approach to code and analyze all qualitative data. We conducted thematic analysis to identify key factors associated with smoking behaviors during COVID-19. Our results indicated that increases in perceived stress and social isolation may have been associated with increased tobacco use during the COVID-19 pandemic. Pandemic-related social isolation contributed to increases in smoking, despite respondents being concerned about the severity of COVID-19. While many respondents felt that smoking relieved their stress from the pandemic, they appeared unaware of the stress-inducing properties of tobacco use. Our findings indicate that pandemic-related stress impacted smoking behavior among older, medically underserved smokers. Results may assist clinicians in addressing the role of tobacco use in response to highly stressful events. Smoking cessation strategies should consider the implications of stress on smoking behavior, including smoking relapse in response to highly stressful events–particularly for medically underserved populations.

Citation: Klaiman T, Farrell N, Sheu D, Belk A, Silvestri J, Kim J, et al. (2024) Use of tobacco during COVID-19: A qualitative study among medically underserved individuals. PLoS ONE 19(8): e0308966. https://doi.org/10.1371/journal.pone.0308966

Editor: Enkeleint A. Mechili, UV: Universiteti Ismail Qemali Vlore, ALBANIA

Received: April 18, 2024; Accepted: August 2, 2024; Published: August 19, 2024

Copyright: © 2024 Klaiman et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: The datasets generated and analyzed during the current study are not publicly available because informed consent stated that any data collected would not be used in future studies; however, de-identified data may be available from the PAIR Center Data Manager at [email protected] on reasonable request.

Funding: This project was funded by the Patient Centered Outcomes Research Institute (PCORI) (PCORI ID: PCS-2018C1-11326 (JH)). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: No authors have competing interests.

Introduction

The COVID-19 pandemic produced exceptional amounts of prolonged financial, social, physical, and emotional stress on the global community [ 1 ]. The persistent, but incorrect, perception that tobacco can be a coping tool for stress relief [ 2 – 4 ] suggests that the conditions during the COVID-19 pandemic can uniquely provide important insight into the relationship between complex stress and tobacco use patterns.

There is minimal existing knowledge of how patients navigated and managed contextual forces, including stress, that may have influenced their tobacco use behaviors and attitudes and led to variations in use patterns during the pandemic [ 5 – 7 ]. Existing evidence of tobacco use during the COVID-19 pandemic suggests that there was variability in whether individuals increased or decreased their use, without a consistent pattern [ 8 ]. For example, survey-based studies investigating tobacco use during the COVID-19 pandemic have consistently revealed that approximately a quarter of individuals increased tobacco use, approximately a quarter decreased tobacco use, and approximately half experienced no change in their use [ 9 – 12 ] Yet, the evidence to date is limited and does not sufficiently explore the mechanisms or causes underlying these patterns [ 1 , 13 – 15 ] which are important for leveraging the knowledge gained to improve tobacco treatment efforts. The social distancing restrictions enacted during COVID-19 changed and may have restricted access to health care, including tobacco treatment, but may have also reduced or changed access to tobacco products.

Further, while there is evidence that age and perceived risk of severe COVID-19 disease was associated with tobacco use patterns, there has been little focused attention to the tobacco use patterns of those most at risk for severe COVID-19 disease [ 5 , 16 , 17 ]. Individuals who are low income and historically marginalized were at especially high risk for severe COVID-19 disease, unemployment, and reduced access to health care [ 18 , 19 ]. These same populations are also disproportionately impacted by tobacco use resulting from targeted tobacco marketing strategies, inequitable access to tobacco treatment, and chronic stress [ 20 ]. For example, tobacco companies market tobacco to low-income populations and people of color [ 21 ], distribute cigarettes to children in low income neighborhoods [ 22 ], support more retailers and more retail window advertising in low income communities [ 23 ], discount prices to improve uptake [ 24 ], and have increased the nicotine concentration of cigarettes over time [ 25 , 26 ]. Prior research has also identified contextual factors such as social norms, economic structures, and high levels of stress from racial discrimination and poverty as contributing to tobacco use among Black and low-income groups [ 27 ]. The pervasive structural stress among these medically underserved groups was further amplified during the COVID-19 pandemic. Therefore, the primary goal of this project was to identify the impacts of the COVID-19 pandemic on tobacco use and preparedness for smoking cessation among individuals who smoke and who are older and medically underserved. Utilizing in-depth qualitative interviews allows contextualization around the patterns seen in the quantitative data that has been published.

We conducted a qualitative study consisting of in-depth interviews with older, medically underserved adults to learn about their smoking behavior during the COVID-19 pandemic. We recruited participants from September 30, 2020, to September 14, 2021 –during the height of the pandemic through the initiation of vaccines. Patient participants were recruited through multiple sampling strategies. First, we utilized the electronic health record of the University of Pennsylvania Health System (UPHS) to identify potential participants. We randomly selected UPHS outpatients who were at least 50 years old and had electronic health record (EHR)-documented daily tobacco use. We sent batches of mailed recruitment letters in randomized fashion to 25 to 50 potentially eligible patients at a time asking them to complete an online screening survey to determine eligibility. Using data available in the EHR, we purposefully sampled for rurality based on ZIP code (i.e., a Rural-Urban Community Area score of ≥2) during later periods of recruitment (i.e., subsequent batches of letters) given that we lacked sufficient rural representation in our initial group of participants and to ensure diverse representation of perspectives.

Second, we approached potential participants through our established partnership with a local, Hispanic serving non-profit agency. Trained staff—as part of the organization’s COVID-19 Mobile Response Unit outreach to low-income urban and rural areas in northeastern and central Pennsylvania—recruited and assessed for eligibility among individuals engaging in their outreach sessions. Third, we relied on snowball sampling, in which participating patients provided information about the study to acquaintances who were then assessed for eligibility using the same approach.

After providing verbal informed consent for participation and documenting it in the recruitment spreadsheet, enrolled individuals participated in a structured telephone interview that was audio recorded with their permission. Consents were collected verbally because all interviews were conducted via telephone. The University of Pennsylvania IRB approved all procedures, including a verbal telephone consent procedure. Participants were given a full description of the study and agreed to participate after expressing understanding of the study procedures. Eligible individuals were using tobacco daily, 50 to 80 years old, and represented at least one of the following demographic groups: reported household income less than 200% of the federal poverty line based on household size, less than a high school level of formal educational attainment, self-identified as Black or African American, Hispanic or Latinx, and/or reported living in a rural area. Only those who spoke English or Spanish were included. Patients received $50 USD for their participation. Interviews were conducted in English or Spanish based on participants’ preferences.

The interview guide (Supplement 1) was developed through literature reviews, in consultation with clinicians who treat lung disease and/or tobacco use disorder, and a stakeholder advisory committee consisting of patient and community advocacy groups, patients, clinicians, and health system leaders. The interviews focused on (1) smoking behavior prior to and during the COVID-19 pandemic, (2) perceptions about the impact of smoking on the development and severity of COVID-19, (3) barriers and facilitators for tobacco treatment prior to and during the COVID-19 pandemic, and (4) stressors and lifestyle changes during the COVID-19 pandemic. All questions were open ended and reflected high-level concepts (such as motivation, or behavior), and all respondents were asked questions focused on these core topics. Recruitment continued until thematic saturation was reached–no new themes arose after three additional interviews [ 28 ]. A professional transcription and translation company transcribed the audio recordings of the interviews and, if needed, translated the text to English from Spanish. The transcription process also removed identifying information in preparation for analysis. The Institutional Review Board of the University of Pennsylvania approved all procedures (protocol #843833).

We used a modified grounded theory approach to code and analyze all qualitative data. Investigators inductively developed a preliminary codebook based on emerging themes and deductively based on behavioral health constructs identified in the literature review (JH), including beliefs about consequences, motivations and goals, environmental context, and resources. All coding was overseen by a Senior Qualitative Research Scientist (TK). Research staff trained in qualitative methods conducted the coding. The codebook was iteratively revised as additional transcripts were reviewed. Research staff used the codebooks to code all transcripts in NVIVO 12.0, with 20% coded by two staff members to assess reliability. Research staff met at least weekly during coding to resolve conflicts. Any disagreements were discussed until consensus was reached with iterative revision of the codebook and review of previously coded transcripts as necessary. Theme sheets were developed for each of the identified themes, and weekly meetings were held with study staff to analyze results within and between themes. The University of Pennsylvania IRB approved this study (protocol #843833).

Thirty-nine patients completed interviews. Respondent demographics are noted in Table 1 .

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https://doi.org/10.1371/journal.pone.0308966.t001

Unrelated to the pandemic, most respondents had attempted to quit tobacco at least once, yet all resumed smoking. Participants identified triggers such as increased anxiety, stress, grief, other substances (e.g., coffee or alcohol), and general boredom as precipitating smoking relapse even after prolonged abstinence.

I stopped smoking–I forget when it was, I think it was in May. I was doing good, and I think my brother-in-law passed in September…and he was my favorite brother-in-law, and when he passed away, it made me feel so bad. So, that’s how I started back smoking. (Respondent 115) Like if I drink coffee, like every time I drink coffee throughout the day. (Respondent 033) Well , I went out drinking and… someone was smoking and you know , I was like , “Oh , let me get one . ” They were like , “Oh no , you don’t smoke anymore ? ” And I was like , “No , give me one . ” And that’s what happened . (Respondent 106)

Tobacco was frequently used by participants as a tool for stress relief. Respondents felt that smoking helped them to calm down, particularly after stressful events or managing grief and anger. The reliance on tobacco as a coping tool for stress was both a precipitant of relapse and a reason to continue use. Some framed their tobacco use for this purpose as distinct from more general dependence on nicotine or smoking.

You know, like… I don’t know, many people don’t understand it, but it really does calm you down. Well, some people need it because they’re regular smokers, but in my case, I see it as a relaxant, for me. (Respondent 022) … I did good for six months, and then one day I got angry, and I bought a packet of cigarettes and did myself in. (Respondent 107) I once stopped smoking , and I stopped for… I’m not lying , for around 8 or 9 months , but when my mom passed away , when I lost my mom , I went back to smoking . I haven’t quit ever since . (Respondent 024)

The impact of COVID-19 on reporting smoking behavior was varied among respondents. Potential pandemic-era structural barriers to accessing tobacco products, such as stay-at-home orders and social distancing requirements, did not play a major role in tobacco purchase or use patterns among our respondents. For example, almost all respondents did not have trouble buying cigarettes from local convenience stores using their same purchasing behaviors. However, participants did report following recommended COVID-19 mitigation measures to reduce their risk of contracting the virus, such as hand washing, mask wearing, and avoiding crowds.

I go to the store and I buy cigarettes by the carton. So, that’s the same way I do now. (Respondent 217) I could be out of cigarettes, and make it for a couple of hours, and then it wouldn’t matter what time of the day or night it was. [laughs] If I was still awake, I’d go out and get a pack. So, I basically purchase them the say way, except now I have to put a mask on when I got into the store. (Respondent 158) Well , it basically hasn’t changed… we have what they call , "Cigarette Outlet Stores . " … They sell cigarettes … Just one particular one that I know is kind of … tucked away , and it’s never very crowded when I go there . So , it’s—it’s nice in that respect because you’re not around a whole lot of other people , because the store is at least—well , see that’s another change in my routine too is , I stay away from the stores on Fridays , Saturdays , and Sundays . I will prefer to go usually on a Tuesday , if I can , because I find that Tuesday for some reason , just in this general area where I live , that it’s not as crowded on Tuesday as it is any other day . (Respondent 156)

Some respondents reported increasing their tobacco use directly due to pandemic-related changes. These included increased anxiety, boredom, or having more unfilled or leisure time due to COVID-related activity restrictions and social distancing. The primary source of anxiety identified by respondents was an increase in social isolation due to the pandemic.

… I’ve always kind of like had a problem with smoking… I can say, oh, it wasn’t as bad as it is now. You know… being …in the house, and you kind of feel like closed in. And so, it’s kind of like… it was kind of like comforting for me. So, I think I’m smoking more… than before. (Respondent 033) I would say like on average, like when I’m home more due to the pandemic, I’ve been smoking more. (Respondent 141) I find myself—it seems that I’m smoking more because of [the COVID-19 pandemic], with the stress and being in the house, and not being able to do things, and being around people. (Respondent 132) Either , either boredom , which is heightened during , um COVID , books or boredom . Or maybe frustration , you know , maybe frustration that I’m not doing very much , which I guess is kind of like boredom . (Respondent 120)

Many respondents believed that, if contracted, their severity of COVID-19 illness would be worse due to tobacco use or due to co-morbidities also tied to tobacco use. This caused increased stress and anxiety among participants who worried about their susceptibility to COVID-19 and the immediate health threat of the virus, including heightened attention to possible mortality. This perception was based on their recognition that tobacco is a pulmonary toxin and COVID-19 is a respiratory virus.

I have a cigarette addiction, but I also need to know that I’m not a millionaire and I can’t spoil myself as I used to. I used to not care because, I was able to touch every door and touch anything, now you can’t touch everything and you need to be careful of someone touching you from behind because… It’s gotten me a bit more anxious, because I start thinking, “what if this virus can’t be cured or something?” You know? So one just gets sort of scared. (Respondent 022) And people who smoke are more susceptible to catch that thing, because your lungs aren’t strong enough to fight off that disease, because people who smoke, carry nicotine in their lungs and that makes it harder to breathe. (Respondent 024) I’ve figured that at some point in the early—early stages of the pandemic , when it was first being announced , I smoke more , and then I was panicky . I was a little nervous about what was going on . I was nervous at how susceptible I would be to it… I think COVID would kill me . I’ve already got a weakened immune system , and then the things that do I hear about it , you know , I have secondary hypertension , diabetes , um , nephrotic syndrome . (Respondent 044)

In part due to these health risks, some respondents described an initial decrease in their tobacco use during the early spread and awareness of COVID-19. However, often related to an acute stressor resulting from the pandemic conditions, respondents described relapses.

Well, from June [2020] I went back down again. When me and my doctor, we first started I think it was in September that we started. And, like in October because I’m taking these pills of Bupropion, and they were helping like a little bit. One point, I was down to like, like four cigarettes a day. And then maybe end of October, I had, I had tragedy in my family. I picked up smoking a little more after that. (Respondent 110) I’d stopped like somewhere in May and I was doing good. And then when I got the call about my brother in-law, and that made me go out straight to the store and buy a pack of cigarette. Now, that’s the time I was smoking cigarette one after another because I couldn’t get over, you know, what happened to my brother in-law and that’s how it all started. (Respondent 115) And then we moved here and I started smoking again , because I was so worried . My nerves are so bad that I was worried about us paying the rent because we’re paying that like almost double of the rent we were paying before . (Respondent 122)

Our results indicate that, for many respondents, increases in perceived stress and social isolation may have been associated with increased tobacco use during the COVID-19 pandemic. While smoking is associated with increased severity of COVID-19 symptoms [ 1 , 2 , 4 ] and worse outcomes [ 29 ], respondents did not appear to rely on the emerging scientific evidence to inform this opinion. In contrast, their perceptions of illness and resulting personal health risks were based on personal experience. While many respondents felt that smoking relieved their stress from the pandemic, they appeared unaware of the stress-inducing properties of tobacco use [ 4 ]. Therefore, a possible explanation for increased tobacco use, despite this increased risk perception, is that many individuals relied on tobacco as a maladaptive coping tool in the face of acute stress. Because acute stress was increased during the pandemic, this may have further exacerbated tobacco use patterns and may have prevented quit attempts despite the “teachable moment” of tobacco-associated COVID-19 risk.

In other settings, near-term health threats have been effective in promoting tobacco treatment uptake and smoking cessation. For example, lung cancer screening is applicable to patients with many years of tobacco use and as many as half continue to use tobacco at the time of screening [ 30 ]. Tobacco treatments are successful in the context of lung cancer screening because of the inherent health and mortality threat patients confront when undergoing the annual screening which is explicitly performed to detect life-threatening cancer [ 31 , 32 ]. Therefore, a health threat (risk of cancer) becomes a strategic moment for patients who may approach tobacco cessation as carrying immediate health benefits. However, our results suggest that tobacco treatment efforts in the context of health-related stress may be augmented by including specific stress management tools. In the case of COVID-19, which carried not just health threats but also immediate financial and social threats, integrating stress management interventions into tobacco treatment during this critical moment may have resulted in fewer patients increasing tobacco use in response.

The strengths of our study include the representation of patients from medically underserved groups and our use of qualitative methods to gain greater insight into the observed patterns of tobacco use during the pandemic [ 5 , 7 , 16 ]. Our study has limitations in addition to its strengths. First, our participants were recruited from a single state (Pennsylvania). This is particularly important given state-specific COVID-19 policies and burdens during the period of study. However, Pennsylvania is a geographically and politically diverse state, and we developed recruitment processes to maximize the sample’s diversity. Second, we conducted cross-sectional interviews, such that we were unable to describe longitudinal patterns or changes in individuals’ perspectives. The study was purely observational, which limits our ability to assess causal mechanisms for increased tobacco use. COVID-related research restrictions included remote-only recruitment, which led to challenges in response rate as we relied on EHR documentation of contact information and mail and phone contacts only. However, such approaches also may have engaged patients who attended in-person appointments less regularly given that we relied on recruitment based on prior visits (i.e., panels of patients) rather than ongoing engagement with health care services. Future work in this area should consider utilizing the concepts we identified as salient to develop a large-scale survey that would allow for statistical comparisons and analyses.

Perceived stress is a well-described risk factor for tobacco smoking and a barrier to successful smoking cessation. Our findings indicate that there were varied responses to the COVID-19 pandemic among older, medically underserved people who smoked. Given the COVID-19 pandemic brought associated health, social, financial, and other stressors, these may have overpowered the health-related motivations to quit smoking due to reliance on tobacco as a maladaptive coping tool. Results may assist clinicians in addressing the role of tobacco use in response to highly stressful events.

Supporting information

S1 file. interview guide..

https://doi.org/10.1371/journal.pone.0308966.s001

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See the Figure for a more detailed summary of the recommendations for clinicians. See the Practice Considerations section for more information on recommended behavioral interventions and pharmacotherapy and for suggestions for practice regarding the I statements. USPSTF indicates US Preventive Services Task Force.

USPSTF indicates US Preventive Services Task Force.

eFigure. US Preventive Services Task Force (USPSTF) Grades and Levels of Evidence

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• Initiating Pharmacologic Treatment in Tobacco-Dependent Adults JAMA JAMA Clinical Guidelines Synopsis January 19, 2021 This JAMA Clinical Guidelines Synopsis summarizes the American Thoracic Society’s 2020 recommendations for treating tobacco dependence with pharmacologic therapy in adults. Atul Jain, MD, MS; Andrew M. Davis, MD, MPH
• USPSTF Recommendation: Interventions to Promote Tobacco Cessation JAMA JAMA Patient Page January 19, 2021 This JAMA Patient Page summarizes the USPSTF 2020 guideline recommending that physicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and drugs shown effective for stopping cigarette and other tobacco use. Jill Jin, MD, MPH
• COVID-19 and the “Lost Year” for Smokers Trying to Quit JAMA Medical News & Perspectives May 18, 2021 This Medical News article describes a reduction in smoking cessation attempts during the COVID-19 pandemic. Mary Chris Jaklevic, MSJ
• Considerations of Sex and Gender in FDA Tobacco Regulation JAMA Viewpoint June 20, 2023 This Viewpoint discusses how sex and gender subpopulations may be differentially affected by tobacco products and suggests that the FDA formulate regulations in clinically meaningful ways. Danielle R. Davis, PhD; Suchitra Krishnan-Sarin, PhD; Carolyn M. Mazure, PhD
• Varenicline or Nicotine Replacement After Initial Treatment Failure JAMA Original Investigation May 28, 2024 This sequential, multiple assignment randomized trial compares treatment strategies and dosages after abstinence from smoking was not achieved after 6 weeks of first-line therapies. Paul M. Cinciripini, PhD; Charles E. Green, PhD; Sanjay Shete, PhD; Jennifer A. Minnix, PhD; Jason D. Robinson, PhD; Yong Cui, PhD; Seokhun Kim, PhD; George Kypriotakis, PhD; Diane Beneventi, PhD; Janice A. Blalock, PhD; Francesco Versace, PhD; Maher Karam-Hage, MD

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US Preventive Services Task Force. Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons : US Preventive Services Task Force Recommendation Statement . JAMA. 2021;325(3):265–279. doi:10.1001/jama.2020.25019

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Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons : US Preventive Services Task Force Recommendation Statement

• Editorial A Comprehensive Approach to Increase Adult Tobacco Cessation Brenna VanFrank, MD, MSPH; Letitia Presley-Cantrell, PhD JAMA
• US Preventive Services Task Force USPSTF Review: Interventions for Tobacco Cessation in Adults, Including Pregnant Persons Carrie D. Patnode, PhD, MPH; Jillian T. Henderson, PhD, MPH; Erin L. Coppola, MPH; Joy Melnikow, MD, MPH; Shauna Durbin, MPH; Rachel G. Thomas, MPH JAMA
• JAMA Clinical Guidelines Synopsis Initiating Pharmacologic Treatment in Tobacco-Dependent Adults Atul Jain, MD, MS; Andrew M. Davis, MD, MPH JAMA
• JAMA Patient Page USPSTF Recommendation: Interventions to Promote Tobacco Cessation Jill Jin, MD, MPH JAMA
• Medical News & Perspectives COVID-19 and the “Lost Year” for Smokers Trying to Quit Mary Chris Jaklevic, MSJ JAMA
• Viewpoint Considerations of Sex and Gender in FDA Tobacco Regulation Danielle R. Davis, PhD; Suchitra Krishnan-Sarin, PhD; Carolyn M. Mazure, PhD JAMA
• Original Investigation Varenicline or Nicotine Replacement After Initial Treatment Failure Paul M. Cinciripini, PhD; Charles E. Green, PhD; Sanjay Shete, PhD; Jennifer A. Minnix, PhD; Jason D. Robinson, PhD; Yong Cui, PhD; Seokhun Kim, PhD; George Kypriotakis, PhD; Diane Beneventi, PhD; Janice A. Blalock, PhD; Francesco Versace, PhD; Maher Karam-Hage, MD JAMA

Importance   Tobacco use is the leading preventable cause of disease, disability, and death in the US. In 2014, it was estimated that 480 000 deaths annually are attributed to cigarette smoking, including second hand smoke exposure. Smoking during pregnancy can increase the risk of numerous adverse pregnancy outcomes (eg, miscarriage and congenital anomalies) and complications in the offspring (including sudden infant death syndrome and impaired lung function in childhood). In 2019, an estimated 50.6 million US adults (20.8% of the adult population) used tobacco; 14.0% of the US adult population currently smoked cigarettes and 4.5% of the adult population used electronic cigarettes (e-cigarettes). Among pregnant US women who gave birth in 2016, 7.2% reported smoking cigarettes while pregnant.

Objective   To update its 2015 recommendation, the USPSTF commissioned a review to evaluate the benefits and harms of primary care interventions on tobacco use cessation in adults, including pregnant persons.

Population   This recommendation statement applies to adults 18 years or older, including pregnant persons.

Evidence Assessment   The USPSTF concludes with high certainty that the net benefit of behavioral interventions and US Food and Drug Associated (FDA)–approved pharmacotherapy for tobacco smoking cessation, alone or combined, in nonpregnant adults who smoke is substantial. The USPSTF concludes with high certainty that the net benefit of behavioral interventions for tobacco smoking cessation on perinatal outcomes and smoking cessation in pregnant persons is substantial. The USPSTF concludes that the evidence on pharmacotherapy interventions for tobacco smoking cessation in pregnant persons is insufficient because few studies are available, and the balance of benefits and harms cannot be determined. The USPSTF concludes that the evidence on the use of e-cigarettes for tobacco smoking cessation in adults, including pregnant persons, is insufficient, and the balance of benefits and harms cannot be determined. The USPSTF has identified the lack of well-designed, randomized clinical trials on e-cigarettes that report smoking abstinence or adverse events as a critical gap in the evidence.

Recommendations   The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and FDA-approved pharmacotherapy for cessation to nonpregnant adults who use tobacco. (A recommendation) The USPSTF recommends that clinicians ask all pregnant persons about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant persons who use tobacco. (A recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of pharmacotherapy interventions for tobacco cessation in pregnant persons. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of e-cigarettes for tobacco cessation in adults, including pregnant persons. The USPSTF recommends that clinicians direct patients who use tobacco to other tobacco cessation interventions with proven effectiveness and established safety. (I statement)

Tobacco use is the leading preventable cause of disease, disability, and death in the US. In 2014, it was estimated that 480 000 deaths annually are attributed to cigarette smoking, including second hand smoke. 1 Smoking during pregnancy can increase the risk for miscarriage, congenital anomalies, stillbirth, fetal growth restriction, preterm birth, placental abruption, and complications in the offspring, including sudden infant death syndrome and impaired lung function in childhood. 1 - 4 In 2019 (the most recent data currently available), an estimated 50.6 million US adults (20.8% of the adult population) used tobacco; 14.0% of the US adult population currently smoked cigarettes; and 4.5% of the US adult population used electronic cigarettes (e-cigarettes). 5 According to data from the National Vital Statistics System, in 2016, 7.2% of women who gave birth smoked cigarettes during pregnancy. 6 There are disparities in smoking behaviors associated with certain sociodemographic factors: smoking rates are particularly high in non-Hispanic American Indian/Alaska Native persons; lesbian, gay, or bisexual adults; adults whose highest level of educational attainment is a General Educational Development certificate; persons who are uninsured and those with Medicaid; adults with a disability; and persons with mild, moderate, or severe generalized anxiety symptoms. 5 According to the 2015 National Health Interview Survey, which reported responses from 33,672 adults, 68% of adults who smoked reported that they wanted to stop smoking and 55% attempted quitting in the past year 7 ; only 7% reported having recently quit smoking and 31% reported having used cessation counseling, medication, or both when trying to quit. 7

Quiz Ref ID The USPSTF concludes with high certainty that the net benefit of behavioral interventions and US Food and Drug Administration (FDA)–approved pharmacotherapy for tobacco smoking cessation, alone or combined, in nonpregnant adults who smoke is substantial .

Quiz Ref ID The USPSTF concludes with high certainty that the net benefit of behavioral interventions for tobacco smoking cessation on perinatal outcomes and smoking cessation in pregnant persons is substantial .

Quiz Ref ID The USPSTF concludes that the evidence on pharmacotherapy interventions for tobacco smoking cessation in pregnant persons is insufficient because few studies are available, and the balance of benefits and harms cannot be determined.

Quiz Ref ID The USPSTF concludes that the evidence on the use of e-cigarettes for tobacco smoking cessation in adults, including pregnant persons, is insufficient , and the balance of benefits and harms cannot be determined. The USPSTF has identified the lack of well-designed, randomized clinical trials (RCTs) on e-cigarettes that report smoking abstinence or adverse events as a critical gap in the evidence.

See the Figure , Table 1 , and the eFigure in the Supplement for more information on the USPSTF recommendation rationale and assessment. For more details on the methods the USPSTF uses to determine net benefit, see the USPSTF Procedure Manual. 8

This recommendation applies to adults 18 years or older, including pregnant persons. The USPSTF has issued a separate recommendation statement on primary care interventions for the prevention and cessation of tobacco use in children and adolescents. 9

Key definitions related to tobacco use are reported in the Box . Although tobacco use refers broadly to the use of any tobacco product, cigarette smoking has historically been the most prevalent form of tobacco use in the US, and most of the evidence surrounding cessation of tobacco products relates to quitting combustible cigarette smoking. Thus, the current USPSTF recommendations focus on interventions for tobacco smoking cessation. Additionally, although e-cigarettes are considered a tobacco product that should also be the focus of tobacco prevention and cessation efforts, for this recommendation statement, the evidence on e-cigarettes as a potential cessation aid for cigarette smoking was also evaluated.

Key Definitions Related to Tobacco Use

Tobacco use.

Tobacco use refers to use of any tobacco product. As defined by the US Food and Drug Administration, tobacco products include any product made or derived from tobacco intended for human consumption (except products that meet the definition of drugs), including, but not limited to, cigarettes, cigars (including cigarillos and little cigars), dissolvables, hookah tobacco, nicotine gels, pipe tobacco, roll-your-own tobacco, smokeless tobacco products (including dip, snuff, snus, and chewing tobacco), vapes, electronic cigarettes (e-cigarettes), hookah pens, and other electronic nicotine delivery systems. 10

Smoking generally refers to the inhaling and exhaling of smoke produced by combustible tobacco products such as cigarettes, cigars, and pipes.

Vaping refers to the inhaling and exhaling of aerosols produced by e-cigarettes. 11 Vaping products (ie, e-cigarettes) usually contain nicotine, which is the addictive ingredient in tobacco. Substances other than tobacco can also be used to smoke or vape. While the 2015 USPSTF recommendation statement used the term “electronic nicotine delivery systems” or “ENDS,” the USPSTF recognizes that the field has shifted to using the term “e-cigarettes” (or “e-cigs”) and uses the term e-cigarettes in the current recommendation statement. e-Cigarettes can come in many shapes and sizes, but generally they heat a liquid that contains nicotine (the addictive drug in tobacco) to produce an aerosol (or “vapor”) that is inhaled (“vaped”) by users. 11

USPSTF indicates US preventive Services Task Force.

All patients should be asked about their tobacco use, whether or not risk factors for use are present, and encouraged to stop using tobacco. When smoking is identified, all patients should be provided interventions to quit smoking. Higher smoking prevalence has been observed in men; persons younger than 65 years; non-Hispanic American Indian/Alaska Native persons; persons who are lesbian, gay, or bisexual; persons whose highest level of educational attainment is a General Educational Development certificate; persons with an annual household income less than $35 000; persons with a disability; and persons with mild, moderate, or severe anxiety symptoms. 5

Common approaches for clinicians to assess patients’ tobacco use include the following.

The 5 As: (1) Ask about tobacco use; (2) Advise to quit through clear, personalized messages; (3) Assess willingness to quit; (4) Assist in quitting; and (5) Arrange follow-up and support. 12

“Ask, Advise, Refer,” which encourages clinicians to ask patients about tobacco use, advise them to quit, and refer them to telephone quit lines, other evidence-based cessation interventions, or both. 12

Vital Sign: Treating smoking status as a vital sign and recording smoking status at every health visit are also frequently used to assess smoking status. 12

Because many pregnant women who smoke do not report it, using multiple choice questions to assess smoking status in this group may improve disclosure. 12

Effective tobacco smoking cessation interventions for nonpregnant adults include behavioral counseling and pharmacotherapy, either individually or in combination. 13 , 14

Combining behavioral and pharmacotherapy interventions has been shown to increase tobacco smoking cessation rates compared with either usual care/brief cessation interventions alone or pharmacotherapy alone. 13 Most combination interventions include behavioral counseling involving several sessions (≥4), with planned total contact time usually ranging from 90 to 300 minutes. 13 The largest effect was found in interventions that provided 8 or more sessions, although the difference in effect among the number of sessions was not significant. 13

Many behavioral counseling interventions are available to increase tobacco smoking cessation in adults. These interventions can be delivered in the primary care setting or can be referred to community settings with feedback to the primary care clinician. Effective behavioral interventions include physician advice, nurse advice, individual counseling with a cessation specialist, group behavioral interventions, telephone counseling, and mobile phone–based interventions. 13 Behavioral counseling interventions used in studies typically targeted individuals who were motivated to quit tobacco smoking. 13 For additional information about behavioral counseling interventions in nonpregnant adults, see Table 2 .

Quiz Ref ID The current pharmacotherapy interventions approved by the FDA for the treatment of tobacco smoking dependence in adults are nicotine replacement therapy (NRT) (including nicotine transdermal patches, lozenges, gum, inhalers, or nasal spray), bupropion hydrochloride sustained-release (SR), and varenicline. 46 All 3 types of pharmacotherapy increase tobacco smoking cessation rates. Using a combination of NRT products (in particular, combining short-acting plus long-acting forms of NRT) has been found to be more effective than using a single form of NRT. 13 Based on a smaller number of studies, varenicline appears to be more effective than NRT or bupropion SR. 13 Information on dosing regimens is available in the package inserts of individual medications or in the 2020 Surgeon General Report on Smoking Cessation. 47

Providing any psychosocial intervention to pregnant persons who smoke tobacco can increase smoking cessation. The behavioral counseling intervention type most often studied in pregnant persons who smoke was counseling. Behavioral interventions were more effective when they provided more intensive counseling, were augmented with messages and self-help materials tailored for pregnant persons, and included messages about the effects of smoking on both maternal and fetal health and strong advice to quit as soon as possible. 12 , 13 Although smoking cessation at any point during pregnancy yields substantial health benefits for the expectant mother and infant, quitting early in pregnancy provides the greatest benefit to the fetus. 12 , 13 Other interventions included feedback, incentives, health education, and social support, although provision of health education alone, without counseling, was not found to be effective. For additional information about behavioral counseling interventions in pregnant persons, see Table 2 .

Primary care clinicians may find the following resources useful in talking with adults and pregnant persons about tobacco smoking cessation.

Centers for Disease Control and Prevention

Health care clinician resources for treatment of tobacco use and dependence https://www.cdc.gov/tobaccoHCP

Tips From Former Smokers https://www.cdc.gov/tobacco/campaign/tips/partners/health/index.html

US Department of Health and Human Services

SmokeFree.Gov Health Professionals Page https://smokefree.gov/help-others-quit/health-professionals

SmokeFreeWomen http://women.smokefree.gov/pregnancy-motherhood

In addition, the following resources may be useful to primary care clinicians and practices trying to implement interventions for tobacco smoking cessation.

Million Hearts tools for clinicians for tobacco cessation https://millionhearts.hhs.gov/tools-protocols/tools/tobacco-use.html

Centers for Disease Control and Prevention state and community resources for tobacco control programs https://www.cdc.gov/tobacco/stateandcommunity/index.htm

The US Department of Veterans Affairs (VA) Primary Care & Tobacco Cessation Handbook https://www.mentalhealth.va.gov/quit-tobacco/docs/IB_10-565-Primary-Care-Smoking-Handbook-PROVIDERS-508.pdf

World Health Organization’s toolkit for delivering brief smoking interventions in primary care http://www.who.int/tobacco/publications/smoking_cessation/9789241506953/en/

In 2020, the Surgeon General issued a Report on Smoking Cessation. 47 The report’s findings were largely similar to that of the USPSTF. The Surgeon General’s report issued some additional findings regarding internet-based interventions for cessation and describes some suggestive but not sufficient evidence about specific e-cigarette use behaviors and increased cessation. Overall, the Surgeon General’s report found that there is inadequate evidence to conclude that e-cigarettes increase smoking cessation. More information on the Surgeon General’s Report on Smoking Cessation is available at https://www.cdc.gov/tobacco/data_statistics/sgr/2020-smoking-cessation/#fact-sheets .

According to data from the National Vital Statistics System, in 2016, 7.2% of women who gave birth smoked cigarettes during pregnancy, 6 and among 1071 pregnant women aged 18 to 44 years, 3.6% reported using e-cigarettes. 48 Smoking during pregnancy reduces fetal growth, increases the risk of preterm birth, and doubles the risk for delivering an infant with low birth weight. It also increases the relative risk for stillbirth death by 25% to 50%. 1 , 2 Quitting smoking early in pregnancy can reduce or eliminate the adverse effects of smoking on fetal growth. 47 For pregnant persons for whom behavioral counseling alone does not work, evidence to support other options to increase smoking cessation during pregnancy are limited. Few clinical trials have evaluated the effectiveness of NRT for smoking cessation in pregnant women. Although most studies were in the direction of benefit, no statistically significant increase in cessation was seen. 13 There is limited evidence on harms of NRT from trials in pregnant persons. Potential adverse maternal events reported in studies of NRT include slightly increased diastolic blood pressure and skin reactions to the patch. 13 Potential adverse events reported in nonpregnant adults include higher rates of low-risk cardiovascular events, such as tachycardia. 13 It has been suggested that NRT may be safer than smoking during pregnancy given that cigarette smoke contains harmful substances in addition to nicotine. The USPSTF identified no studies on bupropion SR or varenicline pharmacotherapy for tobacco smoking cessation during pregnancy.

In the absence of clear evidence on the balance of benefits and harms of pharmacotherapy in pregnant women, clinicians are encouraged to consider the severity of tobacco dependence in each patient and engage in shared decision-making to determine the best individual treatment course.

No tobacco product use is risk-free, including the use of e-cigarettes. Tobacco smoking cessation can be difficult for many individuals; thus, having a variety of tools available to help persons quit smoking would potentially be helpful. Findings from small surveys and qualitative data report mixed findings on whether physicians are recommending e-cigarettes to patients to help them quit smoking. 13 , 49 - 51 Few randomized trials have evaluated the effectiveness of e-cigarettes to increase tobacco smoking cessation in nonpregnant adults, and no trials have evaluated e-cigarettes for tobacco smoking cessation in pregnant persons. 13 Overall, results were mixed on whether smoking cessation increased with e-cigarettes; however, continued e-cigarette use after the intervention phase of trials remained high, indicating continued nicotine dependence. Trial evidence on harms of e-cigarettes used for smoking cessation is also limited. The most commonly reported adverse effects from e-cigarette use reported in trials included coughing, nausea, throat irritation, and sleep disruption. 13 Generally, no significant difference in short-term serious adverse events associated with e-cigarette use was reported. 13 Evidence on potential harms of e-cigarette use in general (whether for tobacco smoking cessation or not) has been reviewed in the National Academies of Science, Engineering, and Medicine report Public Health Consequences of E-Cigarettes. 52 For example, the report found conclusive evidence that in addition to nicotine, most e-cigarette products contain and emit numerous potentially toxic substances. Additionally, an outbreak of e-cigarette, or vaping product, use–associated lung injury (EVALI) that occurred in the US in late 2019 also suggests potential harms of e-cigarette use. The vast majority of cases have been associated with tetrahydrocannabinol (THC)–containing e-cigarettes. 53

Given the high rates of e-cigarette use in children and adolescents currently in the US, 54 the USPSTF recognizes that an overall public health question remains on whether the potential use of e-cigarettes as a tobacco smoking cessation aid (if ever proven effective) could be balanced with the high rates of e-cigarette use in youth as a driver for increasing overall tobacco use. The USPSTF has issued a separate recommendation statement on the prevention of tobacco use, including e-cigarettes, in children and adolescents. 9 The current USPSTF recommendation statement for adults evaluated the evidence on the benefits and harms of e-cigarettes to increase tobacco cessation; the USPSTF found this evidence to be insufficient. Given the proven effectiveness of behavioral counseling interventions in both nonpregnant and pregnant adults, and of pharmacotherapy in nonpregnant adults, the USPSTF recommends that clinicians focus on offering behavioral counseling and pharmacotherapy to increase smoking cessation in nonpregnant adults, and behavioral counseling to increase smoking cessation in pregnant persons.

In 2020, the USPSTF recommended that primary care clinicians provide interventions, including education or brief counseling, to prevent the initiation of tobacco use (including e-cigarettes) in school-aged children and adolescents. 9 The USPSTF found the evidence on primary care interventions for the cessation of tobacco use in youth to be insufficient.

This recommendation statement replaces the 2015 USPSTF recommendation statement on behavioral and pharmacotherapy interventions for tobacco smoking cessation in adults, including pregnant women. 55 The current recommendation statement has been updated to reflect newer evidence and language in the field of tobacco cessation and includes a description of the 2019 EVALI outbreak in the US. However, the recommendations on the services primary care clinicians should provide for tobacco cessation are the same as in 2015.

The USPSTF commissioned a systematic review to evaluate the benefits and harms of primary care interventions on tobacco use cessation in adults, including pregnant persons. 13 , 14 The USPSTF considered evidence on the benefits and harms of behavioral counseling interventions, pharmacotherapy interventions, and e-cigarettes in nonpregnant adults and pregnant persons. The vast majority of evidence identified focused on cigarette smoking cessation.

The USPSTF reviewed evidence on the benefits of behavioral counseling interventions on tobacco use cessation in general adults primarily from 20 systematic reviews that covered approximately 830 RCTs and more than 500 000 participants. 13 The evidence almost exclusively evaluated interventions for cessation of cigarette smoking. Physician advice, nurse advice, individual counseling with a cessation specialist, group behavioral interventions, telephone counseling, and mobile phone–based interventions have all been found to be effective to increase cessation of cigarette smoking. 13

Based on a 2013 systematic review that pooled 26 trials (n = 22 239), rates of smoking cessation at 6 months or more were an average of 8.0% in groups that received physician advice compared with 4.8% in groups that received no advice or usual care (risk ratio [RR], 1.76 [95% CI, 1.58-1.96]). 13 , 56 When stratified by intensity level, both minimal advice (defined as a single session lasting <20 minutes with ≤1 follow-up sessions) and intensive advice (defined as a single session lasting ≥20 minutes or >1 follow-up session) from a physician was associated with significantly increased cessation rates compared with no advice. Although not definitive, some subgroup analyses suggest that more intensive physician counseling (>20 minutes for initial consult, use of additional materials, or >1 follow-up visit) may be associated with an increase in cessation rates, particularly in patients who have smoking-related disease. 13 , 56

Based on a 2017 systematic review that pooled 44 trials evaluating nurse advice, 14.2% of participants who received interventions from nurses achieved smoking cessation at 6 months or more compared with 12.2% of those who received usual care or minimal intervention (RR, 1.29 [95% CI, 1.21-1.38]). 13 , 57 No evidence of effect modification was found when comparing higher- or lower-intensity counseling provided by nurses.

A systematic review from 2017 that pooled 33 trials (n = 13 762) found that an average of 11.4% of participants who received individual counseling with a cessation specialist achieved smoking cessation, compared with 7.7% of those who received minimal contact of less than 15 minutes of advice (RR, 1.48 [95% CI, 1.34-1.64]). 13 , 58 The review found some evidence suggesting that more intensive counseling was associated with higher cessation rates. Another systematic review published in 2017 that pooled 13 trials (n = 4395) also found that participants receiving group behavioral interventions had higher cessation rates compared with those who received a self-help program (10.4% cessation rate in intervention group vs 5.8% cessation rate in control group; RR, 1.88 [95% CI, 1.52-2.33]). 13 , 59

A 2019 review on telephone counseling interventions found that proactive telephone counseling (where telephone counselors called participants directly either to initiate counseling or in response to a participant calling a quitline) was associated with increased cessation rates. 13 , 60 If the telephone counseling was a “cold call” from telephone counselors to initiate counseling, smoking cessation rates were 11.0% in control participants and 13.9% in telephone counseling recipients (RR, 1.25 [95% CI, 1.15-1.35]; 65 trials; n = 41 233). 13 , 60 If telephone counseling occurred in response to a participant contacting a quitline, cessation rates were 7.8% in control participants and 10.8% in intervention recipients (RR, 1.38 [95% CI, 1.19-1.61]; 14 trials; n = 32 484). 13 , 60

A 2019 review that pooled 13 trials (n = 14 133) found higher cessation rates associated with mobile phone–based interventions. 13 , 61 All studies primarily used text messaging as the main intervention component, although a limited number of studies looked at individual mobile phone applications. Smoking cessation rates were an average of 5.6% in participants receiving usual or minimal care and 9.5% in those receiving mobile phone–based interventions (RR, 1.54 [95% CI, 1.19-2.00]).

The USPSTF considered evidence on other behavioral counseling interventions such as print-based, nontailored self-help materials, internet-based interventions, motivational interviewing, biofeedback, exercise, acupuncture, and hypnotherapy 13 ; however, limited evidence was available on these interventions.

The USPSTF reviewed evidence from 4 systematic reviews on pharmacotherapy that reported smoking cessation at 6 months or more. 13

A 2018 review on NRT (133 studies; n = 64 640) 62 found that 16.9% of participants taking any form of NRT achieved smoking abstinence at 6 months or more compared with 10.5% of participants receiving placebo or taking no NRT (RR, 1.55 [95% CI, 1.49-1.61]). All forms of NRT (patch, gum, inhaler, intranasal, and tablets) were found to be effective. Another review found that using combination NRT (patch plus a fast-acting form) was associated with higher smoking cessation rates than using a single form of NRT (16.9% vs 13.9%; RR, 1.25 [95% CI, 1.15-1.36]). 63

A 2020 systematic review on the use of antidepressants for smoking cessation (46 studies; n = 17 866) found that bupropion SR was associated with a significantly higher rate of smoking abstinence at 6 months or more than placebo or no bupropion SR (19.0% vs 11.0%; RR, 1.64 [95% CI, 1.52-1.77]). 64

Based on pooled analyses of 27 studies (n = 12 625), a 2016 systematic review found that varenicline was associated with higher rates of smoking cessation over placebo (25.6% vs 11.1%; RR, 2.24 [95% CI, 2.06-2.43]). 65

Smaller subsets of studies from these reviews directly compared types of pharmacotherapy for smoking cessation. Eight studies (n = 6264) compared varenicline and NRT and found that varenicline was associated with a greater smoking cessation rate over any form of NRT. 65 Six studies (n = 6286) evaluated varenicline vs bupropion SR and found that varenicline was associated with a higher cessation rate. 64 , 65 Smoking cessation rates among participants using NRT vs bupropion SR at 6 months or more did not significantly differ (10 studies; n = 9230). 64

Combinations of behavioral counseling and pharmacotherapy for smoking cessation were also effective, and potentially more effective than behavioral counseling or pharmacotherapy alone. 13 A 2016 systematic review (52 studies; n = 19 488) 66 found that participants who received combination pharmacotherapy and intensive behavioral counseling had a higher abstinence rate at 6 months or more compared with control participants who received usual care, self-help materials, or brief advice on quitting (which was less intensive than the counseling or support given to the intervention groups) (15.2% vs 8.6%; RR, 1.83 [95% CI, 1.68-1.98]). These combination interventions often have behavioral components delivered by specialized smoking cessation counselors or trained staff; however, no difference in effectiveness was seen in studies in which a nonspecialist provided the counseling. 13 Most studies used NRT as the pharmacotherapy. The intensity and format of the behavioral counseling component of the intervention varied greatly, with the majority of studies offering at least 4 behavioral counseling sessions, with a total planned contact time generally ranging from 90 to 300 minutes. Most of the behavioral counseling was delivered by a specialized smoking cessation counselor or trained trial staff.

Another systematic review, 67 which pooled analyses of 65 studies (n = 23 331), found that cessation rates at 6 months or more were modestly higher in participants who received behavioral support as an adjunct to pharmacotherapy than in those who received pharmacotherapy alone. Most studies offered NRT as the pharmacotherapy. Participants in the control group may have also received some counseling or support, but it was less intensive than in the intervention group. The addition of behavioral support to pharmacotherapy was associated with significantly higher cessation rates, approximately 17% in persons using pharmacotherapy alone vs 20% in those using a combination of pharmacotherapy and behavioral support (RR, 1.15 [95% CI, 1.08-1.22]). 13

For benefits of tobacco use cessation interventions in pregnant persons, the USPSTF reviewed evidence from an existing systematic review on behavioral counseling interventions 68 and from primary studies of pharmacotherapy. As with the evidence base in nonpregnant adults, the available evidence primarily addressed smoking cessation.

Based on a systematic review from 2017, 68 the USPSTF found that behavioral counseling interventions in pregnant women were effective at improving rates of smoking cessation as well as some perinatal health outcomes. Pooled analyses from 97 studies (n = 26 637) found that use of any psychosocial intervention was associated with higher smoking cessation rates in late pregnancy relative to control groups (an average quit rate of 12.2% in control groups and 16.4% in intervention groups) (RR, 1.35 [95% CI, 1.23-1.48]). The majority of studies used counseling interventions, and analyses of only counseling interventions (51 studies; n = 18 276) found a significant increase in smoking cessation rates late in pregnancy, from 10.8% in control groups to 14.5% in intervention groups (RR, 1.31 [95% CI, 1.16-1.47]). Studies of other intervention types (health education, feedback, incentives, social support, and exercise) were much fewer, with fewer total participants. Findings of smoking cessation effectiveness by intervention type were all in the direction of benefit, although not all were statistically significant. No subgroup differences by intervention type were found. The same systematic review also assessed the association of behavioral counseling interventions with perinatal outcomes and found lower rates of low birth weight (RR, 0.83 [95% CI, 0.72-0.94]; 18 trials; n = 9402) and increased mean birth weight (mean difference, 55.6 g [95% CI, 29.82-81.38]; 26 trials; n = 11 338). No statistically significant difference in rates of preterm births or stillbirths was found.

The USPSTF identified 5 placebo-controlled trials on NRT during pregnancy. 13 All 5 trials included behavioral counseling or support in addition to NRT. One trial used NRT gum as the intervention, one used an inhaler, while the other 3 trials used a NRT patch. Adherence to NRT in studies was low (<10% in 1 study). Findings of the 5 trials were all generally in the direction of benefit with NRT; however, none of the studies, either individually or when pooled, found a statistically significant difference in smoking cessation (11.9% in NRT intervention groups vs 10.1% in control groups; RR, 1.11 [95% CI, 0.79-1.56]; 5 trials; n = 2033). 13 Seven trials (the 5 placebo-controlled trials previously mentioned plus 2 additional non–placebo-controlled trials) reported on perinatal and health outcomes with NRT during pregnancy 13 ; findings were inconsistent and imprecise. No studies on bupropion SR or varenicline for smoking cessation during pregnancy were identified.

The FDA classifies e-cigarettes as a tobacco product and to date, no e-cigarettes have been approved as a smoking cessation aid. Approximately 4.5% of adults 5 , 69 and 3.6% of pregnant women 48 report using e-cigarettes. Higher e-cigarette use is reported among young adults aged 18 to 24 years (7.6%) 70 and has been increasing in recent years. 70 In addition to young adults, e-cigarette use among adults is higher in men; non-Hispanic White adults and other non-Hispanic adults; lesbian, gay, or bisexual 5 persons; and persons with chronic illnesses (such as cardiovascular disease, diabetes, cancer, asthma, chronic obstructive pulmonary disease, chronic kidney disease, and depression). 13 , 71 Most adult e-cigarette users report that quitting smoking and health improvement are major reasons why they started using e-cigarettes. 72 , 73 This is in contrast to youth, where it has been found that e-cigarette use increases risk of ever smoking cigarettes. 52 Nineteen percent of tobacco users use 2 or more tobacco products, the most common combination being cigarettes and e-cigarettes. 74

The USPSTF identified 5 RCTs (n = 3117) on e-cigarettes for smoking cessation in nonpregnant adults 13 , 75 - 80 and no studies in pregnant persons. 13 All 5 studies were conducted outside of the US (2 in New Zealand, 1 in Italy, 1 in Korea, and 1 in the UK). Four of the studies included participants who either wanted to stop smoking or were attending a stop smoking service. The type of e-cigarette interventions (nicotine content, whether NRT was also given, nicotine cartridge vs e-liquid, and whether behavioral support was also provided) and control interventions (NRT vs nonnicotine e-cigarette) varied across studies, making comparisons difficult. Only 3 of the e-cigarettes used in the studies are currently available in the US. Study size ranged from 150 to 1124 participants.

Reported trial findings were mixed. The 2 largest and most recent trials reported a statistically significant increase in smoking cessation at 6 months; 1 study reported smoking cessation rates of 4% in control groups vs 7% 79 in intervention groups; the second trial reported smoking cessation rates of 25% in control groups vs 35% 78 in intervention groups. The 3 remaining trials reported no statistically significant differences in smoking cessation rates. Three of the studies reported on continued e-cigarette use after achievement of smoking cessation in intervention groups at 6 months to 1 year, with continued e-cigarette use ranging from 38% to 80%. One study reported that 26.9% of all study participants were using e-cigarettes at 1 year. 77

The USPSTF identified limited evidence on harms from behavioral counseling interventions for tobacco cessation. Three systematic reviews (1 on internet-based interventions, another on incentives, and 1 on hypnotherapy) did not find evidence of serious adverse events associated with interventions. 13

The USPSTF identified 4 systematic reviews on NRT that reported on harms 13 : 3 reviews compared harms of NRT vs placebo 62 , 81 , 82 and 1 compared harms from various types of NRT. 63 Twelve to 21 studies (n = 10 234 to 11 647) reported on cardiovascular harms. Statistically significantly more cardiovascular adverse events (in particular, heart palpitations and chest pain) were found for participants randomized to NRT vs placebo (RR, 1.81 [95% CI, 1.35-2.43]; 21 trials; n = 11 647). 82 However, when analyses focused on major cardiovascular adverse events (combined outcome of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), findings were no longer statistically significant (RR, 1.38 [95% CI, 0.58-3.26]; 21 trials; n = 11 647). 82 Other reported harms associated with NRT included nausea, vomiting, gastrointestinal symptoms, and insomnia. Localized increased skin irritation at the NRT patch site has also been reported. No statistically significant increase in headaches, dizziness, anxiety, or depression were found. Cardiac adverse events and other serious adverse events did not differ by type of NRT. 63

The USPSTF considered evidence on harms from bupropion SR for tobacco smoking cessation from 4 systematic reviews. 13 No difference in serious adverse events (RR, 1.30 [95% CI, 1.00-1.69]; 33 trials; n = 9631), 83 cardiovascular adverse events (RR, 1.03 [95% CI, 0.71-1.50]; 27 trials; n = 10 402), 82 or major cardiovascular events (RR, 0.57 [95% CI, 0.31-1.04]; 27 trials; n = 10 402) 82 were found with bupropion SR (compared with placebo or no bupropion SR). No difference in moderate and severe neuropsychiatric events, including rates of suicidal behavior and ideation, were found with bupropion SR (compared with varenicline or NRT) in the recent Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) trial. 84 , 85

Evidence on harms of varenicline for tobacco cessation are available from 3 systematic reviews on varenicline in unselected smokers, 4 systematic reviews of varenicline among persons with severe mental illness, and 1 review on varenicline for cessation of smokeless tobacco. 13 Common adverse effects reported with varenicline include nausea, insomnia, abnormal dreams, headache, and fatigue. 13 One review found an increase in serious adverse events with varenicline in unselected smokers (RR, 1.25 [95% CI, 1.04-1.49]; 29 trials; n = 15 370); however, many of these events included comorbidities that were mostly considered by the study authors to be unrelated to the treatments. 65 Across 3 systematic reviews (encompassing 18 to 38 studies; n = 8587 to 12 706), no statistically significant difference in cardiovascular adverse events or cardiovascular severe adverse events was found. 13 Additionally, no statistically significant increase in neuropsychiatric adverse events (including depression, suicidal ideation, and suicide attempt) was found across several systematic reviews. 13

The USPSTF did not identify any reports of adverse events related to combinations of behavioral counseling interventions and pharmacotherapy. Any harms of combined therapy are assumed to be similar to those of the pharmacotherapy being used.

The primary review that informed the USPSTF on the benefits of behavioral counseling interventions for smoking cessation during pregnancy also summarized evidence on harms of behavioral counseling interventions. 68 Based on analyses of 13 trials (n = 5831), no increase in adverse effects from psychosocial interventions was seen.

Nicotine in general has been shown in animal studies to cause fetal harms. However, NRT does not contain many harmful substances, such as hydrogen cyanide and carbon monoxide, that are present in cigarette smoke. 86 Evidence on harms of NRT during pregnancy is limited; the USPSTF identified 5 placebo-controlled trials (n = 3117), 2 non–placebo-controlled trials (n = 233), and 3 cohort studies (n = 306 721). 13 Findings on potential harms of NRT on birth outcomes from trial evidence is mixed, although most studies reported findings in the direction of benefit rather than harm. Observational evidence from cohort studies generally did not indicate an increase in stillbirth or low birth weight with NRT. Based on observational evidence, there was no evidence of increased risk of premature delivery, small for gestational age, stillbirth, or congenital anomalies associated with the use of NRT, bupropion, and varenicline vs smoking. According to FDA labeling, some fetal harms with bupropion were noted in animal studies, but currently, no adequate, well-controlled studies of bupropion SR use during pregnancy (for any indication) in humans are available. 87 Labeling for varenicline states that available studies cannot definitively establish or exclude varenicline-associated risk during pregnancy. 88

The USPSTF identified 9 RCTs (n = 3942) that reported on harms of e-cigarette interventions for tobacco smoking cessation in nonpregnant adults 13 (the 5 trials previously described that reported cessation rates at 6 months or more, as well as an additional 4 trials that reported on cessation rates at less than 6 months). No trials on harms of e-cigarettes for smoking cessation in pregnant persons was identified. The most commonly reported adverse effects from e-cigarette use reported in trials include coughing, nausea, throat irritation, and sleep disruption. 13 Generally, no significant difference in short-term serious adverse events associated with e-cigarette use was reported. 13 Data on potential long-term harms of e-cigarette use are currently lacking.

Additional evidence on harms from e-cigarette use (whether used for tobacco cessation or not) considered by the USPSTF included data of the 2019 EVALI outbreak in the US 53 and the 2018 report Public Health Consequences of E-Cigarettes by the National Academies of Sciences, Engineering, and Medicine. 52 In late 2019, an outbreak of EVALI occurred in the US. Symptoms of EVALI include cough, shortness of breath, chest pain, nausea, vomiting, stomach pain, diarrhea, fever, chills, and weight loss. As of February 2020, more than 2800 cases of EVALI were reported, with 68 deaths. 53 Based on testing of bronchoalveolar lavage fluid samples of patients with EVALI 89 and testing of products used by patients with EVALI, 53 vitamin E acetate (an additive in some THC-containing e-cigarettes) was found to be strongly linked to EVALI. 53 However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non–THC–containing products, in some reported EVALI cases. 53

The National Academies of Sciences, Engineering, and Medicine report found that in youth and young adults, there is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco and moderate evidence that e-cigarette use increases the frequency and intensity of subsequent cigarette smoking. 52 The report also found conclusive evidence that e-cigarettes contain and emit potentially toxic substances, although substantial evidence shows that other than nicotine, there is significantly lower exposure to potentially toxic substances from e-cigarettes compared with combustible tobacco cigarettes. 52

A draft version of this recommendation statement was posted for public comment on the USPSTF website from June 2, 2020, to June 29, 2020. Several comments expressed concern about the insufficient evidence statement on e-cigarettes for cessation. Some respondents wanted the USPSTF to recommend against e-cigarettes for tobacco cessation, while others wanted the USPSTF to recommend in favor of e-cigarettes. Based on the evidence reviewed, the USPSTF could not determine whether e-cigarettes are effective in helping persons to quit smoking cigarettes, nor could it determine what the potential long-term harms of e-cigarette use are; thus, it cannot recommend for or against their use. Some comments were also received requesting that the USPSTF recommend NRT for smoking cessation during pregnancy. Too few trials were identified for the USPSTF to determine whether NRT during pregnancy provides overall more benefits or harms, and the USPSTF calls for more research on NRT and other pharmacotherapy to help pregnant persons quit using tobacco. Last, edits to clarify language, as well as additional information from the recent 2020 Surgeon General’s Report on Smoking Cessation, have been provided in response to comments.

Because of the well-established health benefits of smoking cessation, 1 , 12 , 47 most of the research on interventions for smoking cessation focuses on cessation (rather than health outcomes) as a primary outcome. The current review identified 1 study 90 of middle-aged men at high risk for cardiorespiratory disease that found lower (although not statistically significant) total mortality, fatal coronary disease, and lung cancer death at 20 years of follow-up in participants who received advice from medical practitioners. 91 The study also found some reduction in all-cause mortality, coronary disease mortality, and lung cancer incidence and mortality at 20 years of follow-up, although these outcomes were not significant. 91

Although not zero, less toxins have been found to be released by e-cigarettes than by cigarettes. It is hypothesized that health outcomes may be improved in adults who completely switch from cigarette smoking to e-cigarette use, although long-term data are not available yet to support this. Evidence on long-term harms of e-cigarette use in general is lacking and is needed. Additionally, emerging evidence suggests that toxicant levels in dual users of e-cigarettes and cigarettes may be higher than in conventional cigarette–only users. 92

The greatest research needs are to gain a better understanding of the effectiveness of e-cigarettes for smoking cessation, as well as potential short- and long-term harms of e-cigarette use, and to understand whether there are effective pharmacotherapy options for pregnant persons.

e-Cigarettes: Given the potential negative effect that increasing e-cigarette use in youth is having on overall tobacco control efforts, there is an urgent need for research that provides both a clearer understanding of whether e-cigarettes may increase adult tobacco smoking cessation, as well as the potential harms of e-cigarette use as a tobacco product. Future research on e-cigarettes for smoking cessation in adults should address the following:

Studies must be well-designed RCTs that compare e-cigarette interventions with placebo, as well as established, effective combinations of pharmacotherapy and behavioral support.

Studies should be adequately powered to detect differences in continued smoking abstinence rates at 6 months or more.

Given the high rate of continued e-cigarette use after smoking cessation, research on both the short- and long-term harms of e-cigarette use is needed, as well as the harms in dual users of e-cigarettes and conventional cigarettes. More research is needed on smoking relapse rates in adults who have used e-cigarettes for smoking cessation and how to help with cessation of e-cigarette use once smoking abstinence has been achieved.

Given the rapidly evolving landscape of e-cigarettes, trials should include current generations of e-cigarettes. Additionally, to successfully conduct these types of studies, standardization of how to quantify e-cigarette use and levels of nicotine exposure from e-cigarettes is needed.

More research is needed to understand the patterns of e-cigarette use in youth and the risk factors for their transition from e-cigarette use to conventional cigarette smoking.

More research is also needed to better understand patterns of e-cigarette use in pregnant persons and potential harms of e-cigarette use to both pregnant persons and their offspring.

More research is needed on understanding how to help adults quit e-cigarettes.

Pharmacotherapy in pregnant persons: Although behavioral counseling interventions have been found to be effective in improving smoking cessation during pregnancy, additional research is needed on pharmacotherapy options, in particular NRT, for pregnant persons for whom behavioral counseling interventions alone are not effective.

Larger studies adequately powered to detect an effect on both smoking cessation rates (during pregnancy and postpartum) and changes in perinatal and child health outcomes are needed.

A better understanding of why adherence rates to NRT during pregnancy is so low would also be helpful.

Although the benefits of behavioral counseling interventions and pharmacotherapy in nonpregnant adults and the benefits of behavioral counseling interventions in pregnant adults are well established, additional research on effective components of behavioral counseling and who to target specific interventions to would be informative. More research on newer modalities and remotely delivered interventions (mobile phone apps, internet-based interventions) would also be helpful. Additionally, the effectiveness of interventions for cessation of other forms of tobacco and whether interventions need to be tailored to individual tobacco product types are also needed. Last, more research is needed on interventions to prevent relapse of tobacco use.

Numerous professional societies and health organizations, including the American Academy of Family Physicians, 93 American College of Physicians, 94 and American College of Obstetricians and Gynecologists (ACOG), 95 recommend that clinicians screen for tobacco use and provide interventions to patients who smoke.

For pregnant persons, ACOG recommends brief behavioral counseling and the use of evidence-based smoking cessation aids as effective strategies for achieving smoking cessation, even for very heavy smokers. 96 ACOG also recommends that NRT should be considered only after a detailed discussion with the patient of the known risks of continued smoking, the possible risks of NRT, and need for close supervision. 95

The American Academy of Pediatrics also has a policy statement recommending that pediatricians screen for the tobacco exposure of children during pediatric care visits and recommend nicotine dependence treatment, including behavioral interventions and pharmacotherapy, to tobacco-dependent parents. 97

More recently some organizations have addressed e-cigarette use in their tobacco use guidelines. The American Academy of Family Physicians, 98 the American College of Preventive Medicine, 99 and the American Heart Association 100 recommend that clinicians screen for e-cigarette use. Organizations vary somewhat in terms of whether they recommend e-cigarettes for smoking cessation. ACOG recommends against use of e-cigarettes in pregnant and postpartum individuals. 95 , 101 The American Cancer Society does not recommend e-cigarettes as a smoking cessation method, 102 and the American Heart Association 100 states that there is not enough evidence for clinicians to counsel patients on using e-cigarettes as a primary smoking cessation aid.

Corresponding Author: Alex H. Krist, MD, MPH, Virginia Commonwealth University, One Capitol Square, 6th Flr, 830 E Main St, Richmond, Virginia 23219 ( [email protected] )).

Accepted for Publication: December 4, 2020.

The US Preventive Services Task Force (USPSTF) members: Alex H. Krist, MD, MPH; Karina W. Davidson, PhD, MAS; Carol M. Mangione, MD, MSPH; Michael J. Barry, MD; Michael Cabana, MD, MA, MPH; Aaron B. Caughey, MD, PhD; Katrina Donahue, MD, MPH; Chyke A. Doubeni, MD, MPH; John W. Epling Jr, MD, MSEd; Martha Kubik, PhD, RN; Gbenga Ogedegbe, MD, MPH; Lori Pbert, PhD; Michael Silverstein, MD, MPH; Melissa A. Simon, MD, MPH; Chien-Wen Tseng, MD, MPH, MSEE; John B. Wong, MD.

Affiliations of The US Preventive Services Task Force (USPSTF) members: Fairfax Family Practice Residency, Fairfax, Virginia (Krist); Virginia Commonwealth University, Richmond (Krist); Feinstein Institute for Medical Research at Northwell Health, Manhasset, New York (Davidson); University of California, Los Angeles (Mangione); Harvard Medical School, Boston, Massachusetts (Barry); University of California, San Francisco (Cabana); Oregon Health & Science University, Portland (Caughey); University of North Carolina at Chapel Hill (Donahue); Mayo Clinic, Rochester, Minnesota (Doubeni); Virginia Tech Carilion School of Medicine, Roanoke (Epling Jr); George Mason University, Fairfax, Virginia (Kubik); New York University, New York, New York (Ogedegbe); University of Massachusetts Medical School, Worcester (Pbert); Boston University, Boston, Massachusetts (Silverstein); Northwestern University, Evanston, Illinois (Simon); University of Hawaii, Honolulu (Tseng); Pacific Health Research and Education Institute, Honolulu, Hawaii (Tseng); Tufts University School of Medicine, Boston, Massachusetts (Wong).

Author Contributions: Dr Krist had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The USPSTF members contributed equally to the recommendation statement.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Authors followed the policy regarding conflicts of interest described at https://www.uspreventiveservicestaskforce.org/Page/Name/conflict-of-interest-disclosures . All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. Dr Barry reported receiving grants and personal fees from Healthwise.

Funding/Support: The USPSTF is an independent, voluntary body. The US Congress mandates that the Agency for Healthcare Research and Quality (AHRQ) support the operations of the USPSTF.

Role of the Funder/Sponsor: AHRQ staff assisted in the following: development and review of the research plan, commission of the systematic evidence review from an Evidence-based Practice Center, coordination of expert review and public comment of the draft evidence report and draft recommendation statement, and the writing and preparation of the final recommendation statement and its submission for publication. AHRQ staff had no role in the approval of the final recommendation statement or the decision to submit for publication.

Disclaimer: Recommendations made by the USPSTF are independent of the US government. They should not be construed as an official position of AHRQ or the US Department of Health and Human Services.

Additional Contributions: We thank Tina Fan, MD, MPH (AHRQ), who contributed to the writing of the manuscript, and Lisa Nicolella, MA (AHRQ), who assisted with coordination and editing.

Additional Information: The US Preventive Services Task Force (USPSTF) makes recommendations about the effectiveness of specific preventive care services for patients without obvious related signs or symptoms. It bases its recommendations on the evidence of both the benefits and harms of the service and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment. The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision-making to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.

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Tobacco dependence: a comprehensive guide to prevention and treatment

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Smoking remains a paramount global public health crisis, representing the leading cause of preventable diseases, morbidity, and mortality. Within this vital context, Tobacco dependence: a comprehensive guide to prevention and treatment emerges as an indispensable resource, aiming to arm healthcare professionals with profound insights spanning the entire spectrum of smoking cessation, from diagnosis to the intricacies of dependence.

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Amaral, A.L., da Costa Andrade, P.A., Lwaleed, B.A. et al. Tobacco dependence: a comprehensive guide to prevention and treatment. Evid Based Dent 24 , 150 (2023). https://doi.org/10.1038/s41432-023-00950-z

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In 2014, the Nation marked the 50th anniversary of the first Surgeon General’s Report on Smoking and Health. In 1964, more than 40 percent of the adult population smoked. Once the link between smoking and its medical consequences—including cancers and heart and lung diseases—became a part of the public consciousness, education efforts and public policy changes were enacted to reduce the number of people who smoke. These efforts resulted in substantial declines in smoking rates in the United States—to half the 1964 level. 1

However, rates of cigarette smoking and other tobacco use are still too high, 2 and some populations are disproportionately affected by tobacco’s health consequences. Most notably, people with mental disorders—including substance use disorders—smoke at higher rates than the general population. 3–6 Additionally, people living below the poverty line and those with low educational attainment are more likely to smoke than those in the general population. As tobacco use is the leading preventable cause of mortality in the United States, 1 differential rates of smoking and use of other tobacco products is a significant contributor to health disparities among some of the most vulnerable people in our society.

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Benjamin w chaffee.

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Stephanie L Clendennen

Suchitra krishnan-sarin, mary ann pentz.

The Tobacco Regulatory Science Program is a collaborative research effort between the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). In 2013, the NIH funded 14 Tobacco Centers of Regulatory Science (TCORS), which serve as partners in establishing research, training, and professional development programs to guide FDA. Each of the fourteen TCORS, and two other NIH-funded research programs, the Center for the Evaluation of Nicotine in Cigarettes (CENIC) and the Consortium on Methods Evaluating Tobacco (COMET), pursued specific research themes relevant to FDA’s priorities. A key mandate for FDA is to reduce tobacco use among young people. This article is a review of the peer-reviewed research, including published and in-press manuscripts, from the TCORS, CENIC, and COMET, which provides specific data or other findings on youth (ages 10–18 years) and/or young adults (ages 18–34 years), from 2013 to 2018. Citations of all TCORS, CENIC, and COMET articles from September 2013 to December 2017 were collected by the TCORS coordinating center, the Center for Evaluation and Coordination of Training and Research. Additional citations up to April 30, 2018 were requested from the principal investigators. A scoring rubric was developed and implemented to assess study type, primary theme, and FDA priority area addressed by each article. The major subareas and findings from each priority area are presented. There were 766 articles in total, with 258 (34%) focusing on youth and/or young adults. Findings relevant to FDA from this review concern impact analysis, toxicity, health effects, addiction, marketing influences, communications, and behavior.

Implications

The Tobacco Centers of Regulatory Science, CENIC, and COMET have had a high output of scientific articles since 2013. These Centers are unique in that the FDA supports science specifically to guide future regulatory actions. The 258 articles that have focused on youth and/or young adults are providing data for regulatory actions by the FDA related to the key priority areas such as the addictiveness of non-cigarette products, the effects of exposure to electronic cigarette marketing on initiation and cessation, and the impact of flavored products on youth and young adult tobacco use. Future regulations to reduce tobacco use will be guided by the cumulative evidence. These Centers are one innovative mechanism to promote important outcomes to advance tobacco regulatory science.

Introduction

There is strong evidence that preventing the onset of tobacco use is the most effective approach to reducing the long-term population-wide prevalence of use. The 1994 and 2012 Surgeon General’s Reports both noted that nearly all cigarette smoking (99%) begins by age 25 years. Thus, if youth and young adults can remain non-users, they are not likely to initiate use and become addicted to smoking. These conclusions come from ongoing national epidemiological data. 1 , 2 However, the same conclusions were found in the tobacco industry’s own documents: “Today’s teenager is tomorrow’s potential regular customer, and the overwhelming majority of smokers first begin to smoke while in their teens.” 3 , 4

A key mandate of the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 is to reduce youth tobacco use. 5 The TCA gave the Food and Drug Administration (FDA) the authority to regulate the manufacturing, distribution, and marketing of tobacco products. These products initially included cigarettes, smokeless tobacco products, and roll-your-own tobacco, but the FDA’s authority was expanded to all tobacco products, including cigars, hookah/water pipe tobacco, and electronic cigarettes (e-cigarettes), via deeming in 2016.

The Tobacco Regulatory Science Program was established as a collaborative research effort between the National Institutes of Health (NIH) and the FDA. The intent of Tobacco Regulatory Science Program is to foster cutting-edge research through the Institutes and Centers at NIH; this research is intended to be timely and relevant to support the FDA’s regulatory authority and mandate over time. 6 In 2012, the NIH issued a call for proposals for Tobacco Centers of Regulatory Science (TCORS), which would serve as partners in establishing research, training, and professional development programs that would provide important data and trained professionals to help guide FDA. In 2016, the original FDA priorities were subsumed under seven primary priority research areas: impact analysis, toxicity, health effects, addiction, marketing influences, communications, and behavior. In 2013, 14 TCORS were funded via the NIH–FDA collaboration to establish centers primarily focusing on FDA research priorities. These TCORS were funded from 2013 to 2018 (TCORS 1.0).

Each of the fourteen TCORS, and two other NIH-funded research programs, the Center for the Evaluation of Nicotine in Cigarettes (CENIC) and the Consortium on Methods Evaluating Tobacco (COMET), pursued specific research themes relevant to the FDA. Despite differences in overall themes of each Center, all produced some research important to the understanding of youth and young adult tobacco use and the seven key priority areas noted earlier. This article is a review of that research, including published and in-press manuscripts, which provides specific data or other findings on youth (ages 10–18 years) and/or young adults (ages 18–34 years), from 2013 to 2018. This review provides substantive insights into the current research originating from the TCORS program, CENIC, and COMET, relevant to these age groups that should be of importance to the FDA’s regulation of tobacco products that may affect young people.

Citations of all TCORS, CENIC, and COMET (referred to as “Centers”) peer-reviewed (accepted or in-press) articles from September 1, 2013 to December 31, 2017 were collected by the TCORS coordinating center, the Center for Evaluation and Coordination of Training and Research. These articles were organized on a spreadsheet by Center. However, some articles included authors from two or more Centers, so these overlapping articles were counted as one article in the review. We then wrote to the principal investigators of each of the 16 Centers in May 2018 to obtain any additional articles from their Center that were published or in press up to April 30, 2018. We asked for articles relevant to youth and/or young adult tobacco use for these additional articles. We allowed the principal investigators until July 2018 to respond to this request and received responses from the Centers. A total of 766 articles were collected after duplicates were removed. Abstracts and copies of all articles were obtained for review and were made available to the writing team.

A scoring rubric was developed to determine eligibility and study attributes for the current review article, and each coauthor coded articles from at least two of the sixteen Centers. The rubric considered whether each article was peer-reviewed, focused on youth and/or young adults, data source, type of study, primary theme, and FDA priority area addressed. Note that the articles in this review needed to focus on data specifically relevant to youth (10–18 years) or young adults (18–34 years). If a larger age range, such as adulthood, was considered, then data had to be presented separately for one/both of these age groups. In addition, if the article focused on young adults, the age range had to include those <25, as our preference was to consider the younger side of the young adult spectrum.

The rubric that was developed included providing yes/no answers to each of the following questions for each article. The first four questions determined eligibility for our review. Eligible articles were required to be peer-reviewed and focus on, or be relevant to, youth and/or young adult tobacco use. The other questions provided information on study attributes.

• Is the article peer-reviewed?
• Does the article focus on/or separately analyze data on youth (eg, ages 10–18)?
• Does the article focus on and/or separately analyze data on young adults (eg, ages 18–34)?
• Is the article specifically relevant to youth or young adult tobacco use (eg, marketing and communication)?
• Is the data source partially attributed to a Center generated study (eg, main study and pilot study)?
• Is the data source from a national data set (eg, on-going youth surveillance, such as Monitoring the Future)?
• Is the study type (yes/no for each): (1) qualitative, (2) cross-sectional, (3) longitudinal, (4) experimental, (5) observational, (6) systematic review or meta-analyses, (7) other?
• Does the primary theme include (yes/no for each): (1) prevalence of use, (2) trajectories of use, (3) transitions in use, (4) specific tobacco product use, (5) dual/poly use, (6) psychosocial risk factors, (7) marketing-related factors, (8) social media factors, (9) communication or communicating risks, (10) sociodemographic factors, (11) toxicity, (12) health effects, (13) addiction, (14) other?
• Is FDA priority research area addressed directly (yes/no for each): (1) impact analysis, (2) toxicity, (3) health effects, (4) addiction, (5) marketing influences, (6) communications, (7) behavior?

After initial coding, the articles were recoded by another investigator or graduate student to ensure reliable coding. There were 258 youth and young adult peer-reviewed articles (after removing duplicates). Of all 258 articles, 141 primarily focused on youth, 128 primarily focused on young adults, and 156 additional articles were relevant to youth or young adult tobacco use. Articles within each priority research area were further reviewed for subareas (as discussed next within each area), as this division of the articles by priority areas was considered by the group to be most important for the FDA’s current regulatory needs. Each member of the writing team reviewed the articles from one of the seven research priority areas. The primary foci and outcomes of these articles by priority research area are summarized next. Articles for each priority area are not mutually exclusive—some articles could be in more than one priority area. Group review of each priority area, subareas, and potential overlap of priority areas was done via group conference calls and e-mail.

Of the 258 articles relevant to youth and/or young adults, 132 articles came from Center-generated data and 45 from national datasets; additional articles included reviews or analyses of data from other datasets. As seen in Table 1 , the majority of articles were cross-sectional ( n = 146) or observational ( n = 141). Further, most articles examined prevalence of tobacco use ( n = 144) or specific tobacco product use ( n = 177). There were at least 18 articles addressing each of the FDA priority areas: impact analysis ( n = 18), 7–24 toxicity ( n = 22), 17 , 25–45 health effects ( n = 33), 25–27 , 32–40 , 43 , 45–64 addiction ( n = 45), 10 , 15 , 22 , 25 , 27 , 32–34 , 36–39 , 41 , 45 , 48 , 50 , 54–56 , 58 , 60 , 64–87 marketing influences ( n = 53), 8 , 9 , 15 , 17 , 20 , 21 , 25 , 29 , 36 , 39 , 45 , 48 , 53 , 55 , 63 , 64 , 71–73 , 86 , 88–120 communications ( n = 62), 7–9 , 14 ,18,19,25, 29–34 , 36–38 , 49–51 , 54 ,55,64,69, 71–73 , 92 ,95,97,99, 102–107 , 115 ,116, 120–143 and behavior ( n = 206). 7–12 , 14–22 , 24 ,25, 27–40 , 43 ,45, 48–51 , 53–65 , 68–81 , 85 ,87,91, 93–99 , 101–108 , 110 ,111,113,114, 117–121 , 123 ,124,127,130,131, 133–135 , 138–140 , 143–171 , 173–243 These are further discussed next. Each section describes articles within predominant subareas, with two or more articles supporting that subarea, within each priority area. The major findings from each priority area are shown in Table 2 .

Primary Classification of Youth and Young Adult Studies From TCORS 1.0, CENIC and COMET (September 2013–April 2018), by Study Type, Primary Theme, and FDA Priority a

CENIC = Center for the Evaluation of Nicotine in Cigarettes; COMET = Consortium on Methods Evaluating Tobacco; FDA = Food and Drug Administration; TCORS = Tobacco Centers of Regulatory Science.

a Classifications of articles in each category are not mutually exclusive.

Main Findings on Youth and Young Adults from TCORS 1.0, CENIC, and COMET (September 2013–April 2018) by FDA Priority Area

Impact Analysis

Eighteen articles focused on impact analyses. 7–24 Several studies examined the impacts of anti-smoking campaigns, including the FDA’s “The Real Cost” campaign, on smoking-related beliefs and how to improve campaign effectiveness. For adolescents aged 13–17 years, one article demonstrated that those who recalled specific ads in the campaign subsequently endorsed the beliefs presented in those specific ads. The beliefs included smoking’s impact on teeth, wrinkles, and loss of control, suggesting how the “The Real Cost” campaign was effective. 14 Another study tested the ability of health messages to reduce the social acceptability of peer smoking on YouTube and shows that exposure to such videos with a message about the mortality risk to those smokers increased beliefs about smoking’s adverse health outcomes and negative attitudes toward smoking by adolescents. 18

Six studies analyzed the effects of existing and potential regulations on youth tobacco use. 12 , 13 , 16 , 19–21 For example, one study 12 examined the consequences of the 2009 flavored cigarette ban among youth, showing reductions in smoking prevalence and cigarette consumption among youth. However, the ban was also positively associated with increased use of menthol cigarettes, cigars, and pipes among adolescents. Two additional studies 20 , 21 assessed the associations between point-of-sale ad bans and youth smoking and found that those bans were associated with lower odds of ever smoking, smoking prevalence, and daily smoking among youth.

National Youth Tobacco Survey 13 analyses found that e-cigarette minimum legal sale age laws were associated with lowered cigarette smoking among adolescents, but this association became nonsignificant after adjusting for covariates. In addition, state e-cigarette minimum legal sale age laws did not affect youth cigarette smoking. With regard to school policies, students attending schools that had an e-cigarette policy, compared to those who attended schools that did not, have lower odds of ever e-cigarette use, susceptibility to use e-cigarettes, and perceived peer use of e-cigarettes. 16 A discrete choice experiment 19 examined the effects of e-cigarette attributes, including warning messages on youth preference on e-cigarettes and found that warning messages reduce the probability of choosing e-cigarettes among youth never users of e-cigarettes.

Further, although these articles, published by the Centers, evaluate the associations of existing or potential regulatory policies with youth tobacco use behaviors, none of the articles address the cost-benefit analysis or the regulatory impact analysis requested by the executive orders. 244 In summary, the literature on the policy impacts on tobacco use behaviors among youth and young adults is sparse and how tobacco use behaviors among this population should be factored into the regulatory impact analysis needs further investigation.

Tobacco Product Toxicity

Of the 22 identified articles, 17 , 25–45 17 specifically discussed toxicity concerns regarding rising youth and young adult use of new and emerging tobacco products, including e-cigarettes 45 and hookah/water pipe. 43 The primary subareas that are summarized for this review were exposure to harmful substances ( n = 3), 41 , 42 , 44 cross-sectional surveys on toxicity perceptions ( n = 3), 29–31 and focus groups on tobacco constituents ( n = 2). 32 , 38

Few studies ( n = 3) assessed biomarkers of exposure to harmful or potentially harmful constituents in samples restricted to young adults, although two studies connected the manner of use to toxicant exposures. Blank et al. 41 assessed the impact of “hyping” a Black & Mild cigarillo (removing the inner tobacco binder) among 20 predominantly male, non-Hispanic black young adults. The authors reported no difference in nicotine intake, topography, or subjective effects but found lower CO exposure under the hyping condition. 41 Ramôa et al. 42 observed young adults under assigned sessions of hookah/water pipe smoking alone or in pairs, finding that as a dyad, individuals took more puffs but had lower expired CO concentrations, whereas the smoke produced contained higher concentrations of butyraldehyde, anthracene, tar, and other toxicants. Elsewhere, plasma menthol glucuronide showed promise as a biomarker of acute inhaled menthol exposure. 44

In addition to toxicant exposures, Center investigators measured toxicity-related perceptions, aiming to inform communication about tobacco constituents. In focus groups, adolescents and young adults expressed lack of awareness but desire to know more about constituents in novel tobacco products, as well as health concerns regarding both familiar (eg, arsenic) and less familiar (eg, N -nitrosonornicotine) chemicals. 38 For novel products, such as hookah/water pipe tobacco, perceived lower health risks were related to being “pure” and with fewer additives relative to cigarettes. 32 In a national telephone survey of adolescents, nicotine was the most familiar chemical in cigarette smoke, but formaldehyde, ammonia, and lead were the constituents viewed as most likely to discourage smoking. 31 Nearly as many adolescents believed manufacturers add most constituents in cigarette smoke as correctly believed that most constituents derive from combustion. 31 In another national telephone survey, young adults were more likely than older adults to seek information about cigarette or cigarette smoke constituents, although only 37% reported that they had. 30 Pooling adolescents and young adults from both surveys, constituents in cigarillo and hookah/water pipe tobacco smoke were found to be more “worrisome” than cosmetic effects (eg, wrinkles), particularly among tobacco users. 29

In summary, few publications have focused on tobacco product toxicity specifically among youth or young adults, representing a research gap for future investigations. Youth and young adults generally perceive specific tobacco product and smoke constituents unfavorably, which could serve as a point of emphasis in tobacco prevention communication.

Health Effects

Ten articles directly discussed health effects in the context of youth and young adults. 32 , 35 , 38 , 40 , 49 , 53 , 55 , 56 , 59 , 60 Given the young age range of participants in the reviewed studies, no studies examined long-term health and disease consequences of tobacco product use. In addition, none of the studies compared health effects between adolescents and young adults. Subsequently, the Centers’ research on health effects of tobacco product use included studies on adolescents and/or young adults, focused on one or more of the following: (1) immediate and short-term physiological and mental health consequences of use ( n = 3) 40 , 59 , 60 ; (2) perceptions and beliefs about health effects of use ( n = 5) 32 , 38 , 53 , 55 , 56 ; and/or (3) discussion about implications of study findings for health effects ( n = 2). 35 , 49

Studies examining physiological or psychological consequences were all in adolescent populations. Mental health problems of depression, panic disorders, and internalizing behavior were more prevalent among e-cigarette users compared to conventional cigarette users. 59 , 60 One article revealed that adolescent e-cigarette users had increased rates of chronic bronchitis symptoms, but more investigation is needed to determine long-term effects. 40 These studies provide important information on potential short-term health effects, particularly focusing on adolescents.

Among the five articles specifically examining perceptions or beliefs about health effects, all included an adolescent sample and three included young adults. The research methods regarding perceptions were not consistent between studies. Three of the articles used qualitative data. Wiseman et al . 38 focused on perceptions and knowledge of constituents in e-cigarettes among youth and young adults; participants wanted to know more about health effects of individual constituents. Wagoner et al . 55 examined e-cigarette use and perceptions in youth and young adults. E-cigarettes were perceived as having fewer risks than cigarettes, and specifically that vapor is not at all harmful. Not knowing what is in e-cigarettes was concerning to participants. Cornacchione et al . 32 examined perceptions of cigar products and hookah/water pipe tobacco in youth and young adults. All participants brought up health effects regarding hookah/water pipe tobacco and cigar products. Because these products are used infrequently, long-term health effects were not a big concern for participants. The remaining articles used quantitative data, one in an adolescent sample in California 56 and one in an adolescent North Carolina sample. 53 Barrington-Trimis et al . 56 found that most students believed both cigarettes and e-cigarettes are harmful to one’s health. Among e-cigarette users, nearly 50% believed they were not harmful. In Kowitt et al . 53 90% of all students believed breathing someone else’s smoke was harmful and 86% agreed or strongly agreed that all tobacco products were harmful. Greater use by a participant was associated with disagreeing that tobacco products are harmful, including secondhand smoke.

The remaining two articles included adult participants. 35 , 49 Mendel et al . 35 examined if adults switch brands to reduce health risks. Older adults were more likely to have switched brands to reduce health risks than young adults. Participants reported switching after learning about specific constituents in one brand. Francis et al . 49 used an experimental design to determine believability of messages in new diseases linked to cigarette smoking in the 2014 Surgeon General’s Report. Approximately 56% of young adults found messages about new diseases associated with smoking to be very believable. There were no differences between older and young adults in believability of messages.

The Centers’ research on addiction included 45 articles, with specific foci including perceptions and correlates of nicotine addiction/dependence, and the potential to become addicted as a theme in tobacco prevention. Other related topics are also discussed next.

Four qualitative studies 11 , 32 , 38 , 55 and two quantitative studies 77 , 79 examined perceptions of nicotine addiction in cigarettes, e-cigarettes, hookah/water pipe tobacco, and little cigars/cigarillos. Study findings suggested that tobacco users and nonusers were aware that nicotine was addictive. 11 , 32 , 38 Nonusers, relative to users, were more likely to report addiction as a negative attribute. 32 , 38 , 55 , 77 , 79 Youth also perceived that non-cigarette tobacco products were less addictive than cigarettes. 10 , 32 , 79 Studies that specifically focused on perceptions of addiction in e-cigarettes found that (1) perceptions of low nicotine addiction were positively associated with e-cigarette initiation and current use 77 ; (2) different e-cigarette devices were associated with different perceived levels of nicotine dependence 55 ; and (3) perceptions of low addiction of flavored e-cigarettes were associated with e-cigarette use. 77

Five quantitative studies, 76 , 80 , 81 , 245 , 246 one ecological momentary assessment study, 75 and one qualitative study 84 examined correlates of nicotine dependence. Nicotine dependence was measured for cigarettes, e-cigarettes, and hookah/water pipe using modified versions or select items of various nicotine dependence measures (eg, Hooked on Nicotine Checklist). 247 The findings showed that greater nicotine dependence was associated with greater tobacco use, 144 difficulties in quitting, 76 multiple tobacco products use 76 , 80 including use of marijuana, 246 and greater likelihood of belittling health warning labels. 54

Two studies using telephone surveys examined reactions to addiction themes used in tobacco prevention. One study found that adolescents were more likely to recall ads in “The Real Cost” campaigns that emphasized themes of physical appearance than loss of control because of addiction. 72 Another study that examined believability of various themes used in cigarette health warning showed that adolescents believed that cigarettes were addictive and that nicotine was an addictive chemical. 34 However, adolescents did not find believable the warnings that menthol cigarettes were more addictive than non-menthol cigarettes.

Three additional themes related to addiction included (1) nicotine dependence being a reason for tobacco use, 15 (2) young adults having reduced smoking satisfaction and psychological reward from low-nicotine-content cigarettes, 65 and (3) activation of neural cue reactivity in response to sweet/fruit-flavored e-cigarette advertisements. 86 One study on cessation observed that e-cigarette use was associated with poor smoking cessation outcomes. 173

Marketing Influences

The Centers’ research publications on tobacco product marketing included 53 articles that primarily focused on: (1) descriptions of marketing techniques that attract youth and young adults, (2) associations between tobacco marketing exposure and tobacco use, and (3) associations between tobacco marketing bans and tobacco use.

Content analyses of tobacco product marketing messages have identified features that could appeal to youth/young adults. These include cartoons, animation, references to video games, product placement in music videos, and themes of happiness, friendship, sex, and success. 100 , 103 , 248 Youth/young adults have self-reported that they prefer descriptions of flavors, price promotions, branding, and marketing claims such as “natural,” for cigars 120 ; attractive packaging, time-limited promotional offers, and social acceptance and entertainment themes for smokeless tobacco products 88 , 91 ; and sex appeal themes for e-cigarettes. 88 An experimental functional magnetic resonance imaging study 86 found that sweet/fruit-flavored e-cigarette ads produced more nucleus accumbens activity, a brain biomarker of product preference, among youth/young adults than tobacco-flavored e-cigarette ads.

Center studies examined associations between tobacco marketing exposure and tobacco use among youth/young adults, using cross-sectional, longitudinal, and experimental designs. In cross-sectional analyses of the Population Assessment of Tobacco and Health Wave 1 survey, 113 the 2014 National Youth Tobacco Survey, 63 a sample of North Carolina high school students, 97 and a sample of college students, 119 self-reported recall of tobacco marketing exposure was associated with tobacco product use. Longitudinal studies of adolescents 114 , 118 found that self-reported recall of e-cigarette and cigar ads at the point of sale or online was associated with increased risk of tobacco product use 6 months later. Young adults who recalled e-cigarette marketing displays at the point of sale reported lower odds of cigarette smoking cessation 6 months later. 111

To prevent recall bias inherent in retrospective self-reports of tobacco marketing exposure, studies have used ecological momentary assessment methods to measure participants’ exposure to tobacco marketing several times per day. An ecological momentary assessment study of young adults 109 found that exposure to e-cigarette or hookah/water pipe marketing messages produced favorable attitudes toward the products and intentions to use the products. Another ecological momentary assessment study 89 found that participants who used tobacco products more frequently reported more frequent exposure to tobacco ads and reported more positive attitudes toward tobacco ads, relative to less frequent users.

Experimental laboratory studies have examined associations between tobacco product marketing exposure and tobacco-related attitudes and beliefs. Youth/young adults who were randomly assigned to view e-cigarette ads exhibited more positive beliefs about e-cigarettes and tendency to choose e-cigarettes in a product choice task, 17 as well as lower perceived risk of combustible cigarettes, 92 compared with youth/young adults who viewed control ads.

The Centers’ studies have examined associations between tobacco marketing bans and tobacco product use. Analyses of adolescent survey data from 130 countries in the Global Youth Tobacco Survey found that adolescent cigarette smoking was less prevalent in countries with point-of-sale tobacco advertising bans. 20 This association was similar among boys and girls and persisted after controlling for numerous individual-level covariates. 21

Communication

The 62 Center research articles on communication about tobacco products have largely focused on three areas: (1) tobacco product warnings, (2) campaign evaluation, and (3) promising themes for health communication.

The Centers’ researchers published ten studies 19 , 33 , 34 , 37 , 54 , 110 , 126 , 132 , 141 , 249 on the impact of tobacco product warnings on adolescents and young adults, including eight experiments, one qualitative study, onez in-person survey, and one longitudinal study. Results from these studies identified several features that can increase warning effectiveness among adolescents and young adults, including graphic versus text, 37 , 126 , 249 warnings that elicit more negative emotion, 37 , 126 , 249 and larger warning size. 126 , 132

Several studies investigated the impact of warning content for various products. For example, one study of adolescents found that a cigar warning focused on lung cancer and heart disease was more believable than those focused on mouth and throat cancer or cigars not being a safe alternative to cigarettes. 33 Similarly, adolescents found cigarette warnings focused on addiction and nicotine to be more believable than a warning focused on the relative risk of menthol cigarettes (compared to non-menthol cigarettes). 34 In neither of these studies, did source of the warning (FDA, Centers for Disease Control and Prevention, Surgeon General) have an impact on believability. A discrete choice experiment found that the inclusion of a text warning decreased the likelihood that a never user would choose an e-cigarette product, suggesting warnings could deter uptake. 19 Finally, a qualitative study of text warnings for hookah/water pipe found that factual warnings about health consequences were preferred over warnings that used sensationalistic wording (“Smoking hookah can kill you.”). 110 In a longitudinal study conducted in four countries, disparagement, in the form of mocking, was positively associated with quit attempts and younger adults were more likely to disparage warnings than older adults. 54

One study also assessed other features of tobacco product warnings, including format. Mays et al. 141 conducted an online experiment of the FDA’s nicotine warning for e-cigarettes on advertisements testing the impact of warning background and warning size. Exposure to warnings on a red background (vs. white) resulted in greater attention and those who reported greater attention had greater recall but lower perceived relative addictiveness (compared to cigarettes). In this study, warning attention and recall did not differ by warning size. These studies highlight the importance of considering several features when designing warnings including format (text vs. pictorial), size, content, and important design features.

Two studies evaluated the impact of the FDA’s The Real Cost campaign on adolescents. 14 , 72 Exposure to the campaign was high (88% reported seeing or hearing one of the four tested campaign ads). Ad recall was associated with greater perceptions of serious cigarette smoking health consequences. 72 A second study found that ad recall was associated with ad-targeted beliefs. In addition, adolescents who endorsed campaign beliefs were less likely to intend to smoke. 14

Twelve studies addressed promising themes for health communication about tobacco product use. 7 , 8 , 18 , 29 , 31 , 32 , 38 , 128 , 129 , 139 , 143 Several studies noted that there is a significant gap in awareness among youth and young adults of the health harms associated with the use of and the constituents present in the smoke or aerosol of non-cigarette tobacco products. 8 , 32 , 38 , 139 In particular, studies noted that long-term health consequences were seen as unlikely because of infrequent use of products such as little cigars/cigarillos and hookah/water pipe tobacco. 32 Other studies found that youth and young adults had generally positive attitudes towards non-cigarette tobacco products. 8 , 32

Across the studies that tested promising themes, several consistent themes emerged. Promising themes included those focused on expression of independence, 7 acute and cosmetic health effects, 32 , 139 social stigma, 7 , 8 industry targeting practices, 129 and constituent-based messages. 29 , 31 , 38 , 128 One study compared loss versus gain-framed messages and generally found loss-framed messages were preferred for health risk themes, addiction, and smoker labeling; however, gain-framed messages were preferred for financial themes. 143 Although not directly assessing a specific theme, one study found that a health message about smoking risks paired with YouTube videos of youth smoking could be an effective way to counteract peer modeling of smoking. 18

Youth and young adult research primarily related to the priority topic of tobacco use behavior included more articles than the other priority areas ( n = 206), and thus was a key focus of the Centers’ research. The articles varied by tobacco product, study design, and population.

However, articles could be grouped under five main subareas: prevalence and trajectories of use ( n = 41), 10 , 53 , 58 , 61 , 75 , 97 , 108 , 130 , 138 , 148 , 149 , 158 , 162 , 169 , 170 , 173 , 181–183 , 186 , 188 , 196 , 200 , 202 , 203 , 208 , 210 , 216 , 220 , 221 , 224 , 225 , 231 , 238 , 241–243 , 250 , 251 , 252 , 253 policies related to youth and/or young adults ( n = 6), 12 , 20–22 , 123 , 175 intrapersonal factors ( n = 53), 8 , 11 , 15 , 28 , 31 , 32 , 36 , 38 , 55 , 56 , 59 , 60 , 62 , 74 , 77–79 , 94 , 98 , 102 , 146 , 151 , 155 , 157 , 159 , 163 , 164 , 174 , 177 , 178 , 180 , 187 , 192–195 , 197 , 199 , 201 , 204 , 209 , 211 , 214 , 217 , 218 , 223 , 226 , 229 , 230 , 232 , 235 , 254 , 255 interpersonal factors ( n = 14), 19 , 87 , 91 , 132 , 147 , 152 , 161 , 176 , 185 , 189 , 191 , 198 , 205 , 239 and social–environmental factors ( n = 10). 93 , 119 , 121 , 133 , 134 , 150 , 156 , 206 , 212 , 236

Articles related to prevalence and trajectories of use included subcategories that examined multiple products ( n = 9), 53 , 108 , 158 , 169 , 188 , 202 , 203 , 216 , 241 e-cigarettes ( n = 16), 10 , 58 , 61 , 75 , 148 , 162 , 181–183 , 186 , 210 , 221 , 231 , 238 , 242 , 251 cigarettes ( n = 5), 138 , 149 , 170 , 173 , 250 and correlates of use ( n = 11). 97 , 130 , 196 , 200 , 208 , 220 , 224 , 225 , 243 , 252 , 253 Two of the articles 108 , 241 examining multiple products used latent class analyses extending prior literature by including new products, such as e-cigarettes and hookah/water pipe, in addition to other substances. These latent class analyses studies are important in identifying groups of people with similar patterns of behavior. Other articles in this subcategory examined trends in poly-use, associations of tobacco with other substances, and patterns of poly-use and progression to other products. Articles primarily researching cigarettes described trajectories of use, patterns of use, and secondhand smoke exposure.

E-cigarette articles included modeling/trajectory articles and descriptive articles. Eight articles 58 , 61 , 182 , 183 , 186 , 210 , 231 , 251 used longitudinal data to determine if e-cigarette use predicted cigarette or other tobacco product use, including one article 186 that showed higher e-cigarette nicotine levels were associated with increased cigarette smoking frequency and intensity. All articles indicated that e-cigarette use predicated future cigarette or combustible product use.

Two articles 162 , 183 showed that e-cigarette use occurred in youth who would not have initiated the use of other tobacco products. Many articles described e-cigarette use, including device type, nicotine levels, and specific behaviors (eg, dripping). Eleven articles assessed correlates of use, many of which have been researched thoroughly for cigarettes, yet most of this literature extended the scientific base to include new and emerging products. 97 , 130 , 196 , 200 , 208 , 220 , 224 , 225 , 243 , 252 , 253 These articles have been particularly important for regulatory efforts as they clearly demonstrate the co-occurrence of all tobacco products, their use with other substances, and the progression of e-cigarette use to combustible tobacco product use, particularly cigarettes.

Among the six articles that were related to policies, two examined raising legal purchasing age to 21, 123 , 175 two used global data to assess potential advertising bans and point of sale; 20 , 21 one examined how the flavored cigarette ban influenced adolescent tobacco use, 12 and one used national data to determine how medical marijuana legalization could affect cigarette use. 22 All articles examined effects of these policies among youth, not young adults. Of these policies, the FDA has direct authority to ban flavors and to implement regulations around marketing. These articles provide evidence about how these regulations may influence behavior, particularly the positive impact on tobacco use by raising the legal purchasing age to 21 and reducing point-of-sale access through monitoring and enforcement.

Fifty-three articles were categorized as examining intrapersonal factors related to youth and young adult tobacco use. Overall, 23 articles focused on adolescents, 22 focused on young adults, and 8 had both youth and young adult samples in their studies. Articles were further subcategorized: weight control ( n = 2), 155 , 204 susceptibility ( n = 3), 74 , 157 , 229 reasons to use ( n = 4), 15 , 209 , 230 , 235 mental health ( n = 7), 59 , 60 , 187 , 174 , 192 , 193 , 223 sensation seeking and impulsivity ( n = 3), 194 , 195 , 232 subjective experiences ( n = 3), 177 , 211 , 217 life transition ( n = 2), 178 , 180 attitudes/beliefs ( n = 5), 146 , 163 , 199 , 226 , 254 and perceptions ( n = 21). 8 , 11 , 28 , 32 , 36 , 38 , 55 , 62 , 77–79 , 94 , 98 , 151 , 159 , 164 , 197 , 201 , 214 , 218 , 255 Of the 21 perception articles, 12 articles focused on harm perceptions or perceptions of risk. 11 , 32 , 77 , 78 , 94 , 98 , 159 , 164 , 197 , 201 , 218 The majority of the articles found that new and emerging products were perceived as less harmful and were associated with fewer risks. Only one article used longitudinal data to examine changes in harm perceptions and the association with future use. 78 The remaining nine were product specific: hookah/water pipe ( n = 2), 151 , 255 e-cigarettes ( n = 4), 8 , 28 , 55 , 62 cigarettes ( n = 2), 36 , 214 new and emerging products ( n = 1), examining benefits and harm perceptions. 38 Targeted and tailored interventions, including communication campaigns, have been shown to be key in reducing tobacco product use and initiation among youth and young adults. 256 These studies provide specific factors on which these interventions can be built; for example, understanding the reasons that young people use specific products and perceptions of these products can inform FDA how to tailor their communication campaigns to youth and young adult populations.

Of the fourteen articles related to interpersonal factors, eight focused on flavors, 19 , 87 , 91 , 147 , 176 , 185 , 205 , 239 five on social networks, 152 , 161 , 189 , 191 , 198 and one on cigarette warning labels. 132 Articles related to flavors mostly focused on e-cigarettes ( n = 7). 19 , 87 , 147 , 176 , 185 , 205 , 239 The articles on flavors indicate that youth and young adults find flavors of tobacco products appealing, including e-cigarettes and smokeless tobacco. Further, youth and young adults disproportionally use flavored e-cigarettes. Together, these articles add to the scientific base to support the FDA’s proposed regulations to ban flavors in all tobacco products. Regarding social networks, all of the articles found that peer use is associated with tobacco product use in adolescence and young adulthood.

The remaining articles ( n = 10) related to social–environmental factors including access ( n = 4), 93 , 150 , 212 , 236 specific opinions/views ( n = 3), 121 , 133 , 156 and social media ( n = 3). 119 , 134 , 206 Only one article looked at these factors in young adults. 119 It is within the purview of the FDA to limit where tobacco products are sold and how they are advertised. These articles indicate that youth are likely to obtain tobacco products, particularly new and emerging products, from online and retail environments and that social media provides unique exposure to tobacco advertising and promotional activities for young people.

Given the short time period of this review (Fall 2013–Spring 2018), the TCORS, CENIC, and COMET investigators published a notable number of peer-reviewed publications relevant to the priority areas of the FDA, with 258 articles relevant to youth and young adult tobacco use, the cornerstone of the FDA’s mandate from the TCA. These articles will provide and have provided important guidance for the regulatory efforts of the FDA.

The TCORS mechanism is unique in that it represents the first-ever attempt of the FDA on this scale to support external scientists to inform its regulatory decisions. When the FDA was granted authority to regulate tobacco products in the United States in 2009, the agency was forced to set aside its traditional “safe and effective” standard, used for the regulation of food and medicine, and create an entirely new paradigm for tobacco regulation. 257 Tobacco regulatory science and the TCORS Centers were developed under an ambitious and innovative strategy to carry out this new charge for the FDA. Thus, although ultimately the Centers’ work will be considered with other research, it is instructive to review what this unique mechanism has been able to accomplish.

Table 2 summarizes the main findings from each of the FDA’s priority areas. Each of these findings are derived from two or more publications. Together, the Centers accelerated research that can guide the FDA in its efforts to reduce youth and young adult tobacco use. Several themes emerge from this review. The first involves the importance of perceptions and attitudes about tobacco products. Youth and young adults may have misperceptions or are uncertain about the constituents of tobacco products, and the short- and long-term consequences of use, including addiction. Changing these perceptions and attitudes—through marketing or communication campaigns —can increase or decrease the attractiveness of tobacco products for youth and young adults. For example, promising themes for health communication directed at youth and young adults include those focused on the expression of independence, acute and cosmetic health effects, social stigma, and industry targeting practices. Yet, many of these themes also are used in marketing tobacco products, making the products more attractive to young people. Importantly, the use of different tobacco products co-vary , and multiple studies reviewed show that e-cigarette use leads to cigarette use in this population. Fortunately, anti-smoking campaigns have been successful in changing perceptions and attitudes and reducing social acceptability of smoking. It is important that these strategies now be used with other new and emerging tobacco products, particularly e-cigarettes.

The FDA has proposed specific actions to reduce tobacco use, including e-cigarette use, among youth. In November 2018, the FDA Commissioner proposed new limits to flavored tobacco products, including having flavored tobacco products in age-restricted locations, banning cigar product flavors, and restricting marketing aimed at youth. 258 In addition, in December 2018, the US Surgeon General issued a public health advisory concerning e-cigarette use as an epidemic among youth. 259 These actions were likely bolstered by the scientific evidence not only from the Centers for Disease Control and Prevention 260 , 261 but also from the publications from the 16 Centers that were cited in this review.

As examples, results from articles reviewed provide support for the proposed banning of flavors based on the findings that youth and young adults find flavors particularly appealing 91 , 176 , 185 and disproportionately use flavored products compared to adults. 147 , 239 Further, the FDA Youth Tobacco Prevention Plan 262 focuses on preventing access to products, curbing marketing of the products, and educating youth of the dangers of using any tobacco product. Findings from the studies in this review provide key insights into the targets for educational opportunities, for example, correcting misperceptions about specific products or constituents of the products. 30 , 31 , 36 , 38 In addition, results from articles on marketing and health communications provide important evidence for the FDA to continue with their plan to curb the tobacco industry’s marketing aimed at youth. 14 , 17 , 29 , 32 Finally, articles included in this review all add to the cumulative scientific evidence for future regulatory efforts that may reduce and prevent youth and young adult tobacco use.

This review was limited by the short time frame of TCORS 1.0, the reliance on the principal investigators to report all publications from their Centers, and the overlap within the FDA priorities so that many articles were categorized under more than one priority area. Also, as noted earlier, the Centers’ research will be part of the cumulative evidence that is considered by the FDA and does not represent the entirety of articles published on these themes over these 5 years. Still, the importance of these articles at a time of significant growth in e-cigarette use among youth and young adults is noteworthy, as data are already available from these studies to guide the current efforts to reduce e-cigarette use among youth. The dynamics of the tobacco company marketplace suggests that ongoing surveillance and research relevant to these young populations must continue so that the FDA’s mandate to reduce tobacco use is expedited and successful.

This work was supported by the National Cancer Institute of the National Institutes of Health (NIH), and the Food and Drug Administration Center for Tobacco Products (Grant numbers: P50 CA180906 to CP, MC, and SC; P50 CA180905 to MAP and JU; P50DDA036128 to CS; P50 CA0180890 to BC; P50DA036151 to GK and KS, P50CA180907 to ELS. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.

Acknowledgments

We would like to thank the following individuals for their contribution to this manuscript: Hannah Wright Matthews (University of Texas Health Science Center at Houston), Olivia Mahlmann (University of Texas Health Science Center at Houston), Kiana Rowshan (University of Southern California), Joanna Hill (University of California San Francisco), Janelle Urata (University of California San Francisco), and Elizabeth N. Orlan (University of North Carolina). Declaration of Interests The authors have no financial relationships or conflicts of interest relevant to this article to disclose.