My colleagues and I submitted this public commento to FDA and NIH regarding their priorities for tobacco cessatio research. The Regulations.gov tracking number is m3p-2qiq-zm6w. A PDF version is available here.
While it was not publicly available when we were preparing this comment, a lot of the suggestions overlap or complement the recently-released Surgeon General report “Eliminating Tobacco-Related Disease and Death: Addressing Disparities.
FDA, NIH, and other agencies must support research to increase reach and engagement in tobacco cessation interventions while also adopting comprehensive and integrated tobacco control policies that promote cessation to properly address health disparities among priority populations disproportionately impacted by smoking-related illness and death
Docket Number FDA-2024-N-4085
Advancing Smoking Cessation: FDA and NIH Priorities
Maya Vijayaraghavan, MD, MASa; Pamela M. Ling, MD, MPH;Lauren K. Lempert, JD, MPH;Stanton A. Glantz, PhD; Chris Shaffer, MS; Nhung Nguyen, PhD; Laura Schmidt, PhD, MSW, MPH; Catherine Bonniot, BAa; Heather Leutwyler, RN, PhD, FNP-BC, CNS, FAAN, FGSA, Stephanie Koenig, MPHa; Bonnie Halpern-Felsher, PhD, FSAHM; Vira Pravosud, PhD; Peter Kovacs, PhD; Vuong V. Do, PhD, MPH; Dorie E Apollonio PhD MPP; Tanner Wakefield, BA; Maria Pamatmat, MPH, CHESa ; Sheiphali Gandhi, MD, MPH, CTropMed; Jelena Mustra Rakic, PhD; Sabrina Islam, PhD, MS; Mark Hawes, PhD, MSW; Seyed Mehrdad Mohammadi, MD, MPH, MALD; Robin Corelli, PharmD
University of California, San Francisco
Center for Tobacco Control Research and Education
November 19, 2024
a Smoking Cessation Leadership Center, University of California, San Francisco
- Because tobacco-related illness and death disproportionately impact certain population groups, FDA, NIH, and other agencies must prioritize advancing research that specifically supports increasing the reach of and access to tailored cessation programs while also increasing the reach of tobacco control policies that support cessation among priority populations to achieve health equity
The burden of tobacco-related illness and death disproportionately impacts priority populations in the US including African Americans, American Indians/Alaska Natives (AI/AN), rural Americans, veterans, sexual and gender minorities,[1] people living with mental illness, people with substance use disorders,[2],[3] people with criminal legal system involvement,[4],[5] and people living below the federal poverty line,[6],[7] including those facing deep poverty such as people experiencing homelessness.[8]
There are intersectional inequities in tobacco use and cessation among race and ethnic groups, as well as among those with mental health and substance use disorders. Compared to Non-Hispanic Whites, smoking rates are higher among those who identify as Non-Hispanic American Indian, Alaskan Native and White (24.4%), Non-Hispanic Asian and Black (34.8%), and Non-Hispanic American Indian (20.7%), Alaskan Native and Black (22.4%).[9]
Among people with criminal legal system involvement, 50% to 83% report current smoking, compared to 11.5% in the general population.[10] Tobacco use rates among people with substance use disorders or any mental illness and criminal legal system involvement in the past year are between 60% and 80%.[11],[12] Mass incarceration is independently associated with current tobacco use; Black men and women are disproportionately impacted.[13],[14]
Among those experiencing homelessness, tobacco prevalence is among the highest at 70%,[15] which has substantial overlap with people with substance use disorders and serious mental illness. The population living with serious mental illness faces substantial socioeconomic disadvantage, with about 2.5 million living below the federal poverty line.[16],[17]
Sexual and gender minoritized populations in the US have more than doubled in the past decade, representing approximately 24 million people in the US.[18] The prevalence of current cigarette use is higher among bisexual women (37.7%), lesbian women (31.7%), gay men (30.5%), and bisexual men (30.1%), compared to heterosexual women (16.6%) and heterosexual men (21.0%).[19] The risk of tobacco use is heightened at the intersection of race, gender identity, and sexual minority status. Smoking risk is 21% higher among White, 55% higher among Black, 119% higher among Hispanic/Latinx, and 145% higher among multiracial/other race sexual minority women compared to White heterosexual women.[20]Transgender individuals are significantly more likely to report current use of any tobacco product (50.3% vs 23.5%) compared to cisgender counterparts.[21]
There are substantial tobacco-related health disparities among disproportionately impacted populations. Black men and women have a higher mortality rate for tobacco-related cancers, coronary heart disease, and stroke compared to white counterparts.[22] Among AI/AN, lung cancer is 5.8% more common as compared to White counterparts. Sexual and gender minority populations have an increased risk of all-cause mortality, cardiovascular disease, and cancers in large part due to increased tobacco-related risk.[23],[24] Tobacco-related conditions are the leading causes of mortality among those with mental health and substance use disorders, and these rates are higher at the intersections of extreme poverty and criminal legal system involvement.[25],[26],[27],[28]
Some individuals smoke to alleviate the stress associated with living with structural, social, economic, and environmental inequities. Recognizing these health disparities and the stress associated as root causes of smoking must be an essential component of any culturally tailored cessation program and is essential to advance health equity.[29]
FDA and NIH should expedite research, development, approval, and increased promotion of and access to cessation aids targeting the priority populations discussed above. Cessation interventions must not only reach priority populations but must also resonate with the lived experiences of people who smoke and address the root causes of why people smoke.
Some individuals smoke to alleviate stress associated with experiences living with social, economic, and environmental inequities. Cessation interventions should recognize the need to target stress as an underlying cause of smoking.[30] There is an urgent need for high-quality clinical trials that evaluate interventions that help people disconnect from and/or gain awareness of their stress, cravings, and tobacco use.[31],[32] Not only is there a need for such interventions but there is a need to rapidly integrate such approaches with standard cessation approaches to help people gain awareness about their smoking experience, which may benefit treatment-seeking people who smoke.[33]
FDA must support community-based participatory research methods with culturally tailored interventions in conjunction with standard cessation approaches that include quitlines or provider-delivered behavioral counseling and pharmacotherapy. Culturally-tailored interventions with standard interventions may increase quitting more than standard interventions.[34] Culturally tailored interventions may include surface-level adaptations like delivering an intervention in different languages or deep-level adaptations that include context that may address specific risk factors or cultural norms for those communities.[35],[36]
Historical trauma and ethnic identity have deeply affected American Indian communities, contributing to smoking as a coping mechanism.[37] Generations of forced relocation, discrimination, and exclusion have limited educational and economic opportunities, increasing stress and trauma.[38],[39] For young AI adults, ethnic identity developed through exploring group membership, can protect against substance use and deepen awareness of historical trauma.[40],[41],[42],[43] While a strong cultural identity can buffer the harmful effects of discrimination, it can also amplify trauma linked to smoking and vaping risk.[44],[45] Therefore, cessation programs must emphasize the resilience of AI cultures while avoiding the reinforcement of helplessness associated with historical victimization.[46]
Culturally tailored interventions delivered by navigators, peer support, health coaches, and community health workers that integrate lived experiences and social norms for those communities have been shown to be more effective than intervention not tailored to target communities.[47] Approaches may include messaging about family or including family in the delivery of cessation interventions in clinical and community-based settings.[48],[49] Interventions that include lived experiences through peer-based interventions have shown to be particularly effective in populations with high rates of tobacco use and at the intersection of criminal legal system involvement, mental health and substance use, and extreme poverty.[50],[51],[52]
The disproportionate toll of tobacco-related burden on some subpopulation groups is a social injustice. Tobacco documents disclosing the social justice implications of predatorily promoted tobacco products could help those subpopulation groups quit smoking.[53] For example, African American smokers might be mobilized toward quitting after reviewing tobacco industry documents about racial targeting by the industry. It has also been shown that the use of tobacco documents revealing the tobacco industry’s attempt to co-opt major African American leadership organizations and its pervasive marketing of menthol cigarettes in low-income African American communities may be an essential component of a culturally tailored cessation program.[54]
FDA must promote multi-sectoral research that identifies approaches and best practices to integrate cessation services within systems and settings where priority populations engage. Using whole-person care approaches (i.e., a patient-centered approach to healthcare that considers their mental, physical, emotional and social health) through disease registries, there is a need for a systems-level quality improvement approach that increases coordination of tobacco treatment as people cycle in and out of mental health, medical, and institutional settings.[55],[56],[57]
FDA must support intervention research that identifies best practices and approaches to integrate current systems of care, including community-based pharmacies, to increase the delivery of cessation services in rural and urban locales. Providing access to community-based pharmacies to provide cessation services and linking pharmacies to social services settings will increase access to cessation services for populations that are disconnected with medical care. Such approaches have been shown to reduce consumption and increase quit attempts among priority populations with high rates of tobacco use, mental health, substance use and extreme poverty.[58],[59],[60],[61]
A comprehensive approach to cessation recognizes not only that individuals should be encouraged to quit smoking using tailored and evidence-based strategies, but policies and programs that create new normalized environments where quitting smoking is easier and acceptable are also essential.[62],[63],[64] Policies that support cessation include state and local efforts to restrict or end tobacco sales.[65],[66] Federal media campaigns should be expanded and continuously funded at levels with high population exposure, as these campaigns increase cessation behavior, including to disparately affected focus population groups[67],[68],[69],[70] when they are sustained.[71] Media campaigns should include communications tailored for priority populations, as such media campaigns have been shown to increase cessation in the general population.[72],[73]
There is strong evidence that tobacco treatment accompanied with smokefree policies in health care, social services, and behavioral health settings increase smoking cessation.[74] These policies with cessation supports have the greatest impact on increasing cessation behaviors among patients in hospitals, [75] residents in shelters,[76] subsidized housing,[77],[78] or residential drug treatment programs,[79],[80] and justice-involved individuals in correctional systems and reentry programs.[81]
Comprehensive and integrated tobacco control policies aimed at social equity,[82] such as eliminating the sales and manufacturing of menthol [83] and other flavored tobacco products, provide powerful cessation opportunities for people who disproportionately use these products.[84] These policies are particularly relevant to priority populations living below the federal poverty line,[85],[86] those who identify as racial/ethnic or sexual gender minorities, [87] and those with mental health and/or substance use disorders [88] where tobacco use is concentrated and contributes substantially to increased morbidity and mortality. A coordinated and integrated approach that includes cessation-focused tobacco control policies with access to evidence-based cessation services could substantially reduce the tobacco-related burden in these populations.
- Cessation interventions tailored for African Americans should take into account the tobacco industry’s deliberate and pervasive targeting of menthol products to this population.
The tobacco industry targeted African American communities with intensive and pervasive marketing campaigns to popularize menthol cigarettes.[89], [90], [91] These efforts were successful, and African Americans who smoke cigarettes are more likely to smoke menthol cigarettes than people of other races or ethnicities who smoke.[92] In a 2023 study of US adults,73% of African American smokers used menthols, compared to 21% of White smokers.[93] A 2020 study found that 85% of African American adults who smoked used menthol.[94] Between 1980-2018, 1.5 million African Americans began smoking menthol cigarettes and as a consequence, 157,000 African Americans died prematurely of smoking-related harms.[95]
Although people who use menthol cigarettes are more likely to make quit attempts than those who smoke non-menthol cigarettes, they are less successful at staying quit.[96] Quit success in the past 5 years was even worse among menthol-smoking African Americans.56 This underscores the need for cessation programs targeted to African Americans who smoke menthol tobacco and who have the most difficulty quitting including public education and enhanced access to free smoking cessation services and products.
Cessation education and services should be addressed every time a tobacco policy is introduced or implemented, and policies should be considered an opportunity to increase cessation behaviors. A comprehensive approach to supporting tobacco cessation should include coordination with and strong support for the FDA to remove menthol and its analogs as an additive from all commercial tobacco products (FDA’s proposed rule would remove menthol as a characterizing flavor from cigarettes and cigars, but not from e-cigarettes). Policies such as menthol and flavored tobacco prohibitions significantly increase cessation.[97] Based on the impact of the menthol ban in Canada, the projected number of people who smoke who would quit after a US menthol ban would be 790,000 individuals who smoke daily (including 200,000 African Americans) and 1,340,000 individuals who smoke daily or non-daily (including 381,000 African Americans).[98],[99] Implementation of such a policy should be strongly supported, and implementation should be accompanied by cessation promotion campaigns as well as barrier-free access to cessation services. A strong tobacco control policy with widespread access to cessation services reinforces each other to create an environment that strongly supports cessation and mitigates the risk of relapse to tobacco use.
FDA/NIH must also support research that identifies effective approaches to increase implementation and enforcement of policies restricting menthol and flavored tobacco products. Such implementation and enforcement approaches are especially necessary for priority populations where local implementation of a flavor ban had minimal effects in reducing the use of menthol tobacco products or increasing cessation.[100] These findings call for a need for the FDA to support regional and national policies that restrict menthol and flavored tobacco and research that identifies effective implementation and enforcement approaches that restrict access and availability of menthol-based tobacco products. The implementation and enforcement of strong tobacco control policies that restrict menthol and flavored tobacco are likely to support cessation.
- FDA, NIH, and other agencies must address the significant and unmet need for cessation treatments for people living with moderate and severe mental illness and substance use disorders.
People living with severe mental illnesses include those living with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, and some trauma and stress disorders. Individuals with severe mental illness are more likely to experience higher nicotine dependence and their smoking is associated with significant morbidity and premature mortality in comparison to individuals without mental illnesses.[101], [102]
Many people who smoke who have severe mental illness desire to quit smoking, and are interested in engaging with cessation services,[103] but few are offered advice or treatments with demonstrated effectiveness.63 Long-term quit rates among this population are lower than in individuals without mental health illnesses and they are less likely to receive the support they require compared to individuals who smoke without mental health conditions.64, [104] Behavioral counseling and pharmacotherapy, although found to be effective among people with mental illness, remain underutilized among adults with serious mental illness.[105]
Studies have shown a general reticence among healthcare providers because of the concern that smoking may be used as a coping mechanism and misperceptions around medications being contraindicated for people with mental illness and serious mental illness, and providers’ lack of training in providing tobacco treatment.[106],[107] Interventions that increase training and education of healthcare providers to provide behavioral counseling and pharmacotherapy—particularly the use of varenicline—with community health workers showed increased abstinence at 2-year follow-up among people with severe mental illness, compared to only provider education or usual care.[108] These and other studies that show that people with severe mental illness do not have worsening psychiatric symptoms or quality of life should reduce reticent among providers to address smoking cessation.[109]
FDA must promote intervention research specific to populations living with serious mental illness. These studies should assess increased engagement with standard cessation services including varenicline, which historically has had lower use among people with serious mental illness. Additionally, there is a need for novel approaches that capitalize on social connectivity, reduce social isolation, and improve physical activity as additional support to reduce cravings and withdrawal symptoms, which are part of the process of smoking cessation.[110],[111],[112]
Cessation programs are especially needed for people living with substance use disorders. Standard treatments need to be integrated into all mental health and substance use treatment facilities where rates of screening and treatment of tobacco use is low.[113] In 2016, among mental health treatment facilities, only 48% reported screening for tobacco use, and even fewer offered counseling (27%), nicotine replacement therapy (25%), and only 48% offered tobacco-free grounds.[114] Among substance use treatment facilities, 64% reported screening for tobacco use, 47% offered counseling, 26% offered NRT, and 35% had tobacco-free grounds.[115] Providing training and support for substance use treatment facilities to integrate tobacco treatment was associated with reduced smoking prevalence and an increase in the use of pharmacotherapy,[116] and should be encouraged. FDA/NIH must support research that identifies new approaches to increase implementation of tobacco-free grounds and tobacco cessation treatment and to address institutional barriers to addressing tobacco use in these environments.
Several treatments show promise for people with co-occurring substance use disorders, particularly substances that are highly co-prevalent with tobacco use. Contingency management has been shown to be highly effective in the treatment of substance use disorders and tobacco use disorders, particularly in populations like pregnant women and mothers of young children and among those experiencing homelessness and with other substance use disorders like alcohol use and methamphetamine use which are highly linked with tobacco use.[117] The VA health system has a highly successful contingency management disseminated across 100 VA hospitals that has reached many thousands of veterans for substance use treatment.[118] There is a significant opportunity to integrate contingency management for substance use treatment with that of tobacco use, particularly populations at the intersections of extreme poverty and substance use.
The FDA and NIH must prioritize research that addresses: (a) dissemination and implementation of contingency management approaches with standard cessation care for disproportionately impacted populations including those in community mental health and substance use clinics, homeless services, and re-entry programs serving adults experiencing incarceration; (b) the use of contingency management not only for cessation abstinence but also for reduction outcomes and treatment engagement in priority populations, (c) the use of digital technologies to provide cash transfers for people living in rural areas, for American Indian and Alaskan Native populations, and for individuals who otherwise would not want to seek or engage in clinical care for substance use treatment. [119],[120]
People living with mental illnesses and substance use disorders are disproportionately impacted by smoking-related morbidity and mortality. To reduce these health disparities and advance health equity, FDA, NIH, and other agencies should support research and focus resources on developing cessation treatments and programs for these populations.
- Research on cessation treatments for sexual and gender minorities.
LGBTQ+ individuals have higher rates of tobacco use compared to heterosexual, cisgender individuals,[121] and smoking prevalence among LGBTQ+ youth and young adults is alarmingly high compared to their non-LGBTQ+ peers.[122] LGBTQ+ individuals have a higher prevalence of mental health and substance use disorders compared to their heterosexual counterparts.[123],[124],[125] The minority stress model attributes these disparities to the excess stress stemming from experiences of discrimination,[126],[127] victimization (particularly during childhood),[128] and psychological distress, which may be associated with increased use of tobacco and substance co-use.
Because of the disproportionate impact of the disproportionately high rates of tobacco use among LGBTA+ adults, young adults, and youth and the associated health impacts, FDA, NIH, and other agencies must develop cessation programs targeting this population. LGBTQ+ individuals have emphasized the importance of tailoring smoking cessation interventions to meet their needs.[129] LGBTQ+-tailored interventions should include participants and counselors who identify with LGBTQ+ identities, focus on centering lived experiences, take place in LGBTQ+-safe spaces, and encourage connections among LGBTQ+ individuals.[130] While studies have shown that tailored and non-tailored interventions may have similar cessation outcomes, tailored interventions are more accessible, acceptable, and are preferred by LGBTQ+ individuals.[131],[132] Tailoring interventions can also focus on anti-smoking messaging that targets young adult, cisgender and transgender, sexual minority women.[133] Tailored anti-smoking messages were associated with increase quit intentions, and decreased intent to purchase cigarettes, marketing receptivity, pro-industry attitudes among this population. Moreover, tailored messaging that influences young adult sexual minority women’s beliefs and attitudes towards the tobacco industry mediated quit intentions in this population.[134]
Given the high rates of poly-tobacco and nicotine product use and dual use of nicotine-containing products with other substances, including alcohol and cannabis, there is a need for interventions that target multiple substance use among LGBTQ+ individuals and that utilize frameworks that integrate multiple substance use practices.[135],[136],[137],[138] These interventions must not only focus on individual-level behavior change but must also integrate place, context, and policy as root causes of inequities that drive tobacco use and cessation practices in LGBTQ+ populations. Such interventions are especially needed for youth and young adult populations where there is a high prevalence of co-use behaviors.[139],[140]
- Cessation trials that include approaches to increase reach, engagement with cessation treatment, and cessation behaviors in priority populations must measure longitudinal cessation outcomes, as well as characterize the trajectories of cessation behaviors.
Smoking cessation clinical trials rely on the gold standard of self-reported abstinence with biochemical verification at a 3- or 6-month timepoint following treatment initiation or end of treatment.[141] All currently approved FDA cessation products have shown greater quit rates maintained for at least four weeks, starting at 6 weeks, compared to placebo. NRT has been shown to be superior to placebo for up to 6 months and varenicline for up to one year. [142] A methodological study suggests that relying on only one measure of abstinence as the primary indicator of the success of a cessation intervention neglects that abstinence may take place at different times during the study period.[143] Moreover, there is a need for research that explores trajectories of quitting behaviors to understand the conditions and psychological predictors that might be linked with successful cessation or relapse to smoking. For example, among adults enrolled in a clinical trial of behavioral counseling and pharmacotherapy, negative affect, craving and composite withdrawal symptoms during treatment engagement for smoking cessation was associated with an increase risk of subsequent relapse.[144] In another study of treatment-seeking adults who smoke, two other psychological metrics that were linked with abstinence was self-efficacy to quit and perceived control over withdrawal symptoms.[145] In another study of treatment seeking adults, participants who were abstinent at 6-months follow-up had lower craving and withdrawal symptoms, and were more likely to rely on substitute activities or environmental reinforcers that mitigated risk of relapse.[146] Other mechanistic outcomes that may influence smoking cessation, including negative beliefs about cravings and ruminations around smoking that may be linked with negative affect, may also influence cessation experiences.[147]
Cessation trials for priority populations should consider multiple measures of abstinence, use of multiple tobacco products, and behavioral measures linked with quitting success or relapse to smoking. Abstinence outcomes measures must determine ahead of time whether the definition of abstinence includes abstinence from all tobacco products, including noncombustible and alternative tobacco products, or abstinence from all combustible tobacco products but “allowing” use of noncombustible and alternative products, or abstinence from all combustible and smokeless products but “allowing” use of alternative tobacco products.[148] Cessation trials must, at minimum, measure abstinence from all tobacco products, with enough data collected to assess abstinence from combustible, non-combustible and alternative tobacco products including e-cigarettes. Given the increased health risks associated with dual use of cigarettes and e-cigarettes compared to just smoking,[149] sustained dual use of both cigarettes and e-cigarettes should not be an acceptable clinical trial outcome.
Abstinence outcome measures must include point prevalence abstinence measures that are either 7-day or 30-day and capture at least a 24-hour intention to quit smoking. While ideally outcomes should be biochemically verified using carbon monoxide assessment or cotinine assessments, it is important to recognize that biochemical verification may not be feasible for some priority populations or contexts.[150] To the extent possible, abstinence outcomes should also include an extended abstinence measure that includes prolonged abstinence measures that include a grace period and lapses in smoking or repeated point prevalence abstinence measures that reflect the realities of quitting smoking.
- Cessation products and programs must be developed for youth, and youth must be included in clinical studies using appropriate safeguards.
Although data from the 2024 National Youth Tobacco Survey (NYTS)[151] on youth tobacco use show a decline in current use of any tobacco product, 2.25 million middle and high school students reported current use of any tobacco product. The decline of youth e-cigarette use from 2.13 million youth in 2023 to 1.63 million youth in 2024 was hailed by FDA as a great success in preventing e-cigarette use;[152] however, it appears that youth e-cigarette users may have migrated to nicotine pouch use, which has become the second most common currently used tobacco products, with nearly one million (890,000) youth who reported ever using nicotine pouches and 480,000 reporting current use of nicotine pouches in 2024. The current use of nicotine pouches overall increased from 1.5% (400,000 students) in 2023 to 1.8% in 2024, the only category that saw an increase in use. Of these current youth nicotine pouch users, 22.4% reported using nicotine pouches daily, and 29.3% reported using nicotine pouches at least 20 of the last 30 days. While 380,000 youth (1.4%) reported current cigarette use, double this number (760,000 youth, 2.8%) reported current use of any combustible tobacco product, and 840,000 (3.0%) reported current use of multiple tobacco products.107
The NYTS data demonstrated alarming racial and ethnic disparities, with 31.7% of American Indian or Alaska Native (AI/AN) youth reporting ever using any tobacco product as compared with 19.0% ever use among all youth, 22.5% using e-cigarettes (14.0% all youth), 11.2% cigarettes (5.8% all), 6.1% cigars (3.9% all), 91% nicotine pouches (3.5% all), 6.0% other oral nicotine products (3.1% all), 7.7% smokeless tobacco (2.9% all), 4.4% hookah (2.4% all), 3.9% heated tobacco products (1.6% all) 4.8% pipe tobacco (1.5% all), 16.4% any combustible tobacco product (9.4% all), and 17.2% multiple tobacco products (8.6% all).107 The 2024 NYTS data provide sufficient evidence that too many youth are regularly using one or more addictive nicotine products and need help quitting.
Many youth report symptoms of nicotine dependence and seek support for cessation.[153] Adolescents who use e-cigarettes are at risk for nicotine addiction, toxicant exposure, and transitioning to cigarettes; however, there are few interventions dedicated specifically to youth vaping cessation.[154] In addition to assessing interest in quitting and quit attempts among adolescents in general, it is important to research quitting among groups that experience tobacco-related health disparities, including sociodemographic minorities and individuals with mental health symptoms.110
For example, in a 2023 cross-sectional study that aimed to investigate vaping behavior and quit attempts among university students who use e-cigarettes in which 31.3% of participants identified as Hispanic, there was a higher likelihood of prior vaping experience and a higher number of quit attempts in the last year (4.36 quit attempts among Hispanics vs 3.15 among Whites).[155]
A 2024 study investigating factors associated with intentions to quit vaping and quit attempts among adolescents[156] found that risk perceptions of vaping was a protective factor for quit intentions, and risk factors for quit intentions included e-cigarette marketing, dual use of e-cigarettes and other tobacco products, vaping due to feeling anxious or stressed, vaping for nicotine buzz, nicotine dependence, and identifying as Gay or Lesbian, bisexual, or Hispanic. Similar associations were observed with quit attempts except that e-cigarette marketing, vaping due to feeling anxious or stressed, vaping dependence, and identifying as Hispanic were not significant. The paper concluded that developing tailored vapinc cessation programs could enhance quit success.112
The rise in nicotine pouch use among youth is especially concerning. They are discreet, smokeless, and come in flavors that are especially appealing to youth, and they have been aggressively promoted to youth using influencers and social media channels. Nicotine pouches are sold to underage youth online and are available in various strengths of nicotine that exceed doses in approved nicotine replacement therapies (e.g. 2mg or 4 mg nicotine gum or lozenges). For example, ZYN pouches come in 3 or 6 mg/pouch,[157] and FRE are sold in strengths of 6, 9, 12, and 15 mg per pouch.[158] Because nicotine pouches are relatively new in the US (Zyn entered the US market in 2014), their short- and long-term health consequences of using nicotine pouches are not clear. However, nicotine is highly addictive, and the flavors in nicotine pouches may increase their appeal, while their alkaline agents may increase delivery of nicotine, especially among youth.115 Highly addictive nicotine pouches can prime the brain for addiction to other substances, can harm the developing adolescent brain, and is toxic to developing fetuses.[159] Increased impulsivity and ADHD-type cognitive impacts are also associated with nicotine’s impact on the developing adolescent brain.[160]
Nicotine pouches are aggressively marketed to youth and the meteoric rise in nicotine pouch sales and use among underage youth mimics the explosion in e-cigarette use after Juul’s aggressive marketing tactics targeting youth. To address the health impacts associated with a new generation of addicted, young nicotine pouch users, FDA, NIH, and other federal agencies must develop cessation programs to help people quit nicotine pouches.
In developing youth cessation programs, FDA should include research that specifically investigates impacts on youth, so long as strict protocols are set and enforced to ensure scientific integrity and protect youth.[161] Empirical evidence related to harm perceptions, product appeal, and the addictive potential of nicotine products among youth must be collected. This evidence should be provided to FDA by tobacco companies in their premarket tobacco product and modified risk tobacco product applications; however, the FDA must ensure that the evidence is objective, reliable, and protected from industry influence and follow specific safeguards. Research on adolescent perceptions as they relate to intentions to use and actual use patterns is essential.117
There is potential for electronic channels including social media platforms and peer support for youth vaping cessation interventions. In 2022, over 95% of adolescents had smartphones, and 97% reported using the internet daily.[162] Adolescent and young adults were most interested in electronic channels to assist with e-cigarette cessation,[163] and in 2020, 48.4% young adults endorsed social media for vaping cessation.[164] Social media platforms have several advantages, including integration into adolescents’ daily life, convenient use anywhere at any time, scalability to wide audiences, and cost-effective delivery, making this a potentially ideal medium to deliver vaping cessation support to adolescents.[165],[166] Systematic reviews of social media smoking cessation interventions including on Facebook, Twitter,[167] and WhatsApp found that they were feasible, acceptable, and achieved increases in quit attempts, greater abstinence, and reduction in relapse.[168],[169],[170],[171] Eighty percentage of adolescents reported that what they see on social media makes them feel more connected to what’s going on in their friends’ lives, and 67% say these platforms make them feel as if they have people who can support them through tough times.[172] A 2022 review of social media behavioral interventions found they effectively raised awareness and called for more to promote behavior change through social support.[173] Since teens seek peer support and connection on social media, a program that emphasizes and leverages peer support fits with what adolescents regularly seek on social media, and fills a gap left by programs that primarily emphasize information. Social media’s popularity among priority populations such as people of color[174] and sexual and gender minoritized (SGM) youth[175] signals the potential to improve health equity, but studies have mixed outcomes, highlighting a key gap in the literature that call for more studies on examining impact of such interventions in priority youth populations.[176]
- Cessation products and programs must be developed for vaping cessation. Cessation trials and programs that include e-cigarettes for cessation must collect data on serious adverse effects from e-cigarettes, longitudinal health outcomes from using e-cigarettes, and must advocate for complete cessation of all tobacco products.
No tobacco products, including e-cigarettes, are safe at any level of use. E-cigarettes are widely available and have been advertised as a smoking cessation aid. However, there is no single e-cigarette product that is currently FDA-approved for cessation.
Observational data based on cosumer use of cigarettes and clinical trial research using e-cigarettes as a cessation treatment is mixed on whether e-cigarettes increase long-term cessation. Observational studies have not shown an increase in smoking cessation with e-cigarettes.[177],[178] One study showed that dual users versus exclusive cigarette users were more likely to attempt to quit; however, few dual users quit smoking at one-year follow-up, with 48.8% reporting dual use, 43.9% reporting current cigarette smoking, 5.9% reporting exclusive e-cigarette use, and only 1.4% reporting quitting both products.[179] In contrast, results from randomized controlled trials show an increase in tobacco cessation with e-cigarettes. A meta-analysis of randomized controlled trials with older forms of nicotine-containing e-cigarettes and in controlled settings have shown that e-cigarettes are as effective as cytisine and varenicline for smoking cessation.[180] In some RCTs, even as nicotine-containing e-cigarette use was associated with more combustible tobacco cessation than NRT, most trial participants continued to use nicotine-containing e-cigarettes at the study endpoints and beyond, sustaining nicotine addiction.[181],[182] Further, most of these studies did not explore the safety of e-cigarettes and health outcomes from e-cigarettes beyond one year, leaving an unanswered question on the safety of e-cigarettes, long-term efficacy of e-cigarettes in the setting of continued nicotine use, and long-term health outcomes of e-cigarettes.[183] There is also a potential risk of youth and young adult populations initiating e-cigarettes and tobacco use.[184]
Although complete switching to use of e-cigarettes from cigarettes reduces exposure to tobacco-related toxicants compared to smoking cigarettes,[185] the use of e-cigarettes is not without harm, and has been shown to be associated with heart and lung disease among young people and adults.[186],[187] Proponents of e-cigarette use for cessation recommend complete switching to non-combustible products to minimize the harmful effects of dual use.[188] Complete switching is also necessary to decrease exposure to tobacco-related carcinogens; longitudinal data from the PATH study showed no significant decrease in biomarkers of exposure among people who smoke who became dual users of cigarettes and e-cigarettes.[189] Dual use among current e-cigarette users is high, with approximately a third also using cigarettes.[190] The most common group includes “predominant smokers” of cigarettes and e-cigarettes,[191] who may be vaping to circumvent smoke-free policies or to try to quit smoking without completely quitting.[192] Dual use should be measured and reported in all clinical trials of e-cigarettes for smoking cessation.
Minoritized populations are especially impacted by dual use, where 7.6% of American Indian/Alaskan Native populations (7.6%) and multiracial individuals (10.4%) have comparable or higher rates than Whites (8.8%).[193] Dual use is more common among LGBT adults than non-LGBT adults.[194] Dual use is also associated with worse psychiatric symptom severity,[195],[196] psychological distress,[197] and more internalizing and externalizing symptoms.[198] While there are dependence scales that assess nicotine dependence for specific products (e.g., cigarettes or e-cigarettes), there is a need for scales that assess dual dependency, and these may offer insights into vaping cessation and smoking cessation.[199],[200],[201],[202]
Taken together, these studies highlight a need for robust clinical trials and observational studies that assess all tobacco product cessation including e-cigarette cessation as well as long-term safety, toxicity, and side effects of e-cigarettes. Additionally, there is a need for vaping cessation interventions that address dual use of e-cigarettes and cigarettes, with measurement of abstinence outcomes from both products.
Conclusion:
In summary, FDA and NIH must prioritize research that:
- Addresses the root causes of tobacco products use and supports the development of interventions that use anti-racist frameworks to address the high rates of stress stemming from a long-standing history of systemic racism.
- Promotes multi-sectoral intervention research that uses community-based participatory research and integrates lived experience-driven solutions with standard approaches of behavioral counseling and pharmacotherapy.
- Promotes interventions for cessation tailored to African American populations and that are linked with policies restricting the sales and use of menthol-based tobacco products, as well as intervention that increase implementation and reinforcement of menthol based policies.
- Promotes research that identifies approaches to better integrate cessation-supporting tobacco control policies with cessation services.
- Promotes dissemination and implementation of contingency management for smoking abstinence and adherence to treatment with opportunities for digital enhancement to reach populations in rural settings, for American Indian and Alaskan Native populations, those experiencing extreme poverty, and pregnant women.
- Supports the development of tailored interventions for LGBTQ+ populations that address multiple tobacco and substance use behaviors, including tobacco use, vaping, and co-use with alcohol and cannabis.
- Requires cessation trials to measure abstinence from all tobacco products, including combustible, non-combustible and alternative tobacco products. Cessation trials must also measure abstinence outcomes through point prevalence and prolonged abstinence measures. Recognizing that smoking cessation is a chronic relapsing and remitting condition, cessation trials must measure mechanistic outcomes on the pathway to quitting success, including reduction in cravings, withdrawals, self-efficacy, and confidence to quit.
- Includes targeted interventions for dual users of cigarettes and e-cigarettes with measures of dual dependency and abstinence outcomes for both cigarettes and e-cigarettes.
- Includes specific cessation programs for youth, and that include youth in clinical studies using appropriate safeguards against industry influence and to protect scientific integrity.
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