Policy Recommendations to Eliminate Tobacco Use and Improve Health from the American Thoracic Society Tobacco Action Committee

Tobacco use is the leading preventable cause of death in the United States, with healthcare costs attributable to tobacco at over $175 billion annually in the United States, representing 5–14% of healthcare expenditures (1). Tobacco smoking causes a myriad of lung diseases, including chronic obstructive pulmonary disease, pulmonary fibrosis, and lung cancer. In 2019, the prevalence of cigarette smoking among U.S. adults was 14.0% (34.1 million adults); more than 16 million adults in the United States live with a smoking-related disease (2). However, rates are considerably higher among some groups defined by race, ethnicity, educational level, socioeconomic status, sexual orientation and sex minority status, and presence of serious mental illness. Many of these groups face disparities in health outcomes (2). Furthermore, 88.5% of African Americans ages 12 and older who smoke cigarettes use menthol cigarettes (3); studies suggest that if menthol cigarettes were removed from the marketplace, 44.5% of African Americans who smoke menthol cigarettes would try to quit (4).

Electronic nicotine delivery systems, such as electronic cigarettes (e-cigarettes), have infiltrated the tobacco market and are included under the umbrella of tobacco products in the discussion below. In 2020, 19.6% of U.S. high school students reported current use of e-cigarettes, one-third of whom reported using for 20 or more days of the preceding 30 days (5). Given the impacts of tobacco on respiratory health across the lifespan, the American Thoracic Society (ATS) and American Lung Association are keenly focused on advocating for tobacco control policies and government regulations to reduce and eliminate the harmful effects of tobacco products worldwide.

More robust tobacco control policies are urgently needed. It is important to have a multipronged approach of policy initiatives that target prevention, tobacco product control, treatment, and research. The ATS Tobacco Action Committee in partnership with the American Lung Association outlines four areas of policy recommendations: 1) strengthen policies to restrict manufacture, sale, and marketing of tobacco products; 2) increase federal investment in tobacco control; 3) increase access and funding for treatment of nicotine and tobacco dependence; and 4) increase research on health effects of tobacco and emerging products, innovations in treatment, and implementation of tobacco treatment programs. These recommendations were developed and identified through discussions with the American Lung Association and through monthly meetings of the ATS Tobacco Action Committee. Charged with organizing and coordinating the ATS tobacco control and tobacco dependence treatment activities, the Tobacco Action Committee reviews government and advocacy activities surrounding tobacco control. Consensus regarding recommendations was developed using informal implicit methods, including iterative discussion and simple voting (6).

Strengthen Policies to Restrict Manufacturing, Sale, and Marketing of Tobacco Products

Although the Obama Administration and Congress successfully passed the Family Smoking Prevention and Tobacco Control Act in 2009, in the 10 plus years since its enactment, there has been a series of delays and missed opportunities to make real progress in reducing tobacco product use. These missed opportunities include 1) failing to prohibit menthol cigarettes in 2011 and scaling back the proposed rule from the Food and Drug Administration (FDA) Center for Tobacco Products in 2015 on regulating other flavored tobacco products, despite the overwhelming evidence on the adverse effects of menthol; 2) delaying by 4 years the industry deadline to submit new tobacco products for FDA review, effectively giving the e-cigarette industry additional years to push their addictive and dangerous product to our youth; and 3) conceding to the Trump Administration’s partial flavoring limitation that still allowed flavors in single use and refillable systems while limiting cartridge e-cigarettes to tobacco and menthol flavors, resulting in a 1,000% increase in flavored single use e-cigarette products among high school students in 2020 after the policy was implemented (5).

What should be done now? It is critical that the Biden Administration and Congress strengthen restrictions on the manufacturing, sale, and marketing of tobacco products. First, all flavored tobacco, including menthol products, should be removed from the marketplace. Flavored tobacco products are appealing to young people and may have harmful effects of their own (7). This includes menthol-flavored products, as data suggest menthol use is associated with subsequent smoking or difficulty quitting (8). The Biden Administration and FDA’s announcement on April 29, 2021, that it intends to issue proposed rules within the next 12 months to end the sale of menthol cigarettes and characterizing flavors in mass-produced cigars including menthol can reduce health disparities experienced by low-income populations, LGBTQ+ individuals, and communities of color, all of whom are far more likely to use menthol products. Once the rules are proposed, these menthol flavoring and flavored mass-produced cigar prohibitions will undergo the rule-making process, including publication of the proposed rules, public comment, and revisions before implementation. It is critical to provide strong support for this policy during this process.

Second, excise taxes should be increased for all tobacco products as outlined by the World Health Organization (9). Data suggest that increases in taxes would reduce all nicotine product use (10). Third, all forms of tobacco or nicotine advertising targeting youth and underserved populations in any venue should be closely regulated. Because almost all nicotine-addicted individuals initiate smoking or vaping before the age of 25 years (11), addressing marketing and sales to young people is essential. Youth are exposed to many sources of advertising, including traditional print, television, and radio; a significant portion access online platforms and social media for information (12).

Legislation exists that, in part, supports the above measures. The Protecting American Lungs and Reverse the Youth Tobacco Epidemic Act of 2020, which includes a provision to prohibit online sales of all tobacco products, should be passed into law. The 2009 Family Smoking Prevention and Tobacco Control Act should be enforced. This legislation already provides the FDA authority to fully review all premarket tobacco production applications, remove illegal products from the market, require graphic warning labels on packages, and implement track and trace systems, which will help identify illegal or harmful products. It is critical for the FDA to engage in transparency and report on products that have applied for premarket review and their status to the public. Federal regulators should work with state and local governing bodies to develop and implement methods for licensing and restricting tobacco outlets based on population size.

Nicotine is the addictive substance that drives the use of cigarettes and other forms of tobacco. Within the past 5 years, the FDA has discussed proposing a tobacco product standard (very low nicotine content) to set the maximum nicotine level for cigarettes so they are rendered minimally addictive or nonaddictive. This policy is still under consideration by the FDA, and no proposed rule has been issued. Before implementation, careful consideration needs to be made so that consumers are not misled into believing that very low nicotine content products are less harmful. In environments in which high-level nicotine products, such as cigars or hookah, are available, studies suggest that consumers will switch from low to high nicotine products if they are available, necessitating the nicotine level in all tobacco products be lowered (13). In addition, product standards would need to be carefully evaluated to be effective for all individuals (irrespective of age, sex, etc.), which may be very difficult given the individual variation in response to nicotine.

Increase Federal Investment in Tobacco Control

It is imperative to increase federal investment in tobacco prevention and treatment to combat tobacco health risks to all people. First, there is a substantial need to increase funding for the Centers for Disease Control and Prevention’s Office on Smoking and Health, which supports state tobacco control programs for prevention and cessation, media campaigns, and data collection, including e-cigarette or vaping use–associated lung injury surveillance. Research suggests that tobacco product use is a potential risk factor for more severe coronavirus disease (COVID-19) (14, 15). As Centers for Disease Control and Prevention resources are allocated to combat the COVID-19 pandemic and improve data modernization, the Office on Smoking and Health should therefore be included in this allocation. Second, investments in youth prevention, such as robust education campaigns, are needed; such campaigns are effective in reducing youth use. Tobacco use among adolescents, particularly of e-cigarettes, remains alarmingly high, despite the recent downward trend (16). Third, to provide scientifically backed programs and policies regulating e-cigarette components and/or devices, more support for research through increased funding for the National Institutes of Health is required. This includes further supporting research focused on the health effects of tobacco products, specifically e-cigarettes; innovative treatments, particularly for youth and adolescent vaping cessation interventions; and implementation science to integrate tobacco education and dependence treatment in community and clinical settings, particularly those that serve underserved populations.

Increase Access and Funding for Treatment of Nicotine and Tobacco Dependence

There is a critical opportunity to address barriers to access in tobacco treatment by ensuring costs for treatment are low, readily available, and of high quality so that individuals understand the relative risks and benefits of various treatment options. First, Congress must pass the Quit Because of COVID-19 Act, which will enhance the comprehensive tobacco dependence benefit for traditional Medicaid plans. Medicaid enrollees smoke at higher rates than those with private health insurance (5). Expanding and promoting Medicaid benefits to include tobacco dependence treatment decreases smoking prevalence (17), improves cessation rates (18), and is cost effective (19). Despite this, as of 2018, only 15 states covered all nine treatments (seven FDA-approved drugs, group therapy, and individual counseling) as part of their Medicaid programs (20). Second, copayments and requirements for prior authorization for patients trying to access evidence-based treatment must be removed. The Affordable Care Act requires states to provide Medicaid expansion beneficiaries with comprehensive tobacco dependence benefits without cost sharing and copayments, yet barriers to access in tobacco treatment, such as the need for prior authorization, copayments, and limits on duration of therapy, have been reported for at least some enrollees in 48 states (20). Third, certified tobacco treatment specialists should be allowed to bill for tobacco dependence counseling for all types of insurance, including Medicare. In addition, reimbursement rates for tobacco counseling should be increased, and incentives should be provided for health systems to invest in funding for tobacco treatment programs. Although Medicare covers up to eight annual visits for tobacco counseling each year, four per quit attempt, the reimbursement rate is so low that it precludes many clinicians from providing this care. For example, psychologists can provide some of the most effective and intensive counseling, but current reimbursement for an “intensive” counseling session is decidedly under cost. This multipronged approach will ensure millions of current tobacco-dependent Americans have barrier-free access to comprehensive tobacco dependence treatments.

Increase Research on the Health Effects of Tobacco and Emerging Products, Innovations in Treatment, and Implementation and Sustainability of Tobacco Treatment Programs

Tobacco research remains underfunded when looking at its disproportionate contribution to death and disability (21). After decades of limited governmental oversight and regulation, electronic nicotine delivery systems such as e-cigarettes have created the next generation of tobacco-dependent Americans in adolescents and young adults. Research is needed to better identify individuals at risk for e-cigarette dependence; better understand what drives initiation, sustained use, and cessation of e-cigarettes; and understand how best to treat resulting nicotine dependence and addiction (22). To help identify individuals who are using e-cigarettes, it is critical to establish International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes for e-cigarette and other electronic nicotine delivery systems. These codes will inform clinical care and allow researchers and providers to collect data on the health outcomes, long-term effects of their use, and prevention and cessation interventions that address multiple product use. Funding research for youth interventions, especially the role of pharmacotherapy for e-cigarette use and nicotine dependence, must be prioritized. Behavioral interventions have traditionally been employed to curb youth tobacco use. Further research is needed on how to elevate and maintain priority of tobacco treatment programs in health systems. Despite numerous studies demonstrating the effectiveness of tobacco treatment programs in hospital systems, uptake of such programs is low (23).

Recommended Tobacco Control Agenda: Quick Action Items

Although legislation will ultimately be the most powerful tool for implementing broad improvements in tobacco control, a number of changes can be made in the short term to increase tobacco abstinence (Table 1). Over the past 50 years, there have been significant reductions in tobacco use because of robust policy and treatment programs. These gains need continued investment to reach our most disproportionately impacted populations, prevent youth initiation, and respond to novel tobacco products. We advocate for continued innovations in policy to reduce economic dependence on tobacco production, such as promoting economically sustainable alternatives for tobacco workers, growers, and sellers, both in the United States and internationally. We know the importance of public health investment in improving health and strongly implore our leaders to build on success in tobacco control to move toward eliminating these harmful products and improving health for everyone. We need stronger international collaborations to advance tobacco control globally. Given varying international regulatory environments after the introduction of new products (e.g., restrictions on advertising and requirements on packaging), U.S. decisions on tobacco control policies could have significant implications for international policies and programs.

Table 1.

Quick action tobacco control recommendations

Agency	High-Impact Agenda
FDA	Robust enforcement of the 2009 Family Smoking Prevention and Tobacco Control Act, such as regulating all flavored tobacco products from the marketplace, regulating the online e-cigarette market, graphic warning labels on cigarette packs, and ongoing regulation of false health claims made by many newer products awaiting FDA premarket review. Continue FDA support for tobacco-related research.
CDC	Continue data collection on tobacco use and harms and prioritize efforts in communities disproportionately impacted by tobacco use.
NIH	Increase allocation of research funds in the NIH budget, particularly in adolescent nicotine cessation interventions and implementation of tobacco treatment programs in health systems.
CMS	Increase Medicare reimbursement for tobacco treatment counseling and allow certified tobacco treatment specialists to bill Medicare for tobacco dependence counseling.

Definition of abbreviations: CDC = Centers for Disease Control and Prevention; CMS = Centers for Medicare and Medicaid Services; FDA = Food and Drug Administration; NIH = National Institutes of Health.