The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and U.S. Food and Drug Administration (FDA)–approved pharmacotherapy for cessation to nonpregnant adults who use tobacco (Table 1). 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 (Table 1). 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 (Table 1). I statement.
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of electronic cigarettes (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 (Table 1). I statement.
See the Practice Considerations section for more information on recommended behavioral interventions and pharmacotherapy and for suggestions for practice regarding the I statements.
Tobacco use is the leading preventable cause of disease, disability, and death in the United States. In 2014, it was estimated that 480,000 deaths annually are attributed to cigarette smoking, including secondhand 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 U.S. adults (20.8% of the adult population) used tobacco; 14.0% of the U.S. adult population currently smoked cigarettes; and 4.5% of the U.S. adult population used 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
The USPSTF concludes with high certainty that the net benefit of behavioral interventions and 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.
See Table 2 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 Table 3. 10 , 11 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 United States, 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.
| Tobacco use | Tobacco use refers to use of any tobacco product. As defined by the U.S. 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, e-cigarettes, hookah pens, and other electronic nicotine delivery systems. 10 |
| Smoking | Smoking generally refers to the inhaling and exhaling of smoke produced by combustible tobacco products such as cigarettes, cigars, and pipes. |
| Vaping | Vaping refers to the inhaling and exhaling of aerosols produced by e-cigarettes. 11 Vaping products (i.e., e-cigarettes) usually contain nicotine, which is the addictive ingredient in tobacco. Substances other than tobacco can also be used to smoke or vape. Although 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 |
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.
Because many pregnant persons who smoke do not report it, using multiple choice questions to assess smoking status in this group may improve disclosure. 12
Nonpregnant Adults. Effective tobacco smoking cessation interventions for nonpregnant adults include behavioral counseling and pharmacotherapy, either individually or in combination. 13 , 14
Combined Behavioral Counseling Interventions and Pharmacotherapy. 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
Behavioral Counseling Interventions. 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 4. 12 , 13 , 15 – 45
Pharmacotherapy. 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, 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 sustained-release. 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
Pregnant Persons. Behavioral counseling interventions. 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 4. 12 , 13 , 15 – 45
Primary care clinicians may find the following resources useful in talking with adults and pregnant persons about tobacco smoking cessation.
In addition, the following resources may be useful to primary care clinicians and practices trying to implement interventions for tobacco smoking cessation.
In 2020, the Surgeon General issued a Report on Smoking Cessation. 47 The report's findings were largely similar to those 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.
Pharmacotherapy for Pregnant Persons. 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 1,071 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 sustained-release 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.
e-Cigarettes in Nonpregnant Adults and Pregnant Persons. 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 common 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 Sciences, 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 that occurred in the United States in late 2019 also suggests potential harms of e-cigarette use. The vast majority of cases have been associated with tetrahydrocannabinol-containing e-cigarettes. 53
Given the high rates of e-cigarette use in children and adolescents currently in the United States, 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 non-pregnant 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 was first published in JAMA. 2021;325(3):265–279.
The “Update of Previous USPSTF Recommendation,” “Supporting Evidence,” “Research Needs and Gaps,” and “Recommendations of Others” sections of this recommendation statement are available at https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions.
The USPSTF recommendations are independent of the U.S. government. They do not represent the views of the Agency for Healthcare Research and Quality, the U.S. Department of Health and Human Services, or the U.S. Public Health Service.
The complete version of this statement, including supporting scientific evidence, evidence tables, grading system, members of the USPSTF at the time this recommendation was finalized, and references, is available on the USPSTF website at https:// www.uspreventive services task force.org/.
This series is coordinated by Joanna Drowos, DO, contributing editor.