NCHR’s Comments on USPSTF’s Draft Recommendation Statement for Tobacco Smoking Cessation in Adults, Including Pregnant Persons

June 29, 2020

National Center for Health Research’s Comments on USPSTF’s Draft Recommendation Statement for Tobacco Smoking Cessation in Adults, Including Pregnant Persons

We are writing to express our views on the US Preventive Services Task Force (USPSTF) draft recommendation statement regarding tobacco smoking cessation interventions in adults, including pregnant persons.

The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We strongly agree with the USPSTF’s recommendation that all physicians ask their adult patients and pregnant patients about their tobacco use. We also agree with the ‘A’ ratings for clinicians to advise both nonpregnant and pregnant individuals to stop using tobacco, and provide behavioral interventions and FDA-approved pharmacotherapy for cessation for nonpregnant individuals and behavioral interventions only for pregnant individuals. We also agree with the ‘I’ rating stating there is insufficient evidence on the effects of pharmacotherapy interventions in pregnant persons. However, we encourage the USPSTF to ensure that health care providers consider the social determinants of health in their recommendation. For example, not all patients will be able to access all forms of interventions offered, so healthcare providers should discuss all aspects of the various options with patients, including cost and accessibility, providing additional information for the interventions that a patient is most interested in.

While we also agree that there is insufficient evidence that electronic cigarettes (e-cigarettes) are effective for tobacco smoking cessation, we do not support the ‘I’ rating due to the evidence we already have of its harms. We encourage the USPSTF to consider the following suggestions that would strengthen this recommendation:

1. We recommend that USPSTF replace the ‘I’ rating for e-cigarettes with a ‘D’ rating to recommend against the use of e-cigarettes for smoking cessation. Studies by the FDA show that e-cigarettes contain similar dangerous chemicals as traditional cigarettes, even though they don’t contain tobacco.1 The CDC has reported serious lung injuries as a result of e-cigarette usage, even after relatively short-term use.2 In addition, many vaping products have higher nicotine levels than traditional tobacco products, which clearly would undermine efforts to quit smoking. Because of this evidence of harm and addiction, we strongly suggest that the USPSTF caution health care providers against recommending e-cigarettes as a smoking cessation tool for adults and for pregnant persons.

2. Although pharmacological smoking cessation treatments are effective, the use of bupropion and varenicline in these drugs can cause serious adverse side effects such as depression, hostility, severe anxiety, and suicidal thoughts.3 In 2009, the FDA issued a “black box” warning on two popular smoking cessation drugs containing bupropion and varenicline for their negative effects on mental health.3 In addition, we testified about the risks of varenicline at an FDA public meeting in October 2014 that was focused on the psychiatric risks and featured patients describing terrifying side effects. We recommend that the USPSTF urge that doctors and their patients be fully informed about these risks of numerous FDA-approved smoking cessation products.

1. American Heart Association (US). Is Vaping Better Than Smoking? 30 October, 2018.
2. Centers for Disease Control and Prevention (US). Outbreak of Lung Injury Associated with E-Cigarette Use, or Vaping. 25 February 2020.
3. U.S. Food and Drug Administration. FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease. 6 June 2011. Retrieved 6 July 2011 at