Our Public Comment on HHS Draft Framework to Support and Accelerate Smoking Cessation

We appreciate the opportunity to submit public comments to the Department of Health and Human Services (HHS) regarding their Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation.

This is an incredibly important issue and we understand that this framework, and its goals, will guide HHS cessation efforts moving forward. We are 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. Below are recommendations for HHS to consider as the smoking cessation framework is developed.


Cigarette smoking is the leading cause of preventable death and illness in the United States. More than 480,000 die annually from smoke-related illnesses and approximately $240 billion was spent on healthcare for smokers in 2018.[1] Safe and effective cessation treatments and techniques are needed to improve the health and longevity of individuals living in the United States. A 2015 study from the Centers for Disease Control and Prevention (CDC) found that 68% of people want to quit smoking, but that desire alone is not enough to maintain a change in the behavior. Research has shown it can take 30 or more tries before a smoker quits successfully.[2],[3] The most common method of quitting for people in the United States is to set a quit deadline and attempt to stop cold turkey on that day. Evidence-based interventions that help assist in quitting have been developed, with some being more successful than others.

It is crucial for HHS to invest in cessation strategies that are safe and effective, including behavioral therapies and nicotine replacement therapies (NRT). Behavioral therapies and nicotine replacement therapies (NRTs) are common, with hundreds of studies looking at which of them are most effective. A 2021 meta-analysis of behavioral therapies found that any form of counseling (e.g., in-person, telephone, self-help, etc.), as well as guaranteed financial incentives, were the most successful forms of therapy.[4] The same study analyzed the economic benefits of behavioral therapies and found that different behavioral therapies were equally cost effective. A 2023 meta-analysis of NRTs looked at 68 studies and found a combination of NRT, such as nicotine gum alongside a nicotine patch, was more effective than using any method individually.[5] The same study also found that higher-dose products are more effective than their lower-dose counterparts and that using NRT prior to quitting smoking can be more effective than starting the NRT after quitting. However, higher-dose products may also have greater risks, and smoking cessation products can have serious psychiatric side effects.[6] Therefore, studies of the efficacy of NRTs compared to each other or to behavioral/counseling treatments need to also consider data on unpleasant or serious side effects.

Some claim that e-cigarettes can be used as a cessation therapy.  This claim has been described as “negligent and misinformed.”[7]  Research in this area needs to be carefully reviewed because despite conflicting findings, there is growing evidence that e-cigarettes are not safe and not effective to aid in smoking cessation.[8],[9] Most of the studies that support e-cigarettes for smoking cessation have flaws making the results questionable (e.g., short term follow up or not randomly assigning participants.) Since vaping is often promoted as a tool to quit smoking, it is essential to have better data to determine whether this is supported by evidence.


Increasing access and coverage of cessation treatments is a key step in decreasing the number of deaths related to smoking. A 2018 study examined patients who were offered smoking cessation treatments by their primary care doctor. The results showed fewer than 20% of smokers accepted any type of therapy.[10] This same study found that White patients were more likely to be offered a prescription for a cessation medication whereas Black patients were more likely to be offered cessation counseling. We recommend HHS determine effective strategies to help primary care providers increase patients’ knowledge about effective cessation therapies and willingness to try them. These key providers can give information to patients about how they can stop smoking and what resources are best at helping them to do so. Providing patients with several effective options, will allow them to find which strategy, or perhaps strategies, work best for aiding their smoking cessation.


Expanding surveillance regarding smoking and cessation behaviors is vital to understand the patterns and trends of the behaviors. Regularly evaluating data from point of sales and compliance with advertising requirements will allow HHS to act on the most up-to-date information and enforce decisions by the court. For example, the FDA banned flavored e-cigarettes after data showed that teenagers used preferred them to traditional tobacco flavors, and that they potentially served as a gateway to nicotine addiction.[11] Similarly, it is important to ensure that advertising restrictions banning the promotion and sales of e-cigarettes aimed at children and teenagers are enforced. We also recommend collecting information about trends in popular cessation therapies such as purchasing trends for NRTs. This will enable HHS to encourage safe and effective cessation methods.


Promoting well-designed research to support and accelerate smoking cessation will help achieve the Cancer Moonshot’s goal to reduce the cancer death rate by 50% over the next 25 years. Better research is needed comparing the effects of different cessation therapies for different demographic groups.  Across races, people who quit smoking, particularly early in their life, have reduced risk of all-cause mortality.[12] However, there is not enough research on the most effective cessation therapies for specific populations. A small study conducted by researchers at the University of Miami found there were greater decreases in perceived stress for African Americans and Hispanics after receiving behavioral therapy for smoking cessation, but the study did not look at the effectiveness of other cessation therapies.[13]


[1] Centers for Disease Control and Prevention. (2022, July 28). Costs and expenditures. Centers for Disease Control and Prevention. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/cost-and-expenditures.html

[2] Babb, S., Malarcher, A., Schauer, G., Asman, K., & Jamal, A. (2017). Quitting Smoking Among Adults – United States, 2000-2015. MMWR. Morbidity and mortality weekly report65(52), 1457–1464. https://doi.org/10.15585/mmwr.mm6552a1

[3] Chaiton, M., Diemert, L., Cohen, J. E… & Schwartz, R. (2016). Estimating the number of quit attempts it takes to quit smoking successfully in a longitudinal cohort of smokers. BMJ open6(6), e011045. https://doi.org/10.1136/bmjopen-2016-011045

[4] Hartmann-Boyce, J., Livingstone-Banks, J., Ordóñez-Mena, J. M… & Aveyard, P. (2021). Behavioural interventions for smoking cessation: an overview and network meta-analysis. The Cochrane database of systematic reviews1, CD013229. https://doi.org/10.1002/14651858.CD013229.pub2

[5] Theodoulou, A., Chepkin, S. C., Ye, W… & Lindson, N. (2023). Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. The Cochrane database of systematic reviews6(6), CD013308. https://doi.org/10.1002/14651858.CD013308.pub2

[6] Campbell, A. R., & Anderson, K. D. (2010). Mental health stability in veterans with posttraumatic stress disorder receiving varenicline. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists67(21), 1832–1837. https://doi.org/10.2146/ajhp100196

[7] McAlinden, K. D., Eapen, M. S., Lu, W., Sharma, P., & Sohal, S. S. (2020). The rise of electronic nicotine delivery systems and the emergence of electronic-cigarette-driven disease. American journal of physiology. Lung cellular and molecular physiology319(4), L585–L595. https://doi.org/10.1152/ajplung.00160.2020

[8] Laucks, P., & Salzman, G. A. (2020). The Dangers of Vaping. Missouri medicine117(2), 159–164.

[9] Venkata, A. N., Palagiri, R. D. R., & Vaithilingam, S. (2021). Vaping epidemic in US teens: problem and solutions. Current opinion in pulmonary medicine27(2), 88–94. https://doi.org/10.1097/MCP.0000000000000757

[10] Hooks-Anderson, D. R., Salas, J., Secrest, S., Skiöld-Hanlin, S., & Scherrer, J. F. (2018). Association between race and receipt of counselling or medication for smoking cessation in primary care. Family practice35(2), 160–165. https://doi.org/10.1093/fampra/cmx099

[11] Leventhal, A. M., Goldenson, N. I., Cho, J., Kirkpatrick, M. G., McConnell, R. S., Stone, M. D., Pang, R. D., Audrain-McGovern, J., & Barrington-Trimis, J. L. (2019). Flavored E-cigarette Use and Progression of Vaping in Adolescents. Pediatrics144(5), e20190789. https://doi.org/10.1542/peds.2019-0789

[12] Thomson, B., Emberson, J., Lacey, B… & Islami, F. (2022). Association Between Smoking, Smoking Cessation, and Mortality by Race, Ethnicity, and Sex Among US Adults. JAMA network open5(10), e2231480. https://doi.org/10.1001/jamanetworkopen.2022.31480

[13] Webb Hooper, M., & Kolar, S. K. (2015). Distress, race/ethnicity and smoking cessation in treatment-seekers: implications for disparity elimination. Addiction (Abingdon, England)110(9), 1495–1504. https://doi.org/10.1111/add.12990