On behalf of the Robert Wood Johnson Foundation (hereinafter “RWJF” or “the Foundation”), Richard Besser, MD, RWJF President and CEO, submitted the following comments in response to the U.S. Food and Drug Administration (FDA) Proposed Rulemaking on a Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products (hereinafter “the Proposed Rule”), published in the Federal Register on January 16, 2025.
RWJF is a leading national philanthropy dedicated to taking bold leaps to transform health in our lifetime. Through funding, convening, advocacy, and evidence-building, we work side-by-side with communities, practitioners, and institutions to get to health equity faster and pave the way together to a future where health is no longer a privilege, but a right.
For more than 30 years, RWJF has partnered with researchers, advocates, community-based organizations, and government, among others, to reduce the toll of commercial tobacco products on everyone. Our comments are grounded in the perspectives and expertise of our grantees and RWJF’s history of supporting commercial tobacco control efforts.
RWJF is supportive of the Proposed Rule to establish a maximum nicotine level in cigarettes and other commercial tobacco products1 in order to reduce the addictiveness of these products and to support the ability of people who are addicted to these products to quit. We encourage FDA to strengthen the Proposed Rule by also addressing premium cigars, hookah, and heated tobacco products and by explicitly exempting traditional tobacco used for ceremonial or medicinal purposes. Overall, the Proposed Rule is an important step toward achieving a future in which health is no longer a privilege, but a right.
Background
Despite significant declines in commercial tobacco use in the United States over the past five decades, commercial tobacco use remains our country’s leading cause of preventable disease, disability, and death.2 More than 490,000 deaths per year are attributable to cigarette smoking and exposure to secondhand smoke (hereinafter “SHS”).3 Commercial tobacco products disproportionately harm many populations that face the greatest barriers to health. According to the 2024 U.S. Surgeon General’s Report, Eliminating Tobacco-Related Disease and Death: Addressing Disparities, exposure to SHS “remains disproportionately higher among Black people than among people in other racial and ethnic groups, youth than among adults, and people from lower socioeconomic backgrounds than among those from higher socioeconomic backgrounds.”4
Disparities also persist with respect to quitting commercial tobacco products. For example, people with lower incomes are less likely to quit despite rates of quit attempts, and people who smoke menthol cigarettes, which includes about 85% percent of Black people who smoke, are less likely to successfully quit than people who smoke non-menthol cigarettes.5
The Marketing of Addictive and Deadly Commercial Tobacco Products Is a Barrier to Achieving Better Health for All
In many communities, and especially in many communities of color, there is a constant flow of advertising, discounts, and displays of harmful and addictive commercial tobacco products. The tobacco industry spent almost $9.5 billion to market its cigarette, smokeless tobacco, and e-cigarette products in 2021, according to the Truth Initiative.6 The industry targets youth, who are highly susceptible to industry advertising. According to the Surgeon General’s 2014 report, The Health Consequences of Smoking—50 Years of Progress, “advertising and promotional activities by the tobacco companies cause the onset and continuation of smoking among adolescent and young adults.”7 Several studies have found a greater number of tobacco advertisements and a larger presence of tobacco advertising in Black neighborhoods.8 Researchers have also found higher tobacco marketing exposure in stores and via mail and email for non-Hispanic American Indian and Alaska Native people than for non-Hispanic White people.9
The industry’s relentless marketing of its dangerous products increases the risk that people will become addicted, and once addicted, it is very hard to quit. Nearly 70 percent of adults who smoke want to quit and about 90 percent wish they had never started. However, overcoming an addiction to nicotine is difficult and people who smoke often need to make multiple quit attempts before succeeding.10 11
Reducing Nicotine Levels in Commercial Tobacco Products to Minimally or Non-Addictive Levels Helps Make All Communities Healthier
For decades, researchers have agreed that nicotine is the fundamental addictive agent in tobacco, leading the U.S. Surgeon General to conclude in the 1988 report, The Health Consequences of Smoking: Nicotine Addiction, that “nicotine is the drug in tobacco that causes addiction.”12 In the Proposed Rule, FDA estimates that reducing nicotine levels in combusted tobacco products would cause 19.5 million people to quit smoking within five years. FDA also estimates that, by the end of the century, the Proposed Rule would prevent more than 48 million youth and young adults from initiating smoking and would save more than 4 million lives. This would be a tremendous public health achievement.
Reducing Nicotine Levels Will Help People Quit Dangerous Commercial Tobacco Products
Reducing the nicotine content in commercial tobacco products to minimally or non-addictive levels will make it easier for people who use these products to quit. According to the 2014 U.S. Surgeon General report, The Health Consequences of Smoking: 50 Years of Progress, “the addiction caused by the nicotine in tobacco smoke is critical in the transition of smokers from experimentation to sustained smoking and, subsequently, in the maintenance of smoking for the majority of smokers who want to quit.”13 14 This conclusion is supported by studies on the impact of very low nicotine content (hereinafter “VLNC”) cigarettes in the U.S.
The first large-scale clinical trial of VLNC cigarettes in the U.S. found that, among individuals who were not interested in quitting, VLNC cigarettes with 0.4 mg/g were associated with smoking fewer cigarettes per day, reduced nicotine exposure, reduced cigarette dependence, and increased likelihood of contemplating or making a quit attempt.15 16 While most clinical trials with VLNC cigarettes have enrolled adults who are not interested in quitting, research also shows that reduced nicotine cigarettes increase abstinence among those who are trying to quit, suggesting that VLNC cigarettes can help people quit.17 18 19 20
Reducing Nicotine Levels Will Prevent Youth and Young Adults from Becoming Addicted to Commercial Tobacco Products
Reducing nicotine levels in commercial tobacco products to minimally or nonaddictive levels will prevent youth and young adults from becoming addicted. Given the dangers of cigarettes, it would not be ethical to conduct studies on non-smoking youth. Preclinical research and trials among youth and young adults who already smoke, however, suggest that reducing nicotine levels to minimally or nonaddictive levels may be effective at preventing addiction among youth and young adults. Studies with adolescents who smoke find that VLNC cigarettes reduce cravings and cigarette consumption.21 22
A secondary analysis of data from the first large-scaled randomized controlled trial found that young adults smoked fewer VLNC cigarettes per day than older adults after two weeks in the trial suggesting that younger populations may be more sensitive and responsive to a nicotine reduction policy.23 While there is no known safe level of exposure to nicotine for youth, these findings taken together demonstrate that the proposed maximum nicotine level would reduce abuse liability among youth as much as, if not more than, it would among adults.
Reducing Nicotine in Commercial Tobacco Products May Reduce Health Disparities
Cigarettes and other commercial tobacco products disproportionately harm marginalized populations. Groups with high smoking or tobacco-use rates include people without college diplomas; people living in poverty; people who identify as lesbian, gay, bisexual, or transgender; American Indian and Alaska Native adults; and people living with a mental health condition or substance use disorder.24 Groups with high smoking or tobacco-use rates also include Black people as compared to White people,25 some Hispanic subgroups as compared to White people,26 and people with fewer years of formal education.27 According to the 2024 U.S. Surgeon General’s Report, Eliminating Tobacco-Related Disease and Death: Addressing Disparities, “Reducing nicotine in cigarettes and other combustible tobacco products to minimally addictive or nonaddictive levels should reduce tobacco use among many population groups experiencing tobacco-related disparities.”28
People with mental health and substance use disorders have especially high rates of smoking and may benefit greatly from reducing nicotine levels in commercial tobacco products. According to data from the 2023 National Survey on Drug Use and Health (NSDUH), roughly 26% of adults aged 26 and older with any mental illness currently smoke, compared to roughly 16% of adults with no mental illness.29 According to the 2019 NSDUH survey, more than one-third (35.8%) of adults with a substance use disorder (alcohol, cannabis, cocaine, or heroin use disorder) reported current (past-month) smoking in 2019.30
Research suggests that people with mental health and substance use disorders are likely to benefit from the proposed nicotine standard. Evidence is well documented on the potential to reduce smoking and tobacco toxicant exposure in people with mental health conditions while having minimal mood disruption or worsening of psychiatric symptoms.31 32 33 34 35 36 37 38 Additionally, VLNC trials enrolling those with established substance use have not found increases in use of alcohol or marijuana.39 40 41 42 43 44 In fact, one study found a reduction in binge drinking among participants assigned to use VLNC cigarettes for 20 weeks.45
Reducing commercial tobacco use among people with mental health and substance abuse disorders not only decreases their risk of developing numerous chronic diseases associated with commercial tobacco use, such as cancer, heart disease, and diabetes, but will also likely help improve their mental health.46 There is consistent evidence that stopping smoking is associated with improvements in depression, anxiety, stress, psychological quality of life, and positive affect compared with continuing smoking—and the effect size of these benefits was found to be equal or larger than those of antidepressant treatment for mood and anxiety disorders.47
Research has also demonstrated reduced addiction potential for VLNC cigarettes in other populations with high smoking rates, including people with low incomes. According to the 2023 National Health Interview Survey (NHIS), the smoking rate among adults with the lowest reported income is nearly twice the overall adult smoking rate (19.4% vs. 10.8%).48 Trials that have included participants with low incomes have found that these participants show reduced smoking and reduced biomarkers of smoke exposure.49 50 51
Address All Combustible and Heated Tobacco Products
To maximize the public health benefits of a nicotine product standard, we urge FDA to consider broadening the scope of the Proposed Rule to include premium cigars, hookah tobacco, and heated tobacco products (hereinafter “HTPs”). As the FDA states in its justification for the Proposed Rule, “[N]icotine is the primary addictive constituent in tobacco products, and it is the nicotine in such products that both creates and sustains addiction and ultimately leads to the significant adverse health effects caused by these products.”52 This statement is as true for combusted cigarettes as it is for all combusted and heated tobacco products that contain nicotine, including premium cigars, hookah, and HTPs. They are all dangerous and addictive. As FDA recognized in its Proposed Rule, reducing nicotine levels in cigarettes without including cigars “would likely be less effective.”53
A 2022 report from the National Academies of Sciences, Engineering, and Medicine found, “There is conclusive evidence that the addictive, toxic, and carcinogenic constituents of cigar tobacco in general are the same as those present in cigarette tobacco.”54 The report also noted, “There is no single, consistent definition of premium cigars accepted by FDA, industry, courts, and the public.”
Given the tobacco industry’s long history of modifying their products to circumvent regulation,55 56 57 the lack of clarity on what constitutes a “premium cigar” creates a significant risk that the tobacco industry will promote premium cigars as substitutes for cigarettes, which could greatly reduce the benefits of the Proposed Rule.
Hookah and HTPs are also dangerous and addictive. According to the CDC, using a waterpipe to smoke tobacco poses serious health risks to users and others exposed to the smoke from the waterpipe tobacco.58 Waterpipe tobacco use is linked to many of the same adverse health effects as cigarette smoking, such as lung, bladder, and oral cancers and heart disease.59 60 Other documented long-term effects include impaired pulmonary function, chronic obstructive pulmonary disease, esophageal cancer, and gastric cancer.61
As a result of exposure to the dangerous chemicals in waterpipe tobacco smoke, research shows that even short-term waterpipe tobacco use is associated with acute health effects, including increased heart rate and blood pressure, reduced pulmonary function, and carbon monoxide intoxication.62 In a typical waterpipe session, users are subjected to up to more than twice the nicotine exposure from smoking a single cigarette.63 64 Further, waterpipe tobacco use is associated with nicotine dependence, including experiences of withdrawal and difficulty quitting, at least among some users.65
Like hookah, cigars, and cigarettes, HTPs can deliver addictive levels of nicotine. While HTPs have not been on the market long enough to accumulate long-term data on health risks, research continues to accumulate on the health risks from using HTPs.66 A recent systematic review and meta-analysis of studies raises some questions about the relative risk of using HTPs compared to cigarettes, stating, “Overall, the findings are so mixed that these data provide no clear indication of the relative risks or benefits of HTPs, including insufficient evidence to indicate any certain benefits over cigarettes.”67 FDA’s finding about reduced exposure to certain harmful and potentially harmful constituents (HPHCs) in smoke released from IQOS products, a brand of HTPs, does not translate into reducing one’s health risk. FDA denied the request to market IQOS as a “reduced risk” product, finding that there was not enough evidence that switching completely to IQOS would present less risk than continuing to smoke cigarettes.68 Consumers already misinterpret messages about reduced exposure as meaning reduced risk.69 Excluding HTPs from the Proposed Rule could reinforce that misunderstanding, leading to consumers believing that HTPs expose them to less nicotine, lower risk of addiction, and lower risk of disease.
Determine if Maximum Levels of Nicotine Should Be Required for E-Cigarettes and Nicotine Pouches
There is little research examining how nicotine reduction in cigarettes and other combustible tobacco products will affect the use of non-combustible tobacco products.70 People who smoke combustible products may completely or partially switch to non-combustible products.
Nicotine strength in non-combustible tobacco products is highly variable but has been increasing over time in e-cigarettes and has started out alarmingly high in some nicotine pouch products. One study that looked at nicotine strength in e-cigarettes from 2017 to 2022 found that the unit share of products containing greater than or equal to 5% nicotine strength increased by nearly 1,500% during the time period and represented over 80% of e-cigarette sales by March 2022.71
Further research is needed to determine whether nicotine should be reduced in non-combustible products. Specifically, FDA, working with federal government partners, should examine the “impact of lowering nicotine levels in noncombustible products in the context of other lower-nicotine combustible products,”72 determine the effects of high nicotine levels in such non-combustible products on sustaining addiction, and whether reducing nicotine levels in these products would be desirable to protect public health and reduce tobacco-related disparities.
FDA should also work with federal government partners to monitor patterns of use of non-combustible tobacco products among both adults and youth over time to see if use of these products is increasing and changing and whether, in the case of adults, complete switching from the tobacco products included in the rule is occurring. For example, of particular concern would be dual use of non-combustible tobacco products and tobacco products included in this rule. Dual use of e-cigarettes and cigarettes has historically been significant,73 is associated with higher toxicant exposure than exclusive e-cigarette use,74 and does not reduce the risk of disease from either product.75
Monitoring patterns of use of all tobacco products across all populations, including populations who have been most harmed by commercial tobacco products, will ensure this rule and any future actions on nicotine levels in tobacco products benefit everyone.
Exempt Traditional Tobacco Used for Ceremonial and Medicinal Purposes
Nothing in the final rule should prevent American Indian and Alaska Native Tribal communities from continuing to plant, grow, harvest, share, and use traditional tobacco. Traditional tobacco has been used across Indian country for centuries, and unlike commercial tobacco, it is used as a medicine for cultural ceremonies and spiritual practices and is typically not inhaled. In fact, there is evidence that restoring the use of traditional tobacco in ceremonies is a protective factor against commercial tobacco abuse.76
Require an Immediate Reduction in All Covered Products to 0.7 MG/G
We agree with FDA’s assessment in the Proposed Rule that the evidence demonstrates a greater public health benefit from an immediate reduction rather than a gradual reduction in nicotine content. A 20-week randomized controlled trial of 1,200 adults that assigned people who smoke to normal nicotine content cigarettes, reduced nicotine content cigarettes (0.4 mg/g), or cigarettes with the nicotine content gradually reduced over the course of the study (from 15.8 mg/g to 0.4 mg/g) found that those in the immediate nicotine reduction condition showed greater reduction in cigarettes per day, greater decreases in measures of dependence, higher rates and duration of abstinence, and greater reductions in biomarkers of smoke exposure compared to the gradual reduction condition.77 No significant differences were found between the gradual reduction condition and the control condition (normal nicotine content cigarettes).
Immediate nicotine content reduction is also preferable because it reduces the possibility of compensatory smoking, whereas evidence suggests that a gradual approach could create opportunities for people who smoke to compensate by smoking more cigarettes. While VLNC cigarettes do not contain enough nicotine for compensation to be feasible,78 people who smoke may be able to compensate with intermediate-level nicotine cigarettes, smoking these products more intensely and exposing themselves to more toxicants.
The enormous public health benefits that would result from the Proposed Rule should not be postponed any longer than absolutely necessary. Postponing the effective date of the rule only means that many hundreds of thousands of people who smoke and people who will initiate smoking will unnecessarily have their lives shortened by an addiction that the Proposed Rule could have prevented. We believe that the FDA’s proposal of an effective date two years from the final rule publication is unnecessarily long. The effective date should be no longer than one year after final publication, an implementation period consistent with the one-year period generally provided for in the Tobacco Control Act.79
Ensure a Robust Cessation Infrastructure
FDA can maximize the benefit of the final rule by working with partners to increase access to culturally and community appropriate and responsive cessation services and by prohibiting the manufacture, distribution, and sale of menthol cigarettes and flavored cigars. Implementation of the Proposed Rule to reduce nicotine levels in all combustible tobacco products to minimally- or non-addictive levels will prompt millions of tobacco users to make a quit attempt, with enormous public health benefits if those attempts are successful. HHS should implement a comprehensive effort to provide strong cessation support to tobacco users, building on the 2024 HHS Framework to Support and Accelerate Smoking Cessation, and restore support for the Office on Smoking and Health (OSH) and the effective Tips From Former Smokers media campaign.
FDA should also work with other government agencies, including the National Institutes of Health, to support community-informed research to help understand how best to support commercial tobacco cessation among people who face the greatest barriers to quitting. Research is also needed to understand how best to support quitting among people who use menthol cigarettes, which are more addictive than non-menthol cigarettes.80
Prohibit the Manufacture, Distribution, and Sale of Menthol Cigarettes and Flavored Cigars
Prohibiting the sale of menthol cigarettes and flavored cigars has independent benefits and can also help maximize the impact of the final version of the Proposed Rule. As the 2024 Surgeon General Report, Eliminating Tobacco-Related Disease and Death: Addressing Disparities, stated, “It is expected that [a policy reducing nicotine content in cigarettes to minimally addictive or nonaddictive levels] could be even more impactful if adopted and implemented in concert with complementary efforts such as restrictions on flavored tobacco products.”81 The report also identified “removal of menthol, mint, and other cooling chemical additives at any level across all tobacco products, including products advertised as low nicotine” as a “potential health equity safeguard” for policies that “[r]educe nicotine in cigarettes and other tobacco products to minimally addictive or nonaddictive levels.”
Equitably Enforce the Final Rule
We recommend that FDA use ChangeLab Solutions’ Equitable Enforcement to Achieve Health Equity: An Introductory Guide for Policymakers and Practitioners82 as a guide to support equitable implementation of the final rule. We support the Proposed Rule’s prohibition of enforcement “against individual consumers for possession or use of [products that violate the rule]” and agree with FDA that enforcement should “only address manufacturers, distributors, wholesalers, importers, and retailers.” These are the entities that are best positioned to prevent widespread distribution, sale, and use of products that violate the final rule.
Monitor the Impact of the Final Rule and Ensure It Benefits Everyone
While we believe the Proposed Rule will reduce commercial tobacco use across all populations and has the potential to reduce tobacco-related disparities, it will be important to monitor the impact of the final rule on different populations. For example, we know that Black people who smoke are more likely to use menthol cigarettes and that menthol cigarettes are harder to quit. This is one reason we believe that FDA should ban the manufacture, distribution, and sale of menthol cigarettes. But if FDA allows the sale of menthol cigarettes with very low nicotine levels, it will be important to assess whether the 0.7 mg/g standard is as effective in helping people quit menthol cigarettes as it is for people who use non-mentholated cigarettes.
It will also be important to assess whether the rule affects men and women differently. While more research is needed, one study found that young men may experience less relief than young women from low-nicotine cigarettes.82 That could have implications beyond gender disparities because smoking rates among men and women differ across populations. There is also evidence that many people who smoke incorrectly perceive VLNC cigarettes to be less harmful than cigarettes with normal levels of nicotine and that rates of misperception may vary by race, ethnicity, and education level.83 This research underscores the need for FDA to monitor the impact of the rule on different populations—especially those most harmed by commercial tobacco—and, if necessary, revisit the nicotine yield standard to ensure that it is non-addictive for all populations.
Conclusion
We support the Proposed Rule and believe it could be strengthened if it also covered premium cigars, hookah, and HTPs and explicitly exempted traditional tobacco used for ceremonial or medicinal purposes. Despite great progress in curbing smoking over the past several decades, smoking continues to be the leading cause of preventable death and disease in the United States and contributes to health disparities. Reducing the nicotine content of cigarettes and other combustibles will reduce nicotine dependence among people who currently smoke, prevent youth from becoming addicted, and help millions to quit smoking, ultimately reducing tobacco-related health harms. An immediate nicotine content reduction will yield greater public health benefits than a gradual reduction. FDA should finalize a comprehensive rule that will have the intended public health impact as soon as possible.
We would appreciate the opportunity to work with FDA and other partners to strengthen the Proposed Rule and implement and evaluate the final rule. FDA should monitor the impact of the final rule on all populations to ensure the final rule benefits everyone and does not exacerbate tobacco-related disparities.
We have included numerous citations to supporting research, including direct links to research. We direct FDA to each of the materials we have cited and made available through active links, and we request that the full text of each of the studies and articles cited, along with the full text of our comment, be considered part of the formal administrative record for purposes of the Administrative Procedure Act. If FDA is not planning to consider these materials part of the record as we have requested here, we ask that you notify us and provide us with an opportunity to submit copies of the studies and articles into the record.
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[1] RWJF uses the term “commercial tobacco products” to make clear that none of our efforts are intended to prevent American Indian and Alaska Native Tribal communities from continuing to grow, share, and use traditional tobacco. See, American Indian Cancer Foundation, Traditional Tobacco: Healing with Culture, Reclaiming Indigenous Health, AICAF (2025), https://www.traditionaltobacco.org/.
[2] U.S. Department of Health and Human Services, Smoking Cessation: A Report of the Surgeon General, HHS (2020), https://www.hhs.gov/sites/default/files/2020-cessation-sgr-full-report.pdf.
[3] U.S. Department of Health and Human Services, Eliminating Tobacco-Related Disease and Death: Addressing Disparities, A Report of the Surgeon General, HHS (2024), https://www.hhs.gov/sites/default/files/2024-sgr-tobacco-related-health-disparities-full-report.pdf.
[4] U.S. Department of Health and Human Services, Eliminating Tobacco-Related Disease and Death: Addressing Disparities, A Report of the Surgeon General, HHS (2024), https://www.hhs.gov/sites/default/files/2024-sgr-tobacco-related-health-disparities-full-report.pdf.
[5] Truth Initiative, Quitting tobacco: Facts and Stats (April 22, 2024), https://truthinitiative.org/research-resources/quitting-smoking-vaping/quitting-tobacco-facts-and-stats#:~:text=DISPARITIES%20IN%20QUITTING&text=Fewer%20lower%2Dincome%20smokers%20quit,use%20them%20at%20low%20rates.
[6] Truth Initiative, The Truth About the Tobacco Industry and the Retail Environment (Jan. 23, 2025), https://truthinitiative.org/research-resources/tobacco-industry-marketing/truth-about-tobacco-industry-and-retail-environment.
[7] U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress, A Report of the Surgeon General, HHS (2014), https://www.hhs.gov/sites/default/files/consequences-smoking-exec-summary.pdf.
[8] Truth Initiative, Tobacco Use in the Black American Community (Aug. 27, 2024), https://truthinitiative.org/research-resources/targeted-communities/tobacco-use-african-american-community#:~:text=The%20tobacco%20industry%20has%20targeted,publications%20popular%20with%20Black%20audiences.
[9] Dana Mowls Carroll et al., Tobacco Industry Marketing Exposure and Commercial Tobacco Product Use Disparities among American Indians and Alaska Natives, Substance Use & Misuse (Sept. 23, 2019), https://pmc.ncbi.nlm.nih.gov/articles/PMC6980664/.
[10] Brenna VanFrank et al., Adult Smoking Cessation — United States 2022, CDC (July 25, 2024), https://www.cdc.gov/mmwr/volumes/73/wr/mm7329a1.htm.
[11] Geoffrey T Fong et al., The near-universal experience of regret among smokers in four countries: findings from the International Tobacco Control Policy Evaluation Survey, Nicotine & Tobacco Research (Dec. 2004), https://pubmed.ncbi.nlm.nih.gov/15799597/.
[12] William R. Lynn, Ronald M. Davis, and Thomas E. Novotny, The Health Consequences of Smoking: Nicotine Addiction, A Report of the Surgeon General, CDC (1988), https://profiles.nlm.nih.gov/spotlight/nn/catalog/nlm:nlmuid-101584932X423-doc.
[13] U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress, A Report of the Surgeon General, HHS (2014), https://www.hhs.gov/sites/default/files/consequences-smoking-exec-summary.pdf.
[14] U.S. Department of Health and Human Services, How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease, A Report of the Surgeon General, CDC (2010), http://www.ncbi.nlm.nih.gov/books/NBK53017/.
[15] Although the Proposed Rule would decrease nicotine levels to 0.7 mg/g, not 0.4 mg/g, we believe it is reasonable to assume that a 0.7 mg/g standard would achieve similar results since—as the Proposed Rule notes (at 5062)—testing of the cigarettes use in the trials found variations in the nicotine content of these cigarettes in the range of 0.4 to 0.7 mg/g.
[16] Dorothy Hatsukami, Xianghua Luo, and Joni Jensen et al., Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial, JAMA (Sept. 4, 2018), https://jamanetwork.com/journals/jama/fullarticle/2698925.
[17] Natalie Walker et al., The combined effect of very low nicotine content cigarettes, used as an adjunct to usual Quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: a randomized controlled trial, Addiction (Oct. 2012), https://pubmed.ncbi.nlm.nih.gov/22594651/.
[18] Hayden McRobbie et al., Complementing the Standard Multicomponent Treatment for Smokers with Denicotinized Cigarettes: A Randomized Trial, Nicotine & Tobacco Research (May 2016), https://pubmed.ncbi.nlm.nih.gov/26045250/.
[19] Karen Becker, Jed Rose, and Anthony Albino, A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation, Nicotine & Tobacco Research (July 2008), https://pubmed.ncbi.nlm.nih.gov/18629723/.
[20] Dorothy Hatsukami et al., Nicotine Reduction Revisited: Science and Future Directions, Tobacco Control (Oct. 2010), https://pmc.ncbi.nlm.nih.gov/articles/PMC4618689/.
[21] Rachel Cassidy et al., Adolescent smokers’ response to reducing the nicotine content of cigarettes: Acute effects on withdrawal symptoms and subjective evaluation, Drug and Alcohol Dependence (May 16, 2018), https://pmc.ncbi.nlm.nih.gov/articles/PMC6057730/.
[22] Rachel Cassidy et al., The impact of reducing nicotine content on adolescent cigarette smoking and nicotine exposure: Results from a randomized controlled trial, Nicotine & Tobacco Research (April 6, 2023), https://pubmed.ncbi.nlm.nih.gov/36482794/.
[23] Rachel Cassidy et al., Age moderates smokers’ subjective response to very low nicotine content cigarettes: Evidence from a randomized controlled trial, Nicotine & Tobacco Research (June 21, 2019), https://pubmed.ncbi.nlm.nih.gov/29718460/.
[24] U.S. Department of Health and Human Services, Eliminating Tobacco-Related Disease and Death: Addressing Disparities, A Report of the Surgeon General, HHS (2024), https://www.hhs.gov/sites/default/files/2024-sgr-tobacco-related-health-disparities-full-report.pdf.
[25] Jessica Ho and Irma Elo, The Contribution of Smoking to Black-White Differences in U.S. Mortality, Demography (April 2014), https://pmc.ncbi.nlm.nih.gov/articles/PMC3606656/.
[26] Andrew Fenelon, Revisiting the Hispanic Mortality Advantage in the United States: The Role of Smoking, Social Science & Medicine (April 2013), https://pubmed.ncbi.nlm.nih.gov/23453311/.
[27] Jessica Ho and Andrew Fenelon, The Contribution of Smoking to Educational Gradients in U.S. Life Expectancy, Journal of Health and Social Behavior (July 21, 2015), https://pmc.ncbi.nlm.nih.gov/articles/PMC4553079/.
[28] U.S. Department of Health and Human Services, Eliminating Tobacco-Related Disease and Death: Addressing Disparities, A Report of the Surgeon General, HHS (2024), https://www.hhs.gov/sites/default/files/2024-sgr-tobacco-related-health-disparities-full-report.pdf.
[29] Substance Abuse and Mental Health Services Administration, Results from the 2023 National Survey on Drug Use and Health Detailed Tables, SAMHSA (July 30, 2024), https://www.samhsa.gov/data/report/2023-nsduh-detailed-tables.
[30] Beth Han et al., Trends in Prevalence of Cigarette Smoking Among US Adults With Major Depression or Substance Use Disorder (2006-2019), JAMA (April 2022), https://pubmed.ncbi.nlm.nih.gov/35471512/.
[31] Jennifer Tidey et al., Effects of very low nicotine content cigarettes on smoking across vulnerable populations, Preventive Medicine (Dec. 2022), https://pubmed.ncbi.nlm.nih.gov/35642796/.
[32] Jonathan Foulds et al., The effects of reduced nicotine content cigarettes on biomarkers of nicotine and toxicant exposure, smoking behavior and psychiatric symptoms in smokers with mood or anxiety disorders: a double-blind randomized trial, PLoS One (Nov. 2, 2022), https://pubmed.ncbi.nlm.nih.gov/36322562/.
[33] Jennifer Tidey et al., Effects of 6-week use of reduced-nicotine content cigarettes in smokers with and without elevated depressive symptoms, Nicotine & Tobacco Research (Jan. 2017), https://pubmed.ncbi.nlm.nih.gov/27613885/.
[34] Jennifer Tidey, Rachel Cassidy, and Mollie Miller, Smoking topography characteristics of very low nicotine content cigarettes, with and without nicotine replacement, in smokers with schizophrenia and controls, Nicotine & Tobacco Research (Sept. 2016), https://pubmed.ncbi.nlm.nih.gov/26995794/.
[35] Jennifer Tidey et al., Separate and combined effects of very low nicotine cigarettes and nicotine replacement in smokers with schizophrenia and controls, Nicotine & Tobacco Research (Jan. 2013), https://pubmed.ncbi.nlm.nih.gov/22517190/.
[36] Stephen Higgins et al., Addiction potential of cigarettes with reduced nicotine in populations with psychiatric disorders and other vulnerabilities to tobacco addiction, JAMA Psychiatry (Aug. 23, 2017), https://pmc.ncbi.nlm.nih.gov/articles/PMC5710465/.
[37] Stephen Higgins et al., Changes in cigarette consumption with reduced nicotine content cigarettes among smokers with psychiatric conditions or socioeconomic disadvantage: 3 randomized clinical trials, JAMA Network Open (Oct. 1, 2020), https://pubmed.ncbi.nlm.nih.gov/33079196/.
[38] Rachel Denlinger- Apte et al., Smoking topography characteristics during a 6- week trial of very low nicotine content cigarettes in smokers with serious mental illness, Nicotine & Tobacco Research (July 16, 2020), https://pubmed.ncbi.nlm.nih.gov/31628475/.
[39] Sarah Dermody et al., The impact of smoking very low nicotine content cigarettes on alcohol use, Alcoholism: Clinical and Experimental Research (March 2016), https://pubmed.ncbi.nlm.nih.gov/26916879/.
[40] Sarah Dermody et al., An evaluation of potential unintended consequences of a nicotine product standard: A focus on drinking history and outcomes, Nicotine & Tobacco Research (June 8, 2021), https://pubmed.ncbi.nlm.nih.gov/33220047/.
[41] Lauren Pacek et al., Evaluation of a reduced nicotine product standard: Moderating effects of and impact on cannabis use, Drug and Alcohol Dependence (Oct. 2016), https://pubmed.ncbi.nlm.nih.gov/27590743/.
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About the Robert Wood Johnson Foundation
RWJF is a leading national philanthropy dedicated to taking bold leaps to transform health in our lifetime. Through funding, convening, advocacy, and evidence-building, we work side-by-side with communities, practitioners, and institutions to get to health equity faster and pave the way together to a future where health is no longer a privilege, but a right.