Evidence-Based Post-Ban Research to Inform Effective Menthol Cigarette Bans in the United States and Other Jurisdictions

Introduction

The U.S. Family Smoking Prevention and Tobacco Control Act, signed into law in 2009, granted the U.S. Food and Drug Administration the authority to regulate tobacco products.¹ In response to substantial existing scientific evidence linking menthol cigarettes to adverse health effects, increased smoking initiation among youth and young adults, difficulties in quitting, and disparities in tobacco use, on April 28, 2022, the Food and Drug Administration issued a proposed rule prohibiting menthol as a characterizing flavor in cigarettes.² The current evidence is sufficient to demonstrate that this rule is appropriate for the protection of public health.^2,3 This is a landmark opportunity for tobacco control in the United States, where adult nonmenthol cigarette smoking has declined substantially over the last two decades, while menthol cigarette smoking has declined at a much slower rate, remained stable, or increased over time across multiple sociodemographic and geographic subgroups.^3,4 The Society for Research on Nicotine and Tobacco supports promulgating these regulations.³ In this commentary, we identify research priorities to ensure successful implementation and enforcement of the menthol ban in the United States and potential future bans in other jurisdictions.

Future studies evaluating the impact of menthol cigarette bans in the United States and in other jurisdictions should address the following five broad dimensions of regulatory science research: (1) Behavioral outcomes and impact on equity, (2) Basic science research and testing of ingredients; (3) Effects on illicit trade; (4) Marketing and consumer perceptions of “replacement” products post-ban; and (5) Effects on the price of cigarettes and other tobacco and nicotine products. These dimensions are not exhaustive, but they provide a starting point for evaluating policy implementation and impact.

Behavioral Outcomes and Impact on Equity

Studies assessing behavioral outcomes (smoking initiation, cessation, and product switching) can evaluate the effects of menthol bans on smoking prevalence nationally and among subgroups of the population. Simulation studies project that a menthol cigarette ban would likely result in a reduction in menthol and nonmenthol smoking prevalence in the United States.^5,6 Prospective cohort studies that have assessed the impact of menthol bans in the Netherlands and Canada found that their bans led to increased quit attempts and quitting among adults who smoked menthol cigarettes.^7–9 A pooled analysis of Canada’s menthol cigarette ban estimated that a U.S. menthol cigarette ban would lead to an additional 1.3 million adults who smoke to quit, including more than 380 000 African American individuals who smoke.¹⁰

Future studies should determine whether equity is being achieved, as current evidence indicates, by examining smoking behaviors among groups that have been economically and socially disadvantaged, most notably Black/African American people, youth/young adults, women, those of lower socioeconomic status (SES), sexual and gender minoritized individuals, and people with mental health conditions who use menthol cigarettes at disproportionately high rates.¹¹ Studies of the impact of menthol bans on access and demand for cessation resources among the general population and among key population groups in which menthol cigarettes are more prevalent, as well as switching to exempted tobacco products (ie, nonmenthol cigarettes, hookah, smokeless nicotine/tobacco products), non-combustible products with a lower toxicant exposure profile (eg, electronic cigarettes and heated tobacco products), and cigarette products that contain synthetic coolants and menthol analogs are critical.¹²

Basic Science Research and Testing of Ingredients

While there are adequate studies that have been conducted on the main constituents and properties of menthol ingredients (eg, biological properties, sensory effects, pharmacological and molecular actions in the brain, and topography),^13,14 post-ban research will be needed to monitor and gain a more in-depth understanding of potentially new menthol analogs. For example, studies have demonstrated how the tobacco industry introduced new menthol analogs and alternatives with synthetic coolants (such as the chemical WS-3) in U.S. jurisdictions such as California, following the statewide ban on menthol cigarettes.¹² Thus, basic science research post-ban will then be needed to identify the specific ingredients used in synthetic menthol analogs, particularly those that activate the Transient Receptor Potential Melastanin 8 (TRPM-8) receptors in the brain to simulate the cooling effects of menthol, as well as the effects of analogs on human health, the consumer’s sensory experience, and nicotine addiction.¹⁵ In addition to menthol analogs, basic science research can also determine if post-ban nonmenthol cigarettes contain significant or trace menthol amounts that can subliminally simulate the cooling effects of menthol, as has been found in pre-ban nonmenthol cigarettes.¹² This research can inform future regulatory decisions and contribute to a comprehensive understanding of how best to regulate menthol analogs.

Effects of the Ban on Illicit Trade

Converging evidence from Canada and the Netherlands suggests that a menthol cigarette ban did not increase illicit purchases of menthol cigarettes or a significant increase in cross-border sales in neighboring jurisdictions without such bans.^16,17 The proposed menthol ban could also decrease illicit trade in some geographic areas in the United States.¹⁸ To assess the extent to which the outcomes are found in the United States context, future publicly funded surveillance research should investigate the extent of illicit cigarette trade in the United States post-ban compared to pre-ban. Additionally, it will be important to capture the illegal manufacture and sale of illicit products; for example, tracking online or cross-border retail sales and distribution, and wholesale purchases from reserves/reservations.

Examining Marketing and Consumer Perceptions of “Replacement” Products Post-Ban

In jurisdictions that have banned menthol cigarettes, tobacco companies have brought products to market that aim to appeal to consumers and undermine and weaken the effectiveness of bans. In Alberta, Canada post-ban, Philip Morris International advertised “non-menthol alternative” cigarettes packaged similarly to menthol cigarettes sold pre-ban.¹⁹ Following California’s menthol cigarette ban in December 2022, RJ Reynolds and ITG Brands brought “non-menthol” cigarettes to market in California and Massachusetts. These products are packaged to communicate flavor characteristics, and for some, their online ingredient list includes WS-3, a synthetic chemical that mimics the effects of menthol.¹² Availability, use, and promotion of menthol flavor accessories (eg, menthol flavor filters, capsules, and flavor cards) have been reported in Canada, the United Kingdom, the Netherlands, the United States, and other jurisdictions.^8,17,20,21 Notably, experimental research has shown that menthol roll-your-own cigarettes are preferred over nonmenthol cigarettes and menthol cigars as a combustible substitute product for adults who use menthol cigarettes in the absence of access to menthol cigarettes.^22,23 Therefore, it is crucial to also monitor the use of roll-your-own tobacco products with menthol accessories to see if these studies reflect actual behavior after the implementation of the menthol ban. Additionally, post-ban market surveillance of local flavor restrictions in the United States shows an increase in the sale and marketing of products without explicit flavor names (ie, “concept flavor descriptors”).¹²

Other valuable issues to be addressed in future research would be tracking communications leading up to the ban from the tobacco industry to consumers, business-to-business marketing (eg, tobacco companies to retailers), and from retailers to consumers. It will also be critical to capture the introduction and marketing of new cigarettes; changes to cigarette packaging; and consumer perceptions and use of replacement products, pre- and post-ban. While many potential replacement products may be subject to premarket review in the United States or banned by the proposed United States national menthol cigarette ban by virtue of being encompassed in any possible definition of “characterizing flavor,” it will be important to identify them for enforcement purposes. Furthermore, other jurisdictions in and outside of the United States may have ambiguous definitions that do not encompass these products, so developing a global agreement on definitions is needed.

Effect on Price of Cigarettes and Other Tobacco and Nicotine Products

In the United States, menthol cigarettes are available at discounted prices in racially and ethnically minoritized communities and those with lower socioeconomic status, compared with primarily white neighborhoods and those with higher socioeconomic status.^24,25 In Poland, the average price per cigarette decreased in the year following its menthol ban, and overall cigarette sales stayed the same as pre-ban.²⁶ Worthwhile topics to be addressed in post-ban surveillance research would be the impact of the menthol cigarette ban on the price of nonmenthol cigarettes and user-preferred substitutes such as menthol and other flavored nicotine products (eg, cigars, roll-your-own tobacco, electronic cigarettes, and nicotine pouches). An emphasis on the price and availability of price promotions in racially and ethnically minoritized and socioeconomically disadvantaged communities is key to tracking the equity impacts of the ban.

Consideration of the Political Environment

While the problem of menthol cigarettes and policy solutions are aligned, we recognize the importance and uncertainty of a favorable policy window, given the U.S. political environment²⁷ and timing of the Food and Drug Administration menthol ban rule. Policies can be diluted, repealed, and/or face litigation; thus, conducting rapid and responsive science to support the timely and successful implementation of a menthol ban is crucial.

Conclusion

Research on many aspects of menthol tobacco products was instrumental in informing and advancing menthol bans in the United States and other countries. These research priorities are also relevant to jurisdictions that have already implemented menthol bans to strengthen their regulatory measures further, including strengthening existing legislation and addressing policy amendments that close existing loopholes. Post-ban research on the impact of menthol bans, including studies on the impact of tobacco industry countermeasures, will be critically important to support and strengthen existing bans and inform the development of more effective ones.

Declaration of Interests

GTF has served as an expert witness on behalf of governments in litigation involving the tobacco industry. MZ serves as an advisor to Qnovia, a start-up pharmaceutical firm seeking U.S. and U.K. authorization for an inhaled medicinal nicotine product for smoking cessation. JEC serves as a paid consultant in litigation against a tobacco company. Other authors have no conflicts of interest to declare.

Author Contributions

Olufemi Erinoso (Conceptualization [lead], Data curation [lead], Investigation [lead], Methodology [lead], Writing—original draft [lead], Writing—review & editing [equal]), Jennifer Brown (Conceptualization [lead], Data curation [equal], Investigation [equal], Writing—original draft [lead], Writing—review & editing [equal]), Allison Glasser (Conceptualization [equal], Project administration [lead], Supervision [lead], Writing—original draft [equal], Writing—review & editing [equal]), Shannon Gravely (Conceptualization [equal], Project administration [equal], Supervision [equal], Writing—original draft [equal], Writing—review & editing [equal]), Geoffrey Fong (Conceptualization [lead], Supervision [supporting], Writing—original draft [supporting], Writing—review & editing [supporting]), Janet Chung-Hall (Data curation [supporting], Writing—original draft [Supporting], Writing—review & editing [supporting]), Christina Kyriakos (Data curation [equal], Writing—original draft [supporting], Writing—review & editing [supporting]), Alex C. Liber (Data curation [equal], Methodology [equal], Writing—original draft [supporting], Writing—review & editing [supporting]), Lorraine Craig (Writing—original draft [supporting], Writing—review & editing [supporting]), Augustus White (Resources [equal], Writing—original draft [supporting], Writing—review & editing [supporting]), Shyanika Rose (Visualization [equal], Writing—original draft [supporting], Writing—review & editing [supporting]), Sabrina Smiley (Validation [equal], Visualization [equal], Writing—original draft [supporting], Writing—review & editing [supporting]), Mitch Zeller (Formal analysis [supporting], Validation [supporting], Writing—review & editing [supporting]), Scott Leischow (Conceptualization [supporting], Formal analysis [Equal], Writing—original draft [Supporting], Writing—review & editing [supporting]), Olalekan Ayo-Yusuf (Visualization [supporting], Writing—original draft [supporting], Writing—review & editing [supporting]), Joanna Cohen (Conceptualization [lead], Methodology [equal], Visualization [lead], Writing—original draft [supporting], Writing—review & editing [supporting]), and David Ashley (Conceptualization [supporting], Supervision [supporting], Writing—original draft [supporting], Writing—review & editing [supporting]).