Introduction
In Spring 2021, the U.S. Food and Drug Administration (FDA) announced plans to ban menthol as a characterizing flavor in cigarettes and cigars. The agency based its decision in part on menthol’s disproportionate impact on communities of color and association with increased youth smoking rates. We agree that these are among many worthwhile reasons to limit menthol use. However, there are potential pitfalls of using a ban to achieve these goals. We argue that a ban is a top-down, paternalistic approach that may lead to an illicit market for menthol products, exacerbate racial disparities in policing, and stifle the broad community buy-in essential for the effort’s success.
We recognize that the tobacco industry has also advanced many of these arguments, albeit with different motives and significant conflicts of interest. This article does not seek to defend the tobacco industry or menthol cigarettes. Instead, we hope to offer a different point of view on the FDA’s current proposal, namely that using race as a principal justification for a ban, even if well-intentioned, may lead to unintended negative consequences.
Since Doll and Hill in 1954 purported a link between smoking and lung cancer, there have been many federal and local efforts to regulate tobacco products. 1 Principle among these is the 2009 Family Smoking and Tobacco Control Act (TCA) which made the FDA responsible for comprehensive tobacco regulation. Considering their disproportionate use among youth smokers, the regulation of flavored tobacco products was a chief concern of the TCA. 3 The 2009 bill banned all characterizing flavors other than menthol in cigarettes. National survey and modeling data estimated that the 2009 flavored cigarette ban reduced the predicted rates of cigarette smoking in both youth (ages 12-17) and young adults (ages 18-25) by 27% and 43%, respectively.Reference Rossheim, Livingston, Krall, Barnett, Thombs, McDonald and Gimm 4 Although difficult to establish a direct causal relationship, it has been observed that while cigarette smoking rates declined, usage of Electronic Nicotine Delivery Systems (ENDS) products skyrocketed, particularly among youth. In January 2020, the FDA announced that all ENDS cartridge-based flavor products (excluding tobacco and menthol flavors) would be subject to prioritized enforcement of a previously unenforced requirement that all ENDS products must obtain premarket authorization. 5 As no ENDS products have this authorization, the announcement amounted to a de-facto ban of all current non-menthol flavored ENDS products.
Menthol Use and Marketing
Menthol is an ingredient naturally found in peppermint plants that creates a cooling sensation when smoked, allowing it to decrease the harshness of cigarette smoke. Menthol flavor was introduced in cigarettes in 1925, and ever since, it has been an integral part of the flavored tobacco landscape. 6 Youths and adults who reported that their first tobacco product was any flavored tobacco product had higher tobacco smoking rates a year later. 7 Of particular concern is the use of menthol among the youth; the Population Assessment of Tobacco and Health (PATH) study from 2013-2014 found that 59.5% of youth smokers used menthol products compared to 37.1% of adults. 8
The disproportionate use of menthol cigarettes by Black Americans is no accident. This racially disproportionate consumption of mentholated cigarettes developed over time due to affirmative actions taken by the tobacco industry. By the 1950s, Black Americans’ rapidly expanding purchasing power, the prevalence of segregated communities, migration to urban areas, and this population’s distinct cultural wants and needs created an ideal advertising market. The tobacco industry was one of the first manufacturers to exploit this opportunity.
While overall smoking rates have declined over the past several decades, between 2004 and 2014, the rate of menthol cigarette use has declined more slowly. Over a quarter of all cigarettes sold in the United States since the 1970s have been mentholated. Other studies have estimated that there are nearly 18.6 million current smokers of menthol cigarettes amongst adult and youth smokers in the U.S. However, the use is not uniform; while only 30% of white smokers are menthol smokers, various studies have estimated that 70-85% of Black smokers smoke menthol cigarettes. Additionally, from 2011 to 2018, declines in menthol cigarette use were seen among non-Hispanic white youth but not among Black or Hispanic youth.Reference Villanti 9
The disproportionate use of menthol cigarettes by Black Americans is no accident. This racially disproportionate consumption of mentholated cigarettes developed over time due to affirmative actions taken by the tobacco industry. By the 1950s, Black Americans’ rapidly expanding purchasing power, the prevalence of segregated communities, migration to urban areas, and this population’s distinct cultural wants and needs created an ideal advertising market. The tobacco industry was one of the first manufacturers to exploit this opportunity. For instance, by 1962, Ebony carried twice as many cigarette ads as did Life. The millions of pages of tobacco industry documents made publicly available after the Master Settlement Agreement between state attorneys general and the major tobacco producers, paint a picture of a deliberate effort by the tobacco industry to target Black Americans through advertising to increase the market share of menthol cigarettes in this community. The tobacco industry advertising campaign targeting Black communities was often coupled with generous financial support of Black community organizations, including civil rights groups. According to scholarship by Yerger and Malone, this was done for three specific business reasons: “to increase African American tobacco use, to use African Americans as a frontline force to defend industry policy positions, and to defuse tobacco control efforts.” This is not to claim that Black community organizations were directly involved in promoting menthol cigarettes, but by supporting these organizations, some tobacco industry executives felt they might prevent Black community organizations and leaders from attacking cigarette manufacturers. 10
In addition to targeting the Black community as a whole, there is evidence that the tobacco industry was involved in deliberately targeting Black children. For instance, evidence presented during a successful lawsuit against the maker of Newport cigarettes showed that in the late 1950s and early 1960s, the company provided Black children as young as nine years old with free cigarettes. Furthermore, one study found that in comparison to other neighborhoods, the cost of Newport cigarettes was significantly lower in convenience stores located near minority-serving high schools.Reference Matthews and Winn 11
While manufacturers often billed menthol cigarettes as healthier, scientific evidence has been mixed, and studies have shown that menthol cigarettes may even pose an increased health risk. 12 Furthermore, a systematic review of eighty-two studies on menthol cigarettes revealed an association between menthol flavor and youth smoking, increased nicotine dependence among menthol smokers compared to non-menthol smokers, and a relationship between menthol flavor and reduced smoking cessation success. 13 However, to date, when considering the totality and weight of the available evidence, there is little to support that menthol cigarettes inherently carry any more or less health risk compared to non-menthol cigarettes. 14
History of Menthol Regulation
In the absence of federal action and in part because of fierce advocacy by tobacco control groups, state legislatures and regulators have taken steps to limit the sale of menthol tobacco products, especially menthol cigarettes. Massachusetts became the first state to ban the sale of all flavored tobacco products starting with e-cigarettes and later to expand to all products; currently, it remains the only state with such a broad ban. Connecticut, New Jersey, New York, and Rhode Island have followed suit, but their bans are limited to flavored e-cigarettes. There are efforts in New York to expand the flavor ban to include all tobacco products; however, such a move is facing opposition in the General Assembly, in part due to concerns for potential losses in tobacco excise tax revenue as a consequence of expanding the ban. While California has also passed such a law, its implementation is pending a referendum vote.Reference Dixon 15 Other states, including Minnesota, have proposed similar bans, but their bills have not become law as of August 2021. Additionally, numerous localities have passed restrictions banning the sale of menthol cigarettes, although these restrictions vary widely in their application. 16 One commonality among all these efforts is that the bans primarily target the sale and distribution of flavored tobacco products, without penalizing their use.
Both the 2009 cigarette flavor ban and the 2020 ENDS cartridge flavor ban excluded menthol, though it had been considered each time. In 2009, the TCA created the Tobacco Products Scientific Advisory Committee (TPSAC), whose first task was to guide decisionmaking on menthol cigarette regulation. Their 2011 report, known as the “Menthol Report,” concluded that banning menthol would be in the interest of the nation’s public health. Shortly after the report, Lorillard, one of the nation’s largest tobacco companies, sued the FDA, claiming multiple violations of the Administrative Procedure Act (APA) and, in particular, the appointment of committee members with alleged financial conflicts of interest. The trial court ruled that the members of the Committee were in fact conflicted, thereby tainting the work product of the Committee. Consequently, the court ordered the FDA to reconstitute the TPSAC membership and enjoined the agency from using the Menthol Report. Even though this was subsequently reversed by the appellate court on standing grounds, progress on further regulation of menthol flavor stalled within the agency. 17 Since then, congressional action on banning menthol flavor through legislative action has also been unsuccessful. 18
In 2013 the Tobacco Control Legal Consortium filed a Citizen Petition with the FDA urging the agency to use its regulatory authority under the TCA to remove menthol cigarettes from the market. 19 In 2020, a coalition of public health, civil rights and educational organizations, including the American Medical Association, led by the African American Tobacco Control Leadership Council and Action on Smoking and Health, filed a lawsuit against the FDA. The suit alleged that the FDA had failed to act on menthol cigarettes contrary to the duties imposed by the TCA in violation of the APA. In particular, the lawsuit alleged that the FDA’s failure to act to prohibit menthol flavor in cigarettes despite ample evidence and two Advanced Notices of Proposed Rulemaking in light of the TCA’s requirement for periodic reevaluation of existing tobacco product standards amounted to “unreasonable delay” of agency action. The lawsuit also alleged that the FDA had failed to provide substantive response to the 2013 Citizen Petition by various public health groups. Among other petitioned reliefs, the plaintiffs requested an order to direct the FDA to begin the rulemaking process for adding menthol to the list of characterizing flavors banned by the TCA, as well as an order directing the agency to provide a substantive response to the 2013 Citizen Petition. Although the case is still active as of August 2021, the FDA had agreed to respond to the amended 2013 Citizen Petition by April 29, 2021, on which date the FDA announced its intention to propose product standards to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. 20
The Pitfalls of a Menthol Ban: Paternalism
In the FDA’s announcement, Acting FDA Commissioner Janet Woodcock said the proposed ban would “reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.” This was followed by a statement from the director of the FDA’s Center for Tobacco Products, Mitch Zeller, acknowledging that progress associated with smoking cessation has not been experienced by everyone equally, referring to the disproportionate effect of tobacco use on Black Americans. He further explained that “[t]hese flavor standards would reduce cigarette and cigar initiation and use, reduce health disparities, and promote health equity by addressing a significant and disparate source of harm.” 21 Although it appears well-intentioned, such paternalistic statements and justifications for government action on their face are problematic.
Paternalism is commonly defined as the “interference with a person’s liberty of action justified by reasons referring exclusively to the welfare, good, happiness, needs, interests or values of the person being coerced.”Reference Dworkin 22 There is a spectrum of paternalistic approaches, but bans are generally viewed as the hardest manifestation of paternalism. Admittedly, in some instances, even extreme curtailing of liberty in the name of public health measures are justified, but they must be closely scrutinized to ensure that the secured benefits outweigh the restrictions on liberty.Reference Pope 23 Furthermore, when the burden of coercion is unevenly carried by a single racial group, namely Black smokers in this case, as evident from the demographics of menthol smokers, it becomes even more suspect. In contrast to menthol flavor, other previously banned flavors were not used disproportionally by any single racial group; consequently, the coercion associated with the ban applied evenly to all racial groups. Although the merits of those other bans can also be debated, they are less problematic from a paternalistic standpoint. Therefore, the ultimate question is, what justifies government intervention limiting choice among Black smokers while leaving white smokers largely unaffected?
The Pitfalls of a Menthol Ban: Criminalization
Beyond concerns regarding the ill effects of paternalism, civil rights organizations have voiced fears of worsening racial disparities in policing and the criminal justice system due to the unintended consequences of this ban. Following the FDA’s April 2021 announcement, a coalition of criminal justice organizations and the American Civil Liberties Union (ACLU) raised “deep concerns” in a letter to the FDA over the agency’s move to ban menthol cigarettes. While recognizing the FDA’s good intentions, the ACLU letter highlights the potential for negative implications on racial justice and potentially increasing tensions between local law enforcement and minority groups. Although the FDA has acknowledged that it lacks jurisdiction (and the intention) to enforce a ban on individual possession and use of tobacco products, the sale and distribution of banned cigarettes is a federal crime punishable as a felony. 24 Consequently, the proposed FDA ban will in effect criminalize the sale and distribution of menthol cigarettes under federal law. Similarly, many previously discussed state laws banning menthol flavor also criminalize the sale and distribution of banned products. There already exists a substantial illicit cigarette market in the U.S., estimated to be at least 8.5% of the market, with other estimates being as high as 21%. Even using the low end of the estimate, there has been an almost three-fold expansion in the illicit market, from 3.2% in 1992-1993 to 8.5% in 2010-2011, primarily due to increased cigarettes taxes.Reference Reuter and Majmundar 25 Undoubtedly, a federal menthol ban will also lead to the expansion of illicit markets for cigarettes with a higher concentration of such markets specifically for menthol cigarettes in Black communities, risking repeating the recent tragic history of tobacco-related police interactions leading to the death of unarmed black men, including Eric Garner. Therefore, there is a high risk of exacerbating existing racial disparities in the criminal justice system due to unintended consequences of criminalization of menthol flavor by transforming a public health issue into a policing matter. 26 Multiple national Black law enforcement organizations and members of Congress, including congresswoman Clarke of New York, a member of the Congressional Black Caucus, have also echoed these concerns.Reference Clarke 27
The Pitfalls of a Menthol Ban: Limitations to Prohibition
The realistic public health gains from a menthol ban are also debatable. Studies have attempted to quantify the potential benefits of a menthol ban. A 2011 modeling study estimated that as a result of a menthol ban, by 2050 there would be an overall reduction in smoking prevalence of 9.7% and a 24.8% reduction of smoking prevalence among Black Americans. This reduction was estimated to translate into 633,252 overall fewer deaths and 237,317 fewer deaths in Black Americans. The study used a validated smoking simulation model and data, assuming a 30% quit rate among current menthol smokers and that 30% of those who would have otherwise initiated as menthol smokers would not initiate tobacco use.Reference Levy 28
However, real-world analyses, though limited, have been less promising. A recent study, which was part of a larger multi-national survey, analyzed the effects of the menthol ban in seven Canadian provinces. The study found that only 21.5% of menthol smokers quit smoking while others either switched to non-menthol cigarettes or continued to smoke menthol cigarettes.Reference Chung-Hall 29 Meanwhile, after Massachusetts instituted its ban on menthol cigarettes, there was a sharp decline in cigarette sales in the Commonwealth. Unfortunately, this decline was coupled with a significant increase in cigarette sales in neighboring states, indicating little to no decrease in tobacco consumption.Reference Boesen 30 While a national ban would be harder to circumvent, these two real-world examples indicate that the ban on its own is unlikely to have as large of an effect as modeling studies have indicated.
Failures of another recent top-down effort, COVID-19 vaccination in minority communities may be the best predictor of potential pitfalls of a top-down effort to ban menthol flavor. Like menthol cigarette use, COVID-19 pandemic case rates and mortality have disproportionately affected the Black community. As vaccines neared approval, national committees such as the National Academies of Sciences, Engineering, and Medicine urged vaccine prioritization that focused on remedying racial health disparities.Reference Johnson 31 The difficulty of an equitable rollout was underscored by polling indicating higher levels of vaccine hesitancy among Black respondents.Reference Funk and Tyson 32
To tackle the challenge, state and national agencies designed programs to boost minority vaccination rates, including vaccine mega-sites, allocating doses specifically for underserved communities, and holding special vaccination events in those communities.Reference Goldhill 33 Despite being well intentioned, these efforts did not anticipate community needs such as lack of transportation, poor internet access, and inability to miss work to get vaccinated. In some cases, these efforts led to a paradoxical widening of a racial gap in vaccinations. 34 In others, better-resourced white recipients were able to co-opt vaccines allocated to minority communities. 35 In contrast to often flawed state and national initiatives, community-led vaccination efforts have seen higher vaccination rates of underserved populations by offering vaccination without appointments, deploying mobile vaccination sites, and taking an individualized approach to combating vaccine hesitancy.Reference Melillo 36
The vaccination example emphasizes the potential limited success of a menthol ban if it does not have broad national and local buy-in from the communities it seeks to serve. Similar cautionary tales of the risks of paternalistic policymaking can be seen in historical efforts to regulate payday lending, limit unhealthy food choices for SNAP recipients, and mandatory sentencing guidelines initially designed to help crime-impacted communities.
As of summer 2021, the Black community’s response to a menthol ban has been mixed. The National Association for the Advancement of Colored People, The Center of Black Health and Equity, and the majority of the Congressional Black Caucus, to name a few, have supported a menthol ban.Reference Kaplan 37 On the other hand, the ACLU letter to the FDA mentioned above had 26 cosigners expressing reservations, many of them small or regional civil rights groups. 38 Previously, a nonprofit founded by prominent civil rights leader Al Sharpton helped defeat a proposed 2019 menthol ban in New York City.Reference Eisenberg 39 It is important to note that the Black community is not a monolith, and local variations in support for the ban may lead to a nationwide mosaic of both its success and failure in addressing health disparities.
Conclusion
There is ample evidence to support the claim that the tobacco industry has intentionally targeted the Black community through the years to promote and sell menthol flavored tobacco products. Furthermore, research has shown that menthol cigarettes are implicated in increasing youth smoking, increasing dependence rates, and reducing cessation success rates. Therefore, the FDA’s move to ban menthol flavor is certainly justifiable from a purely scientific standpoint. However, such a national ban on its own may not be the most effective means of addressing disparities associated with tobacco abuse or even achieving the desired goal of reducing tobacco abuse and thereby reducing its associated morbidity and mortality. If history is any guide, it may exacerbate other areas of racial inequality or further alienate a vulnerable population. A better approach to address the disproportionate prevalence of menthol use among racial minority groups would be to engage stakeholders from those communities and facilitate solutions generated from within.
Note
The authors have no conflicts to disclose.