Doing More with Less: A Proposal to Advance Cigarette Packaging Regulations in the United States

Abstract

Cigarette packages are potent marketing tools. Following guidance from the WHO Framework Convention on Tobacco Control, many countries have sought to diminish this marketing power by mandating that (1) large graphic health warnings be affixed to the packages (i.e., text warnings combined with graphic images of the health consequences of smoking) and (2) all packages be fully “plain” in their design (i.e., all packages use the same drab/bland color and font type; no brand logos, other colors, or designs are permitted). Yet, the United States lags other countries in implementing regulations designed to blunt the marketing power of cigarette packages. This is not because of a lack of effort on the part of the Food and Drug Administration, the main governmental body charged with regulating tobacco products in the United States. Rather, it is because the regulatory options that that have been advanced in the country (e.g., graphic health warnings) have not been found - yet - to be legally feasible by the courts. This commentary works through some of the conceptual, practical, and legal issues regarding packaging regulations in the United States. It considers the political and bureaucratic risks involved with issuing new regulations. The overall intent is to prompt our field to think creatively about what is realistic in this regulatory space and to offer a novel perspective that may help move the United States tobacco control community forward in its efforts to reduce the promotional power of cigarette packages.

Introduction

Tobacco product packages are powerful marketing tools. The tobacco industry designs packages to attract consumers’ attention, shape their thoughts and feelings about tobacco products, prompt purchases, and inspire user loyalty (Slade, 1997). To blunt this persuasive potency, the WHO Framework Convention on Tobacco Control (FCTC) Article 11 recommends that large graphic health warnings (i.e., text warnings combined with graphic images of the health consequences of tobacco use) be affixed to tobacco product packages and that all packages be comprehensively standardized, fully “plain” in their design (i.e., all packages use the same drab/bland color and same font type; and include no brand logos, other colors, or designs).

The legality of graphic health warnings and plain packaging has been litigated and established in many countries (Cunningham, 2022; Moodie et al., 2022). To date, over 120 countries have mandated graphic health warnings and over 20 countries have mandated plain packaging, with most focusing almost exclusively on cigarettes; many countries have enacted both types of regulations on cigarette packages. Several additional countries will likely implement regulations consistent with FCTC packaging recommendations soon.

The United States (U.S.) is not one of those countries. Despite efforts that have lasted for more than a decade, the U.S. lags other countries in implementing initiatives aimed at reducing the promotional power of cigarette packages. Indeed, cigarette packages in the U.S. appear today essentially as they did when a rotating set of four small, circumscribed text-based warning labels was introduced decades ago (e.g., “Cigarette Smoke Contains Carbon Monoxide”, “Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy”). Beyond some tobacco industry-initiated tweaks, brand-specific cigarette package logos, colors, and designs have been remarkably consistent through the years. The inertia that plagues efforts to regulate cigarette packages in the U.S. is surely a source of frustration among tobacco control researchers, public health advocates, government regulators, and many in the public at large.

The purpose of this commentary is to work through some of the conceptual, practical, and legal issues surrounding cigarette packaging regulations in the U.S. and how those issues bear on the future of U.S. tobacco control policy in this domain. The intent is to prompt our field to think creatively about what is realistic in this regulatory space and to argue that new options must be advanced to help move the U.S. tobacco control community forward in its efforts to reduce the promotional power of cigarette packages.

The Promotional Power of Cigarette Packages

The tobacco industry’s intensive efforts to carefully design cigarette packages for maximum consumer impact are well documented (DiFranza et al., 2003; Lempert, & Glantz, 2017; Slade, 1997). Tobacco packages have clearly documented effects on individuals of all ages, genders, racial and ethnic backgrounds, and levels of experience with tobacco. Large displays of tobacco packages in retail spaces (see Figure 1) command significant attention (Dutra et al., 2020; Martino et al., 2019) and exposure to these displays is associated with impulsive cigarette purchases among adults (Siahpush et al., 2016; Wakefield et al., 2008), and skewed cigarette smoking norms (Setodji et al., 2018) and increased intentions to use cigarettes among young people (Shadel et al., 2016; 2023).

Figure 1.

Retail tobacco display, with all packages fully branded.+

In addition to being associated with norms, intentions, attention and impulse purchases, exposure to cigarette packages is linked to consumers’ perceptions of the harms, flavors, and perceptions of the type of person that uses the product. Information about the putative flavor and strength of cigarettes is communicated via packages through brand name and color (Bansal-Travers et al., 2011; Manning et al., 2009; McKelvey et al., 2019). Consumers perceive lighter-colored packages as containing products with a “smoother” taste (Bansal-Travers et al., 2011; McKelvey et al., 2019) and as having less harm (Bansal-Travers et al., 2011; Felicione et al., 2021; Hammond & Parkinson, 2009; Hammond et al., 2009; Stubbs et al., 2022) (see also Lempert & Glantz, 2017). Moreover, even though the tobacco industry has been prohibited from using text descriptors such as “light” and “ultralight” on packaging and advertising since 2010, it has replaced those descriptors with color codes that nonetheless continue to promote faulty perceptions of risk and harm (e.g., “Marlboro Gold” instead of “Marlboro Lights”; “Winston White 100s” instead of “Winston Ultra Light 100s”) (Yong et al., 2016). Labeling or implying through imagery, color, and text that cigarette brands are “natural” or “organic” is associated with lower ratings of harm (Agaku et al., 2015; Czoli & Hammond, 2014; Iles et al., 2021; Moran et al., 2017). Finally, cigarette packages are viewed as conveying information about identity, social standing, and affiliation with certain social groups (Hoek et al., 2012; Scheffels, & Sæbø, 2013; Webb et al., 2017). Each of these constructs – perceived harms and flavor, and smoker identity - has been variously associated with tobacco product uptake, use intentions, and behavior (e.g., Aloise-Young et al., 1996; Berg et al., 2015; Borrelli et al., 2010; Falomir-Pichastor et al., 2020; Gendall et al., 2012; Grevenstein et al., 2015; Manning et al., 2009; O’Conner et al., 2017; Tombor et al., 2013; Villanti et al., 2017; 2019; Weinstein et al., 2005).

Regulatory Efforts to Dampen the Promotional Power of Cigarette Packages

Graphic health warnings

Text-only warnings on cigarette packages can stimulate negative thoughts about smoking (Borland, 1997), but these warnings are typically not noticed or remembered, and therefore they do not typically influence smoking behavior (Richards et al., 1989; Robinson & Killen, 1997).

Graphic health warning labels were designed to amplify text warnings about the health consequences of smoking, with the rationale that large, gruesome images of smoking-related disease combined with text warnings should be more effective at conveying information about the deleterious effects of smoking and at prompting behavioral change than small, text-only warnings (Hammond, 2009). Graphic health warnings typically cover between 30% and 75% of packages, depending on the enacting country.

Qualitative and observational studies have shown that graphic health warning labels are associated with feelings of disgust and fear and with diminished thoughts of smoking (e.g., Hammond et al., 2004; McQueen et al., 2015; Netemeyer et al., 2016). Experimental laboratory studies have found that cigarette packages with graphic health warnings are seen as more effective than text-only warnings (e.g., Cantrell et al., 2013; O’Hegarty et al., 2006; Vardavas et al., 2009). Graphic health warning labels on cigarette packages have been found to deter retail cigarette purchases (Shadel et al., 2019), decrease cigarette consumption (Romer et al., 2018), increase likelihood of attending smoking cessation programs (Guydish et al., 2018), and prompt quitting (Brewer et al., 2017; cf., Strong et al., 2021) (see also meta-analyses by Noar et al., 2015, 2016).

Plain packaging

Plain packaging is intended to diminish attention, refocus people on the harms associated with cigarette use, nullify favorable perceptions related to flavor, rob cigarettes of their identity-signifying status, and minimize use cognitions and smoking behavior. In countries with the most comprehensive level of standardization, such as Australia (which also includes large graphic health warnings), whole packages are designed to be as “plain” as possible – they exhibit a uniformly applied, drab/bland brown-green color. The brand name and product variant appear in the same font size, type, and color in the same location on each package. Beyond legally required markings (e.g., tax stamps), no designs, other colors, logos, or company names are permitted.

Qualitative research has revealed that plain packaging is viewed as less appealing than fully branded cigarette packages (Gallopel-Morvan et al., 2012; Scheffels & Sæbø, 2013; Van Hal et al., 2012). Quantitative studies that have examined standardized packaging alone (i.e., without accompanying graphic health warnings) have found that, compared to fully branded packages, comprehensively standardized packages have low levels of appeal (Ford et al., 2013; Gallopel-Morvan et al., 2012; Hammond et al., 2014), are perceived as having a worse taste (Ford et al., 2013; Hammond et al., 2014), and as having increased potential to harm health (Ford et al., 2013; Moodie & Ford, 2011). Standardized packages help nullify the belief that specific “types” of people identify with specific cigarette brands (Balmford et al., 2016). Plain packaging is associated with enhanced salience of health warnings on cigarette packages (e.g., Hardardottir et al., 2020; McCool et al., 2012; Thrasher et al., 2011). Observational studies have documented an association between a country’s introduction of plain packaging (along with increased graphic health warning size) and increased calls to quit lines (Young et al., 2014) and decreased smoking (Breton et al., 2023) (see also narrative reviews by Freeman et al., 2008; McNeill et al., 2017).

The State of Packaging Regulations in the U.S.

Legal considerations

The U.S. Supreme Court’s interpretation of the First Amendment to the U.S. Constitution led to the creation of commercial speech rights for advertising and labelling, which applies to all businesses including the tobacco industry. Commercial speech is not given the same level of protection as speech considered to be “core speech”. Restrictions on core speech (i.e., political, artistic, and religious expression) undergo a judicial test called “Strict Scrutiny” and are typically not permitted. Accordingly, less stringent tests to determine Constitutionality are applied to restrictions to other forms of speech, including commercial speech (e.g., see extensive discussions in Biggins, 2013). The Central Hudson test (named for Central Hudson Gas & Elec. v. Public Svc. Comm’n, 447 U.S. 557 (1980)) is typically applied in cases of speech restriction: for commercial speech to be restricted, the government must demonstrate that it has a substantial interest, that the interest is advanced by a restriction on speech, and that there is a reasonable fit between the restriction and the interest. The Zauderer test (named for Zauderer v. Office of Disc. Counsel, 471 U.S. 626 (1985)) is typically applied in cases where governments compel speech: the government must demonstrate that the compelled speech is reasonably related to a legitimate governmental interest and that the speech is “factual and noncontroversial”. In practice, determining whether speech is being restricted or compelled is often not entirely clear and in cases where compelled speech is determined not to be “factual and noncontroversial,” it is the Central Hudson test rather than Zauderer that applies; thus, whether the Central Hudson test or Zauderer test is appropriate is not always clear when a particular policy is being developed.

Graphic health warnings

The U.S. Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) establishes a requirement that the FDA implement graphic health warnings on cigarette packages and advertisements with an original deadline set for 2012. The constitutionality of the TCA itself was almost immediately legally challenged, with the tobacco industry and its allies contending that their First Amendment free speech rights were infringed. Although some portions of the TCA were struck down under this initial challenge (e.g., a requirement for black and white “tombstone” advertising), the portion that compels the creation of graphic health warnings was upheld (Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012). In making this determination, the court used the Zauderer test, because in the abstract, graphic warnings were seen as compelled disclosures of uncontroversial facts about cigarette smoking. However, years of subsequent legal challenges by the tobacco industry and its allies have, so far, thwarted implementation. At issue, is the content or substance of the warnings. In 2011, the courts found that the first set of graphic health warnings developed by the FDA infringed on the industry’s commercial free speech rights (R.J. Reynolds v U.S. Food & Drug Admin, District Court: Docket No. 1:11-cv-01482 (D.D.C. Aug 16, 2011; Appeal: Docket No. 11–05332 (D.C. Cir. Nov 30, 2011) and in 2022, a federal court reached essentially the same conclusion with an entirely new set of warnings (R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Admin., 6:20-cv-00176 (E.D. Tex. Dec. 7, 2022)). In these cases, the courts viewed the content of the warnings as neither “factual” nor “uncontroversial”; the Zauderer test was therefore not used. Rather, the more stringent Central Hudson test was applied.

In part because the FDA is compelled by statute to issue graphic health warnings (Am. Acad. of Pediatrics v. U.S. Food & Drug Admin., Civil Action No. 1:16-cv-11985-IT (D. Mass. Feb. 14, 2020)), the U.S. Justice Department promptly appealed this decision in February 2023. If this appeal fails in the Fifth Circuit Court of Appeals, barring a reversal by the US Supreme Court, the Food and Drug Administration will have almost no choice but to “go back to the drawing board” to restart the process of designing, researching, and fighting for a new set of graphic health warning labels. If the tobacco industry continues with its winning streak in the courts (a not unreasonable expectation, given history), the process of the U.S. designing, researching and launching (more new) graphic health warnings then fighting legal challenges could, in theory, continue in perpetuity, with graphic health warnings never actually being implemented – unless, of course, the U.S. Congress intervenes to rescind the portion of the Tobacco Control Act that mandates graphic health warnings.

Conversely, if the Justice Department’s February 2023 appeal of R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Admin is successful, R.J. Reynolds could pursue other options through the Fifth Circuit (i.e., request an en banc hearing) or appeal to the U.S. Supreme Court. If R.J. Reynolds fails in those options, another lawsuit challenging the constitutionality of graphic health warnings, currently on hold, may proceed (Philip Morris and Sherman Group Holdings LLC v U.S. Food & Drug Admin, District Court: Docket No. 1:20-cv-01181 (D.D.C. May 06, 2020)), and there is always the quite likely possibility of additional legal action by the tobacco industry. All told, even the most generous readings would suggest that it will be several more years before graphic health warning labels are implemented in the US, if ever.

Plain packaging

The U.S. FDA, through the TCA, has broad regulatory authority over tobacco products, including product packaging. Even though plain packaging regulations are not explicitly required by the TCA, such regulations are not expressly prohibited either. This leaves open the possibility that standardized, plain packaging could be advanced as a regulation in the U.S..

Nonetheless, the tobacco industry would likely litigate efforts to fully standardize (i.e., as outlined by the FCTC) the trademarked branded elements of a package as an infringement on commercial speech rights, which as reviewed, are protected from excessive regulation by the First Amendment (see Morris, 2015–2016). Indeed, the tobacco industry has successfully challenged prior regulatory actions designed to impose “plainness” on tobacco marketing based on the First Amendment (Commonwealth Brands, Inc. v. U.S., CIVIL ACTION NO. 1:09-CV-117-M (W.D. Ky. Jan. 14, 2010)). A rule that would have mandated that tobacco poster advertising use only black and white colors (i.e., “tombstone advertising”) was successfully blocked in court for being too restrictive of commercial free speech using the Zauderer test. This ruling is thought to be a precedent for what fate might befall fully standardized plain packages in the U.S. (Hinchliffe, 2013; see also Chester, 2013).

Summary of U.S. Regulatory Context, Challenges, and Opportunities for Packaging Regulations

Cigarette packaging regulations in the U.S. are clearly in a state of flux. The application of graphic health warnings has been found to be legal but the legality of the content of those warnings is in question. Even if the FDA wins its current appeal, additional legal actions by the tobacco industry will delay implementation for many years. Plain packaging as defined by the WHO FCTC and applied in many countries throughout the world stands an even lesser chance of passing Constitutional muster in the U.S.. The tobacco industry will not voluntarily cede all its valuable, branded packaging real estate for this purpose. Despite best efforts and ample supportive research, graphic health warnings and plain packaging remain distal solutions for dampening the persuasive power of cigarette packages in the U.S..

So, the U.S. is essentially left with two options. The first is to do nothing but wait until the graphic health warning litigation and all its Constitutional questions are settled, basically allowing cigarette packages to remain “as-is” for that foreseeable future. The benefits of this approach are fewer distractions for U.S. regulators and researchers and a seemingly clearer path to success (i.e., each subsequent iteration of graphic health warnings may get closer to something that is Constitutionally palatable). The risk with this first option is that cigarette packages retain all their promotional power during that time - with all the attendant consequences for smoking uptake and continued use.

The second option is for our field to pursue alternatives: to think creatively about developing and researching novel ideas for regulating cigarette packages. Key benefits of this approach are that it could provide effective interim solutions while other, extant options work their way through the courts or offer alternative courses of action should those other options be indefinitely delayed. Risks include real- and time-related costs of researching such alternatives, expending political capital and resources on lobbying for these alternatives, and additional legal costs, as any such efforts are also likely to be subject of extended litigation if they get to the point of being implemented. Additionally, implementing packaging regulations that fall short of full implementation of WHO FCTC plain packaging and graphic health warning recommendations could be disappointing or prove less efficacious than implementing full FCTC regulations (or even potentially short-circuit efforts in other countries to implement full FCTC regulations).

Pursuing Alternatives: Key Considerations and a Prototypic Regulatory Option

Moving productively forward in the U.S. requires our field to think now about alternative, creative ways to use the 50% of cigarette packages not preserved for industry branding by the courts (as determined in Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012)). This approach would treat a given cigarette package as a canvas that is divided into two smaller portions, each with a different function: With one portion reserved for protected brand information, the other portion could be reserved for regulatory purposes (see Farley & DeVaney, 2015; Morris, 2015–2016). Alternative (non-graphic health warning) uses for this space could include applications of larger versions of existing text-warnings or even a new set of large text-only warnings (e.g., Borland & Hill, 1997).

This space could also be used to introduce carefully selected elements of plain packaging. To be sure, it would be redundant to print the brand and brand variant names in a uniform font style, size, and color on the portion of the package devoted to standardized information given the fact that the protected, branded portion of tobacco packages would also include this information. It could also be potentially counterproductive: Repeating brand names can lead to more favorable impressions of the brand in question (e.g., Avramova et al., 2017). This leaves color standardization (i.e., application of a drab/bland color) on a part of cigarette packages as a novel, potentially viable regulatory option to pursue.

Partial color standardization

To the extent that cigarette packages communicate misleading health risk (and other) information through use of color, the FDA would be well within its authority to propose standardizing the color on parts of cigarette packages so that more accurate information warning about the risks of cigarette smoking is communicated. This standardized coloring would be applied to the 50% of cigarette packaging not preserved for industry branding by the courts (as determined in Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012)), thereby offering a “color correction” to the misinformation conveyed by the robust colors on the branded parts of the package (see Figure 2). The drab/bland color used for fully standardized tobacco packages in many countries (e.g., Pantone 448C) has been consistently found to communicate that an elevated level of risk is associated with use of a product (McNeill et al., 2017). Pairing this color with trademarked, branded cigarette packaging elements could also, in theory (Hofmann et al., 2010; Moran et al., 2023), diminish incorrect impressions that are conveyed by those other branded elements (e.g., brand logos and symbols; see Epperson & Prochaska, 2023).

Figure 2.

Sample cigarette packages with partial color standardization

The need for research

A solid research base will be needed to support the efficacy of any alternative packaging regulations that are proposed, including partial color standardization. Studies that investigate the causal effect of partial color standardization on cigarette purchases and use cognitions would be particularly useful, given concerns raised about the existing body of evidence on graphic warning labels and plain packaging (McKeganey & Russell, 2015; McNeil et al., 2017). That is, relying on only qualitative or observational data would not be sufficient.

Issues that would need to be addressed with partial color standardization include, but are not limited to, the following:

1. How do partially color standardized packages compare to those that are comprehensively standardized (fully plain) and those that are fully branded in terms of affecting perceptions of harm, flavor, and product badge status? What is the effect of partially standardized packages on smoking initiation in adolescents and use and quitting in adult smokers?

2. What is the effect of partially standardized packages on different population subgroups, particularly those with high smoking prevalence (e.g., American Indians and Alaska Natives, sexual and gender minority individuals, individuals with serious mental illness; see Agaku et al., 2020; Cornelius et al., 2023)?

3. Although their final form is not yet settled, graphic health warning labels of some kind may be implemented in the U.S. at some point in the future. How might partial color standardization be combined with graphic health warning labels in the US? For example, if we accept that half a package must be relegated to industry branding, could the remaining half a package include both a standardized color and a graphic health warning label? Is this combination more effective than either alone?

4. There are multiple ways that partial color standardization could be applied to cigarette packages in relation to trademarked brand information. Should the partially standardized portion appear on the top or bottom half of the package (with trademarked brand information appearing opposite; see Figure 2)? Could the industry’s trademarked branding appear in the center of a package, but be surrounded by a standardized color?

Legal questions

Any proposed changes to cigarette packages in the U.S. will no doubt prompt legal challenges by the tobacco industry. If partial color standardization becomes a viable policy option through supportive research, several legal questions would likely need to be considered, including:

1. Can color be considered speech in this context?

2. Would replacing the 50% of packages that is putatively reserved for warnings not with speech, but rather with a uniform color (albeit a color that has the effect of a warning), be found Constitutional?

3. Is the finding that most people find the extant color used on plain packaging in other countries to communicate increased risk sufficiently noncontroversial and factual to pass the Zauderer test?

4. Is the use of a government-mandated color on cigarette packages reasonably related to government interests of accurately conveying harm and then reducing smoking?

Concluding Remarks

The visual appearance of cigarette packages has fundamentally changed in much of the world in the last decade. Victories in this regulatory space have not come easily, and despite successful implementation of graphic health warnings and plain packages in many other countries in line with WHO FCTC recommendations, the battle over packaging regulations continues in the U.S.. Given the historical and legal record, graphic health warnings face a difficult path ahead and an indeterminate future, and fully standardized packages will probably never become a reality in the U.S.. If U.S. researchers, public health advocates, and regulators wish to diminish the persuasive power of cigarette packages as part of a comprehensive tobacco control program that includes a diverse array of efficacious policies and interventions (e.g., anti-smoking media campaigns, Davis et al., 2018; increased taxes, Dunbar et al., 2021; tobacco quitlines, Fiore & Baker, 2021), then, they have almost no choice but to consider packaging regulations other than those promulgated by the WHO FCTC. The U.S. FDA has historically contemplated, studied, implemented, and litigated myriad, diverse tobacco regulatory actions all at once; many such actions are at various stages of this process as of this writing (e.g., communicating about the continuum of risk, Yang et al., 2019; menthol bans or restrictions, Malone, 2017; nicotine reductions in cigarettes, Donny & White, 2022; regulating premium cigars, Teutsch et al., 2022). It is unlikely that adding consideration of and research on alternative packaging regulations to this mix would unduly burden researchers or regulators or distract from ongoing efforts. Focusing attention on the 50% of packages not preserved for tobacco industry product branding is key to consideration of any new regulations. Of course, any “less than” options (e.g., partial color standardization) might be seen as compromising efficacy in service of political and legal expediency, but ultimately, we will not know if those options are meaningful until our field subjects them to empirical, political, and legal scrutiny.