A Proposed Policy Agenda For Electronic Cigarettes In The US: Product, Price, Place, And Promotion
The use of nicotine-containing electronic cigarettes (e-cigarettes) in the United States has created a debate within the public health community. Concern about e-cigarettes centers on the risks that they pose for young people. Support for the devices emphasizes their potential to reduce cigarette smoking and its enormous burden of disease and death.1 Differences in focus notwithstanding, all concur that both young people and adults deserve a future free of tobacco-related disease.
Tobacco use remains prevalent across the US. In 2020 about one in five adults (an estimated 47.1 million people) used tobacco products, with 30.8 million (12.5 percent) smoking cigarettes and more than 9 million (3.7 percent) using e-cigarettes.2 Among high school students, in 2021 more than two million (13.4 percent) used some form of nicotine or tobacco within the thirty days before being surveyed. Of those students, 1.9 percent (280,000) smoked cigarettes, and 11.3 percent (1.72 million) used e-cigarettes.3
Although there is widespread agreement that adolescents should not use nicotine in any form, including e-cigarettes, there is less agreement about whether e-cigarettes help some adults quit smoking.4 However, a growing body of research supports that contention.1 Recent evidence finds e-cigarettes to be more effective for smoking cessation than government-approved nicotine replacement therapy products such as nicotine gum and patches.5 In addition, e-cigarettes are the product most favored by US adults in quit attempts,6 with more self-reported success.7 (Nicotine replacement therapy products are approved for smoking cessation therapy by the Food and Drug Administration [FDA]. As does nicotine replacement therapy, e-cigarettes provide an alternative to cigarettes as a source of nicotine. However, no e-cigarette has been approved by the FDA for use as a therapeutic device.)
Mainstream US public health entities (government health agencies, voluntary health organizations, and medical and public health organizations) and tobacco control activist organizations focus their e-cigarette-related policy, advocacy, and media efforts almost entirely on addressing harms to youth. The principal concerns are that use of e-cigarettes causes nicotine addiction, that e-cigarette use leads to smoking, and that nicotine harms young people’s developing brains. The evidence on the nature and extent of each of these concerns is mixed and controversial;1 nevertheless, media coverage of e-cigarettes strongly emphasizes them.8 A consequence of the extensive coverage of the dangers of e-cigarettes for youth is that most adults, including most smokers, incorrectly consider use of e-cigarettes to be as dangerous as or more dangerous than cigarette smoking.9 Although e-cigarettes are not harmless, authoritative organizations consider them substantially less dangerous than combustible cigarettes.4
In part, the public’s distorted view reflects widespread misunderstanding of the dangers of nicotine. Most Americans, including most physicians, incorrectly believe that nicotine in cigarettes causes cancer, heart disease, and chronic obstructive pulmonary disease.9,10 Although nicotine is not benign, dozens of other toxicants in tobacco smoke cause the diseases associated with smoking. In its comprehensive plan for tobacco and nicotine regulation released in 2017, FDA officials explicitly identified a continuum of risk with regard to all products containing nicotine.11 At the continuum’s low end, there is little evidence that nicotine replacement therapy products create any significant health risks. At the high end, cigarette smoking is a uniquely deadly activity. Scientific evidence demonstrates that e-cigarettes fall closer to the nicotine replacement therapy end of the continuum than to cigarettes.4 Including more than seventy chemicals known to cause cancer, cigarette smoke contains more than 7,000 chemicals in total,12 which is dramatically more than the number of chemicals found in e-cigarette aerosol. Further, for those chemicals found in both cigarette smoke and e-cigarette aerosol, cigarette smoke emits much larger quantities than does e-cigarette aerosol.13
The nation’s overwhelming focus on e-cigarettes’ risks for adolescents may be harming the public’s health.
The public’s ignorance about both nicotine’s and e-cigarettes’ substantially lower risk than that associated with smoking makes it likely that fewer people who smoke will attempt quitting smoking with e-cigarettes than would occur were the public (especially smokers) more knowledgeable about the health risks of e-cigarettes and nicotine per se. In turn, because quitting smoking significantly reduces the risk for disease and death, smoking’s toll is likely higher than it would be in an environment more receptive to the use of e-cigarettes to quit smoking. Inadvertently, the nation’s overwhelming focus on e-cigarettes’ risks for adolescents may be harming the public’s health.
E-cigarette policies may also be unintentionally harming the health of the public. Evidence indicates that some youth-focused e-cigarette policies have unintended adverse consequences for adults. Several states have banned e-cigarette flavors, but for some adults the lack of appealing flavors appears to reduce their use of e-cigarettes to quit smoking.14 A study of adult smoking behavior in Minnesota concluded that e-cigarette taxation, another policy targeting youth, had both increased smoking among adults and reduced smoking cessation. The authors estimated that a nationwide tax on e-cigarettes equivalent to the tax on combustible cigarettes would deter more than 2.75 million adults from quitting in a ten-year period.15
Unfortunately, youth-focused e-cigarette policies also may be inadvertently harming youth themselves. A recent study associated a flavored e-cigarette sales ban in San Francisco, California, with a subsequent sharp upturn in cigarette smoking among the city’s youth. In contrast, youth smoking prevalence continued decreasing in comparison communities that did not have flavored e-cigarette sales bans.16 Other studies have found that state-level minimum-age-of-purchase laws for e-cigarettes were associated with increased levels of youth smoking.17
Carefully structured policies could deter youth use of e-cigarettes without causing a reversion to cigarette smoking. However, although public health authorities seek to reduce youth e-cigarette use, they also need to be able to offer the option of switching to e-cigarettes to adults who are unable or unwilling to quit smoking with the aid of FDA-approved cessation medications. The goal should be a policy mix that can address both objectives constructively.
We have identified eight high-priority policies that we believe can collectively achieve this goal. In many instances, these policies represent necessary compromises on policies sought by proponents of only one of the two objectives. We appeal to colleagues to focus on these two widely shared tobacco control objectives: keeping tobacco and nicotine products permanently out of the hands (and mouths) of US youth and helping as many adults as possible kick their deadly allegiance to combusted tobacco products.
Moving Toward An Optimal Policy Mix
We organized the eight identified policies according to the “four Ps” of marketing: product, price, place, and promotion. The four Ps were introduced in a 1960 textbook to assist companies in effectively marketing products and services.18 Ironically, the four Ps also suggest opportunities for regulation.19
Some recommended policies relate to more than one category (for example, a policy restricting e-cigarette flavors has a product component as well as, arguably, a place component, as discussed below). We selected one category for each policy. Some elements of the priority interventions are specific to a tobacco or nicotine product category. For example, some product standards may be specific to combusted tobacco products, whereas others relate to e-cigarettes. Similarly, marketing regulations differ for cigarettes and e-cigarettes. However, each of the smoking-specific policies we considered has an accompanying and related e-cigarette policy or policies. We did not consider interventions with no direct relevance to e-cigarette policy.
Exhibit A-1 in the online appendix summarizes the eight proposed policies.20
Product
In the marketing literature, product encompasses design, packaging, quality, features, color, and size, all of which are potential targets for regulation.19 Regulations could range from requiring graphic warning labels on product packaging to bans of either all tobacco products, as when several states banned cigarette sales in the 1920s, or versions of a product class, such as recent bans of flavored e-cigarette sales. (See appendix notes A and B for discussions of these bans.)20
Under the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA has the authority to establish tobacco product standards, including those reducing the danger or consumer appeal of combusted tobacco products. Using this authority is the focus of the first set of priority regulations.
Product Intervention 1
The FDA should establish product standards that reduce smoking and make e-cigarettes effective, reduced-risk substitutes for adults who cannot or will not otherwise quit smoking.
The product standard that is most often discussed would limit cigarettes and other combusted products to very low nicotine yields incapable of causing or sustaining addiction;21 this standard is under consideration by the FDA. Rendering cigarettes and other combustible tobacco products nonaddictive would greatly reduce sustained usage among young people who experiment with smoking while also enabling large numbers of adults to quit. FDA modeling has estimated that such a policy would cause 16 million fewer Americans to start smoking by 2060, avoiding 2.8 million premature smoking-related deaths.22
We ranked the very-low-nicotine regulation among the highest priorities of all potential interventions.
We ranked the very-low-nicotine regulation among the highest priorities of all potential interventions. Its expected damage to cigarette sales means, however, that it would confront an onslaught of political and legal opposition. Arguments against the regulation include concern that smokers may compensate by consuming more cigarettes or inhaling more deeply and the possible development of a black market for cigarettes with addictive levels of nicotine. Research suggests that compensation is unlikely, as smokers cannot possibly get sufficient nicotine from very-low-nicotine cigarettes to sustain addiction.11 The National Research Council considers the development of a formidable illicit market also unlikely, especially if consumers have appealing alternative reduced-risk nicotine products available.23
To minimize unintended effects, therefore, a very-low-nicotine regulation should be accompanied by regulations ensuring the availability of alternative products, such as e-cigarettes, reviewed and authorized by the FDA as meeting standards for being appropriate for the protection of the public health. The FDA explicitly recognized the need for reduced-risk products in its comprehensive plan articulated in 2017.11 Consumer appeal is essential because there are lower-risk alternatives, such as nicotine gum, that few smokers consider to be adequate substitutes for cigarettes.
The fate of the e-cigarette market in the US remains under FDA review. In August 2016 all “deemed tobacco products” came under the FDA’s jurisdiction and became subject to its tobacco authorities.24 To continue to be marketed lawfully, new products, including e-cigarettes, were required by the FDA to file a premarket tobacco application by September 9, 2020.25 The FDA received applications covering more than six million products, with the huge number of applications reflecting multiple, often minor variations in products’ flavors, nicotine strengths, and formulations.26 Decisions on applications from some of the companies holding the largest share of the e-cigarette market had not been rendered as of this writing. (See appendix note C for an FDA update on the status of the review of applications.)20 Based on its analyses of e-cigarette premarket tobacco applications, the FDA should consider which e-cigarette features can minimize yields of harmful and potentially harmful constituents, as well as attractiveness to young people, while maintaining the products’ appeal to adults as aids to quitting smoking. The agency should then develop product standards accordingly.
Other combusted tobacco product standards could be developed in addition to the very-low-nicotine standard. These include establishing a minimum pH of combusted tobacco smoke (higher pH makes inhalation less palatable) or maximum emissions of specific toxic substances. (See appendix note D for discussion of establishing maximum toxicant emission standards.)20 These standards would render smoking far less attractive than at present. The availability of FDA-authorized reduced-risk products, including e-cigarettes, could help a subset of people quit smoking by providing them with viable, legal alternatives to less appealing cigarettes.
Product Intervention 2
The FDA should develop a comprehensive set of regulations on tobacco product flavors that reduces attraction for young people but maintains the potential for flavored substitutes, such as e-cigarettes, to aid adults in quitting smoking.
In the Tobacco Control Act, Congress banned all characterizing flavors in cigarettes except menthol. In April 2022 the FDA announced proposed rules banning menthol as a characterizing flavor in cigarettes and banning all characterizing flavors in cigars.27 Two years earlier, the agency had said that it would address flavors in e-cigarettes, prioritizing enforcement against companies selling flavored, cartridge-based e-cigarettes without marketing authorization.28 Tobacco- and menthol-flavored cartridges and all non-cartridge-based e-cigarettes were exempted. (See appendix note E for an explanation of the various types of e-cigarettes.)20 As a consequence, sales of exempted (primarily disposable) e-cigarettes in fruit and dessert flavors rose dramatically.29
Several states and more than 300 cities have adopted bans on e-cigarette flavors to reduce youth use of e-cigarettes. However, adults and youth have similar e-cigarette flavor preferences.30 Banning products that adults use in smoking cessation attempts may promote continued smoking, instead of quitting, by adults at risk for near-term disease and death from smoking.
Instead of a ban on all e-cigarette flavors, a compromise could address both concerns. One option would be a ban on all flavors in combusted products, as the FDA has proposed, and a ban on all e-cigarette flavors other than tobacco and menthol and possibly a relatively small selection of other flavors with clearly adult-oriented marketing that the agency has determined meet its “appropriate for the protection of the public health” standard. This would eliminate the fruit and sweet flavors favored by youth and would end blatantly youth-oriented imagery and brand names.
Many people who are focused on preventing youth e-cigarette use want a ban on all flavors other than tobacco. In contrast, others who focus on the potential of flavored e-cigarettes to aid adults in quitting smoking consider sweeping flavor restrictions unacceptable. We propose coupling flavor policy with restrictions on place of sale and promotion, offering an effective compromise if, based on careful scientific review, some nontobacco flavors are determined to assist adults in ending combustible tobacco use.14
Price
Research indicates that when the price of e-cigarettes rises, demand for e-cigarettes falls and demand for cigarettes increases.31 This indicates that cigarettes and e-cigarettes are economic substitutes. Combined with evidence that e-cigarettes help a subset of people quit smoking,1 this product substitutability leads to a very important price-related policy.
Price Intervention 1
States and the federal government should levy large excise taxes on cigarettes and other combustible tobacco products and a more modest excise tax on e-cigarettes.
A large tax increase on cigarettes would discourage use by all ages, having the greatest impact on adolescents.
This simple policy would decrease youth use of tobacco and nicotine products and increase adult use of e-cigarettes to quit smoking, for three reasons. First, a large tax increase on cigarettes would discourage use by all ages, having the greatest impact on adolescents, who constitute the most price-sensitive age group. Second, imposing a smaller tax on e-cigarettes would help discourage price-sensitive youth from using the products. Third, the resulting large price differential between e-cigarettes and cigarettes, created by a much higher tax on cigarettes, would incentivize heavily nicotine-addicted people who are otherwise unable or unwilling to relinquish cigarettes to try switching from cigarettes to e-cigarettes.
Advocates focusing on the effects of e-cigarettes on young people argue for much higher taxes on e-cigarettes, such as taxes that equalize the tax burden for both products. This ignores the fact that equalizing the tax burden, and hence raising the relative cost of e-cigarettes, risks causing net harm to public health. As noted above, when Minnesota increased e-cigarette taxes to levels comparable to cigarette taxes, smoking cessation decreased and smoking increased among adults.15
Excise taxation should be risk-proportionate. No one has suggested imposing an excise tax on FDA-approved products such as nicotine gum and patches. Given the lower risk profile of e-cigarettes compared with conventional cigarettes and e-cigarettes’ ability to assist in smoking cessation, e-cigarettes should not be taxed at a level equivalent to that imposed on cigarettes, which are the deadliest tobacco product by far.
Place
Policies regarding the place of sale or use of all tobacco products include banning use in certain public places, banning sales within (for example) 1,000 feet of schools, and restricting modes of advertising (for example, billboards). The two priority policies described in this section go beyond these existing place policies.
Place Intervention 1
Governments should restrict the sale of all tobacco and nicotine products, other than those approved by the FDA for medicinal purposes (for example, nicotine gum and patches), to adult-only (ages twenty-one and older) retail outlets, such as tobacconists and vape shops.32 This policy would curtail youth access to all nicotine and tobacco products, not just e-cigarettes, while preserving adults’ access. By reducing the current widespread availability and visibility of all such products (in convenience stores and grocery stores, for example), it would have the secondary advantage of supporting adults who wish to quit smoking by reducing their encounters with tobacco products during a quit attempt.
Restricting sales to adult-only establishments has direct relevance to concerns regarding e-cigarette flavors. It would strike a balance between banning flavors entirely and having them widely available in stores frequented by youth. The adult-only place regulation, combined with the availability of some selection of flavors (those approved by the FDA as appropriate for the protection of the public health), is a compromise that could effectively protect youth and support adult smokers in their attempts to quit. Sales in adult-only stores would significantly restrict young people’s access to e-cigarettes while also maintaining access to selected flavored e-cigarettes for adults who would benefit from substituting them for cigarettes, despite the inconvenience of reduced availability.
Limiting sales to adult-only retail outlets would not entirely eliminate young people’s access to e-cigarettes. As with marijuana and alcohol, some young people would circumvent the law by acquiring products from older siblings, friends, or parents or by purchasing them on the Internet or black market. However, a recent study found that limiting the sale of flavored tobacco products to adult-only retail outlets reduced adolescents’ use of both e-cigarettes and cigarettes.33
Place Intervention 2
State and local governments should establish strict licensing policies and practices that limit youth access to all tobacco and nicotine products.
Best practices for comprehensive licensing policy regarding the sale of tobacco and nicotine products have been widely discussed. They include license fees that cover the cost of implementation and effective enforcement measures; dedicated enforcement officials; and severe, escalating penalties for noncompliance (that is, for sales to minors). (See appendix notes F and G for discussions of best practices for licensing policy.)20 Strict enforcement of tobacco retail licensing policies too often remains the exception. Robust licensing efforts could make compliance and, hence, effectiveness nearly universal.
As noted above, place interventions 1 and 2 would not eliminate youth access to tobacco and nicotine products. Still, the proposed measures would substantially restrict youth access and improve enforcement.
Promotion
Policies regarding promotion entail the restriction of industry messages to customers (or potential customers) that are intended to encourage use of a tobacco or nicotine product. These restrictions would apply to all existing sources of industry advertising and messaging, including ads in print as well as on television, radio, websites, apps, social media, billboards, and other signage. We also considered the promotion of positive health messages by government agencies and voluntary health organizations. All such messages should provide age-appropriate, risk-proportionate, factual information.
Promotion Intervention 1
Government should prohibit all forms of marketing for all tobacco and nicotine products that might appeal to adolescents and young adults to the extent permitted by the United States Constitution. This includes prohibiting all “lifestyle” advertising such as ads associating smoking with affluence, physical attractiveness, and adventure. (See appendix note H, which fully defines lifestyle advertising.)20
Although restrictions might face First Amendment challenges, the FDA has the authority to restrict tobacco product marketing. It should exercise that authority to the fullest extent possible and apply significant resources to enforcement in collaboration with the states.
Promotion Intervention 2
The FDA should limit e-cigarette advertising to a “switch” message in accordance with the continuum of risk.
A switch message would encourage smokers who are unable to quit by other means to try using e-cigarettes instead of combustible cigarettes. The switch message would be limited to any e-cigarette products that the agency has authorized as appropriate for the protection of the public health. Following the continuum of risk, adults should be encouraged to first use FDA-approved smoking cessation pharmaceuticals and then, for those unable to quit with these pharmaceuticals, to switch to e-cigarettes.
Promotion Intervention 3
State and federal government agencies and voluntary health organizations should develop carefully targeted public communications with age-appropriate messaging. These communications should cover the risks of e-cigarettes for youth and potential benefits for nicotine-addicted adults who smoke. All such messaging should be accurate, avoiding exaggeration of risks or efficacy.
Clear information about relative risks across the nicotine continuum of risk should be provided to adults to help them understand the potential benefits of substituting e-cigarettes for combustible tobacco products. Messaging to youth should emphasize that no nicotine-containing product is fully safe to use, all can be addictive, and youth should never start using any tobacco or nicotine product.
To date, nearly all public service e-cigarette messaging in the US focuses on risks to youth. Misleading messages contribute to the public’s dramatic overestimation of the risks of e-cigarettes, including FDA ads depicting their use as metaphorically causing parasitic infestation of the brains of youth34 and the Truth Initiative’s communicating inaccurately, in articles on its website, that the use of e-cigarettes causes depression.35
As a consequence of one-sided, often misleading messaging, many adults who smoke perceive e-cigarettes as being as dangerous as or more dangerous than conventional cigarettes.9 This reduces their likelihood of trying e-cigarettes to quit smoking. Smoking-attributable deaths therefore may well be more numerous than if consumers were accurately informed. That being said, just as messaging targeting young people should not exaggerate e-cigarettes’ risks, messaging directed to adults should not exaggerate their potential benefits.
Discussion
We applaud the pursuit of reducing youth use of e-cigarettes, but the nation also needs to focus on reducing adult cigarette smoking.
More than twenty years ago former Surgeon General C. Everett Koop wrote, “As we take every action to save our children from the ravages of tobacco, we should demonstrate that our commitment to those who are already addicted…will never expire.”36 Both goals are moral imperatives. We applaud the pursuit of reducing youth use of e-cigarettes, but the nation also needs to focus on the urgent priority of reducing adult cigarette smoking. This is a matter of social justice. African Americans suffer disproportionately from smoking-related mortality,37 and Americans with lower educations and incomes, members of the LGBTQ community, and people with mental health conditions constitute a disproportionate share of the smoking population.38 E-cigarettes could help more of these people quit smoking.39
Combined, thoughtful product, price, place, and promotion policies could combat youth e-cigarette use and adult smoking simultaneously and synergistically.
Can the policies recommended in this article actually be adopted and implemented? Each will confront major barriers. Flush with extraordinary economic, political, and legal resources, the tobacco industry will aggressively fight anything that threatens to reduce tobacco product sales, especially extraordinarily lucrative cigarette sales. So too will their economic and ideological allies.
A specific example and the policy compromise it may necessitate illustrate this challenge: Efforts to restrict tobacco and nicotine product sales to adult-only retail outlets will trigger substantial opposition from retailers for which tobacco products constitute a major revenue source. An alternative might permit sales in outlets not restricted to adults, but with all nicotine and tobacco products placed behind the counter, out of sight, and with no advertising of the products either inside or outside of the store. License fees could be higher for non-adult-only outlets, reflecting the higher costs of enforcement of minimum age of sales laws in such establishments.32
Conclusion
Today’s e-cigarette regulation battles are complex. Through compromises within the public health community, however, these battles can be fought to a conclusion that benefits the health of the public. Not long ago, few would have believed that workplace smoke-free policies, including restaurants and bars, could be enacted. Yet today that is the law—and the norm—in most US states and in dozens of countries around the world. Despite substantial industry opposition, the public health community united and won. Our fondest hope is that the public health community will unite again and fight for a set of policies that, through measured compromise, will both reduce the use of e-cigarettes by youth and increase adult smoking cessation.
ACKNOWLEDGMENTS
Kenneth Warner, Clifford Douglas, and Alex Liber are supported in part by a Tobacco Center of Regulatory Science grant to the University of Michigan and Georgetown University from the Food and Drug Administration and National Cancer Institute (Award No. U54CA229974). Douglas and Karalyn Kiessling are project director and project manager, respectively, on a grant to the University of Michigan Tobacco Research Network from the Michigan Department of Health and Human Services supporting the Smoke-free Environmental Law Project. Through the University of California San Francisco, Douglas is an adviser to the National Partnership on Behavioral Health and Tobacco Use. Liber is supported in part by a grant from the Norwegian Cancer Society for a project partnership with the Polish Ministry of Health (Donor Partnership Project No. NMF.PL-NOR.DOI.PDP2_2/20//3725/2020/80). The opinions expressed in this article are the authors’ own and do not reflect the views of any of the organizations and government agencies that have provided support to the authors.
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