Regulation, Implementation, and Enforcement of Policies Regarding E-Cigarette Use Across the Life Span

Date: Oct 24 2020
Policy Number: 20205

Key Words: Tobacco, Cigarettes, Addiction, Adolescent Health

Abstract
The use of e-cigarette devices that can be used to deliver e-liquid-containing nicotine has dramatically increased. Among youth, e-cigarette use has surpassed that of conventional tobacco products such as cigarettes. Although there have been a few regulatory actions at the federal and state levels regarding e-cigarettes, they have remained largely unregulated. Evidence on e-cigarettes’ contribution to nicotine product initiation among people who have never smoked and the role e-cigarettes play in the transition to the use of conventional tobacco products has been established. The legacy of harm of conventional tobacco products necessitates a protective stance, one that assumes that a product is harmful rather than less harmful. This approach is needed until studies of population harms can be funded, developed, validated, and replicated. This legacy, along with emerging evidence about e-cigarette use, requires an immediate public health response. APHA calls for the following policy actions: (1) protect children, youth, and adults, including vulnerable and marginalized populations, from exposure to e-cigarettes; (2) equitably enforce and enhance e-cigarette minimum legal sales age laws; (3) impose and increase taxation on e-cigarettes; (4) restrict advertising, marketing, and promotion of e-cigarettes; (5) conduct research on the association between e-cigarette use and cessation of traditional tobacco products; (6) reduce secondhand exposure to e-cigarette aerosols; (7) prohibit all flavored e-cigarettes; and (8) require disclosure of ingredients and nicotine content in products related to e-cigarette use.

Relationship to Existing APHA Policy Statements
This policy statement is an update to APHA Policy Statement 20186 (Supporting Regulation of Electronic Nicotine Delivery Systems).

APHA Policy Statement 20149: Supporting Regulation of Electronic Cigarettes
APHAPolicy Statement PS 201710: Protecting Children’s Environmental Health: A Comprehensive Framework
APHA Policy Statement 20082: Discouraging Smoking in Feature Films to Avoid Influencing Youth to Smoke
APHA Policy Statement 20076: Tobacco-Free School Environments
APHA Policy Statement 9514: Reducing Youth Tobacco Use through Increased Excise Taxes
APHA Policy Statement 20149: Supporting Regulation of Electronic Cigarettes
APHA Policy Statement 9412: Regulation of Tobacco Products by the Food and Drug Administration
APHA Policy Statement 9302: Tobacco-Free Schools
APHA Policy Statement 9301: Environmental Tobacco Smoke
APHA Policy Statement 9213: Advertising and Promotion of Alcohol and Tobacco Products to Youth
APHA Policy Statement 8710: Smoke Free Indoor Air
APHA Policy Statement 8604: Taxation of Tobacco Products
APHA Policy Statement 8605: Advertising and Promotion of Tobacco Products
APHA Policy Statement 8507: Health Risks and Advertising of Smokeless Tobacco Products
APHA Policy Statement 8318: Toward a Smoking-Free Society in the United States by the Year 2000
APHA Policy Statement 8008: Fire Safe Cigarettes
APHA Policy Statement 7225: Small Cigars
APHA Policy Statement 6301: Cigarette Smoking and Health

Problem Statement
Increases in e-cigarette use have proliferated across the life span in the United States, presenting many public health concerns such as increased incidence and prevalence of nicotine addiction, pulmonary and cardiovascular diseases, negative effects of nicotine found in e-cigarettes on cognitive brain development in youth, potential harm of e-liquid poisoning from ingestion among youth, and acute lung injury.[1,2] Furthermore, emerging evidence indicates that there is a higher risk of COVID-19 among youth and young adults who use e-cigarettes.[3] In addition, policies and programs to address prevention and control have lagged behind the emerging evidence at all levels of governance. Some brands and types of e-cigarettes permit the use of refillable modified pods or cartridges that allow users to add ingredients. In many cases, users may not know what is contained in the “juice” or e-liquid. Furthermore, the Centers for Disease Control and Prevention suggests that purchasing products from unreliable sources, such as friends, family members, or street vendors, may also contribute to this ongoing public health crisis.[4] In 2020, the federal government issued guidance to ban the use of flavors in modified pod electronic devices (except for single-use disposable products). This regulation also exempted tobacco and menthol flavoring, which is disproportionately used by African Americans. This menthol flavor exemption amplifies health inequities within this vulnerable population as it promulgates continued demand and use of e-cigarettes containing menthol-modified pods.

E-cigarette use has increased rapidly across many demographic subgroups, including vulnerable and marginalized groups such as individuals living with psychological distress and youth,[5] among others. E-cigarettes are now the most commonly used nonconventional nicotine product among youth and young adults, even as cigarette smoking has declined in this group.[6,7] In the National Youth Tobacco Survey (NYTS), the prevalence of current e-cigarette use rose from 20.8% in 2018 to 27.5% in 2019 among high school students. During the same period, the survey indicated that use among middle school students rose from 4.9% to 10.5%.[6,8] Although the 2020 NYTS results show that the prevalence of current e-cigarette use among middle and high school students has dropped to 4.7% and 19.6%, respectively, e-cigarettes remain the most used tobacco product among youth.[9] Use among young adults (18–24 years) rose from 5.2% in 2017 to 7.6% in 2018.[7] Surveys have shown that not only are more youth and young adults using e-cigarettes, but the frequency of their use is increasing. Prevalence rates of daily use among youth and young adults increased from 2017 to 2018. There was a higher prevalence of daily use among young adults[7] and a higher prevalence of use among youth on 20 or more days out of 30,[8] elevating the risk of injury among both youth and young adults. Combining recent increases in e-cigarette use among youth and young adults[6,7] and the reported health effects[4] with the lag in policy development, implementation, and equitable enforcement demonstrates the urgent need for policy action by APHA.[1,2]

Evidence-Based Strategies to Address the Problem
Strategies for addressing the problems associated with e-cigarette use are still evolving; however, strategies previously used to address conventional tobacco product use may be useful. There are a myriad of evidence-based policies and programs that address e-cigarette use and are used as prevention and control strategies in both community- and school-based health programming, including comprehensive tobacco control programs.[1,10–12] Additional strategies to consider are listed below.

Protect children, youth, and adults, including vulnerable and marginalized populations, from exposure to e-cigarettes: There are many ways in which to protect children, youth, and adults from exposure to e-cigarettes. A few of the primary strategies—retailer licensing, age verification for online sales, and child-proof packaging—are listed here as public health priority approaches. While this is certainly not an exhaustive list of possible strategies, these alternatives would have the most evidence to support positive outcomes.

Evidence suggests that there may be lower youth initiation of e-cigarette use and conventional tobacco product use in regions that have stringent licensing requirements for establishing a retail operation for e-cigarette sales. Research based on the 2015–2017 Youth Risk Behavior Surveillance System suggests that larger decreases in adolescent e-cigarette use prevalence in Pennsylvania followed the state’s implementation of a licensing requirement for retailers.[13] Similarly, studies have shown lower youth initiation of conventional tobacco use in localities with tobacco retailer licensing requirements.[14]

Stricter licensing requirements might include proximity restrictions from schools and public areas frequented by youth such as public parks and athletic fields. This directly responds to emerging evidence indicating that e-cigarette retail outlets have clustered around schools.[15] Without stricter licensing requirements that include factors related to distance or proximity from schools, availability and access to e-cigarettes will continue to be a public health concern.

Sales of e-cigarettes, including to minors, also occur through online means such as the Internet.[16] This policy statement supports efforts to restrict youth online access to e-cigarettes by using strict standards for age verification.[17] This would prohibit Internet vendors from selling or distributing e-cigarettes to anyone under the legal age of 21 years, as required by federal law.[18]

Considering the poisoning cases related to e-liquids reported to poison control centers across the United States, child-proof or child-resistant packaging is needed. A small number of studies have considered whether child-resistant packages can reduce child poisoning from e-liquids. A review of the few studies conducted in this area suggests that these measures may help reduce injury.[19]

Ultimately, prevention efforts reside in a comprehensive interprofessional collaboration to address public health issues around e-cigarette use. Many health care professionals, including primary care physicians, dentists, nurses, and community health care workers, can facilitate prevention and control initiatives both in the community and in schools.[20,21]

Implement and equitably enforce legal minimum age laws: Similar to conventional tobacco products,[22,23] challenges in implementation and equitable enforcement of control laws exist with the sale of e-cigarettes to youth under the age of 21 years. In 2015, Hawaii became the first U.S. state to legally raise the minimum legal sales age (MLSA) for tobacco products to 21 years, a law commonly referred to as Tobacco 21. Since then, this law has widely spread across states and locales. As of July 2020, more than 550 local jurisdictions, 31 states, and the U.S. federal government had raised the minimum sales age for tobacco to 21 years.[24] Such policies have been found to decrease both access to and use of cigarettes and e-cigarettes.[25–27]

While some success in reducing e-cigarette use among youth has emerged with Tobacco 21 enforcement, existing purchase, use, and possession laws have disparate impacts resulting in disproportionately higher burdens on individuals younger than 21 years, especially those who are members of vulnerable and marginalized populations.[28] This policy statement supports a review and repeal of any tobacco control laws, including those that affect e-cigarette purchase, use, and possession, that do not foster equitable enforcement of the MLSA or eliminate the burden of harm on vulnerable and marginalized communities.

Impose and increase taxation on e-cigarettes: There is strong evidence that increases in excise taxes on conventional tobacco products have led to a decline in the use of cigarettes, particularly among youth and people from economically disadvantaged communities. Central to any effective tobacco program in the United States is high taxes on all tobacco products.[10] Furthermore, Article 6 of the World Health Organization (WHO) Framework on Tobacco Control[29] strongly encourages countries to increase taxes on tobacco products. WHO also recommends that total taxes on tobacco products account for at least 75% of retail prices.[24] Given the economic and health benefits of tobacco taxation,[29] there is merit to examining price sensitivity among purchasers of e-cigarettes. Despite the support for tax increases on e-cigarettes shown by the emerging evidence and the WHO recommendation,[30] e-cigarettes across U.S. states are often not taxed or not taxed to the level of conventional tobacco products.[31] The existing evidence suggests that higher e-cigarette prices are associated with reduced sales of e-cigarettes and use of these products among adolescents.[32] In a modeling study involving six countries in the European Union, Stoklosa et al. found that a 10% increase in the price of e-cigarettes was associated with a short-term decrease in sales of 2.7% and a long-term decrease of 11.5%.[32] A recent longitudinal study by Cantrell et al. on the relationship between changes in the prices of conventional tobacco products showed that higher prices of conventional tobacco cigarettes are positively associated with 30-day e-cigarette use.[33] It is suggested that tax increases on e-cigarettes should be similar to those on conventional tobacco products. This public health approach will prevent users of all forms of tobacco from changing product type based on price point.

Restrict advertising, marketing, and promotion of e-cigarettes: Restricting tobacco advertising, promotion, marketing, and sponsorship has been an established best practice in tobacco control.[10] In the United States, the Master Settlement Agreement abolished tobacco advertising and promotion on television and billboards, which reduced exposure to tobacco advertising. Furthermore, research suggests that, among people who smoke cigarettes, those living in countries where tobacco price promotion is prohibited are less likely than those living in countries without such policies to have misconceptions about smoking.[34] Mass media counteradvertising has shown effectiveness in reducing initiation of use of conventional tobacco products among youth, particularly when paired with community- and school-based comprehensive tobacco control programs.[35] There are no national requirements to limit e-cigarette advertising, and as a result the advertising and marketing of e-cigarettes is ubiquitous. Despite a decrease in tobacco use on college campuses following campus-wide smoke-free policies and restrictions on advertising and promotion of tobacco products,[36] advertising and promotion continues to proliferate. The e-cigarette and tobacco industries continue to target young adults (including college students) by using point-of-sale and price reduction strategies such as coupons at checkout and an emphasis on “buy one, get one free” marketing initiatives.[36]

E-cigarette companies, particularly those owned by tobacco companies, have been advertising and marketing e-cigarettes and lobbying to make such advertising and marketing easier.[37] Tobacco companies continue to market and promote their products in several venues, including public health forums, to initiate new users such as youth and young adults. Documented examples of these efforts include, among others, using online influencers, music and entertainment personalities, and social media for ad campaigns.[37] This form of promotion and advertising is a much cheaper way than traditional magazine and billboard advertising to market products to youth. Approximately 99% of the posts on social media related to JUUL products are generated by people who are not related to the company through “liking” or “sharing” a post.[37] As a consequence, JUUL has emerged as the largest brand of e-cigarettes in the United States.[37,38] This targeted marketing to younger social media users and fans of particular online influencers thereby increases exposure to e-cigarettes during a time in young people’s life span when experimentation and curiosity are at their peak and nicotine has adverse effects on the developing brain.[1,2] Wang et al. found in their analysis of the 2019 NYTS data that curiosity and advertising, marketing, and promotion were among the top reasons cited by middle and high school students for initiating e-cigarette use.[6]

Conduct research on e-cigarettes as smoking cessation devices: Evidence that e-cigarettes help people quit smoking has been subject to numerous scientific reviews, including reviews by the National Academies of Sciences, Engineering, and Medicine (NASEM)[39] and the U.S. surgeon general.[1] NASEM, as with others reviewing the literature, concluded that there is insufficient evidence to determine whether e-cigarettes help people who smoke to quit. However, some evidence on the use of e-cigarettes as smoking cessation options exists. After the NASEM review, a randomized controlled trial was conducted by Hajek et al.[40] in England. This study showed that e-cigarette use as a cessation alternative may result in some sustained abstinence from conventional tobacco products. However, overall adherence to abstinence in the two study groups was similar, with less severe urges to smoke maintained after quit date in the e-cigarette group. The mixed evidence on the effectiveness of e-cigarettes as an aid to smoking cessation may be related to a lack of control for other factors. Youth and young adults may be more likely to be dual users of combustible conventional tobacco products and e-cigarettes than older e-cigarette users. Studies show that youth who initiate nicotine use through vaping may be more likely to develop a nicotine use disorder and other drug use disorders.[2] Given the higher nicotine dosages available in e-cigarettes, physiological dependence is more likely.[2] The vaping habit itself may also make continuing use more likely. The highest risk of smoking relapse occurs within the first year after a quit attempt. Most studies examining the role of e-cigarettes in cessation have a follow-up period of 1 year or less, and thus this policy supports more research to develop evidence of success in using e-cigarettes for smoking cessation with a longer follow-up period.[1]

Prohibit exposure to secondhand e-cigarette aerosols: Although evidence linking secondhand aerosol (SHA) exposure to adverse health outcomes continues to emerge, results from existing studies[1,2,12] and systematic reviews[41] show that SHA is not harmless water vapor but contains harmful chemicals such as nicotine, propylene glycol, carbonyls, and carcinogens that are harmful to both the user and nonusers.[30] Potential adverse health outcomes include cardiovascular diseases, lung cancer, and respiratory complications such as asthma, other sensory irritations, and inflammation among nonusers (including fetuses and offspring).[1,2,12] The evidence indicates that indoor e-cigarette use affects air quality, leading to high levels of fine and ultrafine particles that constitute cardiovascular toxins even in the absence of nicotine.[1,2,12] A study evaluating exposure to ambient levels of nicotine and other tobacco-related toxicants showed that e-cigarette use exposed nonusers to significant amounts of nicotine, with levels differing on the basis of e-cigarette brand and flavor.[42] Other studies have reported that e-cigarettes emit harmful chemicals, although at lower levels than combustible cigarettes.[30] While the dose-response relationship between SHA exposure and these adverse health outcomes is nonlinear,[39] the emerging evidence strongly supports protection of people from exposure through evidence-based policies such as smoke/tobacco/e-cigarette-free policies.

Prohibit flavoring of e-cigarettes: Flavored tobacco products, including e-cigarettes, have been identified as a public health concern as a result of their attraction to youth and young adults and the potential health effects attributed to flavoring chemicals.[1,2,12,43–45] Flavoring of tobacco products was cited among the top reasons (along with marketing and advertising) for initiation of use of all tobacco products, including e-cigarettes, by middle and high school students in the 2019 NYTS.[7] Health concerns linked to specific e-cigarette flavors, such as banana pudding, cinnamon, and butter/cream, include alterations in respiratory pathophysiology (e.g., popcorn lung)[1,2,12] and an increased risk of developing osteoporosis.[46] These concerns culminated in a decision by the Food and Drug Administration (FDA) to prohibit flavoring of e-cigarettes. Effective February 1, 2020, disposable flavored products and tobacco and menthol flavors were exempted from this regulation.[47]

While this regulatory response from the FDA seeks to reduce the use of e-cigarettes among youth and young adults, who have been found to use fruit- and candy-flavored e-cigarettes more often than older adults, there remain regulatory gaps that must be addressed to protect vulnerable populations.[43] For example, some e-cigarettes can use modified pods that are premixed with e-liquid. Other e-cigarettes utilize e-liquid that can be mixed by the user, thereby creating potentially harmful circumstances such as poisoning.[48] Moreover, not including menthol in this regulation amplifies health inequities and disparities among the 88% of African Americans who report using menthol cigarettes (as compared with 26% of non-Hispanic Whites).[49] This pattern of use has been attributed to environmental exposures such as marketing strategies by the tobacco industry[50] and genetic predispositions that may place African Americans at an increased risk of susceptibility to using menthol-flavored tobacco products.[51] To ensure health equity, eliminate health disparities as proposed by Healthy People 2030, and bridge these regulatory gaps, this policy statement supports a review of the list of flavors included in the regulation.

Mandate disclosure of ingredients and nicotine content: Recommendations for regulatory action related to e-cigarette use include reporting ingredients in e-liquid as well as the potency of the nicotine content in each premixed modified pod or cartridge.[52] Recent studies have shown that new, popular pod-based e-cigarettes contain elevated levels of nicotine relative to conventional tobacco products.[53] For example, while JUUL Labs advertises its 3% and 5% nicotine pods to contain 39 mg/ml and 59 mg/ml, respectively, recent toxicity reports indicate that the true level may be as high as 69 mg/ml, and similar devices advertise cartridges to contain more than 5% nicotine.[53] This amount of nicotine is believed to be recognized by young users who have reported experiencing symptoms of nicotine dependence.[49,54] Restricting the amount of nicotine allowed per e-cigarette device may help reduce nicotine initiation among youth and the risk of nicotine poisoning among children.[53] Failing to employ and enforce regulatory actions that ensure transparency of ingredients (e.g., adding quantity and sizes for e-liquid and nicotine potency) similar to the approaches used in regulating conventional tobacco products will expose users, including youth and young adults, to a higher risk of nicotine addiction and poisoning.[54] This policy statement supports a mandate that empowers the FDA to regulate the ingredients allowed in e-cigarette modified pods, as well as the devices themselves, much in the same way the agency does with conventional tobacco products.

Opposing Arguments
Given overwhelming evidence of the costs in terms of both public and individual health from smoking, proponents of e-cigarettes as a method of smoking cessation argue against policies restricting their use. There is some evidence that e-cigarettes can be effective in the fight against tobacco-related morbidity and mortality.[39,55–58]

Inconclusive risks: E-cigarette use may be less harmful than smoking conventional tobacco because vaping generates lower levels of carcinogens and other toxic compounds than combustible tobacco products.[1,2,39] However, vaping is not considered safe because e-cigarettes still contain carcinogens and toxic chemicals such as nicotine, propylene glycol, and carbonyls,[38] all of which are harmful to users and nonusers alike[38] and can adversely impact health outcomes.[1,2,12]

One study conducted for an e-cigarette advocacy group concluded that e-cigarette users’ exposure to chemicals released in SHA showed no evidence of inhalable contaminants among users.[59] This study implies that exposure to SHA is not significantly above acceptable limits for the general population, and thus there is no need to regulate exposure to SHA. However, these findings are in contrast to evidence showing that e-cigarettes emit harmful chemicals[22] that negatively affect air quality.[1,2,12]

E-cigarettes for smoking cessation: E-cigarettes have been recommended for smoking cessation because users can control the amount of nicotine contained in an e-liquid mix such that they can progressively wean from nicotine addiction.[58] Some evidence for the effectiveness of e-cigarettes as cessation devices comes from a systematic review[60] concluding that e-cigarettes increase smoking cessation in the long term. As such, it has been argued that e-cigarettes could potentially be effective in the fight against tobacco-related morbidity and mortality with expansion of harm reduction strategies.[39,55–58] Therefore, regulation of e-cigarettes could deny people who smoke access to alternative cessation therapy with the potential to advance their efforts to consider quitting. However, overall evidence on the effectiveness of e-cigarettes as cessation devices is mixed and insufficient to conclude that they help with quitting,[1,39] with some reviews even showing lower odds of quitting among e-cigarette users.[61]

Overregulation: There are already existing policies to limit the use of tobacco products among youth, and there are arguments that additional regulation is unnecessary. Enforcing new minimum age laws, regulating marketing, and imposing new taxes on e-cigarettes may not have the intended impact and could create an illicit market that cannot be monitored in addition to unnecessarily burdening businesses. It is therefore argued that existing laws and regulations are enough to guide users’ decision making.[58] However, policies such as stringent licensing requirements and higher e-cigarette prices are associated with reduced sales and lower initiation and continued use of e-cigarettes among youth,[13,14,33] suggesting that stronger laws and regulations serve to further limit tobacco product use.

Federal regulation policy: Although policies to address e-cigarette use in the United States seem to lag behind the emerging problems related to use, some would contend that recent legislative changes to increase the federal MLSA to 21 years[18] and to prohibit flavors in e-cigarettes (except tobacco and menthol) are adequate to reduce use among youth.[47] The argument is that additional federal policies and oversight will not have a significant impact in preventing and controlling e-cigarette use because, as pointed out by some, extensive regulation of conventional tobacco products has contributed to relatively small reductions in tobacco use.[58] While challenges to implementation of these laws exist, they have nevertheless reduced cigarette and e-cigarette use.[25–27] Excluding certain flavors from legislative changes, particularly menthol, can also amplify health inequities among African Americans.[49,62] One recent study showed an increase in menthol e-cigarette sales after the FDA prohibited other flavors in 2020, which suggests that current guidance is not sufficient for eliminating e-cigarette use among youth.[63]

Alternative Strategies
Some studies have revealed a positive relationship between e-cigarette retailer density near schools and e-cigarette use among youth, while other studies have shown no association or mixed findings based on youth age. A meta-analysis of 11 studies revealed an association between adolescent smoking and retailer density around residential areas but not schools.[64] This policy statement supports zoning restrictions that require a fixed distance between retailers and areas frequented by youth, including schools, public parks, and recreation areas.

Action Steps
Although governments at the federal, state, tribal, and local levels have regulatory authority over e-cigarettes, the evidence suggests that such authority is underutilized.[65] Therefore, APHA supports the following federal, state, and local actions for each evidence-based strategy.

1. Protect Children, Youth, and Adults, Including Vulnerable and Marginalized Populations, from Exposure to E-Cigarettes

Federal Actions

The Federal Trade Commission and/or the Bureau of Alcohol, Tobacco, Firearms and Explosives should regulate trafficking of e-cigarettes, which would prohibit Internet vendors from distributing products through the U.S. Postal Service
The Consumer Product Safety Commission should add nicotine to its list of substances and should require special packaging such as childproof packaging and warning labels on nicotine e-liquid cartridges to prevent childhood poisoning. Also, the agency should hold all e-cigarettes to the same advertising and sales requirements as those that currently apply to conventional cigarettes.