Emerging Electronic Cigarette Policies in European Member States, Canada, and the United States

Abstract

Background:

Increased electronic cigarette (ECIG) use has motivated new regulations to address the changing landscape of tobacco use and promote public health.

Method:

This policy scan compares ECIG prevalence and regulations in the European Union (EU), Canada, and the United States (US) at the federal- and local-level to foster a policy dialogue around modern tobacco prevention and control regulations.

Results:

We find that, among young adults, 40% in the US, 29% in Canada, and 28% in the EU report ever using an ECIG. Results from the policy scan find significant variation in approach to regulating ECIGs. EU member states are subject to the most stringent requirements regarding nicotine concentration regulations, and several member states have also opted to ban flavors and/or require plain packaging or out of sight retail sales. Among EU and US states, taxation is a popular strategy, though taxing strategies vary widely. Regarding youth use, US states have led the way for increasing the legal age of sale to 21 at the federal level, and in Canada recent federal regulations are innovative in their approach to banning advertising that may appeal to youth.

Conclusion:

Strategies to achieve public health goals related to ECIGs vary widely, with federalism playing an important role in policy innovation, offering opportunities to evaluate their effectiveness and inform future regulations.

1. Introduction

Electronic Cigarettes are an Emerging and Heterogenous Class of Tobacco Products

Since receiving its international patent in 2007 and entering the global market for tobacco products, the electronic cigarette (e-cigarette; ECIG) has steadily grown in popularity, particularly among youth and young adults in Europe, Canada, and the United States.¹ ECIGs are a heterogenous class of tobacco products that vary considerably in materials, design, construction, electrical power, flavors, and the nicotine concentration of the liquid placed inside them. Using battery power, ECIGs heat liquid, which usually contains nicotine, in order to produce an aerosol that users inhale.² While often considered to be a reduced-harm alternative to combusted tobacco cigarettes and thus hold promise to aid cigarette smokers transition off tobacco products entirely, ECIGs are by no means harmless. Evidence is emerging about the acute harms of using ECIGs on the lungs, while the long term consequences on the pulmonary and cardiovascular system may not be known for a decade or more.^3,4 Of equal or greater concern, ECIGs appeal to youth and young adults, many of them naïve to cigarettes,⁵ as they are available in fruit and candy flavors, are perceived to be less harmful than combusted products, and have been advertised with youth-friendly messages on social media platforms.^5–7Among young adults, 40% in the United States, 29% in Canada, and 28% in the European Union reported ever using an ECIG in 2017, and among adolescents in the United States, at least 25% had used an ECIG in the past 30 days. In addition, ECIGs typically contain nicotine, a psychoactive, dependence-producing drug that can make continued subsequent use after initiation difficult to control and can impact adolescent brain development.^8,9 Thus, ECIGs pose a significant challenge for regulators aiming to decrease the overall public health burden of tobacco, as they must balance regulations that encourage smokers to use them for a limited time as to transition off tobacco completely while limiting their appeal and availability among youth.

Recent Trends in Electronic Cigarette Use

While current ECIG use among all adults in 2017 living in Europe, Canada, and the US remains relatively low (2–3%), 40% of young adults ages 18–24 in the US, 28% in the EU, and 29% of adults 20–24 in Canada report ever using an ECIG, and trends in current and ever use are increasing (Note: data on ever use of ECIGs are available for adults ages 18–24 from US and EU surveys but only for adults 20–24 from Canadian surveys).^{10–12,13,14} The ECIG market, particularly in the US, underwent a dramatic shift in 2017 and 2018 with a new generation of products entering the marketplace, such as JUUL, myblu, and Suorin Drop, that offer a more high-tech, discreet appearance that resembles a USB drive and use refillable or disposable pods.^7,15 These devices are often referred to as “pod-mods.” Pod mod devices typically contain a different form of nicotine (“nicotine salts”) than was used in first, second, and third generation devices (the “freebase” form). The nicotine salts in pod mod liquid allows consumers to inhale higher levels of nicotine more easily than products using freebase nicotine.⁵ Data from a 2017 national survey in the US, suggest that 12% of high school students (typically 15–18 years old) used an ECIG in the past 30 days, while 2018 data from the same survey, after the rapid diffusion of pod mod ECIG devices occurred, estimated that 21% of high school students report past 30 day use, and in 2019, the prevalence of past 30 day ECIG use among high school students has surpassed 25%.^16,17 A similar rise in past 30-day use of ECIGs among youth ages 16–19 is occurring in Canada recently, increasing from 8% in 2017 to 15% in 2018, with a concurrent increase in reported use of JUUL among youth.¹⁸ Pod-mods such as JUUL have only recently arrived in Europe, and at a lower nicotine concentration,¹⁹ and data at the EU-level for 2018 or 2019 are not yet available to confirm whether a similar trend is occurring in Europe.

The increasing rates of ECIG use among youth and young adults have reversed significant declines in tobacco use rates over the previous two decades in Europe, Canada, and the US.^13,20,21 For the first time in recent history, rates of youth all-product tobacco use in the U.S. rose, from 24% in 2011 to 27% in 2018 among high school students²⁰ and EU member countries have seen overall tobacco use rates increase from 25% in 2014 to 29% in 2017 among youth and young adults ages 15–24.¹⁴ In light of substantial evidence that ECIG use is associated with progression to combusted tobacco use among youth and young adults,^5,22,23 emerging evidence of potential harms associated with inhalation of ECIG aerosol,^5,22,24 rapid innovation in device characteristics and nicotine delivery,^7,25 and the appeal of ECIGs to youth, policymakers across nations share a common interest in developing effective and dynamic policy strategies to regulate ECIGs to protect public health.

This paper synthesizes the landscape of ECIG epidemiologic and policy trends in the European Union, Canada, and the US, with specific consideration given to particular EU member countries, Canadian provinces, and US states that have made recent reforms in how these products are regulated. These include Estonia, Germany, Greece, Lithuania, Ireland, Italy, Malta, the Netherlands, Finland, Slovakia, and Slovenia in the EU, Alberta, British Columbia, Manitoba, Newfoundland and Labrador, New Brunswick, Nova Scotia, Ontario, Prince Edward Island, Quebec, Saskatchewan in Canada, and California, Michigan, Minnesota, New Mexico, New York, Utah, and West Virginia in the US.

2. Methods

In order to provide a comprehensive perspective on ECIG use and policy trends and place them in the context of regulatory environment, we conducted a policy scan to 1) describe similarities and differences between the current, federal policy and legislative environment for regulating tobacco products in the EU, Canada, and the US 2) compare rates of ECIG use at the member state, province, and state level across all three regions, respectively, using data from the 2017 Eurobarometer (EU), 2017 Canadian Tobacco and Drugs Survey, and the 2017 Behavioral Risk Factor Surveillance System (US) and 3) describe the ways that member states (EU), provinces (Canada), states (US), and localities within these have leveraged their regulatory power to address rising ECIG use rates and implement additional policy alternatives at a sub-federal level.

3. Policy Scan of the Federal Tobacco Regulatory Landscape

Overview

The EU, US, and Canada take a federalist approach to ECIG regulation, where the EU, and federal US and Canadian governments establish a policy framework that sets minimum regulations that apply to all states or provinces while allowing individual states to impose additional restrictions or regulations on ECIGs. In the European Union, member states share authority with the European Parliament to regulate the sale, manufacture, distribution, and advertising of tobacco products within and across borders, with all regulations subject to agreement with the World Health Organization Framework Convention on Tobacco Control (FCTC).²⁶ In the EU, the Tobacco Products Directive (TPD)²⁷ was approved by the European Parliament in 2014 and became effective in all EU member states in May 2016 (see Table 1).²⁸ In Canada, also party to the FCTC, the Tobacco and Vaping Products Act (TVPA), effective May 2018, provides a broad regulatory framework that offers Canadian provinces, territories, and municipalities authority to impose additional restrictions, though nearly all provinces had also imposed some ECIG regulations prior to 2018.^29–31 Similar to the EU and Canada, the authority to regulate tobacco products in the US is shared by the federal government and by individual states, and authority to regulate ECIGs as tobacco products stems from the US Food and Drug Administration (FDA) implementing a “Deeming Regulation” effective August 2016 that brought ECIGs under the agency’s purview.³² The EU TPD, Canadian TVPA, and US FDA regulatory frameworks are discussed in more detail in the subsequent sections, followed by EU member state-, Canadian province-, and US state-specific ECIG regulatory policies.

Table 1.

EU Tobacco Products Directive (TPD), Canada Tobacco and Vaping Products Act (TVPA), and US Food and Drug Administration (FDA) Regulations Regarding ECIGs

	EU (TPD)	Canada (TVPA)	US (FDA)
Prevalence of Ever Use (adults ages 18–24)	28%b	29%c	40%a
Flavors	Member States – should be mindful of the potential attractiveness of such products for young people and non-smokers. Any prohibition of flavored products would need to be justified and notification submitted.	Many provinces restrict flavors for combusted products, though none yet include ECIGs in those bans.	Partial flavor ban for prefilled cartridge products. Youth Tobacco Prevention Plan proposes flavors (except tobacco, mint and menthol) sold in age-restricted in-person locations. Revisiting compliancy policy (premarket applications extended to August 2022) as it applies to flavors.
		TVPA includes a ban on marketing of flavors appealing to youth (see Other Youth Targeted Regulations, below).
Nicotine content (concentration and/or volume)	Nicotine concentration cannot exceed 20 mg/mL. E-cigarettes must deliver nicotine doses at consistent levels.	Nicotine content currently regulated by CCCR, 2001. Nicotine concentration at or above 66mg/g is classified as “very toxic” and prohibited.	N/A
Power, other device characteristics	N/A	N/A	N/A
Taxes	Member States	N/A	States
Packaging (e.g. plain packaging, warning labels)	Labelling and packaging of these products should display sufficient and appropriate information on their safe use, should carry appropriate health warnings, and should not include any misleading elements or features. Include a list of all ingredients contained in the product and indication of nicotine content of the product and delivery of dose, batch number, and recommendation to keep the product out of reach of children.	Health Canada proposed regulations in June 2019 that would include child resistant packaging and labelling requirements under TVPA. The proposed labelling requirements include a list of ingredients, nicotine concentration, and a warning about addictive potential of nicotine and its toxicity.	Required health warning on product packages for e-liquids and aerosol products that are pre-loaded with tobacco-derived substance that contain nicotine. (“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”)
		Additional packaging restrictions are targeted specifically toward reducing appeal to youth (see below).
Quality and Safety	Must have compliant refill mechanisms that provide sufficient protection against leakage. Products are child- and tamperproof, including child-proof labelling, fastenings, and opening mechanisms.	Until additional regulations specific to ECIGs come into force (see above), the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) proscribes use of child-resistant packaging for products based on nicotine concentration.	Advance Notice of Proposed Rulemaking on child-resistant packaging for nicotine-containing e-liquids.
Clean Air	Member States	Provinces	States
Marketing, Advertising	Ban on promotional and misleading elements, including a ban on promotion via press, radio, and audiovisual media. Promotional elements are not allowed on e-cigarette packaging, and cross-border advertising and promotion of e-cigarettes is prohibited.	No advertising may be used which might reasonably appeal to youth, nor lifestyle advertising, testimonials, or sponsorship promotion.	Ban on the use of unsubstantiated “modified risk’ messaging that imply ECIGs are less harmful than combusted cigarettes, false or misleading claims in labelling and advertising (including use of customer testimonials containing such statements), and claims that a product is “approved” or “endorsed” by FDA
Minimum Legal Age to Purchase and/or Use	Member States	Purchase restricted below federal minimum age of 18, provinces have authority to raise the legal age of purchase	Purchase restricted below federal minimum age of 21, states have authority to raise the legal age of purchase
Other Youth Targeted Regulations	Unit packets of e-cigarettes and refill containers include a leaflet with information, including instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers.	No device or ECIG component may be sold if it has ‘sensory’ design attributes (appearance or shape) that would make it specifically appealing to youth.	Youth Tobacco Prevention Plan: a series of actions to stop youth use. Warning letters sent to five top e-cigarette brands whose products were sold to minors to provide FDA with robust plans on how they will address the use of their products by minors. Any adverse effects or potential violations, such as selling to minors, can be reported to the FDA.
		No packaging element may be used to indicate an ECIG product is flavored if that element may appeal to youth.
		No “dessert” or “confectionary” flavors that appeal to youth may be promoted on product packaging.

Notes:

^aThe US e-cigarette ever use estimate is the median for 18–24 year olds for all US states and DC from the 2017 BRFSS.

^bThe EU e-cigarette ever use estimate is the EU average for 18–24 year olds in EU member countries responding to the 2017 Eurobarometer survey. The Canadian e-cigarette ever use estimate is the average for 20–24 year olds in all Canadian provinces from the 2017 Canadian Tobacco Alcohol and Drugs Survey (CTADS). Sources: US State Prevalence Data: Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Population Health. BRFSS Prevalence & Trends Data [online]. 2015. [accessed Sep 9, 2019]. URL: https://www.cdc.gov/brfss/brfssprevalence/index.html; Special Eurobarometer 458: Attitudes of Europeans Toward Tobacco and Electronic Cigarettes [online]. 2017. [accessed Sep 9, 2019]. URL: http://data.europa.eu/euodp/en/data/dataset/S2146_87_1_458_ENG; Canadian Tobacco Alcohol and Drugs (CTADS) Survey: 2017 detailed tables [online]. 2017. [accessed Oct 4, 2019]. URL: https://www.canada.ca/en/health-canada/services/canadian-tobacco-alcohol-drugs-survey/2017-summary/2017-detailed-tables.html

European Union

The TPD seeks to reduce the significant public health burden of tobacco use through discouraging youth tobacco use and informing citizens about the health consequences of associated with using tobacco.³³ Many of its primary strategies for achieving these goals are directed specifically toward traditional combusted cigarettes. However, in light of increasing ECIG use, and what the European Commission cited as a lack of evidence thus far in regard to their impact on public health,²⁸ Article 20 of the TPD also includes specific regulations intended to regulate the sales of nicotine-containing ECIGs to consumers (ECIGs without nicotine are not regulated under the TPD). These regulations include setting a maximum concentration of nicotine (20 mg/ml) in ECIG liquid, maximum volume of liquid for tanks and containers that store the liquid (10 ml), and requiring that ECIG devices and storage containers be child-resistant and minimize the risk of accidental exposure.²⁸ Additionally, vitamins and other additives that create the impression of added health benefits; including caffeine, taurine and other additives and stimulants; colorants and other substances that are harmful to humans, except for nicotine, are not permitted in ECIG liquid. The TPD also requires that consumers be informed about all ECIG ingredients and their nicotine content via mandatory packaging and labelling requirements,²⁷ and that ECIG packaging not contain promotional material.

Regarding health warning statements, “This product contains nicotine which is a highly addictive substance” must appear in the national language of the country in which the ECIGs are sold, with the warning label covering at least on 30% of the two largest surfaces of packaging of nicotine-containing pre-filled ECIGs and refill containers. Further, packaging must include a list of all ingredients (in descending order of their share of weight), nicotine content, nicotine emission per dose, and a notice that the product is not allowed to get into the hands of children. ECIG manufacturers are also required to provide the European Commission and EU member states with information on new products they intend to introduce to the market, including ingredients, emissions, nicotine content, and production, as well as reporting on annual sales, demographics of their users, and product preferences.²⁸ This information, as well as monitoring by member state regulatory authorities, may be used to inform future regulatory action by member states and/or the European Commission. Beyond the TPD, EU member states also have authority to promulgate additional ECIG restrictions, which are discussed in more detail below.²⁷

Canada

At the federal level, ECIGs produced, sold, and distributed in Canada are subject to regulation under four major pieces of legislation.³⁴ The Canadian Food and Drugs Act (CA FDA) applies to products, including ECIGs, that make a health or therapeutic claim (e.g., can be used to quit smoking), and all such products must receive federal authorization from Health Canada before being manufactured, advertised, sold, or imported.³⁴ Receiving authorization is contingent upon meeting safety and quality standards, and a site license is required before an ECIG can be imported, manufactured, or packaged in Canada. Nicotine-containing ECIG products that do not make a health claim are not regulated under CA FDA, but are subject to regulation under the Canada Consumer Product Safety Act (CCPSA), which offers federal authority to take actions on ECIG producers and products such as carrying out inspections, ordering recalls, and ordering tests or studies.^34,35 E-liquid that contains nicotine is also subject to the Consumer Chemicals and Containers Regulations (CCCR, 2001), which classifies nicotine as a toxic substance and sets nicotine concentration thresholds that dictate the packaging and labelling requirements for nicotine-containing e-liquid.^34,35

In addition to the Canadian regulations included in the CA FDA, CCPSA and CCCR, the Tobacco and Vaping Products Act (TVPA) became effective in May 2018, replacing the 1997 Tobacco Act and explicitly including ECIGs in legislation governing the sale, labelling, production, and marketing of tobacco products.^29,34 Prior to 2018, all nicotine-containing ECIGs were regulated at the federal level under the CA FDA and sale required premarket authorization, therefore non-therapeutic use of nicotine-containing ECIGs was primarily regulated at the provincial level (discussed in Section 4, below).³¹ TVPA explicitly designates nicotine-containing ECIGs legal for consumer sales in Canada, sets a federal minimum legal age of sale for tobacco products of 18, restricts the sale of ECIG products that might appeal to youth in their design, bans the use of advertising or promotional strategies that are designed to appeal to youth, including marketing of “dessert” or “confectionary” flavors that appeal to youth,²⁹ and offers Health Canada the authority to promulgate future regulations regarding packaging and labelling, and manufacturing standards and reporting.³⁴ Health Canada has also banned the use of certain additives and flavors in combusted tobacco products, including menthol, but has not extended a flavor ban to ECIG products.³⁶

Health Canada also proposed regulations in June 2019 that would include child resistant packaging and labelling requirements under TVPA, as packaging guidance for nicotine products has thus far been provided solely by CCCR, 2001.³⁵ The proposed labelling requirements include a list of ingredients, information on nicotine concentration, and a warning about the addictive potential of nicotine and its toxicity.³⁷ Additional proposals under consideration include limiting advertising at marketing in point of sale (POS) and public locations accessible to youth, nor in broadcast media or publications geared toward youth.³⁸ As Canadian health authorities seek to reduce the appeal of ECIGs to youth while also allowing legal sale, they have placed significant restrictions on manufacturers and retailers at the federal level, and continue to amend TVPA to clarify and promulgate further regulations.^37–39

United States

As part of the Family Smoking Prevention and Tobacco Control Act in 2009, the US Food and Drug Administration’s Center for Tobacco Products was granted regulatory authority over the manufacture, sale, and marketing of traditional tobacco products. Effective in August 2016, the FDA’s deeming rule designated ECIGs as a tobacco product granting the agency the authority to regulate them.⁴⁰ Under federal regulations, ECIGs may not be sold to individuals under the federal minimum purchase age of 21,⁴¹ nor be sold in vending machines in places where youth are allowed, and retailers are legally responsible for requiring photo identification age verification for individuals under age 27 intending to purchase ECIGs. Beginning in 2018, nicotine-containing ECIG devices and liquid must contain warning statements about the addictive qualities of nicotine that read “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”⁴² FDA also sponsors national surveys on ECIG and other tobacco use and of tobacco regulatory science to produce evidence relevant to developing regulations that advance its public health standard.

As of June 2019, all manufacturers of ECIG devices and liquids currently on the market must submit a list of all ECIG products, ingredients, labeling and advertising to FDA. After FDA’s evaluation of the list is completed, products FDA allows to be marketed are said to be granted “premarket authorization.”^43,44 Further, all ECIGs on the market as of August 2016 are subject to FDA compliance policies, but enforcement has been deferred, particularly for not obtaining premarket authorization. As part of its enforcement duties for ECIGs in violation of marketing authorization, FDA has sent letters to approximately 90 companies seeking information to determine if tobacco products are being marketed illegally and has issued warning letters to six companies notifying them of the need to remove a combined 71 products from the market.⁴⁴ Cited violations of marketing authorization include actions such as advertising online and via social media without using required nicotine warning statements, using modified risk messaging to imply ECIGs are less harmful than combusted cigarettes, and not providing FDA with lists of ingredients, among others.^45,46 However, citing concerns over the protracted pace of FDA’s implementation and enforcement of ECIG manufacturer regulations, a US District Court ordered that preauthorization documents to be submitted by ECIG manufacturers to FDA by May 2020.⁴⁷

The FDA has signaled it is taking several additional steps in its Youth Tobacco Prevention Plan to regulate tobacco products further, many involving ECIGs.⁴⁸ Increased age verification will be required for online sales. Additionally, marketing for ECIG products targeting children will be removed. This regulation includes eliminating animation, as well as popular youth flavors like candy. Reacting to hundreds of vaping-related illnesses and new evidence from 2019 national survey data that ECIG use among adolescents continues to increase, the Trump administration in September 2019 directed the FDA to clear the US market of all non-tobacco flavored ECIG products.¹⁷ A partial flavor ban was enacted in early 2020 to reduce the appeal of ECIGs to youth by banning the sale of fruit and mint flavors in cartridge-based products (like JUUL) popular among youth.⁴⁹ However, the White House and FDA have since retreated from making any decisions regarding ECIG flavors. In addition to federal regulations regarding ECIGs, many US states and localities have passed additional restrictions on ECIGs, discussed in the coming sections.^50,51

Summary

The EU, Canada, and the US each have federal-level frameworks for regulating ECIGs. While all three approaches regulate packaging and labeling, though to varying degrees, several differences in federal regulatory strategies are noteworthy. The EU’s TPD is distinguished by the limits it places on nicotine concentration in e-liquid and on e-liquid volume. In Canada, a broad and restrictive federal regulatory approach for ECIGs was only recently enacted after most provinces had fairly comprehensive ECIG policies already. US federal action on ECIGs is arguably the weakest of the three with many regulations slow to be enacted or enforced (e.g., premarket authorization), with others announced but not implemented (e.g., flavor ban). Nonetheless, states in the US, and likewise members states in the EU, and provinces in Canada have leveraged federalism to enact ECIG policies that extend beyond federal regulatory frameworks. These member state-, province-, and state-level ECIG policies and the prevalence of ECIG use in these regions are discussed next.

4. Comparisons of E-cigarette Regulations and Tobacco Use in EU Member States, US States, and Canadian Provinces

Overview

To understand the motivations for EU member state-specific, Canadian province-specific, and US state-specific regulatory action on ECIGs beyond federal-level policies, we first report differences in ECIG ever use among adults 18–24 in selected EU member countries, Canadian provinces, and US states that recently reformed how these products are regulated. Using data from the 2017 Eurobarometer,¹⁴ the 2017 Behavioral Risk Factor Surveillance System (BRFSS),⁵² and the 2017 Canadian Alcohol, Tobacco and Drugs Survey⁵³ we find that 56% of young adults in Estonia and 40% in Lithuania reported ever using and ECIG, compared to 15% in Italy and 3% in Malta (Figure 1). We find that in the Netherlands, 33% of young adults reported ECIG ever use, similar to the 31% prevalence of ever use among young adults in Finland, Germany and Greece, while reports of ECIG ever use were lower in Slovenia (21%), Slovakia (20%), and Ireland (20%).

Figure 1. Ever Use of Electronic Cigarettes and Electronic Cigarette Policies in Selected EU Member States, Canadian Provinces, and US States.

Note: Michigan and New York have temporary statewide flavor bans. Cities and counties in other localities, including Minnesota, have also banned ECIG flavors but do not have statewide bans.

In the US, ECIG ever use among young adults was highest in New Mexico, where 54% of those 18–24 years of age reported trying the tobacco product at least once. Conversely, ever use of ECIGs among young adults was lowest in Utah (32%). New York (34%) and California (36%), the two most populous states in the US and where tobacco control efforts have historically been robust,⁵⁴ also had among the lowest prevalence of young adult ever ECIG use, with West Virginia (48%), Oregon (47%), Michigan (43%), and Minnesota (41%) somewhere in between.

Rates of ever use among young adults ages 20–24 were generally lower across Canada’s provinces than US state-specific estimates for adults ages 18–24.^52,53 Specifically, ever use among young adults was highest in Newfoundland and Labrador (40%) and lowest in Ontario (19%), with Quebec (35%), New Brunswick (35%), Saskatchewan (34%), British Columbia (30%), Nova Scotia (29%), Manitoba (27%), Prince Edward Island (26%), and Alberta (24%) in between. Ontario Canada’s most populous province,⁵⁵ had the lowest prevalence of ECIG ever use among this age group (19%).

E-cigarette Regulations by European Union Member States

Our policy scan of ECIG regulations in European Union member countries identified several recent policy actions that are noteworthy and focus on German, Ireland, and the Netherlands in the northwest of the EU, Italy, Greece, Malta and Slovenia in the southwest, Slovakia in the east, and Estonia, Finland, and Lithuania in the northeast. EU member states have employed a variety of strategies to regulate the market for ECIGs and to address concerns about youth use. In order to decrease youth access, the Estonian Parliament passed the Tobacco Act (Riigi Teataja) in 2017 that extended combusted cigarette regulations to ECIGs, including bans on use and possession by minors (under age 18).^56,57 Slovenia also bans sale to minors,⁵⁸ and Ireland’s Minister of Health recently (October 2019) received approval to draft the Tobacco and Nicotine Inhaling Products Bill,⁵⁹ which would include similar restrictions on youth use and possession of ‘nicotine inhaling products’ and ban sales of ECIGs in locations intended for use by minors.⁵⁹

Policymakers in many EU member states also place additional, significant restrictions on how ECIGs may be displayed in retail sales locations and what types of locations can sell them, and to what extent manufacturers can visibly advertise or promote their products. In Estonia, ECIGs cannot be visibly displayed in retail trade sales premises and the presentation of the brand of such products in prohibited.^56,57 Further, ECIGs or refill containers must not bear a name, mark, symbol, or any distinctive feature. In June 2019, an amendment to the Republic of Lithuania Law on the Control of Tobacco, Tobacco Products and Related Products prohibits advertising, promotion and sponsorship of ECIGs in Lithuania, and out-of-sight retail is required for all tobacco products.⁶⁰ In Slovenia, advertising, display and promotion of ECIG with and without nicotine is banned.⁵⁸ The Netherlands currently offers the most restrictive policy environment concerning product packing, requiring ECIGs manufacturers and retailers to use plain packaging, prohibiting the use of packaging for advertising or promotional purposes.^61,62 While Italy, like other EU member states, prohibits ECIG advertising as well as cross-border advertising and sponsorship via Legislative Decree 6 12/1/2016,⁶³ “indirect advertising” is relatively common. Shops specializing in “vaping” products are an evident way to advertise ECIGs (e.g., through shop signs and windows where there are not major restrictions).^63,64

Two member states have chosen to regulate the use of characterizing flavors in ECIGs. ECIG flavors other than tobacco are not permitted in Estonia,⁵⁶ and the Finnish government has implemented additional regulations on ECIG liquids, restricting certain additives and characterizing flavors.⁶⁵ Six of the member states included in the policy scan currently include ECIGs in comprehensive tobacco tax policies, and some restrict the use of price strategies to promote products. Finland currently has the highest tax on ECIG liquid at 0.3 Euros per ml.⁶⁶ All ECIG liquids in Estonia are taxed at 0.2 Euros per ml, in addition to a 20% Value Added Tax on the final retail price of ECIGs. Further, ECIGs cannot be obtained for free or at a price which is significantly lower than the maximum retail price, and marketing the sales price by comparing the original and new sale price is not allowed.^56,57 In Italy, a tax on e-liquid was set at 0.393 euros per mL in 2018, which is related to the weighted average price of tobacco cigarettes calculated annually. There is also a 22% Value Added Tax of the final retail price. However, in 2019 the excise in Italy on ECIGs was substantially lowered. It is now 0.0821 Euros per ml of liquid with nicotine and 0.0410 per ml of liquid without nicotine.⁶⁶ Lithuania levies an excise tax of 0.12 euro per ml of ECIG liquid,^60,66 including non-nicotine containing ECIG liquid. On the other hand, Slovenia’s excise tax of 0.18 euro per ml is levied only on ECIG liquids with nicotine.^58,66

Licensure requirements and restrictions on distance sales are also popular policies among member states to regulate the market for ECIGs. Neither online sale nor sale of products via mail is permitted either internally or from outside Estonia, while Lithuania prohibits internal distance sales, cross-border sales of ECIGS and e-liquid refill containers.⁶⁰ Proposed regulations in Ireland include a ban on vending machine and internet sales.⁵⁹ In Italy, online sales initially were prohibited but were legalized in 2019. However, it is not clear whether some of the specific provisions of Italy’s Legislative Decree are being implemented fully, including ECIG monitoring activities performed by the Ministry of Health as well as ensuring manufacturers, importers and distribution channels have adequate information systems to monitor dangerous effects of ECIGs. In both Malta and the Netherlands, retailers who engage in cross-border sales must meet additional requirements.^62,67,68 Regarding licensure for ECIG sales, Slovenia requires points of sales location to obtain a valid permission for sale of ECIG with and without nicotine,⁵⁸ and proposed regulations in Ireland introduce a licensing systems for retailers that would require an annual fee per location to be paid in return for permission to sell tobacco and ECIGs.⁵⁹ Ireland’s proposal also includes fines for violating rules, and minimum suspension periods for retailers convicted of violating licensure guidelines. In the Netherlands, manufacturers of ECIGs also have the option of applying for a medical license, where rules governing medicinal products apply if the license is granted.

To protect non-users, many EU member states restrict where ECIGs may be used, and use clean air laws to discourage youth use. In Estonia, use is prohibited in many public places intended to be used by children,⁵⁷ and Italian authorities specifically restrict use in schools and on schools property. Slovenia prohibits ECIG use in enclosed public and working places, in all vehicles when a minor is present, and on all educational facilities,⁶⁴ and both Malta and Finland prohibit ECIG use where combusted cigarette use is prohibited, including enclosed public spaces, locations intended for use by children.^65,67,68

Germany and Greece take different approaches to regulating non-nicotine-containing ECIGs: in Germany, ECIGs that contain non-nicotine e-liquid are regarded as consumer products and thus are not covered by the German Tobacco Law, however use of non-nicotine ECIGs is banned by youth under 18, the same minimum legal age for nicotine-containing ECIGs.⁶⁹ Conversely, non-nicotine ECIGs are considered tobacco consumer products and banned in Greece according to Law 3730/2008, and nicotine-containing ECIGs are regulated under the EU TPD under the same statute.⁷⁰

E-cigarette Regulations in Canadian Provinces

Among Canada’s ten provinces, eight had adopted and implemented comprehensive ECIG legislation prior to the TVPA was passed at the federal-level in 2018. With the exception of Alberta and Saskatchewan (both currently considering regulating ECIGs), Canada’s provincial governments have either amended previous tobacco legislation to include ECIGS explicitly in their definitions of tobacco products, or passed new legislation defining and regulating ECIGS.³⁰ Nearly uniformly, all eight provinces have banned the sale and supply of ECIGs to minors, though provinces differ in the legal age of sale for tobacco products. British Columbia, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, and Prince Edward Island have raised the minimum legal age of sale to 19 years of age, whereas the other four provinces ban sales to those under the federal minimum age of 18.⁷¹

All eight provinces that regulate ECIGs ban use where smoking is prohibited, though British Columbia, Manitoba, and Ontario have regulatory authority to exempt sampling or use in vape shops, and in locations where youth are not permitted access.³⁰ In Alberta and Saskatchewan, where ECIGS are not currently regulated, many municipalities have amended smoke-free laws to include ECIGs.⁷² With the exception of Manitoba, all provinces have indoor and outdoor clean air restrictions on use in places such as school campuses, in cars when minors are present, and in many entertainment spaces.^30,72 Nearly all provinces ban point of sale (POS) promotion visible from outside the sale location, however Manitoba, New Brunswick, Nova Scotia, Ontario, and Newfoundland and Labrador exempt vape shops from other tobacco POS restrictions such as warning signage, and signage that only advertises product availability and price.³⁰ Contrasting recent efforts by many provinces to limit advertising, Ontario policymakers passed legislation effective in 2018 allowing direct marketing of ECIGs to consumers through advertising in convenience stores.⁷³

The federal government and 7 provinces currently ban characterizing flavors for tobacco products, however no province, nor federal law, currently extends that ban to include ECIGs.⁷² Only Ontario and Quebec explicitly have included language detailing regulatory authority to ban flavored tobacco, though neither province currently bans flavored ECIGs, and Quebec also further restricts promotional activities (pre-TVPA) by banning company names, images, logos, or other branding strategies from all ECIG devices, e-liquids, and components.³⁰ While ECIGs are regulated either as tobacco products, or in a similar manner to tobacco products, across all eight provinces that regulate ECIGs, they are not regulated as such under tax policies governing tobacco product sales. Neither the federal government nor provincial governments currently subject ECIGs to any form of tobacco tax.⁷⁴

E-cigarette Regulation by US States and Localities

States in the US, like provinces in Canada and member states in the EU, often serve as policy laboratories for the federal government where innovations at the state level can inspire federal legislation that affects all states. Many US states have passed legislation specific to ECIGs beyond regulations compulsory at the federal level, however there is considerable variation in the strategies they employ. The following section highlights recent shifts in ECIG policies in California, New Mexico, Oregon and Utah in the western part of the US, Michigan and Minnesota, in the Midwest, and New York and West Virginia in the East.

All US states and the District of Columbia (DC) now have state laws specifically defining ECIGs, though only 23 states and DC explicitly define them as tobacco products thus subjecting ECIGs to all state laws governing the sale, distribution, and use of tobacco products.⁵⁰ Youth use of and access to ECIGs has been a primary focus for public health officials in many states, as well as potential harm to non-users. In order to restrict youth access to ECIGs further, 19 states and DC have raised the minimum legal age of access (MLA) above the federal minimum of 18 years of age, and 17 of those localities have raised the MLA to 21 years of age including California (effective 2016), New York (November 2019), Oregon (2018), Utah (2021), as well as 40 localities in Minnesota and 4 in Michigan.^50,75 All of these actions preceded the implementation of a new, federal law setting MLA at 21 in December 2019.⁴¹ Twenty-nine US states, including seven of the eight states focused on here (except West Virginia), require that ECIG liquid containers be sold in child-resistant packaging unless they are prefilled and sealed⁵⁰ to reduce the growing number of children accidentally exposed to nicotine-containing e-liquid.⁷⁶ Idaho, New Hampshire, New Mexico, and Pennsylvania laws also stipulate that ECIGs must be sold in their original sealed factory package and Oregon requires child-resistant packaging that “is not attractive to persons under 18.”⁵⁰ Utah requires refillable or open ECIG systems to comply with state labeling, packaging, and nicotine content restrictions including a required safety warning, including nicotine concentration, and a prohibition on labels that feature certain additives.⁵⁰

In response growing concerns about safety and increased prevalence of use among youth, Michigan’s governor in September 2019 exercised her executive authority to ban non-tobacco flavored ECIGs containing nicotine for six months in her state.⁷⁷ The ban, which went into effect immediately, can be renewed for another six months by the governor’s executive authority but a further ban would require legislative action. Soon thereafter, New York’s governor also announced that the state’s Public Health and Health Planning Council and state health commissioner would issue an emergency regulation banning all ECIG flavors except for tobacco and menthol.⁷⁸ Montana’s governor also recently has enacted a short-term (120 days or fewer) ban on sales of all flavored ECIGs,⁷⁹ and the Utah Department of Health restricted sales of flavored ECIGs to licensed, specialty tobacco stores alone.⁸⁰ New Jersey and Rhode Island have since followed suit with flavored ECIG bans.⁵¹ In 2019, Massachusetts became the first state to pass a law banning all flavored tobacco products, California passed a similar law in August 2020.⁵¹ In Minnesota, Minneapolis and several other localities in the state require flavored tobacco products, including menthol-flavored products, to be sold in adults-only retail outlets, while in California, Berkley, Beverly Hills, and cities and counties have banned the sale of flavored ECIGs near schools.⁸¹ Effective in 2021, ECIGs and all other tobacco products will be prohibited from being sold at gas stations and convenience stores in the city of Beverly Hills.⁸² In 2019, the city of San Francisco placed a ban on all ECIGs that have not passed FDA’s premarket review, effectively prohibiting all ECIG sales as none have passed the review thus far.⁸³ Finally, two cities in California have recently moved to be the first localities in the US to completely ban commercial sales of all tobacco products.⁸⁴

Cities, counties, and states in the US have also implemented policies to regulate the sale of ECIGs through licensure requirements and taxation, including 23 states and DC that require retailers who sell ECIG liquid to obtain licenses (though no license is required for device sales), for all in-person, vending machine sales, and online sales.⁵⁰ There are no federal taxes on ECIG devices or liquid. However, by December 2020, 20 states, DC, and a number of cities have implemented a tax on ECIG sales,^50,85–87 though taxing strategies vary widely. Some states and localities have chosen to implement taxes based on wholesale purchase price, whereas others have implemented taxes based on the volume of e-liquid sold. Within each category, tax rates also vary widely. For example, effective July 2019 in New Mexico, ECIG products are subject to a 12.5% tax on the value of liquid used in closed system ECIGs and $0.50 for each refill cartridges (combusted tobacco is taxed at 25% in the state). As of 2016 in West Virginia, a tax of $0.075 per ml of ECIG liquid is levied, regardless of whether it contains nicotine. Among cities and states that tax ECIG liquid by volume, the city of Chicago taxes at the highest rate (both $0.55 per milliliter and $0.80 per unit sold), whereas states such as Louisiana and North Carolina are among the lowest and tax ECIG liquid at $0.05 per milliliter.^85,86 In Minnesota, a 95% tax is applied to the wholesale price of ECIG liquid and refill cartridges as well as starter kits if liquid containing nicotine is included in them, thus, the amount of tax applied may vary based on changes in wholesale prices.^50,88 California voters passed a 65% wholesale tax on ECIG liquid and devices that contain or are sold with liquid through a direct ballot proposition instead of through law passed by its elected members of state congress.^50,89 In New York ECIGs are taxed at 20% of the retail price.⁵⁰

To restrict potential harm posed by ECIG aerosol to other groups of non-users, and to restrict use by youth and young adults, many states have also opted to restrict the locations where ECIGs may be used. To date, 19 states and DC, as well as hundreds of US cities and municipalities, restrict ECIG use by including them in comprehensive, statewide smoke-free policies that ban use in spaces such as K-12 and college campuses, entertainment spaces, and worksites, among others.^86,90,91

Summary

In summary, popular policies beyond EU’s TPD among EU member states include restrictions on advertising and promotion at retail sales locations, bans or additional requirements for internal and cross-border distance sales, and taxes. In contrast to wide variation in how individual EU member states have chosen to restrict ECIG use, sales, and distribution beyond guidance from the EU TPD, most Canadian provinces already had comprehensive guidelines in place before adoption in 2018 of the TVPA. Six provinces have raised the minimum legal age of access to 19 and the federal government and 7 provinces currently ban characterizing flavors for tobacco products, but this ban does not currently apply to ECIGs. After nearly half of US states had already or were moving towards raising the minimum legal age to purchase tobacco, the federal government raised the minimum purchase age to 21 years old. States in the US have further extended what is regulated under federal law by banning flavored ECIGs, restricting where flavored ECIGs can be sold, banning the sale of ECIGs all together, and using retailer licensing and ECIG taxes to influence supplier and consumer behavior.

5. Discussion

Increases in ECIG use, especially among youth and young adults, may add to the health risks of tobacco use. The EU, Canada, and the US have enacted federal regulatory policies covering the manufacture, marketing, and sale of ECIGs that apply to all member countries, provinces, and states. As a result of a federalist approach to regulating tobacco products, a number of policy innovations have emerged to address the changing landscape of ECIG use in the EU, Canada, and US. Results from this policy scan identified several recent ECIG regulations that are noteworthy. Estonia and Finland in the EU and Michigan and New York in the US have or are in the process of banning flavored ECIG products, with efforts now underway in several other states. Estonia, Lithuania, and the Netherlands require ECIGs to be out of sight in retail stores and/or require plain packaging, though no US state has implemented similar restrictions to date. Estonia and Lithuania also ban online and distance sales within and across borders, and the Netherlands and Malta require additional reporting and restrictions for retailers engaging in cross-border sales.

Taxing schemes for ECIGs vary widely across the EU and US member countries and states included in our policy scan with Finland (0.3 Euros per ml of liquid) in the EU and Minnesota (95% of the wholesale price) in the US levying the highest taxes. In the US particularly, states with lower combustible cigarette taxes tend to be less likely to tax ECIGs, or to tax them at lower rates relative to states with higher combustible cigarette taxes, offering insight into the wide variation in the overall comprehensiveness of tobacco prevention policies across states and localities.⁸⁷

Looking across EU member states, Canadian provinces, and US states, several lessons surface. Policymakers in the US have yet to implement a range of policy alternatives that have been implemented in EU member states, including out of sight retail sales, plain packaging, limiting nicotine concentration, and requiring ECIG manufacturers to monitor and report consumers’ product preferences and demographics. The EU and Canada have yet to implement initiatives to raise the legal age of purchase at the federal-level to 21 years old, as a number of US states had done, and later the US federal government, to reduce youth access. However, several Canadian provinces have set 19 as the minimum legal age of access, potentially laying the groundwork for federal action in Canada. Selected states in the US and member states in the EU have implemented tax policies, however none of the entities included in the policy scan have considered such price policies at the federal level, while no ECIG taxes are levied in Canada at the federal- or provincial-level missing opportunities to leverage tobacco price policies to steer consumer and industry behavior. Also of note across regions is the extent to which flavor restrictions and other policies are applicable to all ECIGs or solely nicotine-containing ECIGs. Given the abundance of evidence showing that ECIG flavors are specifically attractive to youth, as well as a general lack of knowledge among youth and young adults about whether ECIGs contain nicotine,⁹² extending regulations to non-nicotine ECIGs may also help deter youth use.

Other regulatory strategies as yet employed in these regions include regulating the formulation of the nicotine liquid by banning nicotine salts that have allowed manufacturers like JUUL to make more concentrated e-liquids more palatable. This could be accomplished by regulating the pH of the liquid. Additionally, some tobacco regulatory scientists are coming to the conclusion that “open-system” ECIGs cannot be regulated effectively as they have too many user-accessible features such as tanks that allow users to fill them any e-liquid they choose and devices that allow users to modify the voltage, thus changing how much nicotine is delivered per puff.⁸⁸ As a solution, governments interested in regulating ECIGs could only authorize the sale of “closed-system” ECIG devices and prohibit the sale of “open-system devices” that permit consumers to access and modify.

Tobacco regulations in the EU, Canada, and the US are designed with the intent to protect public health by reducing the burden of tobacco use. Even so, such regulations, including some presented above, may have unintended consequences that cause harm. For example, limiting nicotine concentration in ECIG liquid, as in the EU’s TPD, may cause some consumers to use higher power ECIG devices that aerosolize more liquid, leading users to inhale more nicotine and other toxicants. Further, ECIG flavor bans and taxes levied on ECIG products may prevent youth initiation but also reduce the appeal of ECIGs as cessation aids for combusted cigarette smokers. Recent longitudinal evidence from Minnesota (a US state) regarding the impact of a large increase in ECIG tax supports these concerns, as investigators found that implementing a tax of large magnitude (95% of wholesale price) was positively associated with smoking participation and negatively associated with smoking cessation.⁹³ Such findings point to the critical need to also consider policy alternatives in the context of a continuum of risk, and to seek quantitative evidence regarding the impact of these alternatives on tobacco use among different populations of potential or current users.

6. Conclusion

Increasing the ability of policymakers at the local, state, and federal levels to predict and then evaluate the desired and potential unintended effects of regulatory action requires fostering policy dialogues among these regions who share a common cause to limit the potential harms of ECIGs. Significant variation in federal and locality-specific approaches to ECIG regulation fosters rich collaborative opportunities for quantitative evaluation of the most effective individual and combined policy alternatives, while accounting for the complex interaction between policy outcomes and institutional and population characteristics.

Highlights:

• Regulations to mitigate increasing electronic cigarette (ECIG) use vary significantly.

• ECIG use is common but varies across the EU, Canada, and US.

• Youth access laws and taxation are common policy strategies across regions.

• Regulating nicotine concentration, ECIG flavors, and packaging/advertising policies are strategies where significant variation within and between regions is common.

• Policy innovation offers rich opportunities to evaluate effective regulatory alternatives.

List of Abbreviations

BRFSS

Behavioral Risk Factor Surveillance System (United States)

CA FDA

Canadian Food and Drugs Act

CCCR

Consumer Chemicals and Containers Regulations (Canada)

CCPSA

Canada Consumer Product Safety Act

CDC

Centers for Disease Control (United States)

CTADS

Canadian Tobacco Alcohol and Drugs Survey

ECIG

Electronic cigarette

EU

European Union

FCTC

World Health Organization Framework Convention on Tobacco Control

FDA

United States Food and Drug Administration

MLA

Minimum legal age of access

POS

Point of Sale

TPD

Tobacco Products Directive (European Union)

TVPA

Tobacco Vaping and Products Act (Canada)

US

United States

WHO

World Health Organization