Regulatory controls applied to e-cigarettes vary widely across the world. Different countries generally take one or more of three main approaches to e-cigarette regulation. Some treat e-cigarettes as tobacco products; others treat them as consumer products; a third possible approach is to treat them as medicinal products. See below for a broad overview of e-cigarette regulations in the EU, the US, Canada, New Zealand, and the UK, as well as summaries of specific requirements/restrictions and countries that have introduced:
For a country-by-country summary of the legal/regulatory status of e-cigarettes, see Table 18.14.1. For a detailed summary of regulations in Australia, see Section 18.13. For an overview of the research on policies and programs to reduce e-cigarette use, see Section 18.10. For an overview of the positions of key Australian and international government and health agencies on e-cigarettes and options for regulation, see Section 18.15.
European Union (EU)
In February 2014, the current EU Tobacco Products Directive (TPD) was passed by the European Parliament and became law in April 2014. Member States had until May 2016 to transpose the new rules into national law. Article 20 of the TPD establishes a regulatory framework for e-cigarettes. E-cigarettes containing up to 20 mg/ml of nicotine come under the TPD and are permitted to be made available as general consumer products (rather than under a medicines framework); but products containing a higher level of nicotine, or that are marketed with therapeutic claims will require marketing authorisation as medicines. The TPD also prohibits many forms of advertising and promotion of e-cigarettes. Additional regulations include:
- A size limit for e-liquids of 10 ml for dedicated refill containers and 2ml for electronic cigarette cartridges and tanks.
- Safety mechanisms (such as childproof fastenings and opening mechanisms) for e-liquid containers, cartridges and tanks.
- Warnings on the two largest surfaces of the packs and any outside packaging covering at least 30% of the external area. These must state either ‘This product contains nicotine which is a highly addictive substance’ or the above plus ‘It is not recommended for use by non-smokers’.
- Consumer information must also include instructions on use, information on addictiveness and toxicity, a list of all ingredients and information on nicotine content. Promotional materials on packs are prohibited.
- Manufacturers and importers bear full responsibility for the quality and safety of their product and must notify detailed information about their products to competent authorities in each Member State.
- Prohibition on cross-border advertising, promotion and sponsorship in line with that for tobacco products.
- Prohibition on commercial communications in the media, on radio and in printed publications (with an exemption for publications intended exclusively for professionals).
- Allowance for Member States to prohibit cross-border sales.
- Prohibition on certain additives, including vitamins and colours.
- Member States are able to introduce extra safeguards, for example on age-limits and flavourings in electronic cigarettes. 1
United States of America (US)
In the US, the Food and Drug Administration (FDA) formalised its arrangements so that all electronic nicotine delivery systems, including e-cigarette and vape pens, are now regulated under the Federal Food, Drug and Cosmetic Act (as amended by the Family Smoking Prevention and Tobacco Control Act) in August 2016. 2 This rule gives the FDA regulatory control over the manufacture, import, packaging, labelling, advertising, promotion, sale and distribution of these products. Non-nicotine e-cigarette liquids will also fall under the FDA’s control if they are intended or reasonably expected to be used with or for the human consumption of a tobacco product (e.g. if intended to be mixed with liquid nicotine). 3 Products which make a therapeutic claim (such as being an aid in cessation) are regulated as pharmaceutical products and are required to undergo assessment by the US FDA’s Centre for Drug Evaluation and Research, which oversees the safety and efficacy of pharmaceutical products. 4 In 2022, the FDA received authorisation to regulate synthetic nicotine, having previously only had authority to regulate tobacco-plant based nicotine. 5
E-cigarette manufacturers in the US must comply with a range of provisions, such as submitting Premarket Tobacco Applications (PMTAs), reporting and registration. This also applies retroactively to products already on the market, whereby companies must seek authorisation to continue selling them in the US. Market authorisation is granted to products that have been determined by the FDA to be appropriate for the protection of human health, with respect to the risks and benefits of the product to the population, including users and non-users. 6
Packaging of e-cigarettes containing nicotine must include a prescribed warning statement alerting the consumer to the presence of nicotine in the product. Sale of e-cigarettes to minors is prohibited, and sale by vending machines is restricted to adult-only facilities. The Child Nicotine Poisoning Prevention Act of 2015 also requires child-resistant packaging for e-liquid containers containing nicotine.
In the US, state, tribal and local governments may introduce additional regulations applying to e-cigarette products including regulations regarding taxation of products, sales to minors and restrictions on advertising and promotion. 7
Canada
Since May 2018, e-cigarettes (regardless of nicotine content) are regulated under the Tobacco and Vaping Products Act (TVPA) 8 in Canada. They are also subject to either the Food and Drugs Act (FDA) 9 or the Canada Consumer Products Safety Act, 10 depending on the presence of therapeutic claims. For vaping products subject to the FDA, manufacturers must obtain marketing authorisation from Health Canada prior to sale.
The TVPA prohibits sales to minors, as well as the sending and delivery of vaping products to those under 18. It also bans advertising that is appealing to youth, and prohibits lifestyle advertising, as well as sponsorship promotion and the use of testimonials and endorsements. Display of e-cigarettes and packaging is prohibited at points of sale that would be seen by young persons.
The marketing and sale of e-cigarettes that contain certain additives is prohibited, and there are restrictions on the marketing of flavours used in vaping liquids. 8 The nicotine concentration of vaping products is limited to a maximum of 20 mg/ml. 8 E-cigarette packaging must display the necessary information on emissions, health hazards, and health effects as required by the Vaping Products Labelling and Packaging Regulations. 11
The use of e-cigarettes is prohibited in places where smoking is prohibited. Many subnational provinces and territories within Canada have additional restrictions on the use of e-cigarettes in public places and workspaces. 12
New Zealand
In New Zealand, the Medicines Act 1981 (Medicines Act) and the Smokefree Environments and Regulated Products Act 1990 (SFERPA) regulate the sale, advertising and use of e-cigarettes (the SFERPA having been amended in 2020 to include ‘vaping products’). The controls on vaping products in the SFERPA apply to both nicotine and non-nicotine products. Nicotine is a scheduled substance under the Medicines Act. It is illegal to sell a vaping product (with or without nicotine) while making a therapeutic claim unless it has been approved for that purpose.
In Philip Morris v Ministry of Health [2018] NZDC 4478, the District Court of New Zealand found that a heated tobacco product did not fall within a specific ban on oral tobacco products in the SFERPA but was still considered a tobacco product covered by the SFERPA. 13
The Smokefree Environments and Regulated Products (Vaping) Amendment Act 2020 brought vaping products under the SFERPA. It introduced restrictions on the advertising and sponsorship of vaping products, vaping in public spaces and e-cigarette flavours. Vaping is prohibited in workplaces, around schools and childcare centres, on public transport and in vehicles carrying children. Retailers such as milk bars, service stations and supermarkets are limited to selling only tobacco, mint and menthol flavoured e-cigarette products, while specialist e-cigarette retailers can sell any flavour of vaping products from their shops and websites as long as they are notified products. 14
In addition, products that look like a tobacco product or smoking pipe and can be used to simulate smoking (toy tobacco products) cannot be sold to a person under 18 years, even if they do not contain nicotine. 15
The Smokefree Environments and Regulated Products Amendment Regulations 2023 introduced further vaping requirements, including maximum nicotine levels, prescribed flavour descriptions and a ban on toy or cartoon images for reusable vaping devices. 16
United Kingdom (UK)
In the UK, e-cigarettes are primarily regulated under the Tobacco and Related Products Regulations 2016 (the Regulations). The UK Government endorses the use of e-cigarette products as part of a harm reduction strategy. E-cigarettes seeking to be regulated as medicines require approval through the standard licensing process. As of January 2024, no e-cigarette products have been licensed as a medicine. 17
Following the withdrawal of the UK from the EU, the regulations were amended under the Tobacco Products and Nicotine Inhaling Products (Amendment etc.) (EU Exit) Regulations 2019 and Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020. 12 However the regulations still implement the majority of the EU’s Tobacco Products Directive into the UK.
The nicotine concentration and additives used in e-cigarette e-liquid are subject to restrictions. Packaging of e-cigarettes and refill containers must be child- and tamper-proof, protected against breakage and leakage, and have a mechanism that ensures filling without leakage. The packaging must also include a prescribed warning statement alerting the consumer to the presence of nicotine in the product and constituent information. Sale of e-cigarettes to minors is prohibited and e-cigarette advertising and promotion is also restricted. 18 However, a loophole in the legislation allows retailers and manufacturers to provide free samples of e-cigarette products to people of any age.
18.14.1 Bans on sales and use
Sale of all types of e-cigarettes is banned in 34 countries. 19 In some countries, bans on sales cover nicotine e-cigarettes only, while in others, bans cover both nicotine and non-nicotine e-cigarettes. 18 Use of e-cigarettes is banned in at least 7 countries, including Cambodia, Iran, Nicaragua, Singapore, Syria, Taiwan and Venezuela. 12
18.14.2 Bans on sales to minors
At least 56 countries have introduced age restrictions for the purchase and/or use of e-cigarettes. 18 The majority of country laws set the minimum age to 18 years, with the exception of Jordan and South Korea, where the minimum age is 19 years, and Honduras, Kazakhstan, the US and Uzbekistan where the minimum age is 21. 12
The effectiveness of banning sales to minors is discussed in Section 18.10.2.
18.14.3 Restrictions on use in public places
At least 53 countries, 18 such as New Zealand, the Philippines and Slovenia, have bans or restrictions on the use of e-cigarettes in public spaces. 12
Use in vehicles with minors is prohibited in Cyprus (16 years), Finland (15 years), New Zealand (18 years) and Slovenia (18 years). In Cyprus, use in a personal vehicle while a pregnant woman is present is also prohibited. 20 In the UK, vaping while driving is not illegal, but police may penalise drivers if they believe it impacts their ability to drive safely, leading to charges of dangerous driving or driving without due care and attention. 21
In the US, many states and local councils have adopted their own laws regarding the use of e-cigarettes. As of 1 April 2024, there were 26 state laws restricting e-cigarette use in 100% smokefree venues (including bars, restaurants, gambling facilities and/or non-hospitality workplaces); 16 state laws restricting e-cigarette use in other venues (e.g. schools, state property, railways); 1,061 local laws restricting e-cigarette use in 100% smokefree venues; and 764 local laws restricting e-cigarette use in other venues. 22 In the UK, there are no national regulations concerning the use of electronic cigarettes in indoor public places, workplaces, or public transport. 12
The effectiveness of smokefree policies is discussed in Section 18.10.1.
18.14.4 Product safety requirements
Globally, at least 38 countries have regulations on child safety packaging of e-cigarettes. 18
In September 2015, 33 state attorneys general wrote to the US FDA, urging it to introduce a requirement for proper warning labels on liquid nicotine products and to adopt national standards for child-resistant packaging of liquid nicotine products. 23 The letter was put together in response to a dramatic increase in the incidence of liquid nicotine poisoning among children across the US. In December 2015, the US Senate approved national legislation requiring that nicotine e-liquid be sold in child-resistant packaging, consistent with US Consumer Product Safety Commission standards. The legislation entered into force on 28 January 2016. 2 4 , 25 The law maintains the FDA’s ability to regulate such packaging. The FDA has also indicated that it will introduce child-resistant packaging regulations for e-cigarettes and e-liquids but has not do so yet. 26
The EU Tobacco Products Directive mandated that e-cigarettes sold in Member States must adhere to safety standards (such as childproof fastenings and opening mechanisms) for e-liquid containers, cartridges and tanks by May 2016. 1
18.14.5 Regulation of e-liquid ingredients
18.14.5.1 Nicotine
At least 39 counties/jurisdictions regulate the concentration/volume of nicotine in e-cigarette products. 18 The EU, Canada, UK and a number of other countries limit the nicotine concentration in vaping products to a maximum of 20 mg/ml. 1 , 27 , 28 Regulations introduced in China in 2022 limited the total amount of nicotine per e-cigarette to 200 mg and the nicotine emissions of each puff to 0.2 mg. 29
18.14.5.2 Flavours
As of April 2024, at least seven countries have adopted ‘characteristic flavour’ bans which prohibit the sale of e-cigarette products with ingredients that impart a characteristic flavour or aroma, except for tobacco flavour. Bans on characterising flavours with the exception of tobacco flavours were first introduced in Finland in 2016 and have since been implemented in Hungary (May 2020), Lithuania (July 2022), China (October 2022), Ukraine (July 2023) and the Netherlands (January 2024), and are scheduled to be implemented in Latvia in August 2024. Denmark, Estonia and Slovenia also ban non-tobacco characterising flavours in e-cigarette products with the exception of menthol flavours. Characterising flavours have also been banned in some Canadian provinces and US states. 3 0 , 31
In the US, a federal policy towards e-cigarette flavours is being developed, though the US FDA has so far denied market authorisation to e-cigarettes with flavours other than tobacco and menthol. 30 A number of jurisdictions in the US have gone beyond the requirements of federal e-cigarette laws and have implemented bans on flavoured tobacco products and e-cigarettes, including California, Massachusetts and New York. 31 The effectiveness of flavour bans is discussed in Section 18.10.3.
18.14.5.3 Other ingredients
Several countries have also restricted e-cigarette ingredients that are potentially harmful or that could be perceived as having health benefits. The EU TPD requires Member States to ban the use of colouring agents; vitamins or other additives that create the impression of health benefits; caffeine, taurine and other stimulants; and any additives that have carcinogenic, mutagenic or reprotoxic (CMR) properties in unburnt form. 1 New Zealand’s Smokefree Environments and Regulated Products Regulations 2021 (Schedule 5) prohibit several categories of chemicals in e-cigarette e-liquids including CMR substances; chemicals with specific organ toxicities; sweeteners; vitamins; and vegetable and mineral oils. 32 Canadian laws generally prohibit products which are ‘a danger to human health or safety’ and also restrict the use of similar ingredients in e-cigarettes. 8 , 10 , 30 China introduced e-cigarette standards in 2022 that banned the use of CMR substances, additives and stimulants linked to energy and vitality, substances that could mislead consumers about health benefits or harm reduction, and substances that are only used for dyeing purposes. 29
For a detailed explanation of the chemicals found and produced by e-cigarettes and the health effects related to exposure to these chemicals see Section 18.5 and Section 18.6.
18.14.6 Health warnings
The placement of health warnings on e-cigarette packaging is also required in at least 51 countries. 18 Israel, Denmark and Finland also require plain packaging on all e-cigarettes and refill containers, and Uruguay prohibits brands/patents for e-cigarettes. 12 In the EU, e-cigarettes containing nicotine require health warnings advising consumers that the product contains nicotine. The warning must state either: “This product contains nicotine which is a highly addictive substance” or “This product contains nicotine which is a highly addictive substance. It is not recommended for non-smokers.” 1 Product packaging must also list ingredients, nicotine content and contain a leaflet with instructions for use and information on adverse effects, risk groups, addictiveness and toxicity. 33
US regulations require nicotine containing e-cigarettes to display the following health warning: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” E-cigarettes that do not contain nicotine but are made or derived from tobacco, require a label stating, “This product is made from tobacco”. 34
The effectiveness of e-cigarette health warnings is discussed in Section 18.10.4.
18.14.7 Taxes on e-cigarettes
At least 35 countries/jurisdictions have applied taxes to e-cigarettes, 18 use a specific excise tax based on volume and 15 apply an ad valorem tax. The majority of tax policies apply to only the e-cigarette e-liquid and in some countries only to nicotine-containing e-liquids. Taxes are also applied to e-cigarette accessories in Costa Rica and waste charges apply in the Republic of Korea per 20 cartridges. 18
In the UK, e-cigarettes regulated as consumer products are subject to a 20% VAT, however if they are regulated as medicines, they attract a 5% VAT levy. 20
Within the EU, the TPD allows Member States to decide whether to tax e-cigarettes; 14 EU countries have introduced e-cigarette taxes. 35 However, in 2015, tax policy makers in Europe began considering whether e-cigarettes should be covered by excise duty in all EU Member States, which would drastically increase their cost. 36 In late 2016, the European Commission began a public consultation on the taxing of e-cigarettes. The consultation period ended on 16 February 2017. Results of the consultation were released shortly thereafter, and showed that 90% of respondents were opposed to e-cigarettes and e-liquids carrying an excise tax. 37
In the US, there is currently no national tax on e-cigarettes however, at least 32 states have passed legislation requiring a tax on e-cigarettes. 38
The effects of e-cigarette tax policies are discussed in Section 18.10.5.
18.14.8 Restrictions on advertising and promotion
At least 78 countries/jurisdictions have introduced restrictions or bans on the advertising, promotion or sponsorship of e-cigarettes. 18 In the US, the FDA has the power to regulate the advertising and promotion of e-cigarettes and requires warnings on e-cigarette advertisements. 4 , 39 The FDA has taken regulatory action against e-cigarette products with packaging that strongly resembled candies, cookies and other snacks. 40 In the EU, the Tobacco Products Directive prohibits most advertising and sponsorship associated with e-cigarettes. 1 The Canadian Government bans the promotion of confectionary, dessert, cannabis, soft drink and energy drink-flavoured e-cigarettes. 30 In the Philippines, e-cigarette packaging, labelling and marketing cannot use flavour descriptors that unduly appeal to minors, including references to fruits, candy, desserts or cartoon characters. 41 Several countries, including China, Jordan, Moldova and Guyana, have expressly banned the online advertising and promotion of e-cigarettes. 42-45
The effects of advertising and promotion of e-cigarettes and the effectiveness of e-cigarette advertising bans is discussed in Section 18.2.
18.14.9 Notification and reporting
At least 43 countries/jurisdictions have regulations requiring pre-market notification for e-cigarettes, along with reporting on sales and other specified information. 18
In the EU, e-cigarette manufacturers are required to provide notification before bringing a product on the market through the EU Common Entry Gate. Companies must provide details of the ingredients, emissions and toxicity of e-cigarettes and refill containers through the standard reporting form. 46 , 47 In New Zealand, manufacturers are required to provide notification they intend to sell an e-cigarette product, and the name and amount of chemical ingredients contained in product. 30 Notifications must be renewed every 12 months. Any adverse reactions from products are also required to be reported. 48 In the UK, producers of e-cigarettes and refill containers must notify the Medicines and Healthcare products Regulatory Agency before placing them on the market. 49
In Costa Rica, manufacturers and importers must submit an annual notification to the Ministry of Health with information about ingredients, emissions and analysis methods. Additional notifications are required for modifications or reformulations. 50 In Canada, manufacturers and importers are required by the Vaping Products Reporting Regulations to electronically submit reports on vaping product sales and ingredients to Health Canada. The reporting frequency varies depending on the information provided. 51
Relevant news and research
For recent news items and research on this topic, click here ( Last updated December 2024)
References
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