18B.9 International regulatory overview

Last updated: January 2019            

Suggested citation: Greenhalgh, EM, Grace, C & Scollo, MM. InDepth 18B: Electronic cigarettes (e-cigarettes), Section 18B.9 International regulatory overview. In Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2019. Available from: http://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/indepth-18b-e-cigarettes/18b-9-regulatory-overview   

To date, most countries do not have laws that relate specifically to e-cigarettes. A small number have introduced or are in the process of introducing specific regulations, while others have introduced outright bans. The three main approaches to regulation are to treat e-cigarettes as tobacco products, as consumer products, and/or as medicinal products.1 For a detailed summary of regulations in Australia, see Section 18B.8, and for a country-by-country summary of the legal/regulatory status of e-cigarettes, see Table 18B.9.1.

European Union

In February 2014, the 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. E-cigarettes containing up to 20mg/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 10ml for dedicated refill containers and 2ml for electronic cigarette cartridges and tanks
  • Safety mechanisms (such as childproof fastening and opening) 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, and 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.
  • Member States will be able to introduce extra safeguards, for example on age-limits and flavourings in electronic cigarettes.2

United States of America

In the US, the Food and Drug Administration (FDA) formalised its arrangements so that all electronic 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.  This rule gives the FDA regulatory control over the manufacture, import, packaging, labelling, advertising, promotion, sale and distribution of these products.  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.3  

E-cigarette manufacturers in the US must comply with a range of provisions, such as submitting tobacco marketing applications, reporting and registration. 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.

Canada

Since May 2018, e-cigarettes (regardless of nicotine content) are regulated under the Tobacco and Vaping Products Act (TVPA) in Canada. They are also subject to either the Food and Drugs Act (FDA) or the Canada Consumer Products Safety Act, 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 on sponsorship promotion and the use of testimonials and endorsements. 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. E-cigarette packaging must display the necessary information on emissions, health hazards, and health effects as required by regulation (currently under development).4

New Zealand

In New Zealand, the Medicines Act 1981 and the Smoke-free Environments Act 1990 (SFEA) regulate the sale, advertising and use of e-cigarettes. 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 found that all tobacco products (except types that are chewed or otherwise absorbed through the oral mucosa e.g. snus) may be lawfully imported, sold and distributed under the SFEA. Therefore, the same SFEA regulatory controls, including the ban on sales to minors and restrictions on advertising, apply to smoked tobacco, heated tobacco and vaping products that are manufactured from tobacco. 

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.5

Although smokefree legislation does not currently apply to e-cigarettes, the New Zealand government has announced that the SFEA will be amended to ban vaping where smoking is prohibited.6

18B.9.1 Bans on sales

At least 49 countries have introduced age restrictions for purchasing e-cigarettes, ranging from 15 in Ivory Coast to 21 in Honduras.1

Regulations such as these might not be completely effective in preventing use by teenagers. Several studies in the US have demonstrated that despite laws banning the purchase of e-cigarettes by minors and requiring online vendors to verify customer age, teens can easily buy e-cigarettes online.9, 10 In the UK, compliance testing found that almost 40 per cent of retailers illegally sold nicotine e-cigarettes and vaping liquids to minors.11

18B.9.2 Bans on sales to minors

At least 49 countries have introduced age restrictions for purchasing e-cigarettes, ranging from 15 in Ivory Coast to 21 in Honduras.1

Regulations such as these might not be completely effective in preventing use by teenagers. Several studies in the US have demonstrated that despite laws banning the purchase of e-cigarettes by minors and requiring online vendors to verify customer age, teens can easily buy e-cigarettes online.9, 10  In the UK, compliance testing found that almost 40 per cent of retailers illegally sold nicotine e-cigarettes and vaping liquids to minors.11

18B.9.3 Bans on use in public places

Use of e-cigarettes is banned in several countries, including Cambodia, Jordan, Nepal, Panama, Turkmenistan and the United Arab Emirates.4 A number of other countries, such as Belgium, Greece, South Korea, and Turkey, have banned their use in enclosed public spaces and on public transportation.4   

Use in vehicles with minors is prohibited in Cyprus (18 years), Finland (15 years) and Slovenia (18 years). In Cyprus, use in a personal vehicle while a pregnant woman is present is also prohibited.12

In the US, many states and local councils have adopted their own laws regarding the use of e-cigarettes. As of January 2019, there were 15 state laws restricting e-cigarette use in 100% smokefree venues; 16 state laws restricting e-cigarette use in other venues; 814 local laws restricting e-cigarette use in 100% smokefree venues; and 671 local laws restricting e-cigarette use in other venues.13 In the UK, electronic cigarettes are generally not regulated under smokefree laws, although this has been considered in Wales.14 However, individual premises may ban their use.15  

18B.9.4 Product safety 

In September 2015, 33 state attorneys general wrote to the 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.16, 17 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 was approved by the House of Representatives in January 2016, and appears to have entered into force on 28 January 2016.18, 19

 The EU Tobacco Products Directive mandated that e-cigarettes sold in Member States must adhere to safety standards (such as childproof fastening and opening) for e-liquid containers, cartridges and tanks by May 2016.2

Globally, as of November 2018, 31 countries have regulations on child safety packaging (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, England, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Northern Ireland, Philippines, Poland, Portugal, Romania, Scotland, Slovakia, Slovenia, Spain, Sweden, United States and Wales), and 38 countries mandate the placement of health warnings on e-cigarette packaging (Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, England, Estonia, Finland, France, Georgia, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Maldives, Malta, Moldova, Netherlands, New Zealand, Northern Ireland, Poland, Portugal, Republic of Korea, Romania, Scotland, Slovakia, Slovenia, Spain, Sweden, Tajikistan, United States and Wales).4

18B.9.5 Taxation

When e-cigarettes are privately imported into Australia, they are not classed as tobacco products and are therefore not subject to customs duty. They are also not subject to GST if their customs value is at or below A$1,000.20 Outside of the EU and some US states, only Bangladesh, Indonesia, Kenya, Russia, Serbia and South Korea have applied special taxes to e-cigarettes.1 Italy also had an e-cigarette tax, but in 2018 reduced its tax on e-liquids by 90% on non-nicotine-containing liquids and 80% on those that contain nicotine.21

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.12  

Within the EU, the TPD allows Member States to decide whether to tax e-cigarettes; 13 EU countries have introduced e-cigarettes taxes.1 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.22 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 release shortly thereafter, and showed that 90% of respondents were opposed to e-cigarettes and e-liquids carrying an excise tax.23 A second consultation has recently been launched.1

In the US, there is currently no unified policy regarding the taxing of e-cigarettes. While most states do not impose an excise on e-cigarettes, several states have introduced taxes. These include California, Delaware, District of Columbia, Kansas, Louisiana, Minnesota, New Jersey, North Carolina and Pennsylvania.24   

Some researchers have suggested that lower taxes on e-cigarettes (and other non-combustible nicotine-yielding products) that are determined or deemed likely to pose significantly fewer risks than combustible tobacco products could significantly hasten the move away from cigarette smoking.25, 26  

18B.9.6 Advertising and promotion

Many countries have introduced restrictions or bans on the advertising, promotion or sponsorship of e-cigarettes, including Canada, Japan, New Zealand, and Norway.4 In the USA, the Food and Drug Administration has the power to regulate advertising and promotion of e-cigarettes.3 In the EU, the Tobacco Products Directive prohibits most advertising and sponsorship associated with e-cigarettes.2

 

Table 18B.9.1 
Global legal/regulatory status of e-cigarettes


Source: Shapiro H. No fire, no smoke: The global state of tobacco harm reduction. 2018.1  

Relevant news and research

For recent news items and research on this topic, click here (Last updated January 2019)   

References

1. Australian Institute of Health and Welfare. National Drug Strategy Household Survey (NDSHS) 2016 key findings data tables. Canberra: AIHW, 2017. Available from: https://www.aihw.gov.au/reports/illicit-use-of-drugs/2016-ndshs-detailed/data

1. Shapiro H. No fire, no smoke: The global state of tobacco harm reduction 2018. Knowledge-Action-Change, London 2018. Available from: https://gsthr.org/downloads/GSTHR%20Report/Global-State-of-Tobacco-Harm-Reduction-2018.pdf.

2. European Commission. Revision of the Tobacco Products Directive. 2014. Available from: http://ec.europa.eu/health/tobacco/products/revision/index_en.htm

3. US Food and Drug Administration (FDA). FDA's new regulations for e-cigarettes, cigars, and all other tobacco products. 2016. Available from: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm394909.htm

4. Institute for Global Tobacco Control, Country laws regulating e-cigarettes: A policy scan. John Hopkins: Bloomberg School of Public Health; 2018. Available from: http://globaltobaccocontrol.org/e-cigarette/country-laws-regulating-e-cigarettes.

5. New Zealand Ministry of Health. Vaping and smokeless tobacco.  2018. Available from: https://www.health.govt.nz/our-work/preventative-health-wellness/tobacco-control/vaping-and-smokeless-tobacco.

6. Russell W. Govt announces proposed plans to ban vaping in bars, restaurants and workplaces NZ Herald,  2018. Available from: https://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=12165031

7. E-cigarette politics. E-cigarette laws worldwide. 2014. Available from: 

http://www.ecigarette-politics.com/electronic-cigarettes-global-legal-status.html

 


8. Neporent L. E-cig makers fuming over CVS tobacco ban. abcnews.go.com, 2014. Available from: http://abcnews.go.com/Health/cigarette-makers-fuming-cvs-tobacco-ban/story?id=25229979

9. Nikitin D, Timberlake DS, and Williams RS. Is the e-liquid industry regulating itself? A look at e-liquid internet vendors in the United States. Nicotine & Tobacco Research, 2016. Available from: http://ntr.oxfordjournals.org/content/early/2016/04/01/ntr.ntw091.abstract

10. Williams RS, Derrick J, and Ribisl KM. Electronic cigarette sales to minors via the internet. JAMA Pediatrics, 2015; 169(3):e1563. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25730697

11. Chartered Trading Standards Institute. Study shows four in ten retailers flout laws on nicotine inhaling products. 2016. Available from: http://www.tradingstandards.uk/extra/news-item.cfm/newsid/1950

12. Institute for Global Tobacco Control. Policy domains. 2016. Available from: http://globaltobaccocontrol.org/e-cigarette/policy-domains

13. American Nonsmokers' Rights Foundation. States and municipalities with laws regulating use of electronic cigarettes. 2019. Available from: https://no-smoke.org/wp-content/uploads/pdf/ecigslaws.pdf

14. No authors listed. E-cigarettes face curb in public places in Wales. BBC News, 2014. Available from: http://www.bbc.com/news/uk-wales-26837682

15. Action on Smoking and Health, Electronic cigarettes. London: ASH; 2014. Available from: http://www.ash.org.uk/files/documents/ASH_715.pdf.

16. Shaji R. US states urge FDA to ensure warnings on liquid nicotine products. Reuters,  2015. Available from: http://www.reuters.com/article/2015/09/29/us-usa-ecigarettes-warnings-idUSKCN0RT2NZ20150929

17. Schneiderman E. A.G. Schneiderman and 32 attorneys general sound alarm on dangers of e-cigarettes, urge FDA to require child-resistant packaging and health warnings on all liquid nicotine sales. Office of New York State Attorney General US 2015 Available from: http://www.ag.ny.gov/press-release/ag-schneiderman-and-32-attorneys-general-sound-alarm-dangers-e-cigarettes-urge-fda.

18. Myers ML. Tobacco Free Kids welcomes congressional approval of child nicotine poisoning prevention act. Campaign for Tobacco-Free Kids (CTFK),  2016. Available from: http://www.tobaccofreekids.org/press_releases/post/2016_01_11_nicotine

19. Child Nicotine Poisoning Prevention Act of 2015 (public law no: 114-116 (01/28/2016). Available from: https://www.congress.gov/bill/114th-congress/senate-bill/142.

20. Australian Customs and Border Protection Service, Tobacco – frequently asked questions. Australian Government; 2015. Available from: http://www.customs.gov.au/faq/AlcoholCigTobacco2.asp#Q365.

21. Caruana D. Italy celebrates huge reductions in excise tax on e-liquids. Vaping Post,  2018. Available from: https://www.vapingpost.com/2018/11/30/italy-celebrates-huge-reductions-in-excise-tax-on-e-liquids/

22. No authors listed. Wirral Euro MP blasts e-cigs tax plan. Wirral Globe, 2015. Available from: http://www.wirralglobe.co.uk/news/11804849.Wirral_Euro_MP_blasts_e_cigs_tax_plan/

23. European Commission. Public consultation on excise duties applied to manufactured tobacco.  Available from: https://ec.europa.eu/taxation_customs/consultations-get-involved/tax-consultations/public-consultation-excise-duties-applied-manufactured-tobacco_en.

24. Public Health Law Centre. US e-cigarette regulation: A 50 state review. 2018. Available from: https://publichealthlawcenter.org/resources/us-e-cigarette-regulations-50-state-review

25. Chaloupka FJ, Sweanor D, and Warner KE. Differential taxes for differential risks—toward reduced harm from nicotine-yielding products. New England Journal of Medicine, 2015; 373(7):594–7. Available from: http://www.nejm.org/doi/full/10.1056/NEJMp1505710

26. Stoklosa M, Drope J, and Chaloupka FJ. Prices and e-cigarette demand: Evidence from the European Union. Nicotine & Tobacco Research, 2016. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27085083

 

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