18B.9 International regulatory overview

Last updated: September 2017     

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; 2016. Available from: http://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/indepth-18b-e-cigarettes/18b-9-regulatory-overview   

Internationally, at least 79 countries have legislation in place which applies to various aspects of use, sales, promotion and taxation of e-cigarettes.1 About two-thirds of large countries have implemented some type of e-cigarette regulation, usually using existing laws relating to tobacco or nicotine.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
 

According to a report by the Institute for Global Tobacco Control, as at 31 December 2016 a total of only 14 of the 28 EU countries had implemented the TPD provisions regarding e-cigarettes.3 The report notes that among the countries that have implemented the TPD, there are inconsistencies or variations in how certain provisions are implemented, and that these inconsistencies have the potential to present challenges for enforcement. There were, however, a number of countries which had implemented laws transcending the TPD. For example, Denmark, Germany and Malta have applied the TPD to non-nicotine e-cigarettes, while Estonia, Germany and Lithuania have prohibited the use of e-cigarettes by minors. 

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.4

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. 

18B.9.1 Bans on sales

Sale of all types of e-cigarettes is banned in Argentina, Bahrain, Brazil, Brunei Darussalam, Cambodia, Colombia, Gambia, Greece, Jordan, Kuwait, Lebanon, Mauritius, Nepal, Nicaragua, Oman, Panama, Qatar, Saudi Arabia, Seychelles, Singapore, Suriname, Thailand, Turkey, Turkmenistan, Uganda, United Arab Emirates and Uruguay.1 A two-tier system is in place in some other countries, whereby non-nicotine e-cigarette sales are permitted, but nicotine e-cigarettes face additional restrictions or bans. Examples of this system include Canada, Hong Kong, Hungary, Japan, Mexico, and Norway. 1, 5 While New Zealand has traditionally operated under a two-tier system (with a prohibition on the sale of nicotine e-cigarettes), the New Zealand government recently announced that it intends to legalise the sale of nicotine e-cigarettes in late 2018.6, 7 As with traditional cigarettes, pharmacy chain CVS in the US has banned the sale of e-cigarettes in its stores.8

18B.9.2 Bans on sales to minors

Sales to people aged under 18 are banned in the USA.4 Other countries with a similar ban in place include the United Kingdom, Norway, Vietnam, France, Spain, Italy and Ecuador.9 In the Republic of Korea9 and Ontario10 e-cigarettes must not be sold to anyone younger than 19 years old, while Honduras restricts sales to those 21 and over.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.11,12 In the UK, recent compliance testing found that almost 40 per cent of retailers illegally sold nicotine e-cigarettes and vaping liquids to minors.13   

18B.9.3 Bans on use in public places

Use of e-cigarettes is banned in Cambodia, Jordan, Nepal, Panama, Turkmenistan and the United Arab Emirates.1 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.1   

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.9

In the US, many states and local councils have adopted their own laws regarding the use of e-cigarettes. As of July 2017, there were twelve states and 661 local laws that restrict e-cigarette use in some or all types of smokefree venues. There were also 15 states and over 500 local laws that restrict e-cigarette use in other venues, such as schools, universities, hospitals, or prisons.14   

In the UK, electronic cigarettes are generally not regulated under smokefree laws, although this has been considered in Wales.15 However, individual premises may ban their use.16 In Scotland, patients and visitors may not use electronic cigarettes in hospital grounds.17

18B.9.4 Product safety 

The North Carolina Senate passed a bipartisan bill in April 2015 that would make child-resistant packaging and warning labels mandatory for liquids used with e-cigarette vaporizers.18 New York State also introduced legislation requiring childproof packagingof nicotine e-liquid in 2014.19 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.20, 21 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 2016.22, 23

Other international jurisdictions with regulations in place regarding child-safe packaging of e-cigarette liquids include Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, England, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Northern Ireland, Philippines, Poland, Portugal, Romania, Scotland, Slovakia, Slovenia and Wales.9

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

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$1,000.24  

Togo’s tobacco excise tax (which covers e-cigarettes) is 45 per cent, and South Korea also applies a special tax to e-cigarettes.1 In Italy, the tax on e-liquid for 2017 is 0.393 euros per mL. There is also a 22% Value Added Tax (VAT) on the retail price.9 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.9  

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.25 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.26 An Impact Assessment Report regarding the proposed duty and the consultation results is due to be release in late 2017.26

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, a number of states have introduced taxes. These include California, Louisiana, Minnesota, North Carolina and Pennsylvania.27 New York State has also proposed taxing and regulating e-cigarettes the same way as tobacco cigarettes.28  

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.29, 30    

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.1 In the USA, the Food and Drug Administration has the power to regulate advertising and promotion of e-cigarettes.4 In the EU, the Tobacco Products Directive prohibits most advertising and sponsorship associated with e-cigarettes.2

Recent news and research

For recent news items and research on this topic, click here (Last updated August 2017)    

 

References 

1. Institute for Global Tobacco Control, Country laws regulating e-cigarettes: A policy scan. John Hopkins: Bloomberg School of Public Health; 2015. Available from: http://globaltobaccocontrol.org/e-cigarette/country-laws-regulating-e-cigarettes .

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

3. Awopegba A, Kennedy RD, and Cohen J. Approaches to Transposing the European Union Tobacco Products Directive E-cigarette Rules into Legislation by European Union Member States. Johns Hopkins, Bloomberg School of Public Health, 2017. Available from: https://www.jhsph.edu/research/centers-and-institutes/institute-for-global-tobacco-control/_pdfs/posters-and-presentations/2017/SRNT%20Awopegba%20E-cigarette%20Scan.pdf.

4. 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

5. E-cigarette politics. E-cigarette laws worldwide. 2014. Available from: http://www.ecigarette-politics.com/electronic-cigarettes-global-legal-status.html

6. No authors listed. Government legalises e-cigarettes in effort to make New Zealand smokefree by 2025, in Independent Newspapers Ltd. / STUFF (nz)2017. Available from: http://www.stuff.co.nz/manawatu-standard/business/90962129/Government-legalises-e-cigarettes-in-effort-to-make-New-Zealand-smokefree-by-2025.

7. Jones N. E-cigarettes will be legalised: Government NZ Herald 2017. Available from: http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11827700

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

10. Government of Ontario. Electronic cigarette (vape) rules. 2016. Available from: https://www.ontario.ca/page/electronic-cigarette-vape-rules?_ga=1.71018320.1523457166.1466666528

11. 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

12. 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

13. 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

14. American Nonsmokers' Rights Foundation. States and Municipalities with Laws Regulating Use of Electronic Cigarettes. 2017. Available from: http://www.no-smoke.org/pdf/ecigslaws.pdf

15. 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

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

17. Rutherford N. E-cigarettes to be banned from Scotland hospital grounds. BBC Online, 2015. Available from: http://www.bbc.com/news/uk-scotland-south-scotland-31360682

18. No authors listed. North Carolina passes child resistant packaging bill for e-cigarettes. Packaging Business Review, 2015. Available from: http://www.packaging-business-review.com/news/north-carolina-passes-child-resistant-packaging-bill-for-e-cigarettes-230415-4560213

19. Lindblom EN. Effectively regulating e-cigarettes and their advertising—and the first amendment. Food & Drug Law Journal, 2015; 70:57–94. Available from: http://www.law.georgetown.edu/oneillinstitute/news/documents/March10-LindblomFDLJ_001.pdf

20. Shaji R. U.S. states urge FDA to ensure warnings on liquid nicotine products, in Reuters2015. Available from: http://www.reuters.com/article/2015/09/29/us-usa-ecigarettes-warnings-idUSKCN0RT2NZ20150929.

21. 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.

22. Myers ML. Tobacco-Free Kids welcomes congressional approval of Child Nicotine Poisoning Prevention Act, in Campaign for Tobacco-Free Kids (CTFK)2016. Available from: http://www.tobaccofreekids.org/press_releases/post/2016_01_11_nicotine.

23. 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.

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

25. 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/

26. 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.

27. Public Health Law Centre, Tobacco Control Legal Consortium. US E-cigarette Regulation: A 50 State Review. Available from: http://www.publichealthlawcenter.org/sites/default/files/E-Cigarette-Legal-Landscape-50-State-Review-June-2017.pdf

28. No authors listed. NYSSA rallied in opposition to recently proposed legislation seeking to tax electronic cigarettes and ban indoor use PR Newswire 2015. Available from: http://www.prnewswire.com/news-releases/nyssa-rallied-in-opposition-to-recently-proposed-legislation-seeking-to-tax-electronic-cigarettes-and-ban-indoor-use-300043664.html

29. 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

30. 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


 

      Previous Chapter Next Chapter