* 23/05/2016 - Please note that this page is now outdated and due to be updated soon.
General information Global e-cigarette legal situation, country by country Airlines and transport Local authorities Property owners and Employers
1. General Information
Updates Information on this page may not be current, please check with appropriate government agencies if you need reliable up-to-date facts.
Purpose of use E-Cigarettes and refills are consumer products sold as and used for replacement of smoking, as a consumer alternative. They are neither a tobacco product (as the nicotine can come from any suitable vegetable source or be synthesised) nor a pharmaceutical product (as there is no intention to treat or cure a disease) or to assist smoking cessation (smoking may be regarded as a disease by State agencies although this is untested at law). E-Cigarettes are strictly a consumer purchase, used as an alternative to tobacco cigarettes, for ongoing use. No intention to cease nicotine or inhalation habits is assumed by purchasing such a product; it is designed and sold specifically for continuation of such use.
Pharmaceutical licensing / bans No medical licenses have been issued in any country for any e-cigarette or nicotine-containing refill (at Q1 2013), so where medical licenses and prescriptions are said to be required, a ban is in place. A 'license' is a pharmaceutical license, also known as an MA or market authorisation to sell a product as a licensed medicinal product.
More information The latest information for practical purposes can be obtained from community members or vendors on the appropriate forums, national consumer association websites, or trade association websites. Facebook groups are useful for immediate advice:
Note: there is a difference between personal import and commercial import, and this applies in almost every country. For example in a country where e-cigarette or nicotine refill import is banned, it is usually the case that this applies to commercial imports through Customs. Personal packages via the postal service are often not affected.
Hardware and zero-nic refills are permitted. Health Canada attempts to prevent sales of nicotine-containing refills (and imports), but this update from Paul Bergen suggests that there is no legal basis for such action: E-Cigarettes are NOT banned in Canada
In practice it appears that sales of the hardware are allowed, zero-nic refills are allowed; and nicotine refills are not prohibited by any law; but HC is bullying vendors to try and prevent nic refills from being sold. It is reported that vendors who refuse to submit to illegal threats cannot be prosecuted, since there is no law applicable. In this climate various difficulties will be experienced, but a prosecution does not seem likely.
A state pharmaceutical agency ban on e-cigarettes has been overturned in court, on 7th March 2013, in litigation brought by E-Lites. The agency now has to remove the ban since they missed the appeal date.
The Estonian State Agency of Medicines had banned ecigs but was ordered by the Tartu District Court to remove the ban. This decision is in respect of the E-Lites brand, but as in other countries will in effect apply to all ecigs if the Agency does not appeal or if the decision is upheld on appeal (as costs have been awarded against the Agency, and since further bans would attract more awards of costs against them).
The government had until 7th April 2013 to contest the decision but missed the deadline, therefore e-cigarette import, sale and use are permitted in Estonia by order of the court.
EUROPEAN UNION, EU - Import, sale and use is permitted.
Individual countries have their own regulations. One vendor tells us: "In practice only three EU countries are problem-free for import for us: UK, Germany, Italy". We think this may be a slight over-estimation as for example Holland and Czech Republic are (in theory) unrestricted. Many vendors say postal supplies to customers are hardly ever problematic.
The new TPD, Tobacco Products Directive, will ban nicotine-containing refills if it passes the required Council and Parliament voting stages. This is not expected until 2014, though it may be pushed through more quickly. Note that EU law is superior to national law within the 27 countries; all EU regulations are deemed to be in force and must be complied with.
Applicable law: Directive 2001/95/EC(6) on general product safety applies in so far as there are no specific provisions with the same objective in other EC law. This directive provides for restrictive or preventive measures to be taken if the product is found to be dangerous to the health and safety of consumers. Whether e-cigarettes could be regarded as falling under Directive 93/42/EEC on medical devices depends on the claimed intended use and whether this intended use has a medical purpose. ”It is for each national authority to decide, account being taken of all the characteristics of the product, whether it falls within the definition of a medicinal product by its function or presentation.“ http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/...(2008)
The EU Tobacco Products Directive The TPD covers all tobacco and related products. Currently being revised, at Q1 2013 it appears that in addition to continuation of the Snus ban (except within Sweden, which has a derogation - an exemption), it will include a ban on nicotine-containing refills of over 4mg/ml (0.4%). This is lower than the lowest retail strength of 6mg/ml (retail e-liquid is available from 6mg/ml to 45mg/ml), so in effect is a ban on usable refills. This ban is by virtue of the refills being classed as a pharmaceutical. The EU Health Commission, who are responsible for the TPD, appear to have decided that a blanket ban on the hardware could not be supported at law (as all five legal challenges to government bans have so far succeeded in court [USA, Holland, Germany x2 States, Estonia] and this route is likely to fail), but that nicotine-containing liquids may be easier to ban.
However the latest opinion we hear is that if the new TPD includes the ecig refill ban, it will fail at law: a challenge in the ECJ is likely to succeed in overturning it. This is because it violates three principles of EU law, and because there is also supporting case law: the ECJ have already overturned an unjustified attempt by the pharmaceutical industry to ban a consumer product of a similar nature. The courts, it seems, invariably side with the citizens against governments and their pharmaceutical industry clients.
The new TPD will need to pass two votes: the Council of Ministers (here, the Health Ministers for the 27 EU countries) and the EU Parliament. We expect the Ministers to support the TPD since they generally act to support the pharmaceutical industry, who like the cigarette trade are the main beneficiaries of such a ban (in addition to governments, who would lose tobacco tax revenue if e-cigarettes replace tobacco cigarettes); but many MEPs will vote against the new TPD in the EU Parliament because of increased awareness of its immensely damaging effect on public health. The timescale is not known at this time, but originally it was said that the process will not complete before 2014 or even 2015. Some EU insiders, though, say that the process may be pushed hard by those who stand to benefit, in order to complete by September 2013 before the end of the current session.
April 2013 update Intense pressure is being exerted to push the TPD through before the September end of session. The TPD is being taken through hearings incommittees that have an interest in the outcome: IMCO (inter-country trade) and ENVI (health and environment), for example. Each committee has produced a set of its own preferred 'amendments to the amendments'. It is clear that intense horse-trading is taking place between the three main voting blocks(the pharma seats, the tobacco seats, and the anti-tobacco seats).
A rather worrying event is that a Plan B and Plan C have now appeared, in the event that the ECJ rejects pharmaceutical classification of the refills:
a. It has been suggested in one set of amendments that all products of any kind, when sold by an e-cigarette vendor, would be able to be classified as 'a tobacco product' at any time (e.g. if/when the ECJ rejects a pharmaceutical classification). This would enable them to be banned as 'novel tobacco products'.
b. In addition, other amendments have been tabled that would allow a single committee meeting in Brussels to make major policy changes on tobacco law, as needed, without going through the current tiresome democratic process. In other words: they would be able to hold a committee meeting and ban any/all e-cigarette product/s.
It may be that the latter particularly aggressive amendment will not pass due to being illegal in terms of EU process; but the ability to re-classify ecig products as tobacco products would certainly allow them to be removed, if not immediately, then by stages. A tobacco product classification would be 99% as effective as a pharmaceutical one for removing ecigs when convenient.
It should be noted that the entire EU legislative process in the health / tobacco / pharma product areas clearly works to protect cigarette sales and pharmaceutical industry income. This is the biggest obstacle to the future survival of e-cigarette sales, since the saving of life is not even on the agenda. As a clear example of this, Sweden is the world leader in the reduction of smoking-related disease and death, in which areas it is not only a very long way ahead of any other European country but also in the enviable position of having a realistic chance of reducing smoking mortality to insignificant proportions (a goal absolutely beyond the reach of any other country).
Nevertheless, the EU committees are trying their hardest to stop Sweden's ability to continue progress, and are even trying to reverse the drop in smoking and increase it again in Sweden. This is probably the clearest indication of the fact that public health is not the goal in these EU decisions: votes are split between various factions, but pharma and the cigarette trade seem to have the largest blocks.
All factions see e-cigarettes as a serious threat that must be removed, since they will (1) cut cigarettes sales; (2) hurt pharma income badly due to (a) the removal of a significant part of the vast and hugely profitable drug market for the treatment of sick smokers, plus (b) the improvement in overall public health likely to result, reducing drug sales across the board, plus (c) will reduce sales of smoking cessation drugs (the smallest of the three impact areas); and (3) will make the tobacco control industry all but obsolete (as is the case in Sweden). Public health and e-cigarettes have very few friends in Brussels: there is no money in it.
FRANCE - Partial permission.
E-Cigarettes and nicotine liquid are considered to be consumer goods regulated by general product safety regulations, unless they meet the criteria for medical licensing: if they claim to be for smoking cessation; or if the amount of nicotine in the cartridge is greater than or equal to 10 mg; or if the nicotine strength in a refill is more than or equal to 20mg/ml. http://www.afssaps.fr/Infos-de-securite/Communiques-Points-presse/L-Afss...
FINLAND - Partial permission.
Nicotine-free liquids and e-cigarette devices can both be sold in Finland.
"Any e-cigarette suppliers are allowed to do business in Italy but only Categoria [the 'Categoria' brand] has official approval. This was obtained after extensive product testing." - Prof R Polosa, U.o.Catania.
Government statement: "The Categoria brand of e-cigarettes (including those with nicotine) are the only one approved by the Italian Institute of Health. However, precise legislation (particularly in relation to the liquid contained in the e-cigarette) does not currently exist (neither in Italy nor at a global level) and this will be required at some stage to guarantee the safety of consumers. We are now working towards this direction." http://www.ecigarettedirect.co.uk/ashtray-blog/2011/10/electronic-cigare...(2011)
This reveals an interesting situation in which Italy may be unique: a brand of e-cigarette has been approved by the Institute of Health, with government backing, without a pharmaceutical license.
E-cigarettes may be sold to individuals over 18 years old.
MALAYSIA - Banned.
Electronic cigarettes are considered medical devices and nicotine cartridges as medicinal products. They will be available for purchase over the counter at a pharmacy at a later date, if pharmaceutical licenses can be obtained.
MALTA - Permitted.
Sale and use is permitted, but e-cigarettes fall under the Tobacco Act. They cannot be advertised, they cannot be used in enclosed public spaces, and they can only be used by adults over the age of 18. http://www.maltatoday.com.mt/2010/01/10/t14.html (2010)
Sale, production, distribution, importation or advertisement of any kind are forbidden because the design is too similar to a tobacco product.
NETHERLANDS - Permitted. (Nederland, Holland)
Import, sale and use are permitted.
The government attempted a blanket ban, but it was overturned at law: the 's-Gravenhage court in Holland legalised the import and sale of electronic cigarettes and nicotine-containing e-liquids, in a civil court case 414117/KGAZ 12-209. Judgement is as follows:
1. The court allows e-cigarettes to be imported from outside the EU to be sold in The Netherlands and prohibits the Dutch Government from actions against the import and sales. (The government had imposed a ban on import and sale, based on pharmaceutical classification.) 2. The court ruled that electronic cigarettes are not to be considered pharmaceutical products. (13 March 2012) http://zoeken.rechtspraak.nl/resultpage.aspx?snelzoeken=true&searchtype=...
Due to the size of the country and its separate regions, it may be expected that there is some variation in local application of laws.
Restrictions based on pharmaceutical licensing have been proposed, as for many other countries.
SINGAPORE - Banned.
Import, distribution and sale is prohibited.
Section 16 (1) of the Tobacco (Control of Advertisements and Sale) Act, enforced by the Health Sciences Authority (has) prohibits the importation, distribution, sale or offer for sale of any confectionery or other food product or any toy or other article designed to resemble a tobacco product or packaging which is designed to resemble the packaging commonly associated with tobacco products. Fine is of up to $5, 000 upon conviction. http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/to...(2010)
SOUTH AFRICA - Unclear.
It is believed that a ban may be in force on imports.
Import, sale, advertising and use are permitted. There are some restrictions on advertising.
The UK is, as far as we are aware, the only country in the world where e-cigarettes are comprehensively and effectively regulated at this time.
All standard consumer protections are in force; this means that about 16 separate laws apply to e-cigarettes, refills and ancillaries, and these regulations are enforced at local level by the Trading Standards Institute's inspectors. The ECITA e-cigarette trade association website has a full listing of applicable statutes - PDF, Section 3, p13. There are regulations covering but not limited to: CE marks and associated certification, labelling, packaging, contaminants, electrical safety, consumer sales protection, therapeutic claims, marketing claims.
Customs & Excise control imports, the products are GSP (General Sales Products) and unrestricted in any way. The Dept. of Business oversees consumer product sales, and has enforcement duties shared with the Trading Standards Institute, who provide the inspection, analysis and enforcement staff at local level.
No therapeutic claims are permitted since this implies a medicinal function and an MA would be required (a pharmaceutical license). Therefore, if e-cigarettes are marketed as a smoking cessation aid, they must be licensed as a medicine by the MHRA, Medicines and Healthcare Products Regulatory Agency (this functionality is considered medicinal). The MHRA has served enforcement on rogue traders who marketed their products as a smoking cessation aid.
As a smoking alternative, however, e-cigarettes are a consumer product and unrestricted by medical and tobacco control legislation.
The MHRA attempted to ban e-cigarettes in 2010 but were stopped by the RPC, a higher government agency; however it is expected that they will continue to try to prevent the sale of e-cigarettes if possible (being the pharmaceutical industry's legal arm, in practice), and have stated their intention to do so, and that they will report again by Q2 2013. They have two options in order to successfully outmanoeuvre higher government instructions: (a) to obtain a legal ruling that classes e-cigarettes (or their refills) as a pharmaceutical; (b) to persuade government that regulation of all nicotine-containing products (except cigarettes) is required for consumer safety, typically by 'light-touch' regulations.
Option (a) is unlikely to succeed as it has routinely been rejected by courts worldwide. Option (b) may be more successful, and once the legal framework is in place, the regulations can be gradually tightened in order to remove ecigs from the market.
We expect this route to be followed; although the MHRA may wait for the EU to accomplish this for them in c. 2014, since a legal challenge in Strasbourg (at the EU courts) would be far more difficult and expensive. While in the UK there is a direct route for a legal challenge to regulations implemented unilaterally by a government agency in order to protect a client industry, this does not apply to EU law. However, the ECJ in Strasbourg has previously ruled against pharmaceutical industry attempts to remove consumer products from the market (in the case of garlic pills), so the outlook is favourable.
UNITED STATES, USA – Permitted.
Import, sale, advertising and use are permitted.
The FDA have announced their intention to regulate e-cigarettes and refills as a tobacco product. This would allow them to form a legal framework to do so, then gradually tighten the regulations in order to remove e-cigarettes from the market (as per the UK's MHRA, with whom they share a similar agenda: to act at all times to protect pharmaceutical industry income).
Electronic cigarettes are currently considered to be unregulated tobacco products and this situation is unlikely to persist: some form of regulatory structure based on tobacco regulations is likely to be imposed, if for no other reason (to be fair) than there is an argument that no universal, comprehensive and fully-local consumer product regulatory and enforcement structure exists.
The FDA attempted a ban in 2010 but this was rejected by a series of appeal courts. Judge Leon originally rejected a pharmaceutical classification, and this was upheld on appeal; he stated that if regulation was required, then as a tobacco product would be more appropriate.
The FDA has announced that it intends to assert authority over products that meet the statutory definition of “tobacco products” under the 2009 tobacco regulation law. This would include regulating e-cigarettes as a new tobacco product. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm (April 2011)
Individual States have the power to introduce their own regulations, as do Cities. Some examples are listed below.
US States: general Several States have imposed indoor use restrictions by including e-cigarettes in public indoor smoking bans. These States are not named below, but include for example Utah, N Dakota. A specific regulation is needed as it is unlikely that a court (especially on appeal) would uphold a case brought against an ecig owner accused of 'smoking' indoors in a public place (vaping is not smoking). One State has confirmed that e-cigarettes cannot legally be included in any smoking definition and will not be restricted indoors (Virginia). At Q1 2013 no State has implemented a sales ban.
Arizona - Sale of any products containing nicotine to minors & displaying the product near candy is banned.
Oregon - Sales to minors are banned. Also, electronic cigarettes may not be sold in Oregon unless there is competent and reliable scientific evidence to support the product’s safety claims. In addition, the companies must give the Attorney General advance notice that they intend to sell electronic cigarettes in Oregon, provide copies of all electronic cigarette advertising, and provide copies of the scientific studies they maintain substantiates their claims. The ecig company Smoking Everywhere has been banned from trading in Oregon because of violations of the Unlawful Trade Practices Act.http://www.csdecisions.com/2010/08/12/e-cigarettes-versus-oregon/ (2010)
USDoT - The U.S. Department of Transportation interprets existing federal regulations against smoking on airplanes to apply to e-cigarettes. It is reported that no specific air travel regulations exist, since e-cigarettes are clearly not covered by any smoking laws (there is no tobacco, no ignition, no combustion and no smoke); and their attempt to formally include e-cigarettes in smoking regulations was quietly dropped when they were informed that any regulatory approach would be strongly resisted by CASAA and others. Currently, therefore, the DoT opinion appears incorrect and cannot be enforced, and in practice any enforcement of the DoT opinion would probably fail at law. So far this has not been tested.
USAF - The U.S. Air Force stated that e-cigarette use would be governed by the same regulations that limit the use of tobacco products in the Air Force, including prohibitions on their use in workplaces and public spaces that are not designated smoking areas. www.af.mil/shared/media/document/AFD-100818-044.pdf
Any transport contractor can establish their own regulations applicable to their own vehicles or planes. Some airlines prohibit e-cigarette use, some permit it and sell their own products in-flight.
The US DoT attempted to start a prohibition process applicable to all US airlines, but quietly dropped this when it was pointed out that there would be significant legal obstacles (since vaping is not smoking and cannot be classed as such even by judicious 'bending' of the law). Therefore the situation on US airlines is unclear at this time.
Government agencies (anywhere) never, ever, announce that an initiative has failed, except as a result of a court order or similar.
4. Local authorities
Any local authority, including cities, towns and counties, probably has the statutory right to permit or prohibit specified activities within their area. In many cases this would require a vote by the managing committee.
Although smoking regulations cannot be applied to e-cigarette use, a local authority can bypass this with what are in effect Byelaws, which need no national or Federal basis in law for validity.
Therefore a local authority (and this probably applies worldwide) can prohibit any activity within its public buildings; within property that it owns, including residential property; and outside within public spaces owned or managed by the authority. Such activities might include use of e-cigarettes. In addition a local authority usually has the power to prohibit the sale of a specific class of goods within its area.
5. Property owners
A property owner normally has the legal right to prohibit any specific activity on their property, indoors or out; or to permit any activity not otherwise covered by law.
As a result, some restaurant and bar owners specifically permit e-cigarette use; some specifically prohibit use.
Employers The same usually applies to employers. Some permit or encourage e-cigarette use; some prohibit use.