Regulation of electronic cigarettes

Regulation of electronic cigarettes varies across countries and states, ranging from no regulation to banning them entirely.^[1] As of 2015, around two thirds of major nations have regulated e-cigarettes in some way.^[2] Because of the potential relationship with tobacco laws and medical drug policies, e-cigarette legislation is being debated in many countries.^[3] In respect to making regulatory decisions, regulators are currently evaluating the research on e-cigarettes.^[4]

The legal status of e-cigarettes is currently pending in many countries.^[5] Some countries such as Brazil, Singapore, the Seychelles, and Uruguay have banned e-cigarettes.^[5] In Canada, they are technically illegal to sell, as no nicotine-containing e-fluid is approved by Health Canada, but this is generally unenforced and they are commonly available for sale Canada-wide.^[6] In the United Kingdom, the use and sale of e-cigarettes are legal.^[7] In the US, the use and sale of e-cigarettes are legal.^[8]

In February 2014 the European Parliament passed regulations requiring standardization and quality control for liquids and vaporizers, disclosure of ingredients in liquids, and child-proofing and tamper-proofing for liquid packaging.^[9][10] In April 2014 the US Food and Drug Administration (FDA) published proposed regulations for e-cigarettes along similar lines.^[11][12] In the US, as of 2014 some states tax e-cigarettes as tobacco products, and some state and regional governments have broadened their indoor smoking bans to include e-cigarettes.^[13] As of 9 October 2015, at least 48 states and 2 territories banned e-cigarette sales to minors.^[14]

E-cigarettes have been listed as drug delivery devices in several countries because they contain nicotine, and their advertising has been restricted until safety and efficacy clinical trials are conclusive.^[15] Since they do not contain tobacco, television advertising in the US is not restricted.^[16] Some countries have regulated e-cigarettes as a medical product even though they have not approved them as a smoking cessation aid.^[17] A 2014 review stated the emerging phenomenon of e-cigarettes has raised concerns in the health community, governments, and the general public and recommended that e-cigarettes should be regulated to protect consumers.^[3] It added, "heavy regulation by restricting access to e-cigarettes would just encourage continuing use of much unhealthier tobacco smoking."^[3] A 2014 review said these products should be considered for regulation in view of the "reported adverse health effects".^[17]

Europe

Current legal status of e-cigarettes in Europe:

  Legal

  E-cigarettes that contain nicotine are illegal. Only nicotine-free e-cigarettes are legal.

  De facto illegal

  Illegal. Note that the two countries shown in red are Israel and Lebanon, part of Asia, not Europe.

  Unknown

On 19 December 2012 the European Commission adopted its proposal to revise the European Union Tobacco Products Directive 2001/37/EC which included proposals to introduce restrictions on the use and sales of e-cigarettes.^[18][19][20] On 8 October 2013 the European Parliament in Strasbourg voted down the Commission's proposal to introduce medical regulation for electronic cigarettes, but proposed that cross-border marketing of e-cigarettes be regulated similarly to tobacco products, meaning that sales of e-cigarettes to under-18s would be prohibited in the European Union, along with most cross-border advertising. Warning labels also would be required. The Parliament and Member States are involved in trilogue discussions to reach a common conclusion.^[21] In February 2014, the European Parliament approved new regulations for tobacco products, including e-cigarettes. The new regulations forbid advertising of e-cigarettes, set limits on maximum concentrations of nicotine in liquids, limit maximum volumes of liquid that can be sold, require child-proof and tamper-proof packaging of liquid, set requirements on purity of ingredients, require that the devices deliver consistent doses of vapor, require disclose of ingredients and nicotine content, and empower regulators to act if the regulations are violated.^[9][22] In October 2014 e-cigarette manufacturer Totally Wicked won the right to challenge the directive at the Court of Justice of the EU. The hearing took place on 1 October 2015 and the results will not be announced until early 2016.^[23]

In autumn 2013, the e-cigarette industry ran "a determined lobbying campaign" to defeat proposed European legislation to regulate e-cigarettes like medical devices.^[24] Pharmaceutical manufacturers GlaxoSmithKline and Johnson & Johnson have lobbied the US government, the FDA, and the EU parliament for stricter regulation of e-cigarettes which compete with their products Nicorette gum and nicotine patches.^[25]

A no vaping sign on public transport from Scotland

• In Austria nicotine-containing cartridges are classified as medicinal products and e-cigarettes for nicotine inhalation as medical devices.^[26]
• In Bulgaria, the sale and use of electronic cigarettes are legal, as well as the sale of cartridges and liquids with nicotine. There are no specific regulations from EU.^[27]
• In the Czech Republic, the use and advertising of electronic cigarettes are legal.^[28] Sale of e-cigarettes is regulated in the same way as sale of conventional cigarettes – as such, e-cigarettes cannot be sold to minors and can be sold only at places permitted to sell conventional cigarettes.^[29] Online sale with mail delivery is de facto illegal due to the impossibility for age verification,^[29] however this rule is not enforced and there are plenty of e-shops.
• In Denmark, the Danish Medicines Agency classifies electronic cigarettes containing nicotine as medicinal products. Thus, authorization is required before the product may be marketed and sold, and no such authorization has currently been given. The agency has clarified, however, that electronic cigarettes that do not administer nicotine to the user, and are not otherwise used for the prevention or treatment of disease, are not considered medicinal devices.^[30]
• In Estonia, the Estonian State Agency of Medicines had previously banned e-cigarettes, but the ban was overturned in court on 7 March 2013.^[31] Currently e-liquids containing more than 0.7 mg/ml of nicotine are still considered medicine and as such cannot be legally purchased within the country due to no manufacturer being licensed properly. Following the outcome of EU tobacco directive in October 2013, the legislation is moving towards a more relaxed stance on the issue. As stated by the Estonian minister of social affairs Taavi Rõivas (in charge of tobacco regulation), e-cigarettes will receive an advertisement ban and will clearly be banned for minors but will be available for adults before the end of 2013.
• In Finland, the National Supervisory Authority of Welfare and Health (Valvira) declared that the new tobacco marketing ban (effective 1 January 2012) would also cover electronic cigarettes,^[32] resulting in that Finnish stores or web stores can't advertise e-cigarettes because they might look like regular cigarettes. In theory, e-cigarettes with nicotine-free cartridges may still be sold, as long as their images and prices are not visible. Ordering from abroad remains allowed. Sale of nicotine cartridges is currently prohibited, as nicotine is considered a prescription drug requiring an authorization that such cartridges do not yet have. However, the Finnish authorities have decided that nicotine cartridges containing less than 10 mg nicotine, and e-liquid containing less than 0.42 g nicotine per bottle, may be legally brought in from other countries for private use. If the nicotine content is higher, a prescription from a Finnish physician is required. From a country within the European Economic Area a maximum of one year's supply may be brought in for private use when returning to Finland, while three months' supply may be brought in from outside the EEA. Mail-order deliveries from EEA countries, for a maximum of three months' supply, are also allowed.^[33][34]
• In Germany, the sale and use of electronic cigarettes are legal.^[35] In Germany, there are no age-related restrictions for use of e-cigarettes.^[36] E-cigarettes are either unregulated or are considered a medicinal or tobacco product by different German states and regions, which restrict their sale and use.^[36]
• In Hungary, the sale and use of electronic cigarettes are legal. The sale of cartridges and liquids with nicotine is illegal.
• In Ireland, the sale and use of electronic cigarettes are legal.^[28]
• In Italy, by a Health Ministry decree (G.U. Serie Generale, n. 248, 23 October 2012) electronic cigarettes containing nicotine cannot be sold to individuals under 18 years of age.^[37]
• In Latvia, e-cigarettes are legal.^[38]
• In Lithuania, e-cigarettes are legal.^[38]
• In the Netherlands, use and sale of electronic cigarettes is allowed, advertising is restricted.^[28]
• In Norway the sale and use of electronic cigarettes are legal,^[28] but nicotine cartridges can only be imported from other EEA member states (e.g. the UK) for private use.^[39]
• In Poland, the sale and use of electronic cigarettes are legal.^[28]
• In Portugal, with nicotine it is restricted, without nicotine it is not regulated.^[28]
• In Romania, the sale and use of electronic cigarettes are legal, from 2016 the liquid used in electronic cigarettes will have an excise duty ^[40]
• In Switzerland, the sale of nicotine-free electronic cigarettes is legal. The use and importation of electronic cigarettes containing nicotine is legal, but they cannot be sold within the country.^[41] As of December 2011, the tobacco tax does not apply to e-cigarettes and respective liquids containing nicotine.^[42]
• In Turkey regulation of electronic cigarettes is inconsistent.^[43] Sales are not completely banned ^[44] and there are plenty of online shops. In May 2013 the Minister of Heath stated that electronic cigarettes which contain nicotine are medical devices and thus cannot be imported unless approved by the "Turkish Medicines and Medical Devices Agency".^[45] But according to a WHO report as of 2014 e-cigarettes are not regulated as a therapeutic product. ^[44] However law 4207, which regulates smoking, was amended in June 2013 by article 26 of law 6487 ^[46] to also apply to items which do not contain tobacco: “Herbal water pipes and all kind of cigarettes which do not contain tobacco but are used in a way to imitate tobacco products shall also be deemed as tobacco product.” ^[47] Vaping is thus forbidden indoors and on public transport, and also therefore forbidden for people under 18 years old. And thus, like tobacco products, personal import by mail or courier is forbidden. Specifically vaping is forbidden on high-speed trains.^[48]
• In Slovenia, the sale and use of electronic cigarettes are legal.
• In the United Kingdom, the use, sale and advertising of e-cigarettes are legal and e-cigarettes are not covered by laws restricting smoking in public places.^[7] However, businesses may choose to ban e-cigarettes as well. A notable example is Transport for London, banning smoking and vaping as their Conditions of Carriage.^[49] In 2014 the government announced legislation would be brought forward to outlaw the purchase of e-cigarettes by people under the age of 18.^[7] In October 2014 the UK's Advertising Standards Authority changed the regulations on e-cigarette advertising, allowing the devices to appear in TV ads from 10 November.^[50] The first advert to take advantage of the change, promoting KiK Electronic Cigarettes, aired on the day it came into force.^[51]
  • In June 2015 the Welsh Government announced that under legislation it planned to pass, in Wales electronic cigarettes would be included in existing bans on smoking in workplaces and other public spaces.^[52]

United States

Federal regulation

Regulations concerning the use of electronic cigarettes vary considerably across the United States, although there is more variation regarding laws limiting their use by youth than regarding multi-level regulations, such as banning their use in public places.^[53] The FDA classified electronic cigarettes as drug delivery devices and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA) before importation and sale in the United States. The classification was challenged in court, and overruled in January 2010 by Federal District Court Judge Richard J. Leon, citing that "the devices should be regulated as tobacco products rather than drug or medical products."^[54][55]

In March 2010, the U.S. Court of Appeals for the District of Columbia stayed the injunction pending an appeal, during which the FDA argued the right to regulate electronic cigarettes based on their previous ability to regulate nicotine replacement therapies such as nicotine gum or patches. Further, the agency argued that tobacco legislation enacted the previous year "expressly excludes from the definition of 'tobacco product' any article that is a drug, device or combination product under the FDCA, and provides that such articles shall be subject to regulation under the pre-existing FDCA provisions."^[56] On 7 December 2010, the appeals court ruled against the FDA in a 3–0 unanimous decision, ruling the FDA can only regulate electronic cigarettes as tobacco products, and thus cannot block their import.^[57] The judges ruled that such devices would only be subject to drug legislation if they are marketed for therapeutic use – E-cigarette manufacturers had successfully proven that their products were targeted at smokers and not at those seeking to quit. The District Columbia Circuit appeals court, on 24 January 2011, declined to review the decision en banc, blocking the products from FDA regulation as medical devices.^[58]

In April 2014, the FDA proposed new regulations for tobacco products, including electronic cigarettes. The regulations require disclosure of ingredients used in e-cigarette liquids, proof of safety of those ingredients, and regulation of the devices used to vaporize and deliver the liquid.^{[11][59][60][61]} The FDA proposed regulation would ban the sale of e-cigarettes with nicotine to any individual under 18 years of age.^[62] In August 2014, attorneys general from over two dozen states advised the FDA to enact restrictions on e-cigarettes, including banning flavors.^[63]

State regulation

A no smoking or vaping sign from the US.

With an absence of federal regulations, many states and cities have adopted their own e-cigarette regulations, most commonly to prohibit sales to minors, including Maryland, Kentucky, Minnesota, New Jersey, New Hampshire, Tennessee, Utah, Wisconsin, and Colorado. Other states are considering similar legislation.^[64] As of 2014, some states in the US permit e-cigarettes to be taxed as tobacco products, and some state and regional governments in the US had extended their indoor smoking bans to include e-cigarettes.^[13]

Governor Arnold Schwarzenegger vetoed a bill that would regulate the sale of electronic cigarettes within the state on grounds that "if adults want to purchase and consume these products with an understanding of the associated health risks, they should be able to do so."^[65]

A review of regulations in 40 U.S. states found that how a law defines e-cigarettes is critical, with some definitions allowing e-cigarettes to avoid smoke-free laws, taxation, and restrictions on sales and marketing.^[66]

Many local and state jurisdictions have recently begun enacting laws that prohibit e-cigarette usage everywhere that smoking is banned, although some state laws with comprehensive smoke-free laws will still allow for vaping to be permitted in bars and restaurants while prohibiting e-cigarettes in other indoor places.^[67]

Other countries

• In Australia, the Federal Department of Health and Ageing classifies every form of nicotine, except for replacement therapies and cigarettes, as a form of poison.^[68][69] In Australia, there are no laws pertaining to the regulation of e-cigarettes.^[70] Although there are a number of laws that are relevant to the regulation of poisons, therapeutic goods, and tobacco control which are applicable to e-cigarettes in some cases.^[70] Australia is developing regulations on e-cigarettes.^[71] The sale of e-cigarettes must be registered with the Therapeutic Goods Administration (TGA) before being sold.^[72] Importation of e-cigarettes and their related products is illegal unless approved by the TGA.^[72] The TPA has said that there were no laws preventing the importation of e-cigarettes bought over the internet for personal use, unless prohibited by state and territory legislation.^[73] State laws in Australia's various states are a little bit conflicting. According to the Poisons Standard of 2010, inhaled nicotine is Pharmacy Only, or a Schedule 2 medication when used to help quit smoking.^[74][75] In April 2014 a court decision made it illegal to sell or supply electronic cigarettes regardless of their appearance or nicotine content (even if zero) in Western Australia.^[76] Previously they were banned if they looked like cigarettes. The court ruled that the action they provided in and of itself looks like cigarettes. Precise rules in the other states vary.
• In Argentina, sales, importation and manufacturing have been banned by the local regulatory authority as well as its use has been discouraged by the National Clinical Practice Guideline for Tobacco Cessation from lack of enough evidence.^[77]
• In Brazil, the sale, importation and advertising of any kind of electronic cigarette is forbidden. The Brazilian health and sanitation federal agency, Anvisa, found the current health safety assessments about e-cigarettes to not be yet satisfactory for commercial approval eligibility.^[78]
• In Canada, e-cigarettes are mostly unregulated.^[79] They are technically illegal to sell, as no nicotine-containing e-fluid is approved by Health Canada, but this is generally unenforced and they are commonly available for sale Canada-wide.^[6] Vancouver bans use of electronic cigarettes in public places where smoking is prohibited. Toronto bans use of electronic cigarettes in city work spaces.^[80] The city of Red Deer bans electronic cigarette use where smoking is prohibited.
• In Hong Kong, the sale and possession of nicotine-based electronic cigarettes classified as a Type I Poison, is governed under the Pharmacy and Poisons Ordinance. Sale or possession is not authorized and both are considered punishable by a fine of up to HK$100,000 and/or a prison term of 2 years. However, the law does not cover any non-nicotine inhalers.^[81]
• In India under the Drugs and Cosmetics Act 1940, Nicotine in chemical form is approved only as 2/4 mg Gums or Lozenges.So E-Cigarettes containing Nicotine are unapproved under The Drugs and Cosmetics Act.In the state of Punjab many court cases have been launched for the sale of E-Cigarettes under this act.A violator in Mohali.Punjab was awarded a jail term of 3 yrs and a fine of Rs.1 Lakh on 7/4/16 by District Court.Under the Indian Health Law of 2003, tobacco smoking has been banned in public.Under Section 5 of Cigarettes and other Tobacco Products, Act (COTPA) Advertisement/Promotion/Sponsorship of Tobacco is banned. Since e-cigarettes mimic normal tobacco Cigarettes,a person can be booked under this section.
• In Israel in 2013, the Ministry of Health planned to extend existing laws on smoking in public places to e-cigarettes, a year after warning against the product's usage.^[82]
• In Mexico, the Federal Commission for the Protection Against Sanitary Risks had previously forbidden the selling and promotion of non-tobacco objects that included elements generally associated with tobacco products^[83] but the ban was overturned in court on September 23, 2015.^[84]
• In Nepal, under current cigarette laws, the sale of e-cigarettes is permitted.^[85]
• In New Zealand, e-cigarettes are regulated as medicine and are sold only in drugstores.^[86]
• In Pakistan, the import and sale of electronic cigarettes is legal, but Pakistan Medical and Dental council find that the current health safety assessments of e-cigarettes to not yet be satisfactory.^[85]
• In Panama, the importation, distribution and sale of electronic cigarettes have been prohibited since June 2009. The Ministry of Health cites the FDA findings as their reasoning for the ban.^[87]
• In Philippines, the sale of e-cigarettes is unregulated, which makes them available to children and adolescents.^[88] The Philippine Medical Association has recommended to different city governments to broaden their public places and transportation smoking bans to include e-cigarettes.^[89]
• In Singapore, electronic cigarettes (e-cigarettes) are currently prohibited under Section 16 (1) of the Tobacco (Control of Advertisements and Sale) Act, which is enforced by the Health Sciences Authority (HSA). This legislation prohibits the importation, distribution, sale or offer for sale of any confectionery or other food product or any toy or other article that is designed to resemble a tobacco product or the packaging of which is designed to resemble the packaging commonly associated with tobacco products. HSA takes a serious view on any person who contravenes the law. Those guilty of the offence are liable to a fine of up to $5, 000 upon conviction.^[90] According to Health Minister Khaw Boon Wan, electronic cigarettes are the industry's attempt to attract new users and were marketed to appeal to younger customers, including women.^[91]
• In South Korea, the sale and use of electronic cigarettes is legal, but is heavily taxed. Electric cigarette possession among teenagers remains an issue.^[92]
• In Spain, the Ministry of Health (Spain) said that the use and sale of e-cigarettes will soon be regulated.^[93]
• In United Arab Emirates, the sale and use of electronic cigarettes is illegal.^[94]

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