Legal status of electronic cigarettes

The legal status of electronic cigarettes is currently pending in many countries, because of the relative novelty of the technology, the possible relationship to tobacco laws and medical drug policies, and public health concerns related to the use of electronic cigarettes.^[1] As of 2015, around two thirds of major nations have regulated e-cigarettes in some way.^[2] Current regulations vary widely, from regions with no regulations to others banning the devices entirely.^[1] For example, some countries such as Brazil, Singapore, the Seychelles, and Uruguay have banned e-cigarettes.^[3] E-cigarettes have been listed as drug delivery devices in several countries because they contain nicotine, and their advertising has been monetarily restricted until safety and efficacy clinical trials are conclusive.^[4] The emerging phenomenon of electronic cigarettes has raised concerns in the health community, governments, and the general public.^[5]

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.^[6][7][8] 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.^[9] 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.^[10][11] In October 2014 e-cigarette manufacturer Totally Wicked won the right to challenge the directive at the Court of Justice of the EU.^[12] The hearing is expected to take place in 2015.^[12]

• In Austria nicotine-containing cartridges are classified as medicinal products and e-cigarettes for nicotine inhalation as medical devices.^[13]
• 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.^[14]
• In the Czech Republic, the use and advertising of electronic cigarettes are legal.^[15] 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.^[16] Online sale with mail delivery is de-facto illegal due to the impossibility for age verification,^[16] 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.^[17]
• In Estonia, the Estonian State Agency of Medicines had previously banned e-cigarettes, but the ban was overturned in court on 7 March 2013.^[18] 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) will also cover electronic cigarettes,^[19] resulting in that Finnish stores or webstores 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.^[20][21]
• In Germany, the sale and use of electronic cigarettes are legal.^[22]
• 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.^[15]
• 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 16 years of age.^[23]
• In Latvia, e-cigarettes are legal.^[24]
• In Lithuania, e-cigarettes are legal.^[24]
• In the Netherlands, use and sale of electronic cigarettes is allowed, advertising is restricted.^[15]
• In Norway the sale and use of electronic cigarettes are legal,^[15] but nicotine cartridges can only be imported from other EEA member states (e.g. the UK) for private use.^[25]
• In Poland, the sale and use of electronic cigarettes are legal.^[15]
• In Portugal, with nicotine it is restricted, without nicotine it is not regulated.^[15]
• In Romania, the sale and use of electronic cigarettes are legal, the World Health Organization proposed that electronic cigarettes mustn't be sold to teenagers, though the idea was not estabilshed as a law - electronic cigarette merchants are trying to respect it.^[26]
• 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.^[27] As of December 2011, the tobacco tax does not apply to e-cigarettes and respective liquids containing nicotine.^[28]
• In Turkey electronic cigarettes are legal and there are plenty of online shops: however law 4207, which regulates smoking, was amended in 2013 ^[29] to also apply to items which do not contain tobacco but which imitate any kind of cigarette or hookah. Vaping is thus forbidden indoors and on public transport. And also therefore forbidden for people under 18 years old. Specifically vaping is forbidden on high speed trains. ^[30]
• In the United Kingdom, the use, sale and advertising of electronic cigarettes are legal and electronic cigarettes are not covered by smoking bans.^[31] In 2014 the government announced legislation would be brought forward to outlaw the purchase of electronic cigarettes by people under the age of 18.^[31]
• Wales could become the first part of the United Kingdom to ban electronic cigarettes in enclosed public spaces.^[32]

United States

Federal regulation

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."^[33][34]

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."^[35] 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.^[36] 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.^[37]

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.^{[38][39][40][41]} The FDA proposed regulation would ban the sale of e-cigarettes to any individual under 18 years of age.^[42]

State regulation

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.^[43]

• In New Hampshire, the sale of electronic cigarettes to minors is illegal as of July 2010.^[44]
• Arizona is planning to ban the sale of electronic cigarettes to minors.^[45]
• In Maryland, sales to minors are banned.^[46]
• New York State banned e-cigarette sales to minors starting on 1 January 2013.^[47]
• In Pennsylvania, SB 1055 was introduced by Sen. Tim Solobay in 2013 and would ban sales to minors.^[48] That same year physician members of the Pennsylvania Medical Society called upon the state legislature to pass electronic cigarette laws that have safeguards equivalent to existing tobacco laws.^[49]
• A Kansas law that went into effect July 1, 2012 banned possession of e-cigarettes by anyone under 18.^[50]
• As of October 1, 2014 Connecticut bans the sale and possession to any person under the age of 18
• As of August 1, 2014, Hillsboro, Oregon bans the use of e-cigarettes in public parks.^[51]
• As of July 3, 2014, all states except Connecticut, Iowa, Maine, Michigan, Montana, Nebraska, Nevada, North Carolina, Ohio, Rhode Island, Tennessee, Virginia, Wisconsin & Wyoming have regulations against e-cigarette usage indoors to some degree.
• As of April 2015, Hawaii, New Jersey, North Dakata, and Utah include e-cigarettes in their smokefree laws. ^[52]

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.^[53]

New York City signed a ban into law on December 30, 2013.^[54][55]

States

 Alabama

• Localities in Alabama with e-cigarette bans that include all bars and restaurants:
  • Daphne, banned in all publicly owned city facilities; does not including private workplaces, nor bars and restaurants ^[56]
  • Foley, banned in all enclosed workplaces, including restaurants but exempting bars^[57]
  • Opelika, banned in all enclosed workplaces, including restaurants but exempting bars^[58]

 California

• 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."^[59] Senate Bill 648(Authored by Senator Ellen Corbett), proposed a bill that would classify eCigarettes as tobacco products, thus banning their use wherever smoking was banned. In August 2013, SB648 was shelved for the session, just hours before its hearing in the State Assembly. It has not been determined if Sen Corbett will revise the bill and re-introduce it in 2014.^[60]

 Colorado

• Localities in Colorado with e-cigarette bans that include all bars and restaurants (2 total):
  • Fort Collins, July 15, 2014 banned in all enclosed workplaces, including bars and restaurants; also includes hotel/motel smoking rooms^[61]
  • Lakewood, July 14, 2014 banned in all enclosed workplaces, including bars and restaurants^[62]

 Kansas

• No statewide e-cigarette ban. Instead, e-cigarette usage is generally prohibited on all Department of Corrections property and grounds, by both employees and inmates, with no exceptions whatsoever. All other indoor places, including bars, restaurants, and gambling facilities are entirely exempt from the state e-cigarette regulations. Municipalities may enact laws restricting their usage in public spaces more stringently than the state, but so far Overland Park is the only city to have done so, banning their use in public and sports arenas, restricting sales to minors, and requiring new stores operate from standalone storefronts.^[63]

 Missouri

• No statewide e-cigarette ban. Unlike the Clean Indoor Air Act of 1992, which prohibits smoking only in enclosed public places (including workplaces) and public meetings, except in designated smoking areas that occupy no more than 30% of the place's enclosed area, e-cigarette usage is generally not prohibited anywhere inside and municipalities may enact laws restricting their usage in public spaces as far as local governments are concerned. A ban on sales to minors was passed in September 2014. It was supported by many local vape shops. It was opposed by health groups including Tobacco Free Missouri, the American Cancer Society and the American Heart Association, who said the law's definition of e-cigarettes will allow them to avoid taxes and health requirements.^[53][64]

• Localities in Missouri with e-cigarette bans that include all bars and restaurants (5 total):
  • Branson, October 31, 2014, banned by unanimous city council vote in all enclosed worokplaces
  • Creve Coeur, January 2, 2011, banned by unanimous city council vote in all enclosed workplaces, including bars and restaurants; exempts cigar bars, e-cigarette shops, private clubs, tobacco shops, and hotel/motel designated smoking rooms
  • Jefferson City, January 31, 2011, banned in all enclosed workplaces, including bars and restaurants, after public vote of 58%–42%.
  • St. Joseph, June 7, 2014, banned in all enclosed workplaces and public places, including all bars, restaurants, and private and semiprivate rooms in nursing homes, after public vote of 52.75%–47.25%; exempts private vehicles and residences, 10% of hotel and motel rooms designated as smoking, private clubs (when no employees are present), and casino gaming areas (including bars, restaurants, and lounges within those gaming areas)
  • Washington, April 15, 2013, banned in all enclosed workplaces, including bars and restaurants by unanimous city council vote; also banned in private rooms in nursing homes; exempts only private residences not serving as a workplace and designated smoking rooms in hotels and motels; exempted hookah lounges until April 15, 2014.

 Washington

• No statewide e-cigarette ban. WA Clean Indoor Air Act of 2005 prohibits smoking in all enclosed public places, including bars and restaurants while excluding 25% of hotel/motel smoking rooms and private clubs in enclosed spaces with no employees; businesses on tribal lands are exempt. E-cigarette usage is generally not prohibited anywhere inside or outdoors and municipalities may enact laws restricting their usage in public spaces as far as local governments are concerned.

• Localities with e-cigarette bans that include all bars and restaurants (2 total):
  • King County, banned in all enclosed workplaces, including bars and restaurants^[65]
  • Pasco, banned in all enclosed workplaces, including bars and restaurants

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.^[66][67] The Therapeutic Goods Administration 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.^[68] 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.^[69][70] In April 2014 Western Australia made it illegal to sell or supply electronic cigarettes regardless of their appearance. Previously they were banned if they looked like cigarettes. The court ruled that the action they provided in and of itself looks like cigarettes.
• 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.^[71]
• 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.^[72]
• In Canada, Vancouver bans use of electronic cigarettes in public places where smoking is prohibited. Toronto bans use of electronic cigarettes in city work spaces.^[73] The city of Red Deer bans electronic cigarette use where smoking is prohibited. In Canada, they are legal to sell, however nicotine-containing e-fluid is unapproved by Health Canada - making it technically illegal, although widely unenforced and commonly available for sale Canada-wide.^[74]
• 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 with 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.^[75]
• In India, the use of electronic cigarettes is legal. Under the Indian Health Law of 2006, tobacco smoking has been banned in public. Since e-cigarettes avoid the use of tobacco, they do not fall under this law.^[76]
• 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.^[77]
• In Mexico, the Federal Commission for the Protection Against Sanitary Risks, announced that according to Mexican Law, the selling and promotion of non-tobacco objects that include elements generally associated with tobacco products are forbidden.^[78]
• In Nepal, under current cigarette laws, the sale of e-cigarettes is permitted.^[79]
• 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.^[79]
• 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.^[80]
• 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.^[81] 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.^[82]
• In South Korea, the sale and use of electronic cigarettes is legal, but is heavily taxed. Electric cigarette possession among teenagers remains an issue.^[83]
• In United Arab Emirates, the sale and use of electronic cigarettes is illegal.^[84]

References