Legal Trends


PV and nicotine product legal trends




Usually when a product is sold with therapeutic claims or for a therapeutic purpose (which might mean nicotine, tobacco or smoke cessation), the manufacturer requires a license to confirm that it complies with medical standards of quality, efficacy and safety.

In places where recreational nicotine products are banned, liquid nicotine sales are effectively banned - no medical liquid nicotine or electronic cigarettes have been approved by any authority. Nicotine products also defined as tobacco products are generally not considered to have a therapeutic purpose and are exempted from medical requirements.

Prohibition of non-tobacco recreational nicotine means closure of commercial markets and removal of competition for the tobacco and medical industries. Compulsory licensing prohibits sales but does not necessarily mean the substance is classed as a controlled drug, personal possession and use may be permitted. If you can get unregulated products (it's common to import from China), using them won't break a sales ban law.

The trend with nicotine is for regulators to claim that it has only a medical purpose, they acknowledge no benefits in the free market and argue that recreational sales should be prohibited (have commercial trading safeguards removed) as a precautionary measure to prevent possible safety problems. Claims that consumer safety is not protected under general trading regulations are common. Lack of any evidence of serious harm ever being caused by electronic cigarette products does not prevent speculation and no risk/benefit assessments appear to have been carried out.




This list might not be accurate, please double check if you need reliable information.




Australia: Nicotine’s classification as a poison applies to ecigs, effectively prohibiting sale and marketing in all states and territories.
http://www.tga.gov.au/ndpsc/record/rr200810.pdf
http://www.theage.com.au/national/ban-on-batterypowered-smokes-20081231-...



Austria: Electronic cigarettes are considered medical devices and nicotine cartridges medicinal products. Nicotine cartridges need to be registered as medicinal products before they can be legally sold.



Belgium: Banned, but hardly enforced.




Brazil: Sale and import prohibited.
http://portal.anvisa.gov.br/wps/portal/anvisa/busca




Sale in Brunei is prohibited because it is an imitation of a tobacco product and a fine of $10,000 can be imposed.
http://www.bt.com.bn/news-national/2010/06/05/tobacco-kills-one-person-e...




Canada: Ecigs cannot be imported, advertised or sold.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/notice_avis...




Colombia: Currently - import, advertising and sale of the e-cigarette is unrestricted.




Czech Republic: Electronic cigarette use and advertisement are currently unrestricted.




Denmark: Marketing and distribution of ecigs is banned.
http://www.dkma.dk/1024/visUKLSArtikel.asp?artikelID=14250




Dubai (a state in the UAE): Banned
http://www.khaleejtimes.com/DisplayArticle08.asp?xfile=data/theuae/2009/...




European Union: 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 ecigs 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/...

Electronic cigarettes may fall under the definition of a medicinal product laid down in Directive 2001/83/EC, either if the product is presented as a remedy against nicotine addiction or if it is qualified as restoring, correcting or modifying physiological functions.
http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=P-2009-65...

Member States might be allowed, in application of Article 36 of the Treaty on the functioning of the European Union, to adopt restrictive rules relating to the manufacturing and the marketing of electronic cigarettes in order to protect the life and health of humans. Such measures should be based on scientific and technical data regarding the harmfulness of these products and respect the proportionality principle.
http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=E-2010-02...




Finland: Cartridges containing nicotine are illegal to sell or to purchase with intent to sell but are not illegal to purchase from overseas sources for personal use only.




France: With or without nicotine, a license is required to sell ecigs for smoking cessation. They may be sold normally without nicotine or cessation claims. The status of products sold with nicotine but without cessation claims appears to be unclear.
http://www.afssaps.fr/Infos-de-securite/Communiques-Points-presse/Point-...




Germany: No restrictions on possession and use; no restrictions known on sales. However, the legal situation has not yet been settled. Customs in some states of the Federal Republic of Germany deem e-cigs or nicotine-bearing liquid a medicinal product and do stop commercial or personal imports at the respective customs border (= EU outer border).




In Greece, the recent law on protection from tobacco and alcohol bans the marketing of e-cigarettes unless a Ministerial decision authorises them under certain conditions.
http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/... (page 3)




Hong Kong: Ecigs containing nicotine are classified as poison products and strictly prohibited.
http://www.tco.gov.hk/textonly/english/infostation/infostation_04032009....
http://www.hklii.org/hk/legis/en/ord/cur/138.txt




Indonesia may have a ban on sales, this isn't very clear because apparently ecigs haven't been categorised there yet.
http://www.thejakartaglobe.com/news/imported-e-cigarettes-banned-and-dan...




Iran: Possibly a ban there because of the ingredients in pvliquid.




Israel: Banned, both the import and sale of the product, including those that are marketed as nicotine-free.
http://www.israelnationalnews.com/News/News.aspx/132629




In Italy, use and sales of electronic cigarettes is permitted but all products containing nicotine must be labelled with hazard warning symbols.
http://www.normativasanitaria.it/normsan-pdf/0000/32610_1.pdf




In Japan ecigs can be categorized as pharmaceuticals or medical equipment by law if they contain nicotine. Pharmaceutical law prohibits sale but individuals may import enough for one months use from abroad.
http://www.japantoday.com/category/technology/view/nicotine-detected-in-...




Jordan: Banned
http://www.jordantimes.com/?news=13857




Republic of Korea: Allowed but heavily taxed
http://www.koreatimes.co.kr/www/news/nation/2009/10/113_54218.html




Malaysia: Electronic cigarettes are considered medical devices and nicotine cartridges medicinal products. If any are licensed they will be available over the counter at a pharmacy with a prescription.




Malta: Ecigs fall under the Tobacco Act, they cannot be freely advertised, they cannot be smoked 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




Mexico: Sale, production, distribution, importation or advertisement of any kind are forbidden, mainly because the design is too similar to a tobacco product.
http://201.147.97.103/work/sites/cfp/resources/LocalContent/854/4/b84.pdf




Netherlands: Advertising is forbidden.




New Zealand: The Ministry of Health has ruled that cartridges containing nicotine fall under the requirements of the Medicines Act and cannot be sold except as a registered medicine. New Zealanders are allowed to import device, cartridge and e-liquid (including nicotine) for personal use. It's possible that the products can be legally imported and sold - but not advertised - under the Smokefree Environments Act.
http://www.nzherald.co.nz/health/news/article.cfm?c_id=204&objectid=1063...




Norway: The Norwegian Tobacco Act forbids the import and sale of new tobacco products and/or nicotine products, a classification that encompasses ecig products.
http://www.regjeringen.no/en/dep/hod/Subjects/the-department-of-public-h...




In Panama, importation, distribution and sale has been prohibited since June 2009. The Ministry of Health cites the FDA findings as their reason for the ban.




Singapore: Import, sale or offer for sale prohibited as imitation tobacco products. All new alternative tobacco and nicotine products are banned.
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/to...
http://www.straitstimes.com/BreakingNews/Singapore/Story/STIStory_555623...




South Africa: Electronic cigarette use is currently unrestricted.




Switzerland: Electronic cigarettes containing nicotine can not be marketed in Switzerland although an electronic cigarette and 40 replacement cartridges containing nicotine may be bought for personal use. Electronic cigarettes without nicotine (and no mention of therapeutic properties) can be marketed in Switzerland only if the distributor has taken the necessary measures to ensure product safety.
http://www.stop-tabac.ch/fr/images/stories/cigarette_lectronique_.pdf




Tajikistan: Electronic cigarette use is currently unrestricted.




Thailand: Banned.
http://www.namnewsnetwork.org/v2/read.php?id=51042




Turkey: Sale and advertising banned.
http://arama.hurriyet.com.tr/arsivnews.aspx?id=-621407
http://arama.hurriyet.com.tr/arsivnews.aspx?id=-622303




UAE: Import and marketing of electronic cigarettes banned.




United Kingdom: If ecigs are marketed as a smoking cessation aid, they are licensable as a medicine by the Medicines and Healthcare Products Regulatory Agency. As a smoking alternative, however, the use of ecigs is unrestricted.
CE mark standards, The Poisons Act 1972, The General Product Safety Regulations 2005 and CHIP (packaging) regulations apply.




United States: The FDA have defined electronic cigarettes and eliquid as combination drug and medical devices and as none have authorisation they are banned. US customs are blocking some commercial and consumer imports under the Food, Drug and Cosmetic Act (21 U.S.C. section 331) as unapproved new drugs.

A preliminary judgement by Judge Leon in January 2010 overturned the FDA's definition but The Court of Appeals suspended the Judge's decision. The Appeals Court will be looking at the case again in September 2010.


Arizona prohibits a person to knowingly sell, give or furnish electronic cigarettes to minors and prohibits a minor to knowingly purchase, accept or possess electronic cigarettes.
https://www.azcapitolreports.com/viewhtm.cfm?id=133790
http://www.azleg.gov/legtext/49leg/2r/bills/hb2203p.pdf


In California, Sottera (NJOY) agreed an out of court settlement on a case brought by the Attorney General, this may set a precedent. The company agreed that it will not:

--- Sell electronic cigarettes to minors. Its website will be age-restricted, and a customer will need to provide a government ID before making a purchase. Retail products will be behind a counter. Any advertising will note the age restriction.

--- Sell flavored electronic cigarette cartridges, such as strawberry, mint or bubblegum, that could appeal to minors.

--- Advertise its product as a smoking cessation device unless the FDA approves it as such.

--- Sell cartridges that contain vitamins unless the company obtains competent and reliable scientific evidence to support an implied health claim.

--- Claim that the product is safer than cigarettes, contains no tobacco, no tar, no carcinogens or no second-hand smoke unless there is competent reliable scientific evidence to support the claims.

Sottera also agreed to adopt and implement quality control standards for its products to preclude the presence of harmful substances. The company will regularly be subject to independent audits.

Sottera will also provide a Proposition 65 warning that its products contain nicotine, a chemical known by the State of California to cause birth defects or reproductive harm. The warning will include additional information about risks associated with nicotine, including that it is addictive and toxic if swallowed. The warning will appear on product packaging, Sottera's website and at retail sites.

http://www.courthousenews.com/2010/08/03/Sottera.pdf


Minnesota bans the sale of any products containing nicotine to minors & displaying the product near candy.
http://www.startribune.com/lifestyle/health/99514364.html?page=2&c=y


In New Hampshire sale of e-cigarettes to minors is prohibited.
http://www.gencourt.state.nh.us/legislation/2010/HB1541.html


In New Jersey there is a ban on selling to people under 19 years of age and e-cigarettes are included in the New Jersey Smoke Free Air Act which prohibits smoking in indoor public places and workplaces.
http://www.politickernj.com/thester/35976/wagner-voss-legislation-combat...


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.ktvz.com/Global/story.asp?S=10819729

http://www.csdecisions.com/news/10428/e-cigarettes-versus-oregon.html


Utah has banned ecigs for young people, prisoners and people in facilities for 'help' with mental health problems.
http://le.utah.gov/~2010/bills/hbillamd/hb0088.htm


Virginia's Attorney General has removed ecigs from the list of products banned under smokefree laws on the grounds that they do not emit smoke. "... the heated vapor produced by e-cigarettes does not constitute "smoke" as the word is "commonly understood" and therefore the devices don't violate Virginia's ban on smoking in restaurants or other public places."
http://voices.washingtonpost.com/virginiapolitics/2010/04/battery-operat...
http://www.vaag.com/OPINIONS/2010opns/10-029-Peace.pdf




Uruguay: Banned
http://www.elpais.com.uy/091120/ultmo-455493/ultimomomento/msp-se-opone-...








Most regulators would privately agree the system is absurd. E-cigarettes are caught in a two-box regulatory trap. Nicotine products are in law usually either tobacco products or medicines. A choice between only two options is a dilemma for the regulator.

E-cigarettes, seeking to be tobacco-free, no longer fit the first box. So regulators classify it in the second box, as a medicine. From a smoker's viewpoint, however, it belongs in a third box, as a lifestyle choice or cigarette alternative.

It is also a question of market power. Big Tobacco controls Box no. 1, Big Pharma and the white coat health professional prescribers and dispensers control box no 2, while many smokers addicted to nicotine, the ones most likely to be sitting on death row, are powerless. They would like to buy from Box no. 3, but it is empty.

Dr Murray Laugesen







Nicotine is a natural chemical that can be found in plants such as tobacco, potatoes and tomatoes. Pharmacologically its action is similar to caffeine, it is a stimulant in mammals. It is said to be the main factor responsible for the dependence-forming properties of tobacco smoking.

Banning products from the open commercial market removes competition for pharmaceutical and tobacco companies, lowers incentive to innovate, inflates prices, reduces quality, kills small businesses and supports the unregulated, untaxed, black market which cannot be monitored for safety. Most importantly in terms of public benefit, viable alternatives to harmful smoke and ineffective medicine are denied to consumers who want to continue having a smoking experience, they have no legal option other than to smoke.

It is not clear what medicinal purpose nicotine can have in law or how medicalisation has credibility. There doesn't appear to be evidence to show that nicotine can treat nicotine addiction or compulsive smoking behaviour, it can only sustain addiction which is not a therapeutic treatment. It is possible that medical nicotine treatments actually reduce chances of overcoming addiction and keep people trapped in a harmful cycle of quit and fail with medical and tobacco products.




... ENDS [electronic nicotine delivery systems/ecigs] deliver nicotine and other substances but do not contain tobacco, and smokeless tobacco is produced in ‘cottage’ industries or can be modified significantly by the end user. Both therefore pose a significant challenge to regulation, as they may fall outside the scope of domestic regulatory regimes for tobacco products. Nevertheless, their popularity and the fact that they are marketed as alternatives to cigarette smoking indicate the need to characterize them, regulate them and establish appropriate educational programmes to limit their use....

World Health Organisation study group on tobacco product regulation


... If tobacco smoking is the elephant in the room, electronic cigarettes are like a buzzing insect. The natural instinct is of course to kill the buzzing insect first, just in case it might be harmful. This hostile analogy however, ignores the fact that smokers who like to smoke, smoke either tobacco or e-cigarettes, and a move to e-cigarettes implies a move away from tobacco for the smoker concerned. If the real aim is to end the global cigarette deaths epidemic, banning e-cigarettes is not a sensible first move and could be counter-productive.

... The global distribution of low cost e-cigarettes not manufactured under any recognized international controls, are bypassing the high standards, huge investments and profits of the medicinal licensing system. But that is not to say that e-cigarettes are a public health threat in the same league as tobacco cigarettes, which is the alternative...

Critique of the WHO TobReg report on Electronic cigarettes - Murray Laugesen




This is how some 'health' campaigners see the future of nicotine - the market is to be divided between the tobacco and pharmaceutical industries and then gradually nicotine will be removed from tobacco products until medically approved pharmaceutical nicotine is the only nicotine available:



Toward a comprehensive long term nicotine policy

A long term and comprehensive nicotine policy is proposed here. It envisages both reducing the attractiveness and addictiveness of existing tobacco based nicotine delivery systems as well as providing alternative sources of acceptable clean nicotine as competition for tobacco. Clean nicotine is defined as nicotine free enough of tobacco toxicants to pass regulatory approval. A three phase policy is proposed. The initial phase requires regulatory capture of cigarette and smoke constituents liberalising the market for clean nicotine; regulating all nicotine sources from the same agency; and research into nicotine absorption and the role of tobacco additives in this process. The second phase anticipates clean nicotine overtaking tobacco as the primary source of the drug (facilitated by use of regulatory and taxation measures); simplification of tobacco products by limitation of additives which make tobacco attractive and easier to smoke (but tobacco would still be able to provide a satisfying dose of nicotine). The third phase includes a progressive reduction in the nicotine content of cigarettes, with clean nicotine freely available to take the place of tobacco as society’s main nicotine source.