Electronic cigarette

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An electronic cigarette, or e-cigarette, is an electrical device that attempts to simulate the act of tobacco smoking by producing an inhaled mist bearing the physical sensation, appearance, and often the flavor and nicotine content of inhaled tobacco smoke. The device uses heat, or in some cases ultrasonics, to vaporize a propylene glycol- or glycerin-based liquid solution into an aerosol mist, similar to the way a nebulizer or humidifier vaporizes solutions for inhalation.

Most electronic cigarettes are designed to resemble actual tobacco smoking implements, such as cigarettes, cigars, or pipes, but many take the form of ballpoint pens or screwdrivers since those designs are more practical to house the mechanisms involved. Most are also reusable, with replaceable and refillable parts, but some models are disposable.

The primary stated use of the electronic cigarette is as a smoking cessation device, as it attempts to deliver the experience of smoking without, or with greatly reduced, adverse health effects usually associated with tobacco smoke. Nevertheless, concerns have been raised that use of the device still carries health risks, and that it could appeal to non-smokers, especially children, due to its novelty, flavorings, and possibly overstated claims of safety.

The possible benefits or adverse effects of electronic cigarette use are a subject of disagreement among different health organizations and researchers. Controlled studies of electronic cigarettes are scarce due to their relatively recent invention and subsequent rapid growth in popularity. Laws governing the use and sale of electronic cigarettes, as well as the accompanying liquid solutions, currently vary widely, with pending legislation and ongoing debate in many regions.

The electronic cigarette was invented by Chinese pharmacist Hon Lik in 2003 and introduced to the market the following year. The company he worked for, Golden Dragon Holdings, changed its name to Ruyan (meaning "to resemble smoking"), and started exporting its products in 2005–2006,^[1] before receiving the first international patent in 2007.^[2]

Contents 1 Components 1.1 Cartridge 1.2 Atomizer 1.3 Cartomizer 1.4 Power source and electronics 2 Liquids 3 Markets 3.1 American 3.2 European 4 Health questions 4.1 Food and Drug Administration 4.2 American Association of Public Health Physicians 4.3 Health Canada 4.4 World Health Organization 4.5 Health New Zealand Ltd. study 4.6 Boston University School of Public Health study 4.7 Harm reduction 5 Legal status by country 5.1 The European Economic Area 5.2 United States 5.3 Other countries 6 See also 7 References

[edit] Components

Electronic cigarettes generally consist of three primary components: a cartridge, an atomizer, and a battery unit. Some designs implement a disposable integrated cartridge/atomizer component known as a cartomizer.

Most reusable electronic cigarette models are manufactured according to some standard for their connections, making their components interchangeable. The current (June 2011) dominating attachment standards are the 510 and 808D; most components available are made to fit one of these models.

[edit] Cartridge

The cartridge is a small, usually disposable, plastic container with openings on each end. It generally houses an absorbent, sponge-like material saturated with the liquid solution to be vaporized. The mouthpiece is constructed so that the vapor produced can flow past the solution container to reach the user's mouth.

When the liquid in the cartridge has been depleted, the user can generally choose between refilling it, or replacing it with another pre-filled cartridge.

Some users forgo the use of cartridges and "drip" liquid directly onto the atomizer, in a method that has aptly come to be known as "dripping". Some manufacturers have responded to this practice by creating special mouthpieces that are intended primarily to ease use by the dripping method.

[edit] Atomizer

The atomizer is a heating element that serves to vaporize the solution so it can be inhaled. It contains a filament whose efficiency degrades over time due to a buildup of sediment, or "burns out" entirely, requiring replacement. This creates one of the primary recurring expenses associated with electronic cigarettes.

[edit] Cartomizer

To deal with atomizer degradation and the associated expense, manufacturers introduced an integrated cartridge/atomizer component that is more cheaply produced, known as a cartomizer. They are generally sold in packages of five or more. When their heating elements degrade, they can be disposed of and replaced more cheaply than standalone atomizers.

[edit] Power source and electronics

Most electronic cigarettes are powered by a lithium-ion rechargeable battery. The housing for the battery and electronic circuitry is usually the largest component of an electronic cigarette. It is generally referred to simply as the "battery".^{[citation needed]} This unit may contain an electronic airflow sensor for automated operation, or a button for manual operation. A timed cutoff switch (to prevent overheating) and/or a colored LED may also be included here.

To recharge their batteries, many different types of battery chargers – such as AC outlet, car, and USB – are usually available. Some manufacturers also offer a "Portable Charging Case," or "PCC",which contains a large rechargeable battery that is then used to charge a smaller battery within the individual e-cigarettes.

Another power option is direct USB power, which is available for most electronic cigarette models. A USB-tethered module is attached to the cigarette in place of a battery, and must be plugged into a computer's USB port or a USB AC adapter in order to operate.

[edit] Liquids

Liquids used to produce vapor in electronic cigarettes are widely sold separately for use in refillable cartridges. Liquid is commonly known as "nicotine solution" when it contains the actual nicotine component.^{[citation needed]} Liquids are also sometimes referred to as "e-liquid", "e-juice", etc. in keeping with the "e-" nomenclature. Liquids commonly contain some amount of flavoring, with hundreds of different flavors available. Some flavor varieties attempt to resemble traditional cigarette types, such as regular tobacco and menthol, and some even attempt to mimic specific cigarette brands, such as Marlboro or Camel. Fruit and other flavors, such as chocolate, vanilla, caramel, coffee, and cola, are also available.

Liquid solution consists of flavoring and/or nicotine dissolved in one or several hygroscopic components, which turns the water in the solution into the smoke-like vapour when heated. The most commonly used hygroscopic components are propylene glycol, vegetable glycerin or polyethylene glycol 400, usually referred to as PG, VG and PEG 400 respectively. All three are common food additives and used in a variety of pharmaceutical formulations. Since concerns have been raised by various opponent groups regarding the safety of inhaling these substances, it has been pointed out by proponents that PG has been used as an additive in asthma inhalers and nebulizers since the 1950s, with no serious adverse side effects, and because of its water-retaining properties, is the compound of choice for delivering atomized medication. The U.S. Food and Drug Administration (FDA) includes propylene glycol on its list of substances Generally Recognized as Safe (GRAS), and it meets the requirements of acceptable compounds within Title 21 of the Code of Federal Regulations.

Liquid solutions containing nicotine are available in differing nicotine concentrations to suit user preferences. Concentrations range from zero nicotine, to low/midrange doses (6–8 mg/ml and 10–14 mg/ml respectively), to high and extra-high doses (16–18 mg/ml and 24–36 mg/ml respectively). Nicotine concentration ratings are often printed on the liquid container or cartridge (the standard notation "mg/ml" is often abbreviated simply as "mg").^[3]

[edit] Markets

[edit] American

The Electronic cigarette is legal in the United States, but may be subject to legislation at state level. The Food and Drug Administration (FDA) lost its battle in the courts in January 2010 to have them classified as a drug delivery device and thus bring them under FDA regulation pursuant to the Food, Drug, and Cosmetic Act (FDCA). In September 2010 and appeal, the FDA announced that it would begin regulating e-cigarettes, on the premise that they comprise both a drug and a drug delivery device.^[4] The FDA began regulatory action against five American companies "for violations of the Federal Food, Drug, and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices."^[4] On 7 December 2010, the appeals court ruled against the FDA, in 3-0 unanimous decision, clearing the way for marketing of electronic cigarettes.

Until late of 2006, e-cigarettes didn't become easily available in the U.S., but now there are several million users worldwide, with tens of thousands new e-smokers every week, so at 25 April 2011, FDA plans to regulate smokeless electronic cigarettes as tobacco products and won't try to regulate them under stricter rules for drug-delivery devices.^[5]

[edit] European

In April 2006, the electronic cigarette was brought to Europe, and officially launched at the "RUYAN" Overseas Promotion Conference in Austria.^[6] After its introduction, this product was adapted to the European market and marketed in UK as the "electronic cigarette". In 2007, Reuters visited SBT RUYAN in Beijing, which drew media attention to the technology. According to Matt Salmon, president of the recently formed Electronic Cigarette Association, the total number of e-cigarette users was estimated to be 300,000 in October 2009, based on survey results. In his opinion, Salmon added, the actual figure was in excess of that.^[7]

[edit] Health questions

The health effects of using electronic cigarettes are currently unknown. Several studies regarding the long-term health effects of nicotine vapor, both inhaled directly and second hand, are currently in progress.^[8]

[edit] Food and Drug Administration

In May 2009, the Food and Drug Administration (USFDA) Division of Pharmaceutical Analysis tested the contents of 19 varieties of electronic cigarette cartridges produced by two vendors (NJoy and Smoking Everywhere).^[9] Diethylene glycol was detected in one of the cartridges manufactured by Smoking Everywhere.^[9] In addition, tobacco-specific nitrosamines (TSNAs), known cancer-causing agents, were detected in all of the cartridges from one brand and two of the cartridges from the other brand. The study found that the actual nicotine levels did not always correspond to the amount of nicotine the cartridges purported to contain.^[9] The analysis found traces of nicotine in some cartridges that claimed to be nicotine-free.^[9] Further concerns were raised over inconsistent amounts of nicotine delivered when drawing on the device.^[10] In July 2009, the FDA issued a press release discouraging the use of electronic cigarettes and repeating previously stated concerns that electronic cigarettes may be marketed to young people and lack appropriate health warnings.^[11]

The Electronic Cigarette Association said that the FDA testing was too "narrow to reach any valid and reliable conclusions.”^[9] Exponent, Inc., commissioned by one manufacturer to review the FDA's study in July 2009, objected to the FDA analysis of electronic cigarettes lacking comparisons to other FDA-approved nicotine replacement therapy products where similar levels of TSNA were detected. Exponent concluded that the FDA's study did not support the claims of potential adverse health effects from the use of electronic cigarettes.^[12]

[edit] American Association of Public Health Physicians

The American Association of Public Health Physicians has come out in support of electronic cigarettes. The AAPHP recommends that the FDA reclassify the electronic cigarette as a tobacco product (as opposed to a drug/device combination) and believes that the effects of second-hand smoke will be significantly decreased using electronic cigarettes.^[13][14]

[edit] Health Canada

On 27 March 2009, Health Canada issued an advisory against electronic cigarettes. The advisory stated "Although these electronic smoking products may be marketed as a safer alternative to conventional tobacco products and, in some cases, as an aid to quitting smoking, electronic smoking products may pose risks such as nicotine poisoning and addiction."^[15]

[edit] World Health Organization

The World Health Organization stated in September 2008 that it did not consider electronic cigarettes to be a legitimate smoking cessation aid. It demanded that marketers immediately remove from their materials any suggestions that the WHO considers electronic cigarettes safe and effective.^[16] The WHO states that to its knowledge, "no rigorous, peer-reviewed studies have been conducted showing that the electronic cigarette is a safe and effective nicotine replacement therapy. WHO does not discount the possibility that the electronic cigarette could be useful as a smoking cessation aid." WHO Tobacco Free Initiative director ad interim Douglas Bettcher stated that claims that electronic cigarette can help smokers quit need to to be backed up by clinical studies and toxicity analyses and operate within the proper regulatory framework. He added: "Until they do that, WHO cannot consider the electronic cigarette to be an appropriate nicotine replacement therapy, and it certainly cannot accept false suggestions that it has approved and endorsed the product."^[17]

In 2010 the Tobacco Regulation meeting held in Uruguay came out with warnings about electronic cigarettes. Signatories of the meeting's treaty included representatives of countries such as Canada, Brazil, Thailand, Hong Kong, and Saudi Arabia, where electronic cigarettes had been banned.^{[citation needed]}

The secretariat of the meeting refused and stated that electronic cigarettes do not violate articles 9 and 10 of the framework convention for tobacco control regarding COMPOSITION (toxins, carcinogens, harm to self) or EMISSIONS (second hand smoke or harm to others). The secretariat stated that the problems regarding electronic cigarettes relate to regulatory issues and not to the work that the convention is tasked with. In the memo they also mentioned that electronic cigarettes can be considered a medical product only IF the marketer wanted to make medical claims, otherwise they are a tobacco product.^{[citation needed]}

[edit] Health New Zealand Ltd. study

In 2008, Dr. Murray Laugesen, of Health New Zealand, published a report on the safety of Ruyan electronic cigarette cartridges funded by e-cigarette manufacturer, Ruyan; Laugesen and the WHO claim that the research is independent.^[18] The presence of trace amounts of TSNAs in the cartridge solution was documented in the analysis. The results also indicated that the level of nicotine in the electronic cigarette cartridges was not different from the concentration of nicotine found in nicotine patches.^[18] John Britton, a lung specialist at the University of Nottingham, UK and chair of the Royal College of Physicians Tobacco Advisory Group said “if the levels are as low as in nicotine replacement therapy, I don’t think there will be much of a problem.”^[18] The study's detailed quantitative analysis concluded that carcinogens and toxicants are present only below harmful levels. It concluded: "Based on the manufacturer’s information, the composition of the cartridge liquid is not hazardous to health, if used as intended."^[19]

[edit] Boston University School of Public Health study

A study by researchers at the Boston University School of Public Health in 2010 concluded that electronic cigarettes were safer than real cigarettes and may aid in breaking the habit of smoking. Researchers said that while further studies on electronic cigarettes were needed, "[f]ew, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns." Electronic cigarettes were found to be "much safer" than traditional tobacco ones, and had a level of toxicity similar to existing nicotine replacements.^[20][21][22]

In the report, the level of carcinogens in electronic cigarettes was found to be up to 1,000 times lower than regular cigarettes. It also said early evidence shows that electronic cigarettes may help people to stop smoking by simulating a tobacco cigarette.^[20][21]

[edit] Harm reduction

Manufacturers promote electronic cigarettes as a safer alternative to smoking cigarettes by claiming that most of the harmful material produced by the combustion of tobacco in traditional cigarettes is not present in the atomized liquid of electronic cigarettes. Despite claims that electronic cigarettes are safer because they contain no carcinogenic substances, manufacturers include warning labels with their products because they contain nicotine.

According to Cancer Research UK, "For a smoker, the health hazards of continuing to smoke greatly outweigh any potential risks of using nicotine replacement therapy".^[23] However, while electronic cigarettes are purported to deliver nicotine to the user in a manner similar to that of a Nicotrol inhaler, no electronic cigarette has yet been approved as a medicinal NRT product or provided the necessary clinical testing for such approval. Moreover, doubts have been raised as to whether electronic cigarettes actually deliver any substantial amount of nicotine at all.^[24]

Research carried out at the University of East London on the effects of the use of an electronic cigarette to reduce cravings in regular tobacco smokers showed that there was no significant reported difference between smokers who inhaled vapour containing nicotine, and those who inhaled vapour containing no nicotine. The report concluded that although electronic cigarettes can be effective in reducing nicotine-related withdrawal symptoms, the nicotine content does not appear to be of central importance, and that other smoking related cues (such as taste, vapour resembling smoke) may account for the reduction in discomfort associated with tobacco abstinence in the short term.^[25][26]

Though manufacturers have marketed electronic cigarettes as a way to curtail an addiction to nicotine,^[27] international health organizations have stated they may not be marketed as a cessation device.^[16] A number of regulatory agencies have issued warnings regarding the health effects of these products. The recently formed Electronic Cigarette Association aims to eliminate unsubstantiated health claims made by electronic cigarette companies, and those companies that wish to participate in the association must agree to refrain from making such claims.^[28][29] In a recent online survey from November 2009 among 303 smokers, it was found that e-cigarette substitution for tobacco cigarettes resulted in reduced perceived health problems, when compared to smoking conventional cigarettes (less cough, higher ability to do exercise, and a better sense of taste and smell).^[30]

[edit] Legal status by country

Because of the relative novelty of the technology and the possible relationship to tobacco laws and medical drug policies, electronic cigarette legislation and public health investigations are currently pending in many countries.

[edit] The European Economic Area

The EU 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 EU 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."^[31]

Because of this vague EU position, member countries in the European Economic Area currently have very dissimilar rules:

• 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.^[32] The use of electronic cigarettes has not been prohibited in Copenhagen Airport, but at least one airline (Scandinavian Airlines) has decided to ban their use on board flights.^[33]
• In Finland, e-cigarettes with nicotine-free cartridges may be sold. 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.^[34][35]
• In Latvia, the Ministry of Health has warned that the e-cigarette can cause harm to cardiovascular, hepatic and renal systems,^[36] however, e-cigarettes are legal, and are sold via the internet to individuals at least 18 years old.
• In the Netherlands, use and sale of electronic cigarettes is allowed, but advertising is forbidden pending European Union legislation.^[37]
• In Norway electronic cigarettes and nicotine can only be imported from another EEA-country (f.ex. the UK) for private use. I.e. what is allowed in another EEA-country is automatically allowed all over the EEA (Norway is an EEA country, not EU). So, obtaining electronic cigarettes for personal use is permitted from any country within the European Economic Area.^[38]
• In Sweden the legal status for e-cigarettes is the same as in Denmark, Norway and Finland: e-cigarettes and nicotine-free cartridges may be sold, but nicotine cartridges are prohibited, pending authorization and EU legislation.
• In United Kingdom the sale and use of electronic cigarettes is legal, and they are sold in many pubs where they can also be used indoors.

[edit] United States

The Food and Drug Administration (FDA) classified electronic cigarettes as drug delivery devices and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA) prior to importation to and sale in the United States. The classification was challenged in court, and overruled by Judge Richard J. Leon citing that "the devices should be regulated as tobacco products rather than drug or medical products".^[39] In March 2010, a US Court of Appeal 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.".^[40] 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.^[41] 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 of Columbia Circuit appeals court declined to review the decision blocking the products from FDA regulation as medical devices on 24 January.^[42]

On 22 September 2009, under the authorization of the Family Smoking Prevention and Tobacco Control Act, the FDA banned flavored tobacco (with the notable exception of menthol cigarettes) due to its potential appeal to children.^[43] Wagner says that the use of flavorings such as chocolate could encourage childhood use and serve as a gateway to cigarette smoking.^[43]

Concerns about public safety have been raised. However, some former smokers say they have been helped by e-cigarettes, and scientists at the University of California, Berkeley said that e-cigarettes had great potential for reducing the morbidity and mortality related to smoking.^[44]

Individual states have differing legal treatment of electronic cigarettes:

• California Governor Arnold Schwarzenegger vetoed a bill that would ban 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."^[45]
• In 2009, New Jersey voted to treat the electronic cigarette in the same category as tobacco products by including under the New Jersey Smoke Free Air Act. Assemblywoman Connie Wagner sponsored the legislation arguing that they "looked like the real thing"; she also objected to the potential appeal of flavored electric cigarettes to children.^[46]
• Pennsylvania has begun efforts to restrict electronic cigarette use in various forms.^{[citation needed]}
• The sale of electronic cigarettes to minors in New Hampshire was legal. A group of students and a group called “Breathe New Hampshire” were concerned that electronic cigarettes will serve as a gateway to smoking cigarettes through appearing to be trendy: one compared electronic cigarettes to “having a new cell phone. It’s cool. It’s electronic.” They launched petitions to the state government to ban the sale of electronic cigarettes to minors.^[47] It is now illegal to sell e-cigarettes to minors as of July 2010.^[48]
• New York lawmakers are considering a state-wide ban, due to the concern of some health officials that e-cigarettes can be addictive, and could encourage children to start smoking.^{[citation needed]}
• Arizona has a planned ban of selling electronic cigarettes to minors.^[49]
• In Washington state, the King County board of health has banned smoking of electronic cigarettes in public places, and prohibited sales to minors.^[50] Neighboring Pierce County also prohibits sales to minors, but allows e-cigarette use in places such as bars and workplaces.^[51]

[edit] 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.^[52][53] However, in the state of Victoria, the Therapeutic Goods Administration said there were no laws preventing the importation of e-cigarettes bought over the internet for personal use, unless prohibited by state and territory legislation.^[54]
• In Brazil, the sale, importation and advertisement of any kind of electronic cigarettes are forbidden. The Brazilian health and sanitation federal agency, Anvisa, found the current health safety assessments about e-cigarettes not to be yet satisfactory to make the product eligible to be approved for commercialization.^[55]
• As of March 2009, the import, sale, and advertising of electronic cigarettes containing nicotine are banned in Canada, while non-nicotine e-cigs are legal and may be sold and advertised. Health Canada advised Canadian consumers not to purchase or use any electronic smoking products, cited prohibition of electronic smoking products containing nicotine in the Food and Drugs Act; no market authorization has been granted for any electronic smoking product.^[15]
• In China the sale and use of electronic cigarettes are legal.^[56] However, the low street price of tobacco cigarettes makes e-cigs an expensive alternative.
• In New Zealand, the Ministry of Health has ruled that the Ruyan e-cigarette falls under the requirements of the Medicines Act, and cannot be sold except as a registered medicine. Since the ruling, Ruyan has obtained registration, and sale is currently allowed in pharmacies.^[3]
• In Panama, importation, distribution and sale have been prohibited since June 2009. The Ministry of Health cites the FDA findings as their reason for the ban.^[57]
• In Singapore, the sale and import of electronic cigarettes, even for personal consumption, is illegal. According to Health Minister Khaw Boon Wan, electronic cigarettes were the industry's attempt to attract new users and were marketed to appeal to younger customers, including women.^[58]
• In South Korea the sale and use of electronic cigarettes are legal, but heavily taxed.^[59] Possessing electric cigarettes among teenagers is a problem.^[60]
• In Switzerland, sale of nicotine-free electronic cigarettes is legal. Use and import of electronic cigarettes containing nicotine is legal, though they cannot be sold in Switzerland.^[61] Electronic cigarettes are taxed in the same way as tobacco products.^[62]

[edit] See also

• Dissolvable tobacco
• Passive smoking
• Smoking ban
• Smoking cessation
• Snus
• WHO

[edit] References

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