An electronic cigarette, or e-cigarette, is an electrical device that simulates 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; though without its odor, and intended to omit its health risks. 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 portable, self-contained cylindrical devices the size of a ballpoint pen or magic marker; though sizes vary, mainly due to differing battery capacities. Many electronic cigarettes are designed to resemble actual cigarettes or cigars, or even pipes. Most are also reusable, with replaceable and refillable parts, but some models are disposable.
The primary stated use of the electronic cigarette is an alternative to tobacco smoking, or 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.
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. Concerns have been raised that use of the device still might carry health risks, and that it could appeal to non-smokers, especially children, due to its novelty, flavorings, and possibly overstated claims of safety.
The modern electronic cigarette's design was devised by Chinese pharmacist Hon Lik in 2003, though the earliest known description of its concept was authored by Herbert A. Gilbert in 1963.
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The electronic cigarette concept first appeared in a patent acquired by Herbert A. Gilbert in 1963.[1] The device was described as, "...a smokeless non-tobacco cigarette ... to provide a safe and harmless means for and method of smoking by replacing burning tobacco and paper with heated, moist, flavored air..." Due to the limitations of technology available at the time, and because tobacco was not yet generally accepted as harmful, this device never reached manufacturing.
The modern 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,[2] before receiving the first international patent in 2007.[3]
Electronic cigarettes all share three essential components:
A "cartomizer" option is available for most models that replaces the separate cartridge and atomizer components with a single integrated piece. This option is disposable, as opposed to standalone atomizers which are reusable and comparatively expensive.
Most reusable electronic cigarette components are manufactured according to some standard for their threaded (screw-on) fittings, making them interchangeable. Current (June 2011) dominating attachment standards include the 510 and 808D. The majority of components are manufactured to fit these models.
The cartridge is a small, usually disposable plastic container, with openings on each end. One end is placed in the user's mouth, while the other attaches to the atomizer (heating element).
This component serves as both a liquid reservoir and mouthpiece, and as such, must allow the passage of liquid to the atomizer, as well as vapor from the atomizer back to the user's mouth, without allowing liquid into the mouth. This is usually accomplished via an absorbent sponge-like material to keep the liquid in place, resting on a plastic barrier separating it from the mouth-end opening; The mouthpiece casing is constructed with side channels that allow vapor to pass from the atomizer, around the liquid chamber, to the mouth-end opening.
When the liquid in a cartridge has been depleted, the user can usually choose between refilling it, or replacing it with another pre-filled cartridge.
Some users forgo the use of liquid reservoirs altogether, and "drip" liquid directly onto the atomizer. This method 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.
The atomizer is the heating element responsible for vaporizing the liquid, and generally consists of a simple filament and wicking metal mesh to draw the liquid in. It is positioned in the center of the three components that make up the entire electronic cigarette cylinder, as the cartridge attaches to one end, and the power unit to the other. The atomizer's filament tends to lose efficiency 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.
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. When their heating elements degrade, they can be disposed of and replaced more cheaply than standalone atomizers.
Most portable power units contain a lithium-ion rechargeable battery, while wired units often draw power through a USB connection. The housing for the power source and electronic circuitry is usually the largest component of an electronic cigarette.
This unit may contain an electronic airflow sensor, in the case of "automatic" electronic cigarettes, so that activation is triggered simply by drawing breath through the device. Other "manual" electronic cigarette power units are constructed with a button that activates the heating element, and must be held during operation. A timed cutoff switch to prevent overheating, and/or a colored LED to announce activation, may also be included in the power unit casing.
Like most electronic devices, chargers of many different types are available for electronic cigarette batteries, such as AC outlet, car, and USB. Some manufacturers also offer a "Portable Charging Case," or "PCC": a portable case that contains a large battery, which in turn charges smaller batteries within individual e-cigarettes. PCCs are often designed to resemble traditional cigarette packs.
Liquids used to produce vapor in electronic cigarettes are widely sold both as separate bottled products, for use with refillable cartridges, and as pre-filled disposable cartridges. Bottled liquid is sold under a variety of names, including "e-liquid", "e-juice", and "nicotine solution".
Contents of liquid solutions vary, but their common aspects include water and flavorings in a propylene glycol or glycerin base. Nicotine is also included in solutions intended to fulfill a nicotine replacement role.
Hundreds of different flavor varieties are available. Some attempt to resemble traditional cigarette types, such as regular tobacco and menthol, and some even claim to mimic specific cigarette brands, such as Marlboro or Camel. A wide variety of food flavors are also sold, from the traditional (vanilla, coffee, cola) to the more exotic (strawberry daiquiri, Boston cream pie).
Liquid solutions containing nicotine are available in differing nicotine concentrations to suit user preference. Dosing nomenclatures are not standardized and vary by manufacturer, but tend towards the following rough figures:
Actual numerical nicotine concentration ratings are usually printed on liquid containers or cartridge packaging. Often, the standard notation "mg/ml" is shortened to a simple "mg".[4]
Flavors and nicotine are dissolved in hygroscopic components, which turn the water in the solution into a smoke-like vapor when heated. Commonly used hygroscopic components include propylene glycol, vegetable glycerin, and polyethylene glycol 400 (often sold under the abbreviations PG, VG, and PEG 400, respectively).
All three liquid bases are common food additives used in a variety of pharmaceutical formulations. Propylene glycol, the current dominating liquid base, has been utilized in asthma inhalers and nebulizers since the 1950s, 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.
Questions have also been raised over the standard practices of e-liquid and electronic cigarette manufacturing and the lack of regulations that surround it. The two main producers of e-liquid as of 2011 are China and the United States.
In China, manufacturers must obtain nontoxic testing permits to regulate the amount of pure nicotine that is mixed with e-liquid batches, but no other documentation is needed to produce and distribute. Some concern has been raised over the quality of ingredients used in Chinese manufacturing, but no substantiated evidence has been brought forward to discredit Chinese manufacturers. Many Chinese companies comply with standards implemented by the International Organization for Standardization (ISO).
In the United States, manufacturers must adhere to guidelines put forth by the Federal Food, Drug and Cosmetic Act, though there are no other required certification processes to be obtained for production and distribution of e-liquid. The FDA is currently underwriting regulation for the manufacturing and sale of e-liquid and electronic cigarettes.
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.[5]
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).[6] Diethylene glycol was detected in one of the cartridges manufactured by Smoking Everywhere.[6] 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.[6] The analysis found traces of nicotine in some cartridges that claimed to be nicotine-free.[6] Further concerns were raised over inconsistent amounts of nicotine delivered when drawing on the device.[7] 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.[8]
The Electronic Cigarette Association said that the FDA testing was too "narrow to reach any valid and reliable conclusions.”[6] Exponent, Inc., commissioned by NJOY 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.[9] Furthermore, FDA methods "have been lambasted in journals" by some medical and health research experts who noted the potentially harmful chemicals were measured at "about one million times lower concentrations than are conceivably related to human health.”[10]
As of April 2010, The American Association of Public Health Physicians (AAPHP) supports electronic cigarettes sales to adults, "because the possibility exists to save the lives of four million of the eight million current adult American smokers who will otherwise die of a tobacco-related illness over the next twenty years." However, the AAPHP is against sales to minors.[11] The AAPHP recommends that the FDA reclassify the electronic cigarette as a tobacco product (as opposed to a drug/device combination).[12][13]
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."[14]
The World Health Organization stated in September 2008 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 cigarettes can help smokers quit need 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."[15]
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 and regions such as Brazil, Thailand, Hong Kong, and Saudi Arabia, where electronic cigarettes had been banned.
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.
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.[16] 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.[16] 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.”[16] 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."[17]
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.[18][19][20]
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.[18][19]
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".[21]
A report from a UK Government advisory unit favoured to adopt "smokeless nicotine cigarettes" instead of the traditional "quit or die" approach believing this would save more lives.[22]
While electronic cigarettes are purported to deliver nicotine to the user in a manner similar to that of a nicotine inhaler, no electronic cigarette has yet been approved as a medicinal nicotine replacement therapy (NRT) product or provided the necessary clinical testing for such approval. Doubts have also been raised as to whether electronic cigarettes actually deliver any substantial amount of nicotine at all.[23]
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.[24][25]
Though manufacturers have marketed electronic cigarettes as a way to curtail an addiction to nicotine,[26] the World Health Organization has stated they know of no evidence confirming these claims.[27]
In an 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, improved ability to exercise, improved sense of taste and smell).[28]
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.
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 electronic cigarettes could be regarded as falling under Directive 93/42/EEC on medical devices depends on the claimed intended use and whether this intended use has a medical purpose. "It is for each national authority to decide, account being taken of all the characteristics of the product, whether it falls within the definition of a medicinal product by its function or presentation."[29]
Because of this vague EU position, member countries in the European Economic Area currently have varying rules.
Individual states have differing legal treatment of electronic cigarettes.
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.[30] Wagner says that the use of flavorings such as chocolate could encourage childhood use and serve as a gateway to cigarette smoking.[30]
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 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."[31] Judge Leon ordered the FDA to stop blocking the importation of electronic cigarettes from China and indicated that the devices should be regulated as tobacco products rather than drug or medical devices.[32]
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."[33] 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.[34] 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 2011.[35]
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.[36]
Under laws currently in existence, the use of electronic cigarettes are considered legal. Under the Indian Health Law of 2006 smoking has beened banned in public. This law states that smoking of tobacco in any form, whether in the form of cigarrettes, cigar, beedi or otherwise with the aid of a pipe, wrapper or any other instruments is illegal. As e cigarettes avoids the use of tobacco or any of its products it does not fall under this law and as all the contents of an e cigarretes are legal to use in public the e cigarette is considered legal to use untill new laws have been passed. [52]