The Electronic Cigarette
Reprinted Under Creative Commons License (http://en.wikipedia.org/wiki/Electronic_cigarette)
Electronic Cigarette
An electronic cigarette, also known as an e-cigarette or personal vaporizer, is a battery-powered device that provides inhaled doses of nicotine by way of a vaporized solution. It is an alternative to smoking tobacco products, such as cigarettes, cigars, or pipes. In addition to purported nicotine delivery, this vapor also provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no smoke or combustion is actually involved in its operation.
An electronic cigarette takes the form of some manner of elongated tube, though many are designed to resemble the outward appearance of real smoking products, like cigarettes, cigars, and pipes. Another common design is the "pen-style", so named for its visual resemblance to a ballpoint pen. Most electronic cigarettes are reusable devices with replaceable and refillable parts. A number of disposable electronic cigarettes have also been developed.
History The electronic cigarette was first developed with a registered patent, in April 2003 by SBT Co. Ltd., a Beijing based company, which is now controlled by the Golden Dragon Group Ltd. In 2004, Ruyan took over the project to further develop the emerging technology. Ruyan officially absorbed SBT Co. Ltd. and their name was changed to SBT RUYAN Technology & Development Co., Ltd. Already in May 2004, Ruyan sold the first electronic cigarette in China. In its first 3 years of production, SBT RUYAN saw steady increases in sales, from $13 million HKD ($1.7 million USD) in 2004 to $136 million HKD ($17 million USD) in 2005, and $286 million HKD ($37 million USD) in 2006
Electronic Cigarette Operation
Operation In automatic models, when a user inhales through the device, air flow is detected by a sensor, which activates a heating element that vaporizes a nicotine solution stored in the mouthpiece. On manual models, the user must depress a button to activate the heating element to produce vapor which is then inhaled by the user. On most models an LED on the opposite end of the device is also activated during inhalation, which serves as an indicator of use. The LED color is usually a matter of preference, as the most widely used electronic cigarettes come with options for many different ones.
Electronic Cigarette Components
Components A disassembled cigarette-shaped electronic cigarette.
A. LED light cover
B. battery (also houses circuitry)
C. atomizer (heating element)
D. cartridge (mouthpiece). While electronic cigarettes take many forms, they each generally employ the same basic components: a mouthpiece, a heating element, a rechargeable battery, and various electronic circuits.
Mouthpiece ("cartridge")
Mouthpiece ("cartridge") The mouthpiece is a small disposable plastic cup-like piece affixed to the end of the tube. Inside the mouthpiece is a smaller plastic cup which holds an absorbent material that is saturated with a flavored liquid solution that may contain nicotine. This inner cup is made such that air is able to flow around it and through a hole in the end of the outer piece; this is necessary for the device to provide the ability for suction to move the vapor into the user's mouth. The mouthpiece is referred to in the industry as a "cartridge". When the liquid in the cartridge has been depleted, it can either be refilled by the user or replaced with another pre-filled cartridge.
As an alternative to the traditional plastic mouthpiece, some manufacturers have created dedicated mouthpieces just for dripping, such as Super-T manufacturing's stainless steel T-Tip drip tip. Another alternative to using cartridges is the direct dripping method using drip tips. By removing the absorbent material, one is able to simply remove the plastic mouthpiece and drip several drops of e-liquid directly onto the atomizer bridge. To further ease dripping, some manufacturers have created specialty mouthpieces made of stainless steel or plastic that are intended just for dripping and do not require removal each time you drip.
Heating element ("atomizer")
The heating element ("atomizer") serves to vaporize the liquid in the mouthpiece so that it can be inhaled. This component is referred to in the industry as an "atomizer". Atomizers have a finite life of about one month (on average) and are one of the recurring expenses associated with electronic cigarettes. Some models combine an atomizer and pre-filled cartridge into one disposable component referred to as a "cartomizer".
Battery and electronics
Battery and electronics An electronic cigarette battery connected to a USB charger. Most electronic cigarettes employ a lithium-ion rechargeable battery to power the heating element. Battery life varies depending on the battery type and size, frequency of use, and operating environment. Many different battery charger types are available, such as wall outlet, car, and USB chargers. The battery is generally the largest component of an electronic cigarette.
Some electronic cigarettes employ an electronic airflow sensor to automatically activate the heating element upon inhalation, while other models require the user to press a button while inhaling. Various other electronic circuits are usually employed as well, such as a timed cutoff switch to prevent overheating and a colored LED to signal activation of the device.
Traditionally, electronic cigarettes have utilized an electronic means of activation. This involved the use of small tactile switches, vacuum switches and the related wiring and electronics necessary to run them. Users soon discovered these could be unreliable. With the advent of "mods", several manufacturer's have created all mechanical electronic cigarettes that eliminate the use of any wiring, solder or electronics in an effort to improve switch reliability.
While some larger electronic cigarette models employ a user-replaceable standard-size battery cell, many models are too small to house a standard-size cell and instead require a proprietary component made by the electronic cigarette manufacturer. For those models, the battery and electronic components are housed within a single replaceable part, which is still generally referred to in the industry simply as the "battery".
Nicotine and non-nicotine solution
Nicotine solution Nicotine solutions sold separately for use in refillable cartridges are sometimes referred to as "e-liquid" or "e-juice", and commonly contain some amount of flavoring, with several different flavors available. They consist of nicotine dissolved in propylene glycol (PG) and/or glycerin (glycerol). Both PG and glycerin are common food additives.
Solutions are also available in differing nicotine concentrations, to let the user decide the amount of nicotine to be taken in. Concentrations range from Zero Nicotine, low and midrange doses (6–8 mg/ml and 10–14 mg/ml respectively), to high and extra-high doses (16–18 mg/ml and 20–54 mg/ml respectively). The concentration ratings are often printed at the e-liquid bottle or cartridge, although the standard notation "mg/ml" often gets abbreviated to just "mg". Solutions are also available that contain no nicotine at all.
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 are also available, such as vanilla, caramel, and coffee.
Below are some of the different liquid solution compositions available:
An electronic cigarette, also known as an e-cigarette or personal vaporizer, is a battery-powered device that provides inhaled doses of nicotine by way of a vaporized solution. It is an alternative to smoking tobacco products, such as cigarettes, cigars, or pipes. In addition to purported nicotine delivery, this vapor also provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no smoke or combustion is actually involved in its operation.
An electronic cigarette takes the form of some manner of elongated tube, though many are designed to resemble the outward appearance of real smoking products, like cigarettes, cigars, and pipes. Another common design is the "pen-style", so named for its visual resemblance to a ballpoint pen. Most electronic cigarettes are reusable devices with replaceable and refillable parts. A number of disposable electronic cigarettes have also been developed.
History The electronic cigarette was first developed with a registered patent, in April 2003 by SBT Co. Ltd., a Beijing based company, which is now controlled by the Golden Dragon Group Ltd. In 2004, Ruyan took over the project to further develop the emerging technology. Ruyan officially absorbed SBT Co. Ltd. and their name was changed to SBT RUYAN Technology & Development Co., Ltd. Already in May 2004, Ruyan sold the first electronic cigarette in China. In its first 3 years of production, SBT RUYAN saw steady increases in sales, from $13 million HKD ($1.7 million USD) in 2004 to $136 million HKD ($17 million USD) in 2005, and $286 million HKD ($37 million USD) in 2006
Electronic Cigarette Operation
Operation In automatic models, when a user inhales through the device, air flow is detected by a sensor, which activates a heating element that vaporizes a nicotine solution stored in the mouthpiece. On manual models, the user must depress a button to activate the heating element to produce vapor which is then inhaled by the user. On most models an LED on the opposite end of the device is also activated during inhalation, which serves as an indicator of use. The LED color is usually a matter of preference, as the most widely used electronic cigarettes come with options for many different ones.
Electronic Cigarette Components
Components A disassembled cigarette-shaped electronic cigarette.
A. LED light cover
B. battery (also houses circuitry)
C. atomizer (heating element)
D. cartridge (mouthpiece). While electronic cigarettes take many forms, they each generally employ the same basic components: a mouthpiece, a heating element, a rechargeable battery, and various electronic circuits.
Mouthpiece ("cartridge")
Mouthpiece ("cartridge") The mouthpiece is a small disposable plastic cup-like piece affixed to the end of the tube. Inside the mouthpiece is a smaller plastic cup which holds an absorbent material that is saturated with a flavored liquid solution that may contain nicotine. This inner cup is made such that air is able to flow around it and through a hole in the end of the outer piece; this is necessary for the device to provide the ability for suction to move the vapor into the user's mouth. The mouthpiece is referred to in the industry as a "cartridge". When the liquid in the cartridge has been depleted, it can either be refilled by the user or replaced with another pre-filled cartridge.
As an alternative to the traditional plastic mouthpiece, some manufacturers have created dedicated mouthpieces just for dripping, such as Super-T manufacturing's stainless steel T-Tip drip tip. Another alternative to using cartridges is the direct dripping method using drip tips. By removing the absorbent material, one is able to simply remove the plastic mouthpiece and drip several drops of e-liquid directly onto the atomizer bridge. To further ease dripping, some manufacturers have created specialty mouthpieces made of stainless steel or plastic that are intended just for dripping and do not require removal each time you drip.
Heating element ("atomizer")
The heating element ("atomizer") serves to vaporize the liquid in the mouthpiece so that it can be inhaled. This component is referred to in the industry as an "atomizer". Atomizers have a finite life of about one month (on average) and are one of the recurring expenses associated with electronic cigarettes. Some models combine an atomizer and pre-filled cartridge into one disposable component referred to as a "cartomizer".
Battery and electronics
Battery and electronics An electronic cigarette battery connected to a USB charger. Most electronic cigarettes employ a lithium-ion rechargeable battery to power the heating element. Battery life varies depending on the battery type and size, frequency of use, and operating environment. Many different battery charger types are available, such as wall outlet, car, and USB chargers. The battery is generally the largest component of an electronic cigarette.
Some electronic cigarettes employ an electronic airflow sensor to automatically activate the heating element upon inhalation, while other models require the user to press a button while inhaling. Various other electronic circuits are usually employed as well, such as a timed cutoff switch to prevent overheating and a colored LED to signal activation of the device.
Traditionally, electronic cigarettes have utilized an electronic means of activation. This involved the use of small tactile switches, vacuum switches and the related wiring and electronics necessary to run them. Users soon discovered these could be unreliable. With the advent of "mods", several manufacturer's have created all mechanical electronic cigarettes that eliminate the use of any wiring, solder or electronics in an effort to improve switch reliability.
While some larger electronic cigarette models employ a user-replaceable standard-size battery cell, many models are too small to house a standard-size cell and instead require a proprietary component made by the electronic cigarette manufacturer. For those models, the battery and electronic components are housed within a single replaceable part, which is still generally referred to in the industry simply as the "battery".
Nicotine and non-nicotine solution
Nicotine solution Nicotine solutions sold separately for use in refillable cartridges are sometimes referred to as "e-liquid" or "e-juice", and commonly contain some amount of flavoring, with several different flavors available. They consist of nicotine dissolved in propylene glycol (PG) and/or glycerin (glycerol). Both PG and glycerin are common food additives.
Solutions are also available in differing nicotine concentrations, to let the user decide the amount of nicotine to be taken in. Concentrations range from Zero Nicotine, low and midrange doses (6–8 mg/ml and 10–14 mg/ml respectively), to high and extra-high doses (16–18 mg/ml and 20–54 mg/ml respectively). The concentration ratings are often printed at the e-liquid bottle or cartridge, although the standard notation "mg/ml" often gets abbreviated to just "mg". Solutions are also available that contain no nicotine at all.
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 are also available, such as vanilla, caramel, and coffee.
Below are some of the different liquid solution compositions available:
Substance | Recipe 1 | Recipe 2 | Recipe 3 | Recipe 4 | Recipe 5 |
---|---|---|---|---|---|
Propylene glycol | 85% | 80% | 90% | 80% | <65% |
Nicotine | 1.6% | 2.4% | 3.2% | 0.1% | <3% |
Glycerol | 2% | 5% | - | 5% | <20% |
Tobacco essence | - | 4% | 4.5% | 1% | <5% |
Essence | 2% | - | 1% | 1% | <5% |
Organic acid | 1% | - | - | 2% | <1% |
Anti-oxidation agent | 1% | - | - | - | - |
Butyl valerate | - | 1% | - | - | - |
Isopentyl hexonate | - | 1% | - | - | - |
Lauryl laurate | - | 0.6% | - | - | - |
Benzyl benzoate | - | 0.4% | - | - | - |
Methyl octynicate | - | 0–5% | - | - | - |
Ethyl heptylate | - | 0.2% | - | - | - |
Hexyl hexanoate | - | 0.3% | - | - | - |
Geranyl butyrate | - | 2% | - | - | - |
Menthol | - | 0.5% | - | - | - |
Citric acid | - | 0.5% | 2.5% | - | - |
Water | - | - | - | 2.9% | <10% |
Alcohol | - | - | - | 8% | - |
2,3,5-Trimethylpyrazine | - | - | - | - | <1% |
2,3,5,6-Tetramethylpyrazine | - | - | - | - | <1% |
2,3-Dimethylpyrazine | - | - | - | - | <1% |
Acetylpyrazine | - | - | - | - | <1% |
Terpineol | - | - | - | - | <1% |
Ethyl maltol | - | - | - | - | <1% |
Guaiacol | - | - | - | - | <1% |
Acetylpyridine | - | - | - | - | <1% |
Octalactone | - | - | - | - | <1% |
The contents of a commonly imported tobacco flavored liquid from China.
Scientific Name | CAS | 6 mg Core | 11 mg Core | 16 mg Core |
---|---|---|---|---|
Megastigmatrienone | 13215-88-8 | 14.00% | 14.00% | 14.00% |
Beta-Damascenone | 23696-85-7 | 12.00% | 12.00% | 12.00% |
G2-Acetylpyrazine | 22047-25-2 | 0.10% | 0.10% | 0.10% |
2,5-Dimethyl pyrazine | 123-32-0 | 0.20% | 0.20% | 0.20% |
1,3-Propanediol | 57-55-6 | 68.10% | 67.60% | 67.10% |
L-Nicotine | 54-11-5 | 0.60% | 1.10% | 1.60% |
Linalool | 11-05-54 | 5.00% | 5.00% | 5.00% |
Markets
American
The Food and Drug Administration (FDA) has classified electronic cigarettes as drug delivery device and subject to market approval prior to sale under the Food, Drug, and Cosmetic Act (FDCA). In January 2010, this classification was overturned by a federal judge. An appeals court overruled this classification on March 2010. Despite this, a number of electronic cigarette companies have emerged online. However, it is unclear what actions the FDA will take to ensure that only compliant products are on the market.
European
In April 2006, the electronic cigarette was brought to Europe, and officially launched at the "RUYAN" Overseas Promotion Conference in Austria. 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.
Health issues
The health effects of using electronic cigarettes are currently unknown. Several studies regarding the long-term health effects of inhaling nicotine vapor are currently in progress, though it will be many years before the results are known.
Health Effects of Nicotine
Nicotine is a vasoconstrictor; it constricts arteries, making it harder for the heart to pumpblood through the body. Repeated nicotine exposure contributes to accelerated coronary artery disease, acute cardiac ischemic events, and hypertension. Additionally, studies have shown that nicotine exposure contributes to stroke, peptic ulcer disease, and esophageal reflux. Further, nicotine may cause wounds to heal more slowly and may associate with reproductive toxicity. Moreover, nicotine can cause the body to release its stores of fat and cholesterol into the blood. While nicotine has not been shown to cause cancer, it is still a strong poison in large enough doses.
NRP
Nicotine replacement therapies, such as nicotine gum, that were used for long periods of time may be associated with an increased risk of contracting oral cancer. Additional research must be conducted in order to determine whether nicotine found in smoking cessation aids, such as nicotine gum and lozenges, may increase the risk of mouth cancer.
Food and Drug Administration
(USA) In May 2009, the US FDA'sDivision of Pharmaceutical Analysis tested the contents of 19 varieties of electronic cigarette cartridges produced by two vendors (NJoy and Smoking Everywhere). Diethylene glycol was detected in one of the cartridges manufactured by Smoking Everywhere. In addition, tobacco-specific nitrosamines (TSNAs) 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. The analysis found traces of nicotine in some cartridges that claimed to be nicotine-free. Further concerns were raised over inconsistent amounts of nicotine delivered when drawing on the device. 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.
In response to the FDA study, the Electronic Cigarette Association said that the testing was too "narrow to reach any valid and reliable conclusions.” The FDA's study was reviewed in July 2009 by scientific consulting firm Exponent, Inc., in a report commissioned by the manufacturer of one of the electronic cigarettes tested by the FDA. Some of the criticisms in Exponent's report are poor standards of documentation and analysis. Exponent lists previous studies that have detected TSNA levels in FDA-approved nicotine replacement therapy products comparable to those the FDA detected in their study, and objects to the FDA making no comparisons to such products in their analysis of electronic cigarettes. Ultimately the review concludes that the FDA's study did not support the claims of potential adverse health effects from the use of electronic cigarettes.
American Association of Public Health Physicians
The American Association of Public Health Physicians has stated that the electronic cigarette is at least a thousand times less hazardous to human health than regular cigarettes, and supports legalization.
Health Canada
On March 27, 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.
World Health Organization
The World Health Organization proclaimed in September 2008 that it does not consider the electronic cigarette to be a legitimate smoking cessation aid, and demanded that marketers immediately remove from their materials any suggestions that the WHO considers electronic cigarettes safe and effective.[26] 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 states, "If the marketers of the electronic cigarette want to help smokers quit, then they need to conduct clinical studies and toxicity analysis and operate within the proper regulatory framework. 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."
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. Ruyan funded the research, but both Dr. Laugesen and the WHO claim that the research is independent. [27]. The presence of trace amounts of TSNAs in electronic cigarette vapor 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. [28]. 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.” [29]. The study conducted detailed quantitative analysis and concluded that carcinogens and toxicants are present only below harmful levels. The final conclusion of the safety report is: "Based on the manufacturer’s information, the composition of the cartridge liquid is not hazardous to health, if used as intended.
Harm reduction
Public health advocates often promote harm reduction strategies in order to reduce tobacco-related morbidity. There are two major approaches to harm reduction in tobacco. The first is the use of medicinal nicotine replacement therapies such as gum, patches, or inhalers, and the second is the use of tobacco products that claim to contain fewer carcinogens or lower levels of nicotine than regular cigarettes. . Manufacturers are promoting electronic cigarettes as a safer alternative to smoking cigarettes, 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, manufactures include warning labels with their products. For instance, the following advisory appears on the website of Green Smoke, a electronic cigarette company: “Warning: Nicotine is highly addictive. This product is not intended to diagnose, treat, cure or mitigate any disease or condition.” Another company, The E-Smoke Stop LLC, as well as other countless electronic cigarette companies, claim that with electronic cigarettes there are "...No nicotine withdrawals [if one purchase cartridges with nicotine]...[and that the vapor is]...not harmful for others around you...". They also conclude that these statements are based on independent studies and are not opinions reflected by the US Food and Drug Administration.
According to Cancer Research UK, "For a smoker, the health hazards of continuing to smoke greatly outweigh any potential risks of using NRT". It may be worth noting, however, that 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 undergone the extensive clinical testing necessary for such approval. Moreover, doubts have been raised as to whether electronic cigarettes actually deliver any substantial amount of nicotine at all.
Though some have marketed electronic cigarettes as a way to curtail an addiction to nicotine, international health organizations have stated they may not be marketed as a cessation device. 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. In a recent online survey from November 2009 among 303 smokers, it was found that e-cigarette substitution for tobacco cigarettes resulted in perceived health benefits, when compared to smoking conventional cigarettes (less cough, higher ability to do exercise, and a better sense of taste and smell).
Legal status by region 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.
- In Australia, the sale of electronic cigarettes containing nicotine is illegal.
- In Brazil electronic cigarettes sales, importation or advertisement of any kind are forbidden. Anvisa, the Brazilian health and sanitation federal agency, found the current health safety assessments about e-cigarettes not to be yet satisfactory to make the product eligible to be approved for commercialization.
- In Canada, as of March 2009, imports, sales, and advertising are banned. In March 2009, Health Canada also advised Canadians not to purchase or use any electronic smoking products. Health Canada cited the Food and Drugs Act, stating that electronic smoking products containing nicotine require market authorization before they can be imported, marketed, or sold. No market authorization has been granted for any electronic smoking product.
- In Denmark, the Danish Medicines Agency classifies electronic cigarettes containing nicotine as medicinal products. Thus, authorization is required from the retailer before the product may be marketed and sold. 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. 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 onboard flights.
- In Netherlands, use and sale of electronic cigarettes is allowed, but advertising is forbidden pending European Union legislation.
- 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.
- 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.
- In Singapore, the sale and import of electronic cigarettes, even for personal consumption, is illegal.
- In United Kingdom, use and sale of electronic cigarettes is currently unrestricted, although the MHRA has proposed bringing all nicotine products except tobacco within the medicines licensing regime.
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.“
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.
United States The Food and Drug Administration (FDA) has classified electronic cigarettes as drug delivery device and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA). As a result, they require market authorization prior to importation and sale into the country. This classification was overruled by Judge Richard J. Leon citing that “the devices should be regulated as tobacco products rather than drug or medical products”, Leon continued, saying “This case appears to be yet another example of F.D.A.’s aggressive efforts to regulate recreational tobacco products as drugs or devices”. However, a US Court of Appeal upheld the FDA's original classification in March 2010 allowing them to restrict and ban unauthorized products. 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 last 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."
In addition to this, states have begun to consider either including electronic cigarettes in bans that affect tobacco or banning their sale entirely. 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."The fact that California has some of the strictest cigarette laws in the country further complicates the picture. Further, the state of New Jersey has recently sought to include the electronic cigarette under the New Jersey Smoke Free Air Act. One of the main justifications New Jersey Assembly woman Connie Wagner seeks to use is the flavoring of electric cigarettes. On September 22nd 2009, under the authorization of the Family Smoking Prevention and Tobacco Control Act banned flavored tobacco (with the notable exception of menthol cigarettes) due to its potential appeal to children. Ms. Wagner advocates that the use of flavorings such as chocolate could encourage childhood use and serve as a gateway to cigarette smoking. In addition to New Jersey, New Hampshire, New York and Pennsylvania have begun efforts to restrict electronic cigarette use in various forms.
New Hampshire’s reform campaign fits into its own dynamic and unique category. In New Hampshire a group of students, partnered with a group called “Breathe New Hampshire” petitioned the state government to ban the sale of electronic cigarettes to minors. While sale of electronic cigarettes to minors remains legal, some worry that electronic cigarettes will serve as a gateway to smoking cigarettes. One teen involved in the legal proceedings claims that her peers will see electronic cigarettes as similar to “having a new cell phone. It’s cool. It’s electronic.”
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