Monday, 9 May 2016

IMA White Paper on Electronic cigarettes

IMA White Paper on Electronic cigarettes

  • Electronic cigarettes or e-cigarettes are a type of electronic nicotine delivery system.
  • They are battery-operated devices that heat a liquid to produce a vapor that the user inhales.
  • E-cigarettes were invented in 2003 in China.
  • Compared with nonusers and conventional cigarette smokers, e-cigarette users are younger, more educated and have higher incomes.
  • Most adult and adolescent regular users of e-cigarettes already smoke conventional cigarettes.
  • First-generation e-cigarettes mimic the shape and size of conventional cigarettes and may be referred to as "cigalikes."  Second-generation e-cigarettes are larger than conventional cigarettes and are either pen-style (medium size) or tank-style (large size). Third-generation e-cigarettes are known as "personalized vapors."
  • Unlike conventional cigarettes, which burn tobacco and generate smoke, e-cigarettes have a cartridge containing a liquid (sometimes referred to as "e-liquid"), which contains nicotine and other constituents. The liquid is heated to produce a vapor the user inhales
  • Across all brands, the main components of the liquid vaporized are nicotine, propylene glycol or glycerol, and flavorings.
  • The nicotine content of e-cigarettes and liquids vary and usually range from none (nicotine-free) up to 36 mg/mL. Common nicotine concentrations of e-cigarette liquids are 6 mg/mL, 12 mg/mL, 18 mg/mL, or 24 mg/mL.
  • Propylene glycol or glycerol is the main component of most e-cigarette liquids; some products may use ethylene glycol.
  • Unlike conventional cigarettes, e-cigarettes can be sold with flavorings. More than 7000 flavors are available, including candy, fruit, soda, and alcohol flavors. Flavorings may increase the attractiveness of e-cigarettes to youths, especially those who are not already smokers.
  • Some e-cigarettes contain enough alcohol, used to vaporize nicotine to affect motor skills, without the user knowing it (December 24 in Drug and Alcohol Dependence).
  • Metals such as tin, lead, nickel, and chromium have been found in e-cigarette liquids and vapor. Other compounds detected include tobacco-specific nitrosamines, carbonyl compounds, metals, volatile organic compounds and phenolic compounds.
  • Nicotine exposure from e-cigarette use, as with cigarette smoking, increases heart rate and produces measurable levels of blood cotinine, a nicotine metabolite.
  • Experienced e-cigarette users tend to take longer puffs and use the device more intensively compared with novice users. As a consequence, they have higher blood nicotine levels that more closely resemble the levels achieved by smoking conventional cigarettes. In less-experienced users, however, the nicotine delivered by e-cigarettes is consistently lower than nicotine delivered by conventional cigarettes
  • E-cigarettes do not expose the user to many of the constituents of cigarette smoke (e.g., tars, oxidant gases, and carbon monoxide) that are responsible for many of the tobacco-attributable diseases
  • Most believe that inhaling e-cigarette vapor is likely to be less harmful than inhaling cigarette smoke but the consequences of chronic inhalation of e-cigarette vapor are unknown, and levels of toxic and carcinogenic compounds may vary by e-cigarette liquid components and device used.
  • Little is known about the overall safety or the carcinogenic effects of propylene glycol or glycerol when heated and aerosolized. At high temperatures, propylene glycol decomposes and may form propylene oxide, a probable human carcinogen.
  • Glycerol produces the toxin, acrolein, though the levels produced are lower than conventional cigarettes.
  • Both propylene glycol and glycerol decompose to form the carcinogens formaldehyde and acetaldehyde, with levels depending on the voltage of the battery used in the e-cigarette.
  • Other carcinogenic compounds have been found in e-cigarettes but in trace amounts that are much lower than levels found in conventional cigarettes. These include tobacco-specific nitrosamines, carbonyl compounds, metals, volatile organic compounds, and phenolic compounds.
  • Similar to cigarette smoke, e-cigarette vapor contains particles.
  • It is not known whether the particles in e-cigarette vapor have any toxicity.
  • The limited, available evidence suggests there may be potential for e-cigarettes as a smoking cessation and/or harm reduction tool but more trials are needed to evaluate the safety and use of e-cigarettes in smoking cessation.
  • Studies have suggested that e-cigarettes may decrease cigarette cravings and reduce symptoms of nicotine withdrawal. However, the efficacy and safety of e-cigarettes as smoking cessation tools and how they compare with the available US Food and Drug Administration (FDA) approved pharmacotherapies are unknown.
  • Given the concerns that e-cigarette use may be a gateway to nicotine dependence in adolescents, many public health authorities have recommended restricting e-cigarette marketing and advertising to youth, much in the same way that conventional cigarette smoking advertising is restricted.
  • The nicotine in e-cigarette fluid poses a potential for accidental ingestion, especially by children. The typical 5 mL vial of e-cigarette liquid refill may contain a nicotine concentration of 20 mg/ml (100 mg/vial). The known lethal dose of nicotine is about 10 mg in children.
  • There are concerns about the potential health consequences of secondhand exposure to e-cigarette vapor.
  • Passive exposure to e-cigarette vapor produces small increases in serum cotinine, comparable with that from passive exposure to cigarettes. However, passive exposure to e-cigarette vapor is expected to be less toxic to bystanders than combustible cigarette smoke.
  • e-cigarettes have been banned in some countries (including Brazil, Singapore, Canada, and Uruguay)
  • In Europe, the European Parliament approved a directive that regulates nicotine-containing e-cigarettes with concentrations up to 20mg/mL as tobacco products
  • E-cigarettes with higher nicotine concentrations are regulated as medical devices. The directive includes regulation for the maximum amount of nicotine in e-cigarette liquids and requires child tamper-proof packaging.
  • As per WHO, regulations are needed to stop promotion of e-cigarettes to nonsmokers and young people, minimize potential health risks to users and nonusers, stop unproven health claims about e-cigarettes, and protect existing tobacco control efforts.
  • In a ruling on May 5, 2016, the US FDA’s Center for Tobacco Products (CTP) finalized a rule to regulate electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.
  • Use of e-cigarettes should not be permitted in hospitals or healthcare facilities. Conventional cigarettes are not allowed in these venues.
  • Nicotine replacement products, not e-cigarettes, should be used to manage nicotine withdrawal symptoms in hospitalized smokers.
  • Though it does not produce smoke but it is producing vapors, which may be harmful to the person sitting in vicinity. Therefore, it should be under the jurisdiction of antismoking rules of India i.e. COTPA (Cigarettes and Other Tobacco Products Act, 2003).
  • In India, we have many types of tobacco products available such as bidi, cigarette, chilling, Hukka, snuff, Gutkha, Paan etc. e-cigarette is nothing but yet another type of Nicotine.  In the western world, cigarette is the main mode of tobacco use therefore people are tempted to use it. But we already have many types of tobacco products. Studies have proved that all types of tobacco are harmful.
  • Since it is taken as aerosol, e-cigarettes should be placed in the category of Hukha, which also produces vapors.

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