Electronic cigarettes (e-cigarettes) are devices, about the size of a regular cigarette. They operate by electronically vaporizing a solution that often contains nicotine and/or tobacco extracts, creating a mist which is then inhaled. E-cigarettes are available in various flavors and claimed strengths of nicotine cartridges. The World Health Organization (WHO) classifies it as electronic nicotine delivery systems (ENDS).
How an Electronic Cigarette Works?
When a user inhales on the mouth piece, the vaporizer is turned on and converts the liquid in the cartridge into a vapor. A rechargeable battery powers the vaporizer and has an indicator light to show when the device is in use.
- The components of a typical e-cigarette are illustrated below:
Figure 1 : Components of e-cigarette
- Cartridges generally contain nicotine, flavoring, and other chemicals.
- Quality control of the ingredients is of concern.
- Cartridges are sold with various amounts of nicotine, from 0 mg to 18 mg of nicotine or more, although the U.S. Food and Drug Administration (FDA) testing has shown that these advertised strengths can be very different than the actual amount of nicotine in the cartridges.
- Some users refill their own cartridges, which may be dangerous because it involves dealing with toxic levels of nicotine. Some refill bottles contain over 1,000 mg of nicotine, and the fatal dose for children is estimated at only 10 mg and for adults is estimated at (30-60) mg.
- Ruyan, a Chinese company, claims to have originally invented and patented the e-cigarette.
- There are now a number of companies selling e-cigarettes both on the internet and in retail shops, kiosks, supermarkets, specialized tobacco shops, markets/ market stalls in various locations in Malaysia.
Are e-cigarettes legal?
In Malaysia, e-cigarettes are still unregulated and can be sold to almost anyone. Internationally, the legality of e-cigarettes varies; for example, they are banned in Brazil, the Seychelles, Singapore and Uruguay.
ENDS designed for the purpose of direct nicotine delivery to the respiratory system fall into a regulatory gap in most countries, escaping regulation as drugs, and avoiding the controls applicable to tobacco products. There is also insufficient evidence currently to assess whether ENDS may be used to aid cessation, whether they create or sustain addiction, and whether they deliver constituents other than nicotine to smokers.
Claims that these products have health benefits, reduce harm, or can be used to aid smoking cessation need to be scientifically proven. They should be regulated as nicotine delivery devices, and where this regulation is not possible under tobacco-control laws, should be subject to regulation of contents and labeling, prohibitions against use in public places, and restrictions on advertising, promotion, and sponsorship.
Clinical trials, behavioural and psychological studies, and post-marketing studies at individual and population levels are needed to answer these issues. There are concerns that the quality and safety of ENDS have not been established. Regulators of medical and tobacco products to collaborate in assessing the regulatory framework within their own countries to determine the most effective means of regulating (or possibly banning) ENDS to protect public health.
Where health and/or therapeutic claims are being made or implied, quality, safety and efficacy data substantiating those claims should be presented to the appropriate national regulatory body.
Potential Youth Appeal
There is concern that electronic cigarettes may appeal to youth because of their high-tech design, easy availability online or via mall kiosks, and the wide array of flavors of cartridges including chocolate and mint and tobacco brands.6
Safety and Quality Control
While some manufacturers have funded research on electronic cigarettes, few independent studies on e-cigarettes are currently available. The U.S. FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes, and found that the tested products contained detectable levels of known carcinogens (chemicals that cause cancer) and toxic chemicals. In one sample, the FDA detected diethylene glycol, a chemical used in antifreeze that is toxic to humans. In several other samples, the FDA detected carcinogens, including nitrosamines.
The U.S. FDA’s other important findings include the following:
- The testing suggested that the quality control processes used to manufacture these products are inconsistent or non-existent. For example, three different e-cigarette cartridges with the same label were tested and each cartridge emitted a markedly different amount of nicotine with each puff.
- The e-cigarette cartridges that were labeled as containing no nicotine had low levels of nicotine in all cartridges tested, except one.
- In addition to the known carcinogens and toxic chemicals, tobacco-specific impurities suspected of being harmful to humans, anabasine, myosmine, and β-nicotyrine, were detected in a majority of the samples tested.
- One high-nicotine cartridge delivered twice as much nicotine to users when the vapor from that e-cigarette brand was inhaled than was delivered by a sample of the nicotine inhalation product approved by the FDA for use as a smoking cessation aid that was used as a control.
However, it has been debated that only trace levels of carcinogens (0.07% – 0.2% of the corresponding levels in cigarettes) have been detected, which are at levels similar to the nicotine patch and nicotine gum (NRT products approved for smoking cessation – How to Quit). In addition, diethylene glycol was found in only one of the 18 samples tested (a chemical that has not been found in any other brand since).
In summary, until sufficient evidence is available regarding the safety and efficacy of ENDS, including e-cigarettes, it is best to consider them as alternatives to cigarettes and not as effective smoking cessation aids.
- Electronic cigarettes: achieving a balanced perspective. Theodore L. Wagener TL, Siegel M, Borrelli B. Addiction. 2012. 107, 9, 1545–1548.
- Electronic nicotine delivery systems, including electronic cigarettes. Report by the Convention Secretariat Conference of the Parties to the WHO Framework Conventionon Tobacco Control:Fifth Session.Seoul, Republic of Korea, 12–17 November 2012. Provisional agenda item 6.5. FCTC/COP/5/13, 18 June 2012. Available from: http://apps.who.int/gb/fctc/PDF/cop5/ FCTC_COP5_13-en.pdf
- Consumer Updates: FDA Warns of Health Risks Posed by E-Cigarettes. 2009 July 24, 2009 [cited 2009 August 12, 2009]; Available from: http://www.fda.gov/ForConsumers/ ConsumerUpdates/ucm173401.htm.
- FDA and public health experts warn about electronic cigarettes [press release]. 2009 July 22, 2009 [cited 2009August 12, 2009]; Available from: http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm173222.htm.
- Summary of results: Laboratory analysis of electronic cigarettes conducted by FDA. 2009 July 22, 2009 [cited 2009August 12, 2009]; Available from: http://www.fda.gov/NewsEvents/ PublicHealthFocus/ucm173146.htm.
- INCHEM, I.P.o.C.S.I. Nicotine. 1991 [cited 2009 August 12, 2009]; Available from: http://www.inchem.org/documents/pims/chemical/nicotine.htm.
- Ruyan asserts patent rights to e-cigarette in key China court ruling. 2009 [cited 2009 August 12, 2009]; Available from: http://www.ruyanamerica.com/News/News.cfm?NewsID=1008.
- Westenberger, B.J., Evaluation of e-cigarettes. 2009, FDA, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis: St. Louis, MO.
|Last Reviewed||:||7 February 2015|
|Writer||:||Prof. Dr. Mohamad Haniki Nik Mohamed|
|Accreditor||:||Dr. Sallehudin Abu Bakar|