E-Cigarette Regulation Background Information
Electronic cigarettes, also called e-cigarettes, vaporizers, and hookah pens, are electronic devices that produce a smoke-like aerosol (commonly referred to as vapor). This aerosol typically contains nicotine, propylene glycol and/or vegetable glycerin, chemical flavorings, and may have additional contaminants. E-cigarettes vary widely in terms of product design and manufacturing.
E-cigarettes have become a popular alternative to combustible cigarettes among adults who smoke. Surveillance data suggest that among adults, approximately 15% of current smokers and 22% of recent former smokers currently use e-cigarettes (CDC NCHS, 2015). However, a concerning trend has emerged among youth in Orange County. Local data show that 37% of high school students have ever used an e-cigarette and 18% used an e-cigarette in the past 30 days (YRBS, 2015). Although use of combustible cigarettes and overall tobacco use have been dropping for many years, overall tobacco use and corresponding nicotine addiction began to increase with the introduction of e-cigarettes and other vapor products. Click here for more information about youth tobacco use.
The research is inconclusive on whether e-cigarettes are an effective cessation tool. One systematic review found that using an e-cigarette with nicotine may help adults who smoke cut down on the amount they smoke and did not find evidence that short-term e-cigarette use was associated with health risk; due to the limited number of studies available, however, the authors noted that confidence in these results is low (McRobbie, et al., 2014). However, heavy smokers who significantly reduce their smoking, and even those who smoke just 1-4 cigarettes per day, may not reduce their risk of premature death (Tverdal & Bjartveit, 2006; Bjartveit, 2005).
The Surgeon General has recognized that in combination with rigorous surveillance and aggressive strategies to end combusted tobacco use – e-cigarettes could help complement “end game” strategies by allowing complete nicotine substitution among cigarette smokers (US DHHS, 2014). A recent systematic review found that, as currently being used, e-cigarettes are associated with a significantly less likelihood of quitting among people who smoke compared to those who do not use e-cigarettes (Kalkhoran & Glantz, 2016).
E-cigarettes are not currently marketed as therapeutic devices and are therefore not regulated by the Federal Drug Administration (FDA) as cessation products, although the FDA has proposed to extend its authority to cover e-cigarettes as tobacco products (FDA website).
In general, studies are limited and do not yet prove the safety or efficacy of these devices, although research continues to emerge.
There are seven FDA-approved smoking cessation medications, including nicotine patches, gum, and lozenges, also known as Nicotine Replacement Therapy (NRT). Orange County provides free NRT, while supplies last, to adults who live or work in the county and participate in eligible smoking cessation counseling. Click here for more information.
An emerging body of research on e-cigarettes suggests that emitted aerosol may contain potentially harmful chemicals in addition to nicotine. Although there are likely fewer toxins in e-cigarette aerosol than in smoke from lit tobacco products (Goniewicz et al., 2013), the aerosol may be harmful, especially for more vulnerable populations. Research on the acute health impacts e-cigarettes is limited, and there is no adequate research on the long-term health effects.
- Injury: Lithium batteries, which are used in many e-cigarette devices, carry an inherent risk of flame and explosion that are currently not well marked on product packaging and which can cause significant injury among users (Colaianni, et al. 2016; Jablow & Sexton, 2015).
- Nicotine Poisoning: Take caution in handling nicotine refill solutions, or “e-juice”, as there is a risk of nicotine poisoning when it comes in contact with the skin or when ingested, especially among children (AAPCC website).
- Nicotine Exposure: The evidence is sufficient to caution children and adolescents, pregnant women, and women of reproductive age because of the potential for fetal and adolescent nicotine exposure to have long-term consequences for brain development. (Surgeon General Report, 2014)
- Flavors: Several chemicals commonly used as flavorings in e-cigarettes, such as diacetyl and cinnamaldehyde, have known associations with respiratory disease. Studies demonstrate that the level of exposure through inhaling e-cigarette aerosol may be of toxicological concern. (Allen, et al. 2015; Behar, et al. 2014; Farsalinos, et al. 2014; Lerner, et al. 2015; Tierney, et al. 2015; Rowell, et al. 2015; Sussan, et al. 2015)
- Propylene Glycol: Propylene glycol is generally considered a low toxicity compound and is widely used in many products. However, occupational exposures have led to acute ocular and upper respiratory irritation, cough, reduced lung function, and chronic work-related wheezing and chest tightness. (Wieslander, et al. 2001; Varughese, et al. 2005)
- Acute Health Effects: Limited research on adverse short-term effects include increased airways resistance and respiratory irritation and cough, particularly among individuals with asthma. (CDC NIOSH, 2015; Vardavas, et al. 2012; McConnell, et al. 2015)
- Secondhand Exposure: Research demonstrates the potential for secondhand exposure to e-cigarette aerosol through biomarkers of nicotine exposure, as well as through studies done in controlled indoor conditions. (Balbé, et al. 2014; Thornburg, et al. 2014; Thornburg, et al. 2016)
- Vulnerable Populations: For ethical reasons, there is limited research on the human health effects of secondhand aerosol exposure among vulnerable populations. Research in mice, however, suggests that chemicals in e-cigarettes may exacerbate asthma and that there is potential for e-cigarette aerosols to affect development of neonates. (Lim & Kim, 2014; McGrath-Morrow, et al. 2015; Wu, et al. 2014)
Variability in e-cigarette emissions makes it very difficult to assess risk. In addition, users sometimes mix and use their own e-liquid, rather than one commercially available, which is challenging to simulate in toxicological studies and other research. (Cheng, 2014)
Regulation: Sale and Packaging
There is currently no federal legislation with respect to labeling or packaging of nicotine refill solution, although North Carolina law requires child-resistant packaging (NC GS §14-401.18A). In this state, minors are not allowed to purchase e-cigarettes (NC GS §14-313(b)), although online purchasing is allowed (NC GS § 14-313(b2)) and research suggests that minors can easily buy the products online (Williams, et al. 2015). North Carolina levies an excise tax on vapor products at the rate of five cents (5¢) per fluid milliliter of consumable product (NC GS §105-113.35).
For More Information
Annotated References - April 2016
Presentation to the Orange County Board of Health by Jonathan Thornburg, Ph.D., Director of Exposure and Aerosol Technology at RTI International - E-Cigarettes and Vapor Products: The State of the Science
CDC Letter of Evidence on Electronic Nicotine Devices - http://www.tobaccopreventionandcontrol.ncdhhs.gov/Documents/CDC-LetterofEvidenceonElectronicNicotineDeliverySystemsNorthCarolina-April2015.pdf
North Carolina Department of Health and Human Services - Electronic Cigarettes Fact Sheet
Synopsis of Electronic Nicotine Devices Information from 2012 and 2014 Surgeon General's Reports
Electronic Nicotine Device Systems: Key Facts CDC Office of Smoking and Health
Food and Drug Administration (FDA) Warns of Health Risks Posed by E-Cigarette