National Academies Press: OpenBook

Public Health Consequences of E-Cigarettes (2018)

Chapter: 6 Research Needs: E-Cigarette Devices, Constituents, and Exposures

« Previous: 5 Toxicology of E-Cigarette Constituents
Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×

6

Research Needs: E-Cigarette Devices, Constituents, and Exposures

The committee was tasked to provide a list of research needs to inform the Food and Drug Administration (FDA) and e-cigarette regulation that will be prioritized with respect to

  • Research to gather information of most importance for the regulation of e-cigarettes to protect the population health
  • Research that should be a priority for federal funding

Given the relatively short time that e-cigarettes have been in use, it is understandable that the evidence base regarding their effects is limited. There is a great need for more evidence, as other research groups have documented (Walton et al., 2015). Manufacturers will need to produce this research in a short amount of time if current statutory deadlines remain in place. Researchers from academia will also be involved directly (in contracts with manufacturers and in grants from government and others) in the generation of these data. Some types of research involve a long-term horizon; other important and informative research requires much less time to conduct. One type of research does not substitute for the other; a complete portfolio of research is needed. The committee understands that, in any new field, researchers struggle to conduct optimal research due to limitations of knowledge. Also, researchers feel the urgency to study a new important question and adapt what they know, without complete adjustments in research design or methods sufficient to address the nuances of the problem. Finally, the rapidly changing nature of the devices has made comparisons among studies difficult.

Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×

The committee identified many gaps in the literature during its review and identified dozens of specific research needs that are important for understanding the effects of e-cigarettes and for FDA regulatory action. The committee identified two overarching research needs: addressing gaps in substantive knowledge and improving research methods and quality. Specific items for consideration identified by the committee are noted for each of these and are not listed in any priority order.

ADDRESSING GAPS IN SUBSTANTIVE KNOWLEDGE

Recommendation 6-1: The committee recommends that the Food and Drug Administration and other federal research sponsors and/or device manufacturers prioritize e-cigarette research that addresses key gaps regarding knowledge about e-cigarette devices, constituents, and exposures. This might include rapid response funding opportunities. Specific items for consideration follow.

  • Study the effects of carrier solvents and additives, including flavor ingredients and device characteristics (including the type of coil and power), on aerosol generation, aerosol physical properties, and the chemical profile of e-cigarette emissions.
  • Study the stability of e-liquid ingredients when heated, identify potential by-products of thermal degradation and of compounds that were not initially present in the e-liquid, and ascertain determinants of change in aerosol composition.
  • Study the impact of e-cigarette use on indoor air quality and biomarkers of secondhand e-cigarette exposure in scenarios and exposure surveys that are relevant for the populations exposed, including workers in vape shops and vaping convention attendees, children, pregnant women, and patients with cardiorespiratory disease who live with adults who use e-cigarettes.
  • Conduct research that would inform product standards regarding ingredient purity, batteries and chargers, and priority and novel emissions.
  • Establish procedures to rapidly evaluate changes to products currently on the U.S. market, focusing on device designs, design evolution (initiated by both manufacturers and users) and the corresponding alteration of chemical substance release patterns.

Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×

IMPROVING RESEARCH METHODS AND QUALITY

Recommendation 6-2: The committee recommends that the Food and Drug Administration and other federal research sponsors and/or device manufacturers prioritize research that improves the quality of e-cigarette research to better understand the devices, constituents, and exposures. This includes protocol and methods validation and development and use of appropriate study design, including the use of the appropriate control groups. Specific examples are given below.

  • Develop one or more standardized puffing protocols that are different from the standard puffing protocol for combustible tobacco cigarettes and reflect a range of how e-cigarettes are used in real-life settings, including extreme use.
  • Develop and validate methods to produce aerosols and to analyze target constituents in e-cigarettes; the standardized method should reflect not only the average puffing conditions observed among the users in real-life settings, but also intensive puffing behaviors.
  • Develop and validate a standardized method to measure particle size distribution and respiratory deposition of e-cigarette aerosols.
  • Develop analytical methods to test chemicals in e-cigarette liquids and aerosols with a focus on screening and identifying potentially toxic compounds, including study of the effects of power and temperature and other device characteristics that generate such compounds.
  • Use exposure conditions and animal models that are relevant to real-life inhalation exposure in humans.
  • Evaluate potentially biologically relevant interactions between nicotine and other constituents, such as flavorings, in in vitro and in vivo bioassays.

REFERENCE

Walton, K. M., D. B. Abrams, W. C. Bailey, D. Clark, G. N. Connolly, M. V. Djordjevic, T. E. Eissenberg, M. C. Fiore, M. L. Goniewicz, L. Haverkos, S. S. Hecht, J. E. Henningfield, J. R. Hughes, C. A. Oncken, L. Postow, J. E. Rose, K. L. Wanke, L. Yang, and D. K. Hatsukami. 2015. NIH electronic cigarette workshop: Developing a research agenda. Nicotine & Tobacco Research 17(2):259–269.

Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×

This page intentionally left blank.

Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×

Section II

Effects of E-Cigarettes on Health

Although laboratory tests of e-cigarette ingredients, in vitro toxicological tests, and short-term human studies suggest that e-cigarettes are likely less harmful than combustible tobacco cigarettes, due to lack of long-term epidemiological studies and large clinical trials, the implications for long-term effects on morbidity and mortality are not yet clear and the absolute safety of the products cannot be unambiguously assessed at this time. Use of e-cigarettes instead of combustible tobacco cigarettes by those with existing respiratory disease might be less harmful.

7 MODES OF ACTION

8 DEPENDENCE AND ABUSE LIABILITY

9 CARDIOVASCULAR DISEASE

10 CANCERS

11 RESPIRATORY DISEASES

12 ORAL DISEASES

13 DEVELOPMENTAL AND REPRODUCTIVE EFFECTS

14 INJURIES AND POISONINGS

15 RESEARCH NEEDS: EFFECTS OF E-CIGARETTES ON HEALTH

Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×

This page intentionally left blank.

Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×
Page 217
Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×
Page 218
Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×
Page 219
Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×
Page 220
Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×
Page 221
Suggested Citation:"6 Research Needs: E-Cigarette Devices, Constituents, and Exposures." National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes. Washington, DC: The National Academies Press. doi: 10.17226/24952.
×
Page 222
Next: 7 Modes of Action »
Public Health Consequences of E-Cigarettes Get This Book
×
Buy Paperback | $120.00 Buy Ebook | $99.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Millions of Americans use e-cigarettes. Despite their popularity, little is known about their health effects. Some suggest that e-cigarettes likely confer lower risk compared to combustible tobacco cigarettes, because they do not expose users to toxicants produced through combustion. Proponents of e-cigarette use also tout the potential benefits of e-cigarettes as devices that could help combustible tobacco cigarette smokers to quit and thereby reduce tobacco-related health risks. Others are concerned about the exposure to potentially toxic substances contained in e-cigarette emissions, especially in individuals who have never used tobacco products such as youth and young adults. Given their relatively recent introduction, there has been little time for a scientific body of evidence to develop on the health effects of e-cigarettes.

Public Health Consequences of E-Cigarettes reviews and critically assesses the state of the emerging evidence about e-cigarettes and health. This report makes recommendations for the improvement of this research and highlights gaps that are a priority for future research.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!