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A Questions from the Center for Tobacco Products of the Food and Drug Administration Submitted for the Committeeâs Consideration SPECIFIC QUESTIONS TO BE CONSIDERED INCLUDE: Health Effects in Users 1. What are the known short- and long-term health effects of electronic cigarettes in users who have not used tobacco products, users of other tobacco products and electronic cigarettes, and users who switch completely from smoking combustible tobacco cigarettes or other combustible tobacco products to using electronic cigarettes? a. What unique issues should be considered in the evaluation of the short- and long- term health effects in users of electronic cigarettes in combination with combustible tobacco cigarettes, other combustible products, smokeless tobacco, and other tobacco products? 2. What are the potential short- and long-term health effects of inhaling humectants (e.g., propylene glycol, glycerin), flavorings, and other e-liquid additives or constituents? What are the specific impacts of these constituents on the following systems: a. Cardiovascular b. Immune c. Oropharyngeal (e.g., the oral microbiome) d. Pulmonary Â· e. Other 3. What biomarkers and clinical endpoints should be used to assess the impact of electronic cigarettes on user health? 4. What other risks are associated with electronic cigarette exposures in users (e.g., overheating or explosion resulting in burn injuries)? Effects of Electronic Cigarettes on Smoking Cessation 5. Do electronic cigarettes help combustible tobacco cigarette smokers quit smoking? A-1 PREPUBLICATION COPY: UNCORRECTED PROOFS
A-2 PUBLIC HEALTHCONSEQUENCES OF E-CIGARETTES 6. Do cigarette smokers who quit smoking using electronic cigarettes continue using electronic cigarettes, and if so, for how long? Is there evidence that there is relapse of smoking after smokers quit cigarettes and use electronic cigarettes for some time? 7. Do electronic cigarettes promote current smokers to completely switch to electronic cigarette products or is dual or polytobacco use common? 8. Does the type of electronic cigarettes product used or e-liquid flavor impact any of the above questions in 1A? Health Effects in Vulnerable Populations 9. What populations of users may be at lower or higher risk of adverse effects related to electronic cigarette use? 10. What unique health effects may be of concern for users with underlying disease (e.g., chronic obstructive pulmonary disease, cardiovascular disease, diabetes mellitus, cancers, mental health disorders)? 11. What factors should be considered in the evaluation of risk in vulnerable populations? Health Effects in Youth 12. What unique health effects may be of concern in youth e-cigarette users? 13. How should the short- and long-term health risks associated with youth initiation and ongoing use be evaluated? Health Effects of Use During Pregnancy 14. What are the short- and long-term health effects of e-cigarette use during pregnancy? What is the impact of e-cigarette use during pregnancy on the pregnant woman and on the fetus? 15. How should the short- and long-term effects of e-cigarette use during pregnancy be evaluated? Health Effects in Non-Users 16. What chemicals/toxicants are delivered to non-users who are exposed to electronic cigarette aerosols? 17. What are the impacts of electronic cigarette use on the levels of particulate matter and chemicals/toxicants from the e-cigarette in enclosed spaces such as cars, homes, office settings, and public buildings? 18. What are the short- and long-term health risks, including cancer and non-cancerârelated illnesses, of secondary exposure to electronic cigarette aerosols? 19. What are the short- and long-term health risks, including cancer and non-cancerârelated illnesses, of tertiary exposure to electronic cigarette aerosols? 20. What populations of non-users are at higher risk of adverse health effects related to electronic cigarette exposures? 21. What other risks are associated with electronic cigarette exposures in non-users (e.g., overheating or explosion resulting in burn injuries)? PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX A A-3 22. What are the hazards associated with inadvertent exposure to electronic cigarettes by young children (e.g., accidental dermal exposure or oral ingestion of liquid nicotine, choking on e-cigarette components, e-cigarette inhalation)? Research Needs 23. What research should be conducted to evaluate the short- and long-term health effects of electronic cigarettes in users and non-users to better address the questions above? 24. What research on short- and long-term health effects is the highest priority to inform Food and Drug Administration regulation of electronic cigarettes? PREPUBLICATION COPY: UNCORRECTED PROOFS