The US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) receives and reviews voluntary reports from consumers, healthcare professionals and members of the public on adverse experiences (AEs) associated with tobacco products. Reports from consumers and concerned citizens have described AEs not only in users, but also in non-users of e-cigarettes.1,2
AE reports received by FDA between 1 January 2012 and 31 December 2014 were reviewed to evaluate AEs associated with e-cigarettes in non-users. The reports were received via the Safety Reporting Portal, MedWatch, mail and email. Of 136 reports related to e-cigarette AEs, 40 involved non-users (table 1).
Table 1.
Tobacco product adverse experience reports submitted to FDA*
| Year | Total number of reports |
Total number of e-cigarette reports |
Total number of e-cigarette AE reports |
Number of non-user e-cigarette AE reports |
Non-user AE e-cigarette report categories |
||
|---|---|---|---|---|---|---|---|
| Passive aerosol exposure |
Burn | Other | |||||
| 2012 | 29 | 23 | 16 | 1 | 0 | 0 | 1 |
| 2013 | 69 | 61 | 41 | 10 | 8 | 1 | 1 |
| 2014 | 138 | 109 | 79 | 29 | 27 | 2 | 0 |
| Total Reports | 236 | 193 | 136 | 40 | 35 | 3 | 2 |
All tobacco product reports submitted to FDA are voluntary.
AE, adverse experience; FDA, US Food and Drug Administration.
Thirty-five reports were related to passive aerosol exposure (typically in indoor spaces). Respiratory symptoms (n = 26) were most common and included asthma exacerbations, bronchitis, cough, difficulty breathing and pneumonia. Additional passive aerosol exposure symptoms included eye irritation (n = 8), headache (n = 8), nausea (n = 6), sore throat/irritation (n = 6), dizziness (n = 5) and racing/irregular heart rate (n = 5). Eleven reports identified recurrent problems associated with repeat exposure (positive rechallenge) and six reports described AEs in multiple individuals. Six cases reported seeking medical attention; three of which reported prescription of medications, two reported self-treatment and one reported hospitalisation. Of 27 reports providing information about pre-existing conditions, 11 indicated a history of respiratory or allergic conditions and nine of those AEs may have been related to the underlying condition.
The remaining five non-user reports included three reports of burns (due to contact with an overheated device (n = 2) and to device explosion (n = 1) while recharging),i one report of lip cheilitis (after kissing an e-cigarette user) and one report of infant death after choking on an e-liquid cartridge.ii
The majority of non-user reports (n = 36) were in adults. The four reports in children included the infant death (above), burns in a 3-year-old following an e-cigarette explosion and breathing problems in a 3-year-old and ‘raspy’ voice in a 4-year-old after passive aerosol exposure.
Although small in number, e-cigarette AE reports submitted to FDA are increasing. Twenty-nine per cent (40/136) of the e-cigarette AE reports received January 2012–December 2014 involved non-users and included symptoms related to passive aerosol exposure and device overheating or explosion. Additional e-cigarette risks in non-users, especially young children, include unintentional exposure to e-cigarette components and e-liquids resulting in choking associated injuries and nicotine toxicity.3
The AEs may provide important information about the potential impact of e-cigarettes on public health. However, because reporting AEs associated with tobacco products to FDA is voluntary, the reports received likely under-represent the true number and types of AEs associated with e-cigarettes and the AEs reported may not have a causal relationship to product exposure. Therefore, data cannot be used to calculate incidence (occurrence) rates or estimate risk. In addition, the January 2014 launch of CTP’s web-based safety reporting portaliii may have influenced reporting rates and report content.
Research evaluating e-liquids, e-cigarette devices, exhaled aerosol constituents and their impact on health effects in users and non-users will be important to better understand their impact on public health.
Acknowledgments
The authors would like to thank Paul Aguilar, MPH, Cathy L. Backinger, PhD, MPH, Corinne G. Husten, MD, MPH, and Deborah Neveleff for their help in the preparation of this manuscript.
Footnotes
Contributors All authors contributed to the concept of the article, reviewed the final version of the paper and approved it for publication. ELD and SFR analysed the FDA AE reports.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Of note, FDA has also received reports of burns in e-cigarette users during use and nonuse situations, such as recharging.
This AE was also reported by Chen who described e-cigarette AEs reported to FDA through first-quarter 2012.1
Link to Safety Reporting Portal: http://www.safetyreporting.hhs.gov.
REFERENCES
- 1.Chen IL. FDA summary of adverse events on electronic cigarettes. Nicotine Tob Res. 2013;15:615–616. doi: 10.1093/ntr/nts145. [DOI] [PubMed] [Google Scholar]
- 2.Durmowicz EL, Chen IL, Rudy SF. Electronic cigarettes: risks to nonusers. American Academy of Pediatrics National Conference and Exhibition [Poster]; October 2014; San Diego CA. [Google Scholar]
- 3.Chatham-Stephens K, Law R, Taylor E, et al. Notes from the field: calls to poison centers for exposures to electronic cigarettes—United States, September 2010–February 2014. MMWR Morb Mortal Wkly Rep. 2014;63:292–293. [PMC free article] [PubMed] [Google Scholar]