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Electronic cigarettes: analysis of FDA adverse experience reports in non-users
  1. Elizabeth L Durmowicz,
  2. Susan F Rudy,
  3. Ii-Lun Chen
  1. Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, Maryland, USA
  1. Correspondence to Dr Elizabeth L Durmowicz, Office of Science, Center for Tobacco Products, Food and Drug Administration, WO 75/Room 5476, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA; Elizabeth.durmowicz{at}fda.hhs.gov

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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).

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Table 1

Tobacco product adverse experience reports submitted to FDA*

Thirty-five reports were related to passive aerosol exposure (typically in indoor spaces). Respiratory symptoms …

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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.

  • i Of note, FDA has also received reports of burns in e-cigarette users during use and nonuse situations, such as recharging.

  • ii This AE was also reported by Chen who described e-cigarette AEs reported to FDA through first-quarter 2012.1

  • iii Link to Safety Reporting Portal: http://www.safetyreporting.hhs.gov.

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