Article Text

Download PDFPDF
E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs


Background Electronic cigarettes (e-cigarettes) are a frequently debated topic in public health. It is essential that clinical trials examining e-cigarettes are fully and accurately reported, especially given long-standing concerns about tobacco industry research. We assess the reporting of clinical trials sponsored by Juul Labs, the largest e-cigarette company in the USA, against accepted reporting standards.

Methods We searched for all trials sponsored by Juul Labs and determined those with registry data consistent with coverage by the Food and Drug Administration (FDA) Amendments Act 2007 (FDAAA). For trials with a primary completion date more than 1 year earlier, we searched, the academic literature and a Juul-funded research database (JLI Science) for results. For located results, we compared reported outcomes with registered outcomes in line with Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines.

Results We located five registered trials sponsored by Juul Labs that appeared covered by the FDAAA 2007 in the public data. All five trials did not have results available on We found one publication and four poster presentations reporting results for four of the five covered trials outside of Of 61 specified outcomes, 28 were CONSORT compliant. Specific outcome reporting issues are detailed.

Discussion Our findings raise substantial concerns regarding these trials. Clinicians, public health professionals, and the public cannot make informed choices about the benefits or hazards of e-cigarettes if the results of clinical trials are not completely and transparently reported. Clarification and potential enforcement of reporting laws may be required.

  • electronic nicotine delivery devices
  • public policy
  • tobacco industry

Data availability statement

The dataset for this study, including detailed outcome assessments, are available via FigShare (DOI: 10.6084/m9.figshare.14627346). Detailed assessments are also included as online supplementary material.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.