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E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs
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  • Published on:
    Response to “E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs.”


    I write on behalf of Juul Labs in response to “E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs.” We appreciate the public health community’s interest in understanding the Company’s research. However, we want to clarify the article’s reporting on Juul Labs’ research program and publications to date, as well as our legal obligations to report the results of clinical investigations.

    First, our studies were conducted in anticipation of our submission of a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA). As such, raw data, results, and statistical code underlying our analyses of all ten registered Juul Labs studies referenced in the Tobacco Control paper have been submitted to FDA (1)

    In addition, we have been working on sharing our data in publications and posters. In fact, by the end of this month, we will have published or presented data on nine of the ten studies, in addition to having provided the clinical results to FDA. Of our ten registered studies, we have published the results of four (2, 3, 4, 5) submitted the results of an additional two studies for peer review, presented the results of two as posters (6,7) and have the results of one accepted for presentation this summer. We appreciate that the authors of the Tobacco Control paper may have drafted their article months ago, but note that there...

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    Conflict of Interest:
    Senior Vice Preseident, JUUL Labs
  • Published on:
    Trials Transparency in E-cigarette Research


    On behalf of my co-authors, we thank Dr. Mishra for taking the time to comment on our paper examining reporting of trials registered by Juul Labs Inc.

    We do not doubt that Juul has submitted the results from all of these studies to the FDA as part of their Premarket Tobacco Product Application (PMTA). Unfortunately, this step does not ensure the full results of these trials will be made available to the public, clinicians, and other key stakeholders.

    We also acknowledge and appreciate that since conducting our analysis in August 2020, two additional studies, of the five we examined, have appeared in the peer reviewed literature (published in December 2020 and January 2021)[1,2] and additional results may become available through other methods. We understand that these publications may contain additional outcome reporting compared to the posters we assessed. We welcome any and all additional results disclosures from Juul Labs. That said, we believe the risk of outcome reporting bias remains and is, unfortunately, not addressed in Juul’s comment despite being a major facet of our paper. The one publication that was available as of our analysis date excluded 4 of the 19 prespecified secondary outcomes without comment and another 5 outcomes had clear issues in their reporting compared to the registered outcomes. While we have not conducted a detailed assessment of the two new publications, it is apparent that journal publication does no...

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    Conflict of Interest:
    None declared.