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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that the authors of the Tobacco Control paper may have drafted their article months ago, but note that there are outdated references to publication or presentation of the five studies included by the authors in their analysis. While the article asserts that just one of the five studies that was incorrectly registered as an “applicable device clinical trial” has been published, as of this writing, results from three of the five studies have been published. (8) Across our research program, we have published a total of 17 articles (all publicly available on our science website www.juullabsscience.com) and are working on additional publications.
Finally, although not obligated to do so (9), Juul Labs voluntarily submitted registration information for ten studies to the ClinicalTrials.gov registry. As voluntary submissions, all of the studies should have been registered as a “voluntary other trial.” Due to an administrative error at Juul Labs, six of those studies were instead registered as an “applicable device clinical trial.” These errors are in the process of being corrected and, in fact, four of the studies have been formally updated on ClinicalTrials.gov to reflect this change. (10, 11, 12, 13)
We look forward to continuing to share results from our science and research program with the scientific and public health community as we work to advance harm reduction for adults who smoke, and to support the scientific basis for the category.
Re: Juul: less than half of e-cigarette trial outcomes were properly reported or declared, study finds
Dear Editor,
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 are outdated references to publication or presentation of the five studies included by the authors in their analysis. While the article asserts that just one of the five studies that was incorrectly registered as an “applicable device clinical trial” has been published, as of this writing, results from three of the five studies have been published. (8) Across our research program, we have published a total of 17 articles (all publicly available on our science website www.juullabsscience.com) and are working on additional publications.
Finally, although not obligated to do so (9), Juul Labs voluntarily submitted registration information for ten studies to the ClinicalTrials.gov registry. As voluntary submissions, all of the studies should have been registered as a “voluntary other trial.” Due to an administrative error at Juul Labs, six of those studies were instead registered as an “applicable device clinical trial.” These errors are in the process of being corrected and, in fact, four of the studies have been formally updated on ClinicalTrials.gov to reflect this change. (10, 11, 12, 13)
We look forward to continuing to share results from our science and research program with the scientific and public health community as we work to advance harm reduction for adults who smoke, and to support the scientific basis for the category.
Sincerely,
Snigdha Mishra, SVP Regulatory Science
References
1. See 21 U.S.C. § 387j(b)(1)(A) (requiring that manufacturers submit in a PMTA “full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products.”)
2. Jay, et. al. Five-Day Changes in Biomarkers of Exposure Among Adult Smokers After Completely Switching From Combustible Cigarettes to a Nicotine-Salt Pod System. Nicotine & Tobacco Research 2019. https://doi.org/10.1093/ntr/ntz206
3. Goldenson, et. al. Abuse liability assessment of the JUUL system in two nicotine concentrations compared to combustible cigarette, nicotine gum, and comparator electronic nicotine delivery system. Drug and Alcohol Dependence 2020. https://doi.org/10.1016/j.drugalcdep.2020.108441
4. Goldenson, et. al. Abuse liability assessment of the JUUL system in four flavors relative to combustible cigarette, nicotine gum and a comparative electronic nicotine delivery system among adult smokers. Nicotine & Tobacco Research 2020 https://doi.org/10.1016/j.drugalcdep.2020.108395
5. Oldham, et al. Room air constituent concentrations from use of electronic nicotine delivery systems and cigrettes using different ventilation conditions. Scientific Reports 2021 https://doi.org/10.1038/s41598-021-80963-9
6. https://www.juullabsscience.com/wp-content/uploads/sites/8/2020/09/CPDD-...
7. https://www.juullabsscience.com/wp-content/uploads/sites/8/2020/09/Chara...
8. See supra notes 3-5.
9. Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and implementing regulations issued by the National Institutes of Health (NIH) do not require registration of clinical trials involving tobacco products, as defined under the Federal Food, Drug, and Cosmetic Act (FDCA). See 42 USC 282(j); 42 CFR Part 11.
10. https://clinicaltrials.gov/ct2/show/NCT03596034?term=Juul&recrs=e&draw=2...
11. https://clinicaltrials.gov/ct2/show/NCT03605641?term=Juul&recrs=e&draw=5...
12. https://clinicaltrials.gov/ct2/show/NCT03700112?term=juul&cntry=NZ&draw=...
13. https://clinicaltrials.gov/ct2/show/NCT03719391?term=Juul&draw=3&rank=10
Competing interests: Senior Vice President, Regulatory Science, for Juul Labs