As we work to fulfill our mission to help adult smokers switch from combustible cigarettes, JUUL Labs is committed to both conducting and supporting durably designed, painstakingly executed preclinical, clinical, and behavioral research examining the public health impact of our products. We occupy a unique space in this industry as we seek to completely eliminate combustible cigarettes by providing smokers an alternative nicotine delivery system.
We understand that there are many questions about the health impact of vapor products, and JUUL products in particular, and we are committed to contributing to the body of global public health research on these topics. To that end, JUUL Labs has built a robust scientific research program to assess the harm-reduction potential of JUUL products, including their impact on the individual user, their ability to switch adult smokers from combustible cigarettes, and the net-population impact on public health.
Preclinical and toxicological research encompasses ingredient and analyte testing of JUUL e-liquids and product aerosols for a variety of substances, including harmful and potentially harmful constituents (HPHCs) commonly found in combustible cigarettes and other tobacco products. This research also involves testing the impact of JUUL products on cytotoxicity (cell death) and genotoxicity (cell mutation). Our testing is conducted through reputable, independent third-party laboratories and we provide the results of these tests to regulatory bodies as required for market entry.
Our clinical program involves human subjects and examines how people use the product, how much and how often they use it, how biomarkers of exposure and potential harm change over time compared to cigarettes, the environmental impact to others, and the potential physiological impact to the individual. Our clinical trials are reviewed and approved by Institutional Review Boards (IRBs) and follow the highest ethical standards for human clinical research.
Our behavioral research examines what smokers do in the real world when exposed to JUUL products. We seek to answer the following questions: What are their switch and recidivism rates; who are the smokers that are most successfully able to switch and who are not; and what attributes drive switching? We collect this information through IRB-approved research surveys of JUUL users, and we currently have over 70,000 participants enrolled in behavioral studies around the world. We believe this is the largest behavioral research program in the world dedicated to the study of vapor products and we plan to further grow the program with tens of thousands of more participants by year end. Results from our most recent studies are promising and find that approximately half of all smokers demonstrate 30-day abstinence from combustible cigarettes at follow-up assessments after just three months of JUUL use.
We are conducting this research in order to share it with the scientific and public health community and our regulators. We do this by submitting our research to the peer-reviewed publication process, presenting at conferences, and publishing scientific papers. We are committed to asking the right and relevant questions – and we take direction on what to research from FDA’s public and policy statements, including its draft guidance on PMTAs for vapor products, as well as issues identified by leading public health researchers.
While we have built a robust, reliable, and transparent research program, we also know that we cannot answer these questions alone. There are simply too many pressing issues, and we need independent researchers from around the world to contribute to the public understanding of vapor products. In order to promote further study, JUUL Labs has established an Investigator Sponsored Research (ISR) program to fund independent research examining the public health impact of JUUL products. ISR studies are executed independent of JUUL Labs, and researchers retain control over the analysis and public disclosure of their results, including the publication process. We have funded a number of ISR studies to date and are in active discussions with a number of other interested researchers and institutions.
We understand the common distrust of historical tobacco companies around scientific research and how they have misled the public with false claims and cherry-picked data, leading to warranted skepticism of newcomers to the nicotine delivery space. But JUUL Labs is a next generation company dedicated to transparency and information sharing. We embrace nonpartisan science that informs and advances public health.
JUUL Labs is committed to earning the trust of the scientific community by conducting and funding research over the long-term, and continuing to openly share that research through peer-reviewed publications, conference presentations, and regulatory submissions.