In accordance with New York Public Health Law, Article 17, and the New York State Department of Health’s implementing regulations, 10 N.Y.C.R.R. §§ 1006.2(b)(1)(iii) & (b)(2)(iv), JLI is providing the following information about the nature and extent of investigations and research performed by or for JLI concerning the effects on human health of its products or ingredients. By providing this information in compliance with New York law, JLI is not making any health claims about its products, and nothing contained herein should be construed as making a health claim.
Nature and extent of investigations or research concerning the effects on human health of JUUL products or ingredients
JLI’s assessment of the potential effects on human health of the JUUL System and the ingredients in each product draws from original studies conducted and/or commissioned by JLI, published literature, and reported complaints and adverse events.
Specifically, JLI has conducted more than 75 nonclinical studies and 13 clinical studies as well as a computational modeling study.
Information from nonclinical studies can provide insight into exposures, disease risks and mechanisms, as well as context for interpreting data from human studies. In its nonclinical evaluation, JLI has performed comparator product analyses to evaluate the relative health risks compared to other tobacco products, including combustible cigarettes, heated tobacco products, and other ENDS products. JLI’s nonclinical assessment of the JUUL System includes:
- Chemical Characterization and Evaluation: JLI has conducted a series of chemical analyses to inform its evaluation of the potential health risks, including targeted analyses of HPHCs and other constituents in the JUUL System e-liquids and aerosols, non-targeted analyses to evaluate the presence of compounds in the JUUL System aerosols not otherwise measured in the targeted analyses, and comparison of the aerosol constituents yields in the JUUL System aerosols to the levels generated by comparator products.
- Non-Clinical Toxicity Studies: JLI has conducted a series of nonclinical toxicity studies, both in vitro and in vivo. For both e-liquid and aerosol, JLI has conducted in vitro Neutral Red Uptake (NRU) assays to assess cytotoxicity, bacterial mutagenicity studies (Ames essay) to assess mutagenicity, and micronucleus (MN) assay to assess genotoxicity. For Virginia Tobacco 3.0%, JLI has conducted follow-up in vivo studies to further evaluate genotoxicity. JLI also has conducted inhalation studies to assess potential toxicity.
- Risk Assessments: Based on the totality of the available nonclinical evidence, including thorough review of ingredients, materials extractables and leachables, aerosol HPHCs and other chemicals identified in the aerosols, JLI has performed health risk assessments to inform its evaluation of the health risks of the JUUL System.
JLI has conducted 13 clinical studies and one computational modeling study, with support from literature reviews. These studies fall into the areas of nicotine pharmacokinetics (PK) assessments, biomarkers of exposure (BOE) studies, puffing topography studies, and environmental exposure studies. Comparator products used in JLI clinical studies include combustible cigarettes, other closed-system ENDS products, heated tobacco products, and 4 mg nicotine gum. JLI commissioned these studies to:
- Assess the manner in which JUUL products deliver nicotine, as well as how the nicotine PK of JUUL products compares to cigarettes and other comparator products;
- Measure exposure to toxicants, as measured through BOEs among smokers who:
- Switch completely to JUUL products;
- Continue smoking;
- Dual use, continuing smoking (up to half of their daily cigarette consumption) and use JUUL products; or
- Abstain from smoking for the duration of the study;
- Characterize puffing topography when adult smokers and ENDS users use JUUL products; and
- Assess potential secondhand exposures to HPHCs from JUUL product aerosols as compared to potential secondhand exposures to cigarette smoke.
JLI clinical studies have been performed in accordance with the ethical principles and international standards for human clinical studies, including International Council for Harmonization Good Clinical Practice and Organization for Economic Cooperation and Development Good Clinical Practice guidelines, including obtaining written informed consent from study subjects and ethical oversight from an authorized and properly constituted Institutional Review Board.
In addition to nonclinical and clinical research and analyses, JLI has a behavioral research program to assess how the JUUL System is actually used by consumers. JLI has conducted over 21 behavioral studies, including cross-sectional surveys, longitudinal studies, examinations of consumer response to JUUL products labeling and promotional advertising, and abuse liability assessments. JLI also monitors and analyzes national survey data.
Finally, JLI has conducted a quantitative analysis of net population impact using statistical population modeling.
