Developing Evidence To Inform Regulatory Policy On Nicotine Content In E-Liquids - Summary Abstract Regulation currently relies heavily on machine-generated emissions to predict harmful and potentially harmful constituent (HPHC) exposure from using products under review, without a good understanding of how the product will impact public health under real-world conditions. This study addresses the question of whether ecig users who currently choose to use lower nicotine eliquids are actually consuming less nicotine compared to those who choose to use higher nicotine eliquids. We will provide evidence on the extent to which using low nicotine eliquids reduces one’s overall exposure to HPHC. We will monitor N=120 pod and pen-style regular ecig users in their natural environment for one week, collecting ambulatory topography data using RIT’s wPUMTM monitors along with daily salivary cotinine, subject effects and exposure and health effect biomarkers. Data will be evaluated in the context of the joint effect of product characteristics and behavior on product emissions and, ultimately, on public health. Aim 1: Evaluate HPHC exposure using the traditional approach of salivary cotinine, a well-accepted biomarker for nicotine exposure, and other urinary and salivary biomarkers of exposure and adverse health affect. Aim 2: Evaluate HPHC exposure using a novel alternative outcome measure we call behavior-based yield, which incorporates one-week of intensive puff-by-puff topography and product-specific emissions, Aim 3: Add pharmacokinetics to improve the predictive utility of the behavior- based yield model by incorporating personalized reaction kinetics, which will then be applied to predict the time-course of salivary cotinine for one-week of natural use. We expect the outcomes to support the premise that exposure to both nicotine and total particulate matter are important in risk assessment, and the potential to inadvertently increase one by decreasing the other must be considered when making product choices and regulatory decisions. This project will; (1) Provide evidence that regulating nicotine concentration alone does not reduce nicotine uptake, nor reduce adverse health effect; (2) Provide device-independent evidence that users of lower nicotine eliquids do not consume less nicotine and may consumer more total particulate matter compared to users of higher nicotine eliquids; (3) Provide evidence supporting the need for rigorous accounting of behavior when reporting HPHC exposure in PMTA and MRTP applications; and (4) Provide evidence in support of establishing a causal relationship between tobacco product characteristics and health effect.
