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110 Comparing adult smokers who switched to JUUL vs continuing smokers: biomarkers of exposure and of potential harm and respiratory symptoms "More research on the effects of long-term switching in real-world contexts is needed to complement existing evidence from short-term randomized studies that switching from cigarette smoking to ENDS reduces toxicant exposures, and also extends to reduction in clinical symptoms. This cross-sectional, observational study assessed adults who had smoked ≥10 cigarettes/day for ≥10 years. Analyses compared two groups: (1) 124 continuing cigarette smokers (Smokers); and (2) 140 former smokers who switched to JUUL-brand ENDS exclusively for at least 6 months, with the average being 3 years (Switchers). Analyses examined geometric means for biomarkers and arithmetic means for other endpoints adjusted for demographics, smoking history, and lifestyle factors. Nicotine levels were significantly higher in Switchers, who were unusually-heavy users of JUUL (>2.5 times more likely to consume at least 20 pods/month than a more general JUUL-user sample). All other biomarkers of exposure [NNAL (BOE for NNK); HPMA3 (acrolein); COHB (CO); MHBMA (1,3-butadiene); SPMA (Benzene); HMPMA (Crotonaldehyde); CEMA (Acrylonitrile)] were significantly lower among Switchers. Even after adjustment for demographic and lifestyle factors, multiple biomarkers of potential harm (sICAM-1 [primary], and e.g., white blood cell count, MCP1, HbA1c, 8-epi-PGF2α) were significantly lower in Switchers than Smokers; HDL was significantly higher. Dependence on JUUL among Switchers was significantly lower than Smokers’ dependence on cigarettes. Switchers’ respiratory symptom scores were significantly lower than Smokers’. Compared to continuing smokers, smokers who switched to JUUL and were using JUUL heavily had substantially lower exposures to multiple toxicants; favorable differences in markers of inflammation, endothelial function, oxidative stress, and cardiovascular risk; and less respiratory symptoms. These findings suggest that switching from cigarettes to JUUL likely reduces smokers’ health risks." 111 Utilizing real-world topography data to define smoke machine puffing regimen for ENDS The standards set by the International Organization of Standardization (ISO) for puff regimen serve the important role of unifying testing parameters under which products can be compared against one another and provide a baseline for establishing standard outputs or thresholds for determining product limits. These standards shaped the early landscape of tobacco product evaluation and created a harmonized pathway toward building methods to evaluate product constituents. Early in the development of tobacco product standards the Federal Trade Commission (FTC) stated that the standards they used were not intended to determine the amount of exposure individual consumers had to products (combustible cigarettes at the time), but instead, to determine the product output given a prescribed machine puffing regimen. This same distinction is made when considering and adopting ISO standards. Although the purposes of these standards are clear, the utilization of data generated under these conditions by regulatory bodies has been called into question by academic institutions and public health officials as they may not accurately reflect real world use of new products (ENDS in particular). In order to understand the perceived differences between standardized testing regimen and the ways in which consumers use ENDS products, nearly 1.5 million puffs, collected in an ambulatory real-world setting, were evaluated to determine the use characteristics of consumers. With this data it is possible to determine the various percentiles of use, defining upper and lower bounds of testing parameters for machine puffing regimen to accurately reflect device outputs relative to consumer use. 112 Design of a randomized multi-site, open-label, 8-week, electronic nicotine delivery system (ENDS) actual use study The FDA Center for Tobacco Products recommends assessment of the public health impact of new tobacco products, either in a simulated use setting or a real-world environment, to understand how U.S. adult consumers actually use the products. We designed a randomized, multi-site, open-label, 8-week, prospective observational study, at sites geographically dispersed within the U.S among adult tobacco consumers between 21 and 60 years of age. Participants are regular smokers of at least 5 cigarettes per day and are provided the Study IP, an Electronic Nicotine Delivery System, for ad libitum use over a 6-week Actual Use Period (AUP) in their real-life environments. The study consists of a pre-screening period, a screening/enrollment visit, a 1-week baseline assessment period (BAP), a 6-week AUP, and a 1-week close-out period. Subjects will choose freely among the Study IP available in one of the three study arms to which they are randomly assigned. The three study arms are organized by Study IP flavor categories: tobacco, menthol, and non-tobacco-non-menthol, available in two flavored variants and in two nicotine concentrations (i.e., 1.5% and 5%). Enrollment is determined based on subjects indicating an interest to use all three variants. This design has been chosen to assess the relative impact of availability and use of different e-liquid flavors on changes in cigarette consumption. Participants complete interviewer-led surveys and are resupplied Study IP at the site visits. Participants self-report their daily use of all combustible cigarettes and any other tobacco and nicotine product (TNP) use during BAP and AUP (including Study IP) on an eDiary. Adverse health experiences are collected through passive surveillance via a hotline throughout the study. 113 Switching exclusively from smoking to using glo results in significant, substantial reductions in exposure to cigarette smoke toxicants "A proposed tobacco harm reduction approach for those who would not otherwise quit smoking relies on the proposition that the health burden of smoking can be reduced by encouraging switching exclusively to products that while not being risk free have the potential to reduce or eliminate toxicant exposure and reduce smoking-related harms. Heated Tobacco Products (HTP) deliver a nicotine-containing aerosol with lower or immeasurable levels of toxic constituents associated with combusting tobacco. This randomized, ambulatory study assessed whether selected biomarkers of exposure (BoE) to cigarette smoke toxicants are reduced in smokers switched exclusively to a glo HTP for three months, compared to those who continue to smoke cigarettes. Participants were healthy smokers assigned to continue smoking or to switch exclusively to one of five variants of the glo HTP, smokers who abstained from cigarette smoking, and never-smokers. BoE to a range of carcinogens and respiratory, cardiovascular, and reproductive toxicants included in FDA’s established list of HPHCs were assessed at baseline and three months. Daily SMS questionnaires and haemoglobin levels of N-(2-cyanoethyl)valine were used to assess compliance with cigarette smoking restrictions. Compared to the continued smoking group, the groups switched to the glo HTP exhibited significant and substantial reductions from baseline in levels of BoE to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone, 1,3-butadiene, acrolein, benzene, and carbon monoxide, along with several secondary endpoint BoE. Alongside chemical and toxicological studies undertaken on the glo HTP used in this study, these findings add to the weight of evidence that support our belief that smokers who switch exclusively to use of the glo HTP reduce their exposure to tobacco smoke toxicants linked with smoking-related diseases compared to those continuing to smoke." 114 Applying factor analysis to understand product differences observed in clinical studies "Objectives: The objective of this study was to identify factors that underly nicotine pharmacokinetics and subjective effects assessments and to examine how test products are differentiated along the identified factors. Methods: We conducted Principal Component Analysis (PCA) using data from three randomized crossover pharmacokinetic clinical studies: 1) nicotine pouch (NP) strength study (n=30) tested seven products: five different nicotine strength (ranging from 1.5mg to 8mg) mint NPs, participants’ own-brand cigarettes (OBC) and moist smokeless tobacco (MST). 2) NP flavor study (n=42) tested seven products: six different flavored NPs (4mg nicotine) and participants’ OBC. 3) e-Vapor study (n=30) tested five products: four different flavored e-vapor products and participants’ OBC. Results: Based on PCA results, top factors identified were conceptualized as product satisfaction, adverse feelings, and tobacco nicotine withdrawal effect. In NP strength study, these factors together explained 57.5% of data variation. We observed that product types (e.g., cigarettes versus oral products) can be differentiated by the product satisfaction factor, where the factor score is highest for OBC, followed by own-brand MST and new products (NP/e-vapor). Product nicotine levels can be differentiated by adverse feelings factor for NPs, where the factor score is highest in NPs containing 8mg nicotine compared to lower nicotine NPs. Product flavor variation was not differentiated by any of the identified factors for NPs and e-vapor products. Implications: While PK and subjective responses can be used to assess product platform and nicotine strength differences effectively, product flavor varieties may not be strongly associated with differences in PK and subjective responses."