Justification of measures to protect against exposure nicotine-containing products in enclosed spaces

Introduction. The introduction of amendments and additions to the anti-smoking Federal Law No. 15-FZ of 23.02.2013 in 2020 contributed to the cardinal revision of the name of this law and the introduction of a ban on consumption of any nicotine-containing products in public places. There are no separate, specially allocated isolated premises provided for the consumption of tobacco products and other types of nicotine-containing products by law, even though specially conducted studies have shown significantly different levels of additional inhalation risk arising from air pollution when consuming tobacco products and electronic nicotine delivery systems or heating tobacco. The aim of the study: based on experimental data, to justify the multiplicity of air exchange in unique isolated rooms designed to protect against the effects of ambient tobacco smoke, the consequences of tobacco consumption or nicotine-containing products. Materials and methods. The study was subject to 3 types of nicotine-containing products: tobacco cigarettes (cigarettes), an electronic nicotine delivery system (ENDS) and an electronic tobacco heating system (ETHS). In the course of the study were carried out: a series of experiments on the consumption of nicotine-containing products in various ways in a specially equipped indoor room, air sampling and laboratory studies were performed, the gross and specific emissions of chemicals entering the air environment from one unit of production per hour were calculated, the selection of priority chemicals for calculating the air removed from the room when using nicotine-containing products of each type was carried out, the necessary level of air exchange of premises was calculated, intended for the consumption of tobacco or nicotine. Results. The indoor air quality assessment showed that the main components of the gross intake into the air environment are suspended particles and carbon monoxide when smoking cigarettes. However, taking into account the values of the maximum permissible concentrations, the most significant contribution to the integral indicator is made by acetaldehyde and suspended particles PM10 and PM2.5. Using ENDS, the most significant pollutants were acetaldehyde and carbon monoxide, using ETHS - acetaldehyde and suspended particles PM10 and PM2.5. For all the investigation types of products, the priority substance for calculating the removed air is acetaldehyde, its share in the structure of all detected pollutants was: for cigarettes - 56.27%, for ENDS - 62.7%, for ETHS - 82.51%, in connection with which its specific values can be used to calculate the consumption of the removed air when modelling a specially allocated room intended for the consumption of tobacco products and other types of nicotine-containing products. Conclusion. The obtained findings demonstrated an obvious, more than 10-fold difference in the requirements for air exchange of premises intended for cigarette smoking and premises intended for the consumption of ENDS or ETHS, at the same intensity of consumption. Therefore, when organizing specially designated places for smoking or the consumption of nicotine-containing products, it is advisable to separate them depending on the type of products consumed: tobacco smoking separately, ENDS and ETHS consumption separately.

Proposed Standard Test Protocols and Outcome Measures for Quantitative Comparison of Emissions from Electronic Nicotine Delivery Systems

This study introduces and demonstrates a comprehensive, accurate, unbiased approach to robust quantitative comparison of Electronic Nicotine Delivery Systems (ENDS) appropriate for establishing substantial equivalence (or lack thereof) between tobacco products. The approach is demonstrated across a family of thirteen pen- and pod-style ENDS products. Methods employed consist of formulating a robust emissions surface regression model, quantifying the empirical accuracy of the model as applied to each product, evaluating relationships between product design characteristics and maximum emissions characteristics, and presenting results in formats useful to researchers, regulators, and consumers. Results provide a response surface to characterize emissions (total particulate matter and constituents thereof) from each ENDS appropriate for use in a computer model and for conducting quantitative exposure comparisons between products. Results demonstrate that emissions vary as a function of puff duration, flow rate, E-Liquid composition, and device operating power. Further, results indicate that regulating design characteristics of ENDS devices and consumables may not achieve desired public health outcomes; it is more effective to regulate maximum permissible emissions directly. Three emissions outcome measures (yield per puff, mass concentration and constituent mass ratio) are recommended for adoption as standard quantities for reporting by manufacturers and research laboratories. The approach provides a means of (a) quantifying and comparing maximal emissions from ENDS products spanning their entire operating envelope, (b) comparative evaluation of ENDS devices and consumable design characteristics, and (c) establishing comparative equivalence of maximal emissions from ENDS. A consumer-oriented product emissions dashboard is proposed for comparative evaluation of ENDS exposure potential. Maximum achievable power dissipated in the coil of ENDS is identified as a potentially effective regulatory parameter.

A Literature Review and Framework Proposal for Halitosis Assessment in Cigarette Smokers and Alternative Nicotine-Delivery Products Users

Halitosis is a health condition which counts cigarette smoking (CS) among its major risk factors. Cigarette smoke can cause an imbalance in the oral bacterial community, leading to several oral diseases and conditions, including intraoral halitosis. Although the best approach to decrease smoking-related health risks is quitting smoking, this is not feasible for many smokers. Switching to potentially reduced-risk products, like electronic vapor products (EVP) or heated tobacco products (HTP), may help improve the conditions associated with CS. To date, there have been few systematic studies on the effects of CS on halitosis and none have assessed the effects of EVP and HTP use. Self-assessment studies have shown large limitations owing to the lack of reliability in the participants' judgment. This has compelled the scientific community to develop a strategy for meaningful assessment of these new products in comparison with cigarettes. Here, we compiled a review of the existing literature on CS and halitosis and propose a 3-layer approach that combines the use of the most advanced breath analysis techniques and multi-omics analysis to define the interactions between oral bacterial species and their role in halitosis both in vitro and in vivo. Such an approach will allow us to compare the effects of different nicotine-delivery products on oral bacteria and quantify their impact on halitosis. Defining the impact of alternative nicotine-delivery products on intraoral halitosis and its associated bacteria will help the scientific community advance a step further toward understanding the safety of these products and their potentiall risks for consumers.

Part Two: Pharmacokinetic Evaluation of E-Liquid Flavors of Vuse Solo Electronic Nicotine Delivery System, An Unblinded, Parallel, Randomized Study To Assess Nicotine Uptake In Smokers

This paper reports the findings of a randomized nicotine pharmacokinetic (PK) study of a closed electronic nicotine delivery system (ENDS). The study evaluated four flavor variants of Vuse Solo ENDS where subjects used their randomized investigational product (IP) for 10 minutes ad libitum and blood samples were collected for PK assessments that included maximum plasma nicotine concentration (Cmax) and area under the nicotine concentration-vs-time curve up to 60 minutes (AUCnic0–60). Baseline-adjusted mean Cmax ranged from 6.53 to 8.21 ng/mL, and mean AUCnic0–60 ranged from 206.87 to 263.52 ng*min/mL for all ENDS IPs. Results for Cmax and AUCnic0-60 values were consistent among the ENDS IP flavor variants tested and results indicate that flavors did not affect nicotine uptake in human subjects.