Library

A comparison of select smokeless tobacco and tobacco-free nicotine pouches utilizing validated methods for nicotine dissolution using the dissolution apparatus 1 and dissolution apparatus 4.

This study presents the results of a method validation for nicotine dissolution using the United States Pharmacopeia (USP) basket apparatus (Apparatus 1). Furthermore, dissolution profiles of select oral tobacco products (OTP) and tobacco-free nicotine pouches (TFNP) were generated and compared with a validated method using the USP flow-through cell apparatus (Apparatus 4). Nicotine quantification at each fraction collection time from each apparatus was achieved using a single method of analysis. This study provides robust data for the validation of nicotine dissolution using Apparatus 1 (App1). Additionally, justification is provided for using App1 or Apparatus 4 (App4) when determining the nicotine dissolution profiles for any of the products included in this study. Lastly, nicotine release profiles generated from both apparatuses are compared using the difference factor (f1) and similarity factor (f2) according to the United States Food and Drug Administration (FDA) Guidance for Industry: Dissolution testing of immediate release solid oral dose forms (FDA CDER, 1997).

Evaluation of environmental emissions from glo heated tobacco products and combustible cigarettes

Environmental Advances, 2024

Identification and Quantitation of Nicotine Polacrilex in Nicotine Pouches and Other Oral Nicotine Delivery Products

Contributions to Tobacco & Nicotine Research, 2023

Does the Level of NNK in Tobacco and Tobacco Products Depend on the Level of Pseudooxynicotine or of Nicotine-1′-N-Oxide?

Contributions to Tobacco & Nicotine Research, 2022

A Single-Center Evaluation of Environmental Emissions from Electronic Cigarettes and Combustible Cigarettes

Contributions to Tobacco & Nicotine Research, 2021

Machine Vaping of Electronic Cigarettes – A Comparison of Puffing Regimes

Several machine-based puffing regimes for collection of e-cigarette aerosol were evaluated with the objective of recommending one regime for standardization. The study involved a comparison of several candidate regimes for which puff volume, duration, interval, profile shape, and puff number were defined and varied.

Development of a quantitative method for assessment of dose in in vitro evaluations using a VITROCELL® VC10® smoke exposure system

The aims of this study were to investigate dosimetry during whole smoke exposure in the VITROCELL® VC10® smoking robot using quartz crystal microbalances (QCMs) and to support the use of photometers for concurrent assessment of ‘dose’ during whole smoke exposures. QCM results showed consistent deposition across different exposure chambers, between dilution bars, experiments and modules.

Analysis of Traces of Tobacco-Specific Nitrosamines (TSNAs) in USP Grade Nicotine, E-Liquids, and Particulate Phase Generated by the Electronic Smoking Devices

The present study describes the development of a liquid chromatography tandem mass spectrometry (LC-MS/MS) technique for the analysis of trace levels of four tobaccospecific nitrosamines (TSNAs): nitrosoanabasine (NAB), nitrosoanatabine (NAT), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), and nitrosonornicotine (NNN).

Particle Size Distribution of E-Cigarette Aerosols and the Relationship to Cambridge Filter Pad Collection Efficiency

Described here is a study in which e-cigarette aerosols were collected on Cambridge filters with adsorbent traps placed downstream in an effort to capture any material passing through the filter.

Electronic Cigarette Aerosol Particle Size Distribution Measurements

Inhalation Toxicology, 2012

Differential cell-specific cytotoxic responses of oral cavity cells to tobacco preparations

The objective of this study was to investigate the cytotoxic effects of different standardized tobacco preparations on a panel of human oral cavity cells.

In Vitro Toxicological Evaluation of glo menthol and non-menthol Heated Tobacco Products

Heated tobacco products (HTPs) are non-combustible, inhaled tobacco products that generate an aerosol with fewer and lower levels of toxicants, with a potential to reduce risk relative to cigarette smoking. Here, we assessed in vitro toxicological effects of three menthol (glo neo neoCLICK, neo Smooth Menthol and Fresh Menthol) and one non-menthol (neo Smooth Tobacco) variants of glo HTP, along with market comparators for cigarettes and HTPs.

Evaluation cytotoxicity and oxidative stress of whole aerosol from Vuse Alto ENDS products

Assessment of in vitro cytotoxicity is an important component of tobacco product toxicological evaluations. However, current methods of regulatory testing involve exposing monolayer cell cultures to various preparations of aerosols from cigarettes or other emerging products such as electronic nicotine delivery systems (ENDS), which are not representative of human exposure.

A Systematic Review of Preclinical Studies Evaluating the Association between Nicotine and the Initiation and Progression of Cancer

The association between cigarette smoking and the increased risk of many cancers is well established. Conversely, epidemiological studies of smokeless tobacco demonstrate decreased risk, or no elevated risk, of certain cancers versus smoking. However, it is unclear what role, if any, nicotine plays in these associations. The objective of this systematic review was to synthesize the available evidence from preclinical studies that examined the potential association between nicotine and the initiation and/or progression of cancer.

Validation of the VITROCELL Mammalian 48 Exposure Module Using In Vitro Cytotoxicity via the Neutral Red Uptake Assay in Chinese Hamster Ovary Cells Following Exposure to Whole Smoke from Combustible Cigarettes

The Vitrocell® Mammalian 48 exposure module offers a high throughput platform for air-liquid interface (ALI) exposures that mimic human exposure conditions for assessing the potential cytotoxicity of a test article. The aim of this study was to evaluate the in vitro cytotoxic response of whole smoke in Chinese hamster ovary (CHO) cells, using the Neutral Red Uptake Assay across two modules. The secondary aim was to further characterize the system utilizing three dosimetry techniques.

Characterization of smoke and aerosol deliveries from combustible cigarettes, heated tobacco products and electronic nicotine delivery systems in the Vitrocell® Mammalian 6/48 exposure module

The rapid development associated with Next Generation Tobacco Products (NGTP) has necessitated the development of high throughput methodologies to test their genotoxic potential in vitro when compared to conventional cigarette smoke (CS). An assessment of two Vitrocell® Mammalian 6/48 exposure modules in three independent experiments was made by comparing results from multiple dosimetric techniques applied to aerosol generated from 3R4F Kentucky Reference cigarettes, commercially available electronically heated tobacco product (eHTP) and Electronic Nicotine Delivery System (ENDS) using the Vitrocell® VC10®. Real-time aerosol particle concentration was assessed by means of light scattering photometers and expressed as area under the curve (∑AUC).

Ciliary Beat Frequency: Proceedings and Recommendations from a Multi-laboratory Ring Trial Using 3-D Reconstituted Human Airway Epithelium to Model Mucociliary Clearance

Cigarette Smoke Preparations, Not Electronic Nicotine Delivery Systems (ENDS) Preparations, Induce Features of Lung Disease in a 3D Lung Repeat-Dose Model

Impact of Cigarette Versus Electronic Cigarette Aerosol Conditioned Media on Aortic Endothelial Cells in a Microfluidic Cardiovascular Model

Genotoxicity evaluation of tobacco and nicotine delivery products: Part One. Mouse Lymphoma Assay

Optimization of Normal Human Bronchial Epithelial (NHBE) Cell 3D Cultures for in vitro Lung Model Studies

Genotoxicity evaluation of tobacco and nicotine delivery products: Part Two. In vitro micronucleus assay

Cigarette and ENDS preparations differentially regulate ion channels and mucociliary clearance in primary normal human bronchial 3D cultures

A systematic review and meta-analysis of the association between e-cigarette use and cigarette abstinence or changes in continued cigarette smoking among individuals who smoke cigarettes

With recent marked increase in e-cigarette use, potential associations between e-cigarette use and combustible cigarette smoking are an important public health issue. Following AMSTAR 2 and PRISMA guidelines, this evidence synthesis identified and characterized associations between e-cigarette use and abstinence from/quitting smoking cigarettes and changes in cigarette smoking quantity/frequency.

U.S. healthcare provider risk perceptions of tobacco and nicotine-containing products

U.S. healthcare providers (HCPs) are a valuable source of information about the health impact of using tobacco products and the health benefits of quitting cigarette smoking thus it is important to understand their perceptions of the absolute and relative risks of tobacco and nicotine-containing products (TNPs). The study objectives were to assess: (a) HCP perceptions about the relative risks of TNPs; (b) how much of the risk of smoking cigarettes HCPs attribute to combustion versus other factors; and (c) whether HCPs believe that partial or complete switching from cigarettes to using other TNPs can reduce health risks. A 15 min self-administered online survey was completed by 700 HCPs enrolled in a national online panel. Mean overall health risk ratings on a 100-point scale differ significantly for cigarettes (95.9), e-cigarettes (79.5), smokeless tobacco (76.4), nicotine pouches (60.3), and nicotine replacement therapy (40.3). HCPs attribute less than 40% of the risk of lung cancer associated with smoking cigarettes to combustion. Half of HCPs do not believe that switching completely from cigarettes to e-cigarettes or smokeless tobacco can reduce health risks. These findings indicate that HCPs are aware that not all TNPs present the same health risks, but that their perceptions of the relative risks of combustible and non-combustible products are not consistent with published estimates from authoritative sources. HCPs are generally unaware that the smoke from burning tobacco is the primary source of risk associated with cigarette smoking and most do not believe that switching completely from cigarettes to e-cigarettes or smokeless tobacco products can reduce health risks. Together, these findings suggest that many HCPs do not have accurate information about the relative risks of non-combustible TNPs and that broadening awareness about the harm reduction associated with those products is a vital step to ensuring that HCPs can provide their patients who smoke with accurate information about the benefit of switching completely from cigarettes to other types of non-combustible TNPs.

Randomized crossover clinical studies to assess abuse liability and nicotine pharmacokinetics of Velo Oral Nicotine pouches

Oral nicotine pouches (ONPs) are a newer category of smokeless tobacco products containing pharmaceutical-grade nicotine but no tobacco leaf. These products have the potential to help smokers transition away from cigarettes. To assess their potential role as alternatives to cigarettes, we evaluated the abuse liability (AL) of Velo ONPs with varying nicotine content (4–12 mg per pouch), pouch size (600 mg or 400 mg) and flavor (six varieties) in comparison to high (cigarettes) and low (nicotine replacement therapy [NRT] gum) AL comparators.

Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study

This study aimed to assess the AL of glo HTPs, operated in either Standard or Boost Modes, compared with high- and low-AL comparators (subjects’ usual brand cigarettes and nicotine gum, respectively).

A systematic review and meta-analysis of the association between e-cigarette use among non-tobacco users and initiating smoking of combustible cigarettes

Purchase Intent and Intended Use of the glo Heated Tobacco Product

This study assessed current cigarette smokers' interest in using the gloTM heated tobacco product (HTP), whether those interested are likely to quit or greatly reduce their cigarette consumption, and whether never tobacco users are interested in the glo HTP.

A systematic review investigating associations between e-cigarette use among former cigarette smokers and relapse to smoking cigarettes

As e-cigarette use has steadily increased over the recent years, the public health interest in the potential implications of e-cigarette use on cigarette smoking has grown in parallel. With strict adherence to PRISMA guidelines, this systematic review examined the potential associations between e-cigarette use and relapse to cigarette smoking among former cigarette smokers.

Abuse liability of two electronic nicotine delivery systems compared with combustible cigarettes and nicotine gum from an open-label randomized crossover study

An assessment of the likelihood of use and abuse potential for new tobacco products is an important part of tobacco product regulation in the United States and abroad. This paper reports the results of a randomized, open-label, crossover clinical study that assessed factors related to product adoption and abuse liability (AL), comparing two closed electronic nicotine delivery system (ENDS) products to combustible cigarettes and nicotine gum, high- and low-AL comparator products, respectively.

Purchase Intent and Product Appeal of Velo Nicotine Pouches Among Current Tobacco Users and Nonusers of Tobacco

Oxidative Stress and Lung Fibrosis: Towards an Adverse Outcome Pathway

Changes in Biomarkers of Exposure and Potential Harm in Smokers Switched to Vuse Vibe or Vuse Ciro Electronic Nicotine Delivery Systems

Purchase Intent and Appeal of ENDS Products among Current, Former and Never Ever Users of Tobacco Products in the U.S.

Experimental Design and Results from Non-Targeted Analyses of glo Heated Tobacco Products

Overall, this study finds that glo HTP aerosols contain fewer and significantly lower levels of constituents than combustible cigarette smoke. Toxicological reviews determined that the overall toxicological impact of glo HTP aerosol exposure on the consumer is likely to be less than that of combustible cigarette smoke, consistent with supporting in vitro data. Study results are consistent with the abundance of chemistry, non-clinical toxicology, and clinical data submitted to FDA, supporting a conclusion that the use of glo HTPs is likely to present substantially less harm to individuals than cigarette smoking.

End-to-End Review of ENDS Product PMTA Science Package: Vuse Case Study

This study presents evidence on Vuse Alto and its potentially reduced risks compared to combustible cigarettes.

Topography Study of glo Hyper, a Tobacco Heated Product

Topography is useful in assessing the health risk of a tobacco product by measuring how a user consumes a product.

Velo Nicotine Pouch Use Behaviors and Smoking Reduction among U.S. Adult Smokers With and Without Intentions to Quit Smoking

Behavior results from this study suggest that the availability of Velo pouch products may contribute positively to public health by decreasing cigarette consumption, regardless of expressed quit intention.

A Cross-Sectional Survey of Healthcare Provider Awareness and Perceptions of Tobacco and Nicotine-Containing Products

The "continuum of risk" for different types of tobacco and nicotine-containing products (TNPs), based primarily on whether the product is burned, has been recognized by the FDA and it central to tobacco harm reduction.