Posters & Presentations – Page 2

Mar 24th 2026

Clinically Relevant Doses for Electronic Nicotine Delivery System and Heated Tobacco Product In Vitro Testing

Extrapolating in vitro toxicology results to humans would be more meaningful if clinically relevant exposure doses were known. For both Electronic Nicotine Delivery Systems (ENDS) and Heated Tobacco Products (HTP) clinical studies reporting plasma nicotine values were used to calculate clinically relevant in vitro exposure doses for the extrathoracic (ET), tracheobronchial (TB) and alveolar (AL) regions of the human respiratory tract on a mass of nicotine/cm2– min basis.

Mar 24th 2026

Tobacco Harm Reduction: In Vitro Toxicological Assessment of Next Generation Tobacco and Nicotine Products versus Combustible Cigarettes and Smokeless Tobacco

Next generation tobacco and nicotine (NGP) products, which include Electronic Nicotine Delivery Systems (ENDS), Heated Tobacco Products (HP), and Nicotine Pouch (NP) products, provide alternative, potentially less harmful, nicotine products to adult smokers and nicotine consumers wanting to transition from combustible and other tobacco containing products. NGPs must undergo the premarket tobacco product application (PMTA) process and obtain a marketing granted order (MGO) from FDA Center of Tobacco Products (CTP) to become authorized for marketing. Currently, FDA-CTP PMTA submissions require comprehensive listings of product ingredients and components, harmful and potentially harmful constituents (HPHC), product stability and information on potential health risks including risk assessments, in vitro toxicological, and clinical testing to establish a Weight of Evidence (WoE) to determine if the marketing of an NGP is appropriate for the protection of the public health (APPH). This assessment will examine the in vitro toxicological testing of representative ENDS, HP and NP products (all menthol or mint flavor varieties) through three standard genotoxicity and cytotoxicity assays and compared to combustible cigarettes (CC) and traditional smokeless tobacco (ST). The three standard regulatory toxicology assays utilized include the Ames (mutagenicity), in vitro micronucleus (ivMN: genotoxicity), and neutral red uptake (NRU: cytotoxicity) following respective Health Canada (HC) and OECD guidelines. Test samples from CC, HP, and ENDS included pad-collected total particulate matter (TPM: CC & HP) or aerosol collected material (ACM: ENDS), all combined with their respective gas vapor phase (GVP) preparations as well as combustible cigarette whole smoke (WS) and whole aerosol (WA) from ENDS and HP (NRU). NP products with either tobacco-derived (TDN) or synthetic (SYN) nicotine and ST (snus) were tested using complete artificial saliva (CAS) extracts in all three assays.

Mar 24th 2026

Tobacco and Nicotine Product Assessments: Quantitative Derivation of Excess Lifetime Cancer Risk for Oral Route of Exposure

In 2024, the United States Food and Drug Administration (FDA) published two toxicology memos focusing on the calculation of Excess Lifetime Cancer Risk (ELCR) for ENDS products as part of Premarket Tobacco Application (PMTA) evaluation. ELCR estimates the likelihood of cancer development over a lifetime of exposure to one or more substances (cumulative ELCR). Globally, there are over 300 million users of oral tobacco products such as snus, moist snuff, and nicotine pouches. Unlike combustible and vapor products, smokeless tobacco products are generally placed in the mouth in direct and prolonged contact with the oral mucosa, resulting in a different absorption route for nicotine and harmful and potentially harmful constituents (HPHCs) – oral versus inhalation. As FDA’s memos do not address risk assessments for oral tobacco products, this work presents an approach to calculating ELCR for smokeless tobacco products via the oral route of exposure, utilizing cancer slope factors and average human body weight in lieu of inhalation unit risk factors and inhalation rates. Reference data from CORESTA Smokeless Tobacco Reference Products, along with usage assumptions under “average” and “heavy” consumption scenarios, demonstrate the feasibility and practical application of this method.

Mar 24th 2026

Quantitative Risk Assessment: Use of Cumulative Excess Lifetime Cancer Risk in an Electronic Nicotine Delivery System Premarket Review

The U.S. Food and Drug Administration (FDA) has recently incorporated cumulative excess lifetime cancer risk (ELCRc) estimates to inform its scientific evaluations of Electronic Nicotine Delivery System (ENDS) Premarket Tobacco Product Applications (PMTAs).

Mar 24th 2026

Modern Approaches for Cumulative Excess Lifetime Cancer Risk: FDA’s Use in ENDS Premarket Reviews

Tobacco Harm Reduction is A Better Way to A Better Tomorrow. Our science & technology is bringing potentially reduced risk alternatives to the almost 30 million adult smokers. Knowledge and choice drive change.

Mar 24th 2026

In Vitro Toxicological Assessment of Modern Oral Nicotine Product Extracts in the Ames, Micronucleus, and Neutral Red Uptake Assays

Current next generation tobacco products (NGPs) include Modern Oral (MO) nicotine products containing nicotine, either synthetic or derived from tobacco, and tobacco leaf. In vitro toxicological assessments of tobacco products are a significant part of the US FDA’s premarket tobacco product application (PMTA) process, providing data for a weight of evidence (WoE) approach to determine if the marketing of a new MO tobacco product is appropriate for the protection of the public health (APPH). Data for these products is important due to the limited information for this product class and their accelerating growth in the market.

Nov 11th 2025

Update on Insights from Reverse Dosimetry for in vitro Electronic Nicotine Delivery System (ENDS) and Heated Tobacco Product Testing (HTP)

Recent work demonstrates acute increase in mucus velocity when ENDS are used. (Bennett et al., 2024) Typical cells lines used for in vitro studies have documented metabolic differences compared to the human lung cells (Courcot et al., 2012; Oesch et al., 2019), so how should potential toxicity measured in these in vitro studies be interpreted?

Oct 22nd 2025

Reduction in Biomarkers of Exposure Following Short-Term Switching From Cigarettes to Velo Nicotine Pouches in Adult Smokers

This study was designed to assess changes in Biomarkers of Exposure to certain tobacco- and tobacco smoke toxicants when smokers switch to exclusive use of one of five Velo nicotine pouch products.

Oct 22nd 2025

Quantitative Risk Assessment in Action: FDA’s Use of Cumulative Excess Cancer Risk in ENDS Premarket Reviews

When the risk assessment includes Tier 1 – 4 constituents, the ELCRc for the new [VUSE Alto] products fall between 1 – 10% of the 1R6F CC ELCRc indicating lower cancer risk relative to CC [combusted cigarettes].