Altria (United States)

BackgroundCigarette smoking causes many serious diseases, including lung cancer, Chronic Obstructive Pulmonary Disease (COPD), mouth cancer, and tobacco-related heart disease. For adults who smoke and are unable or unwilling to quit all tobacco, switching completely from cigarettes to lower-risk smoke-free tobacco products, may reduce the health risks associated with tobacco use. In this review, we summarize epidemiological findings and provide evidence about the potential risk differential between cigarette smoking and the use of oral smoke-free tobacco products used in the US, Sweden, and Norway. Due to the wide range of compositions and health risks associated with ST products around the world and to provide evidence most relevant to the US and Western European populations, we focused on epidemiological studies conducted in these regions only.MethodsWe used a two-stage approach to obtain recent risk estimates from relevant publications. First, we identified relevant meta-analyses and systematic reviews published from Jan. 2000- Feb. 2022. Second, we identified relevant individual studies published subsequent to the most recent meta-analysis or systematic review. Studies were selected using pre-defined inclusion/exclusion criteria. All eligible studies were assessed using National Heart, Lung, and Blood Institute Study Quality Assessment Tools. The relative risk estimates (RR) are reported compared to nonusers.ResultsOur search identified 25 systematic reviews. Meta-analyses consistently showed large and statistically robust RRs for cigarette smoking and lung cancer (i.e., RR ranging from 10.1 to 14.6), whereas no statistically significant associations (null associations) were observed for ST products used in the US, Sweden, and Norway, congruent with the lack of pulmonary exposure with the use of oral tobacco products. For COPD, mouth cancer, and heart diseases, we consistently observed higher RRs for cigarette smoking compared to using these ST products. Findings from individual studies are generally in line with these results. Importantly, a few studies documented those individuals who stopped cigarette smoking and used ST products from these regions (i.e., individuals who switched) had lower risks of lung cancer, mouth cancer, and heart diseases compared to those who continued to smoke. We identified no such studies for COPD, yet the risk estimates were generally comparable between those who switched and those who quit all tobacco products.ConclusionFindings from our literature review suggest that, relative to continued smoking, switching from cigarette smoking to the ST products commonly used in the US, Sweden, and Norway is associated with reduced risks of lung cancer, mouth cancer, COPD, and tobacco-related heart diseases. Future longitudinal studies that directly measure switching behavior will provide further evidence about the potential benefits of switching and the magnitude of the harm reduction potential.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12889-025-23280-4.

Tobacco use has been identified as a risk factor for oral cancer worldwide. However, relative oral cancer incidence among adults who smoke cigarettes, use smokeless tobacco products (ST), have transitioned from cigarettes to ST, quit cigarettes and/or ST ("quitters"), or never used tobacco has not been well studied. We aim to present population-based oral cancer incidence rates for adults who smoke cigarettes, use ST, are former smokers who now use ST, or quit. We estimated cross-sectional incidence rates and incidence rate ratios (IRRs) using data from statewide cancer registries (Colorado, Florida, North Carolina, and Texas) and population counts derived from national surveys using combined data from 2014-2017. A random-effect meta-analysis approach was used to summarize estimates among these groups, based on multiple imputation-based IRR estimates by state and age group while considering potential heterogeneity. A total of 19,536 oral cancer cases were identified among adult males 35 years and older in the study geographies and period. The oral cancer incidence rate among adults who smoke was significantly higher than the ST group (2.6 times higher, 95% CI 2.0-3.3, P<.001), 3.6 (95% CI 3.2-4.1, P<.001) times higher than the never users, and 2.4 (95% CI 1.8-3.1, P<.001) times higher compared to former smokers who now use ST. The IRR among the ST group relative to never users was 1.4 (95% CI 1.1-1.9, P=.02). The IRR between former smokers who now use ST and those who quit was 1.4 (95% CI 1.0-2.1, P=.08). Findings from this population-based study with a large number of oral cancer cases support significantly high oral cancer incidence among adults who smoke and a lower risk of oral cancer incidence among never users, quitters, users of ST, and former smokers who now use ST compared to cigarettes. Future studies with detailed control of tobacco history and other relevant confounders are needed to confirm these findings.

Response to the article written by Rita Rubin, “Controversial FDA Decision Authorizes Menthol-Flavored E-Cigarettes Despite Risks” JAMA. 2024 Aug 7. doi: 10.1001/jama.2024.14243 [https://doi.org/10.1001/jama.2024.14243]. Online ahead of print.

Cigarette smoking is a leading cause of morbidity and mortality. For adults who smoke cigarettes and cannot or will not quit smoking, smoke-free products, such as nicotine pouches, have been recognized as a potential alternative to smoking combusted cigarettes to reduce harm due to cigarette smoking. The role of flavors in these smoke-free products in tobacco harm reduction has not been fully understood. This study evaluates the effect of flavors in on! nicotine pouch products (research products) in the reduction of cigarette smoking among adults who smoke cigarettes in their natural environment. This study uses a sequential, multiple assignment, randomized trial design. Approximately 400 eligible adults who smoke cigarettes will be enrolled and randomized to have access to either the Original (unflavored) on! nicotine pouch product only or a complete flavor profile (ie, Berry, Cinnamon, Citrus, Coffee, Mint, Original, and Wintergreen) of on! nicotine pouch products. After 3 weeks, participants in the Original-only arm will be randomized again, with half remaining in the Original-only arm and half having access to the complete flavor profile for another 3 weeks. Primary outcomes are expired-air carbon monoxide (CO) levels. Secondary outcomes are self-reported cigarette consumption and CO-verified cigarette abstinence. Recruitment and data collection started in September 2023 and is projected to last until March 2025. We anticipate completing the data analysis in 2025. As of May 2024, we have enrolled 314 participants. This study will provide empirical evidence about the effect that flavor availability in smoke-free products may have in reducing cigarette smoking. ClinicalTrials.gov NCT06072547; https://clinicaltrials.gov/study/NCT06072547. DERR1-10.2196/56565.

Summary This study describes the dissolution release profiles of nicotine and flavor markers from three loose moist smoke-less tobacco (MST) products, same brand, each made with a distinct flavor. The US Pharmacopeia flow-through cell dissolution apparatus 4 (USP-4) was employed, following a previously published method that was validated to study the nicotine release from MST products. Herein, we expanded the scope of the analytical method by incorporating three flavor markers including methyl salicylate, ethyl salicylate, and glycyrrhizic acid to provide an understanding of the dissolution release profiles of not only nicotine but also of flavor markers. The dissolution release profiles of nicotine were found to be equivalent across all three tobacco products. In contrast, the release profiles of the studied flavor markers exhibited distinct differences, primarily influenced by their chemical properties, particularly polarity. Notably, glycyrrhizic acid demonstrated the most rapid release rate, while ethyl salicylate exhibited the slowest release rate. This study serves as a valuable resource for researchers, manufacturers, and regulatory bodies involved in the evaluation of MST products attributes and performance.

Abstract Background Tobacco use has been identified as a risk factor for oral cancer worldwide. However, oral cancer risk among people who smoke cigarettes, use smokeless tobacco products (ST), have transitioned from cigarettes to ST (“switchers”) or quit both cigarettes and/or ST (“quitters”) has not been well studied. This study compared oral cancer incidence between 2014–2017 relative to never tobacco use.Methods We estimated incidence rates and incidence rate ratios using data from state-wide cancer registries (i.e., Colorado, Florida, North Carolina, and Texas) and population counts derived from national surveys. A random-effect meta-analysis approach was used to summarize estimates among these groups, based on multiple imputation-based incidence rate ratio estimates, by state and age groups while considering potential heterogeneity.Results A total of 19,536 oral cancer cases were identified among adult males 35 years and older in the study geographies and period. People who currently smoked cigarettes were 2.6 (95% CI = 2.0-3.3) times as likely to be diagnosed with oral cancer compared to individuals who currently used ST. The incidence rate ratio among people who currently smoke cigarettes was 3.6 (95% CI = 3.2–4.1) relative to never users, 2.4 (95% CI = 1.8–3.1) relative to switchers and 1.4 (95% CI = 1.0-2.1) among switchers relative to quitters. The incidence rate ratio of current users of ST relative to never-users was 1.4 (95% CI = 1.1–1.9).Conclusions Findings from this population-based study with a large number of oral cancer cases support lower risk of oral cancer among users of ST compared to cigarettes. Compared to those who continue to smoke, oral cancer risks can be reduced by switching to ST products or quitting all tobacco.

BACKGROUND: The FDA’s modified risk authorization for IQOS® is contingent upon approved post-market surveillance studies. The IQOS® Cross-Sectional Post-Market Adult Consumer Study (hereinafter termed IQOS® CS PACS) and the IQOS® Longitudinal Cohort Post-Market Adult Consumer Study (hereinafter termed IQOS® LC PACS) are contiguous surveys designed to fulfill this proviso. OBJECTIVES: IQOS® CS PACS seeks to assess tobacco use patterns in IQOS® users, risk perceptions of IQOS®, and tobacco transition and cessation behaviors related to IQOS®. The IQOS® LC PACS aims to follow over time, and in comparison with cigarette users, these same parameters with additional emphasis on transitions and health outcomes. METHODS AND RESULTS: The IQOS® CS PACS is a repeated cross-sectional study to be conducted annually for four years. The IQOS® LC PACS is a longitudinal study, planned to follow a cohort of new IQOS® users for two years. Potential adult IQOS® consumers aged 21 and older will be recruited from an IQOS® consumer database. Both studies will use self-administered online screening and survey assessment. At least 250 adult ever established IQOS® users (current and former) constitute the target sample size for each administration of the IQOS® CS PACS. The target sample size for the IQOS® LC PACS is 2,100 adult IQOS® users and 1,600 adult cigarette smokers as control. Data analysis includes descriptive statistics for pre-defined outcomes and inferential statistics (e.g., generalized estimating equations and propensity scoring) to compare outcomes among IQOS® and cigarette smokers. The IQOS® CS PACS is designed to commence one year after IQOS® modified risk tobacco product authorization (MRTPA) and will recur annually over the course of four years. The IQOS® LC PACS will begin two years after issuance of the IQOS® modified risk order and has been designed to follow up with participants at 3-, 6-, 12-, 18-, and 24-months from initiation. Final reports will be generated and shared with the FDA when the studies are completed. CONCLUSIONS: Postmarket studies can help inform outcomes related to risk perceptions, tobacco use patterns, and health status related to IQOS® use in a real-world setting.