Tobacco Regulatory Science

Objectives: We examined the prevalence of and factors associated with usually purchasing tobacco online. Methods: We analyzed Waves 1 (2013-14) and 4 (2016-17) of the US Population Assessment of Tobacco and Health adult (18+) and youth (12-17) studies: 15,450 adults and 495 youth in 2013-14 and 15,037 adults and 465 youth in 2016-17. Z-tests compared the prevalence of usually purchasing tobacco online between waves and weighted multivariable regressions identified associations between purchasing online and sociodemographics...

Objectives: Canada is the only country that currently uses cigarette pack inserts to communicate health messages to smokers, including tips to quit. Messages about strategies for quitting smoking are also central to the US Food and Drug Administration's (FDA) Every Try Counts (ETC) campaign. This study assessed US smokers' responses to Canadian and ETC-based messages formatted for pack inserts. Methods: US adult smokers (N = 524) were recruited from an online consumer panel and rated 8 insert messages: 4 based on Canadian inserts and 4 based on ETC...

OBJECTIVES: Electronic cigarette (ECIG)-generated aerosol contains particulate matter with a diameter less than 2.5 microns (PM2.5 ). Particles of this size may be injurious to the health of those who inhale them. Few studies have assessed the relationship between ECIG aerosol PM2.5 and ECIG liquid ingredients or ECIG device power. METHODS: Two studies were conducted in which participants generated aerosols with ECIGs: in one, ECIG liquids contained various vegetable glycerin/propylene glycol ratios and in the other, ECIG devices varied by electrical power output...

Objectives: Past research has not examined secondhand and thirdhand smoke (THS) exposure in children of cigar smokers. We examined hand nicotine and cotinine levels in children of cigar smokers to explore the contribution of cigar smoke to tobacco smoke exposure (TSE). Methods: Participants were children (N = 24; mean (SD) age = 6.5 (3.6) years) whose parents smoked cigars only or poly-used cigars and/or cigarettes. Primary outcomes were hand nicotine and urinary cotinine levels...

Objectives: Given the need to understand e-cigarette retail and its impact, we examined sociodemographic, tobacco and marijuana use, and e-cigarette retail experiences as correlates of (1) past 30-day e-cigarette use, (2) past 30-day advertising/media exposure, and (3) point-of-sale age verification among young adults. Methods: We analyzed baseline survey data (September-December, 2018) among 3006 young adults (ages 18-34) in 6 metropolitan areas (Atlanta, Boston, Minneapolis, Oklahoma City, San Diego, Seattle) in a 2-year longitudinal study...

OBJECTIVES: In this study, we examined whether visual exposure to the heated tobacco product (HTP) IQOS, which was authorized for sale by the US Food and Drug Administration in 2019, acts as a cue to increase cigarette craving and smoking behavior among smokers. METHODS: Young adult smokers (N = 105) were randomly assigned to view a video depicting use of either IQOS or bottled water. Main outcomes were changes in cigarette and e-cigarette desire and latency to smoke between the groups...

Objectives: The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative study of the US population on tobacco use and its effects on health, with 3 waves of data collection between 2013 and 2016. Prior work described the methods of the first wave. In this paper, we describe the methods of the subsequent 2 waves and provide recommendations for how to conduct longitudinal analyses of PATH Study data. Methods: We use standard survey quality metrics to evaluate the results of the follow-up waves of the PATH Study...

Objectives: Intentional and unintentional exposures to electronic nicotine delivery system (ENDS) e-liquids can cause illness and death. In this study, we describe acute nicotine toxicity due to e-liquid exposure (ANTEE) information found on Twitter and contextualize ANTEE experiences to clarify conditions associated with exposure. Methods: We obtained 20,180 ANTEE-relevant tweets from 2013-2018. We excluded retweets, suspected bots, non-English tweets, tweets not originating in the US, and advertisements...

Objectives: Toxic pollutants leaching from littered cigarette butts (CB) raise environmental impact concerns. The US Food and Drug Administration (FDA) is required to assess the environmental impacts of its tobacco regulatory actions per the US National Environmental Policy Act (NEPA). Methods: We determined the chemical constituents in CB leachate through analyses of 109 field-collected CB and literature compilation and characterized their ecotoxicity to aquatic organisms...

Objective: This study's objective was to characterize the nicotine delivery profile of a variable voltage, tank-style electronic nicotine delivery system (ENDS). Methods: Ten cigarette smokers (8 men, 2 women) completed this within-subject study assessing effects of 2 device power settings (15 W, 45 W) and 3 liquid nicotine concentrations (0, 3, and 6 mg/ml) using a tank-style ENDS. Participants completed one directed (10 puffs) and one ad libitum use period for each condition, with blood sampled throughout...

Objectives: The US Food and Drug Administration (FDA) issued new requirements to strengthen and increase the size of cigar warnings. Although these requirements were challenged in court by the cigar industry, and later struck down, cigar manufacturers had the option of voluntarily complying during the injunction. In this study, we examined voluntary warning compliance on a sample of discarded cigar wrappers. Methods: Warnings were examined on a sample of 1352 discarded cigar wrappers and packs obtained from 15 census tracts in Oakland, California in February 2019...

Objectives: Gutka is industrially manufactured in India and some Indian states have instituted bans on the sale of manufactured gutka as a public health initiative. We explored whether gutka was still available for purchase after the ban and also sought to observe methods of ban circumvention. Methods: We visited 5 different markets at different locations separated by at least 15-20 km around the Mumbai Metropolitan Region (MMR) area, consisting of Mumbai and its satellite towns in Maharashtra, India during August- September, 2019...

Objectives: Measurement of electronic cigarette (ECIG) puff topography provides an understanding of how product characteristics and user behavior affect nicotine delivery. However, mouthpiece-based topography devices may affect natural puffing behavior. This study was designed to compare ECIG topography measured by mouthpiece-based eTop computerized device and mouthpiece-free video recordings. Methods: ECiG-naïve cigarette smokers (N = 18) and ECIG-experienced users (N = 25) puffed on a standardized ECIG via eTop or conventionally; both sessions were videotaped...

Objectives: Instagram influencers have many followers and are often paid to promote products, including e-cigarettes. This experimental study assessed effects of sponsorship disclosures on perceptions of e-cigarette Instagram influencer posts. Methods: Young adult e-cigarette users (age 18-29; N = 917) were randomly assigned to 3 experimental conditions varying the clarity of sponsorship disclosure on simulated Instagram influencer posts: clear (eg, "#sponsored") ambiguous (eg, "#sp"), or no disclosure (ie, vaping-related hashtags only)...

Objectives: Urine propylene glycol (PG) and vegetable glycerin (VG) were evaluated as potential markers for discriminating ECIG users from non-users and verifying ECIG abstinence. Methods: Urine samples from 51 ECIG users (collected pre/post 12-hours ECIG abstinence), and 50 controls (who do not use nicotine/tobacco) were analyzed for urine cotinine, PG, and VG concentration. Results: Of 42 ECIG users with pre-abstinence urine cotinine indicating nicotine use, mean (SD) urine cotinine concentration was 1053...

Objectives: When examining the relationship between smoking intensity and toxicant exposure biomarkers in an effort to understand the potential risk for smoking-related disease, individual biomarkers may not be strongly associated with smoking intensity because of the inherent variability in biomarkers. Structural equation modeling (SEM) offers a powerful solution by modeling the relationship between smoking intensity and multiple biomarkers through a latent variable. Methods: Baseline data from a randomized trial (N = 1250) were used to estimate the relationship between smoking intensity and a latent toxicant exposure variable summarizing five volatile organic compound biomarkers...

Objectives: Health warning messages could be an effective means of communicating the health risks associated with waterpipe (WP) smoking. The objective of this study was to select a message that conveyed the risks associated with WP smoking. Methods: A mixed-methods approach was used to explore the effectiveness of the Food and Drug Administration's (FDA's) mandated message, and others, among young adults using focus groups and surveys. Two focus group studies and one convenience survey were conducted to examine the FDA's mandated message and 11 other WP warning messages...

On 20 December 2018, Altria, the largest US cigarette company, announced an offer for a 35% share of the large and rapidly growing vaping product company, Juul Labs. On 2 April, 2020, the Federal Trade Commission issued a complaint that the deal was anticompetitive and should be voided. This paper analyzes the deal. We find that the deal gives Altria market power in the e-cigarette market through its support of Juul in retail stores and through the agreement not to otherwise compete in the e-cigarette market...

Objective: We assessed how many peer-reviewed publications reporting chemical quantities and/or yields from electronic nicotine delivery systems (ENDS) have included adequate method validation characteristics in the publication for appropriate interpretation of data quality for informing tobacco regulatory science. Methods: We searched 5 databases (Web of Knowledge, PubMed, SciFinder, Embase, EBSCOhost) for ENDS publications between January 2007 and September 2018...

Objectives: The province of Ontario, Canada banned menthol in cigarettes and other tobacco products effective January 1st , 2017 adding to an existing flavour ban. However, all flavoured e-cigarettes, flavoured cigars larger than 6g, and alcohol flavoured cigars without filters over 1.4g were exempted. This paper examines the association between use of flavoured non-cigarette products and self-reported cigarette smoking cessation after the ban. Methods: Current past-30 day cigarette smokers (N=913) who were 16 years or older, living in Ontario were recruited between September-December 2016 and re-contacted January-August 2018...