Standardized topography protocols for testing cigarette emissions include the Federal Trade Commission/International Standard Organization (FTC/ISO), the Massachusetts Department of Health (MDPH), and Health Canada (HC). Data are lacking for how well these protocols represent actual use behavior. This study aims to compare puff protocol standards to actual use topography measured in natural environments across a range of cigarette brands. Current smokers between 18 and 65 years of age were recruited. Each participant was provided with a wPUM™ cigarette topography monitor and instructed to use the monitor with their usual brand cigarette ad libitum in their natural environment for one week. Monitors were tested for repeatability, and data were checked for quality and analyzed with the TAP™ topography analysis program. Data from n = 26 participants were analyzed. Puff flow rates ranged from 17.2 to 110.6 mL/s, with a mean (STD) of 40.4 (21.7) mL/s; durations from 0.7 to 3.1 s, with a mean (STD) of 1.5 ± 0.5 s; and volumes from 21.4 to 159.2 mL, with a mean (STD) of 54.9 (29.8) mL. Current topography standards were found to be insufficient to represent smoking across the wide range of real behaviors. These data suggest updated standards are needed such that emissions tests will provide meaningful risk assessments.

Many Electronic Nicotine Delivery Systems (ENDS) employ integrated sensors to detect user puffing behavior and activate the heating coil to initiate aerosol generation. The minimum puff flow rate and duration at which the ENDS device begins to generate aerosol are important parameters in quantifying the viable operating envelope of the device and are essential to formulating a design of experiments for comprehensive emissions characterization. An accurate and unbiased method for quantifying the flow condition operating envelope of ENDS is needed to quantify product characteristics across research laboratories. This study reports an accurate, unbiased method for measuring the minimum and maximum aerosolization puff flow rate and duration of seven pod-style, four pen-style and two disposable ENDS. The minimum aerosolization flow rate ranged from 2.5 to 23 (mL/s) and the minimum aerosolization duration ranged from 0.5 to 1.0 (s) across the ENDS studied. The maximum aerosolization flow rate was defined to be when the onset of liquid aspiration was evident, at flow rates ranging from 50 to 88 (mL/s). Results are presented which provide preliminary estimates for the effective maximum aerosolization flow rate and duration envelope of each ENDS. The variation in operating envelope observed between ENDS products of differing design by various manufacturers has implications for development of standardized emissions testing protocols and data reporting required for regulatory approval of new products.

The popularity of electronic cigarettes in the United States and around the world has led to a startling rise in youth nicotine use. The Juul® e-cigarette was introduced in the U.S. market in 2015 and had captured approximately 13% of the U.S. market by 2017. Unlike many other contemporary electronic cigarette companies, the founders behind the Juul® e-cigarette approached their product launch like a traditional high-tech start-up company, not like a tobacco company. This article presents a case study of Juul’s corporate and product development history in the context of US regulatory actions. The objective of this article is to demonstrate the value of government-curated archives as leading indicators which can (a) provide insight into emergent technologies and (b) inform emergent regulatory science research questions. A variety of sources were used to gather data about the Juul® e-cigarette and the corporations that surround it. Sources included government agencies, published academic literature, non-profit organizations, corporate and retail websites, and the popular press. Data were disambiguated, authenticated, and categorized prior to being placed on a timeline of events. A timeline of four significant milestones, nineteen corporate filings and events, twelve US regulatory actions, sixty-four patent applications, eighty-seven trademark applications, twenty-three design patents and thirty-two utility patents related to Juul Labs and its associates is presented, spanning the years 2004 through 2020. This work demonstrates the probative value of findings from patent, trademark, and SEC filing literature in establishing a premise for emergent regulatory science research questions which may not yet be supported by traditional archival research literature. The methods presented here can be used to identify key aspects of emerging technologies before products actually enter the market; this shifting policy formulation and problem identification from a paradigm of being reactive in favor of becoming proactive. Such a proactive approach may permit anticipatory regulatory science research and ultimately shorten the elapsed time between market technology innovation and regulatory response.

Usage of waterpipes is growing in popularity around the world. Limited waterpipe natural environment topography data reduces the ability of the research community to accurately assess emissions and user exposure to toxicants. A portable ergonomic waterpipe monitor was provided to study participants to use every time they smoked their own waterpipe during a one-week monitoring period in conjunction with their own choice shisha tobacco. Users provided demographic information and logged their product use to supplement electronic monitor data. A total of 44 prospective study participants were invited to an intake appointment following an on-line pre-screening survey. Of these, 34 individuals were invited to participate in the study and data for 24 individuals who completed all aspects of the 1-week monitoring protocol is presented. 7493 puffs were observed during 74 waterpipe sessions accumulating over 48 h of waterpipe usage. The 95% CI on mean puff flow rate, duration, volume and interval are presented, yielding grand means of 243 [mL/s], 3.5 [s], 850 [mL], and 28 [s] respectively. The middle 95% of puff flow rates ranged between 62 to 408 [mL/s], durations from 0.8 to 6.8 [s], and puff volumes from 87 to 1762 [mL]. A waterpipe emissions topography protocol consisting of 13 flow conditions is proposed to reflect 93% of the observed range of puff flow rate, puff duration and puff volume with representative inter-puff interval, cumulative session time and aerosol volumes.

The popularity of electronic cigarettes in the United States and around the world has led to a startling rise in youth nicotine use. The Juul e-cigarette was introduced in the U.S. market in 2015 and had captured approximately 13% of the U.S. market by 2017. Unlike many other contemporary electronic cigarette companies, the founders behind the Juul® e-cigarette approached their product launch like a traditional high-tech start-up company, not like a tobacco company. This article presents a case study of Juul’s corporate and product development history in the context of US regulatory actions. The objective of this article is to demonstrate the value of government-curated archives as leading indicators which can (a) provide insight into emergent technologies and (b) inform emergent regulatory science research questions. A variety of sources were used to gather data about the Juul e-cigarette and the corporations that surround it. Sources included government agencies, published academic literature, non-profit organizations, corporate and retail websites, and the popular press. Data was disambiguated, authenticated, and categorized prior to being placed on a timeline of events. A timeline of four significant milestones, nineteen corporate filings and events, twelve US regulatory actions, sixty four patent applications, eighty seven trademark applications, twenty three design patents and thirty two utility patents related to Juul Labs and its associates is presented spanning the years 2004 thought 2020. This work demonstrates the probative value of findings from patent, trademark, and SEC filing literature in establishing a premise for emergent regulatory science research questions which may not yet be supported by traditional archival research literature. The methods presented here can be used to identify key aspects of emerging technologies before products actually enter the market, this shifting policy formulation and problem identification from a paradigm of being reactive in favor of becoming proactive. Such a proactive approach may permit anticipatory regulatory science research and ultimately shorten the elapsed time between market technology innovation and regulatory response.