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Development of a panel of U.S. adult tobacco users to inform tobacco regulatory science

ABSTRACT: Highlights • FDA developed the TCS Panel to field tobacco regulatory research studies.• TCS Panel is a rigorous probability-based panel of ∼4,000 U.S. adult tobacco users.• TCS Panel represents a spectrum of U.S. cigarette, cigar, and smokeless users.• Comparisons with NHIS suggest lack of systematic bias in estimates from TCS Panel.• Panels can be a feasible method for conducting tobacco regulatory science research. The National Panel of Tobacco Consumer Studies (TCS Panel) is a probability-based panel of about 4,000 U.S. adult cigarette, cigar, and smokeless tobacco users developed by the U.S. Food and Drug Administration’s Center for Tobacco Products to conduct observational and experimental studies to inform tobacco regulatory activities. This paper describes the methods and characteristics of the current panel. The TCS Panel employed a stratified 4-stage sample design and in-person screening of U.S. sampled households. Selected eligible adults participated in an enrollment interview and completed a baseline survey assessing tobacco use behaviors to enroll in the Panel; 3,893 individuals were enrolled from September 2016–August 2017. Replenishment occurred from July 2019–December 2019 with 2,260 new members, for a current panel of 3,929 members. Demographic and tobacco use characteristics of the current panel were analyzed in 2020. Most demographic characteristics of the TCS Panel are similar to those of U.S. tobacco users in the 2018 National Health Interview Survey, suggesting a lack of systematic bias in the Panel. Small, but statistically significant, differences were observed in the proportion of 18- to 25-year-olds; high school diploma and bachelor’s degree/higher; never married and married (p < 0.05 for all). The TCS Panel appears to be representative of U.S. cigarette, cigar, and smokeless tobacco users; such panels can be a feasible method for conducting tobacco regulatory science research. The TCS Panel has been used to field studies examining purchasing behaviors, receipt and use of free samples/coupons, and the impact of a hypothetical tobacco product standard.

SUBMITTER: Liu S

PROVIDER: S-EPMC9284368 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

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Development of a panel of U.S. adult tobacco users to inform tobacco regulatory science

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