Surveillance of U.S. Corporate Filings Provides a Proactive Approach to Inform Tobacco Regulatory Research Strategy

Abstract

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.

Moving targets: how the rapidly changing tobacco and nicotine landscape creates advertising and promotion policy challenges

“…73 JUUL has produced devices in the UK and Canada with Bluetooth connected to a phone app to allow tracking of vape consumption claiming utility to prevent youth use, 70 71 74 and JUUL continued to file patent applications for 'smart' ENDS in 2020. 75 HTPs that resemble personal electronic devices may appear to be safer due to perceived technological advancement or because they share the familiar ubiquity of electronic devices in everyday life. Differentiation from cigarettes and association with personal electronics may be advantageous in markets where cigarette smoking is denormalised.…”

“…Korean IQOS’ Bluetooth technology can record battery level and usage, and a third-party app uses the information to track number of tobacco sticks smoked per day, as well as the days and times IQOS is used most 73. JUUL has produced devices in the UK and Canada with Bluetooth connected to a phone app to allow tracking of vape consumption claiming utility to prevent youth use,70 71 74 and JUUL continued to file patent applications for ‘smart’ ENDS in 2020 75. HTPs that resemble personal electronic devices may appear to be safer due to perceived technological advancement or because they share the familiar ubiquity of electronic devices in everyday life.…”

Fundamentals of vaping-associated pulmonary injury leading to severe respiratory distress

“…However, vaping-associated pulmonary injury (VAPI) in a minority of users is a well-documented and growing concern in the clinical setting with multiple independent reports of severe respiratory illness including acute respiratory distress syndrome including potential pulmonary circulation impairment ( 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ). Life-threatening consequences of VAPI emphasized by high profile media coverage over the last couple of years have raised public awareness of danger linked to vaping ( 18 , 19 , 20 , 21 ) with increased calls for regulatory oversight and expanded research ( 22 , 23 ). Fundamental unresolved issues using commercial vaping products from reputable sources include (1) how do individual-specific biological factors influence susceptibility to VAPI; (2) what is the underlying pathogenesis of VAPI leading to respiratory distress; and (3) how does progression of VAPI precipitate pulmonary circuit failure?…”