International Journal of Environmental Research and Public Health Article Surveillance of U.S. Corporate Filings Provides a Proactive Approach to Inform Tobacco Regulatory Research Strategy Samantha Emma Sarles 1, Edward C. Hensel 2,* and Risa J. Robinson 2 1 Engineering Ph.D. Program, Rochester Institute of Technology, Rochester, NY 14623, USA; [email protected] 2 Department of Mechanical Engineering, Rochester Institute of Technology, Rochester, NY 14623, USA; [email protected] * Correspondence: [email protected] 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. Citation: Sarles, S.E.; Hensel, E.C.; Data were disambiguated, authenticated, and categorized prior to being placed on a timeline of Robinson, R.J. Surveillance of U.S. events. A timeline of four significant milestones, nineteen corporate filings and events, twelve US Corporate Filings Provides a regulatory actions, sixty-four patent applications, eighty-seven trademark applications, twenty-three Proactive Approach to Inform design patents and thirty-two utility patents related to Juul Labs and its associates is presented, Tobacco Regulatory Research Strategy. Int. J. Environ. Res. Public Health 2021, spanning the years 2004 through 2020. This work demonstrates the probative value of findings 18, 3067. https://doi.org/10.3390/ from patent, trademark, and SEC filing literature in establishing a premise for emergent regulatory ijerph18063067 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 Academic Editors: Aoife DeBrun, products actually enter the market; this shifting policy formulation and problem identification from a Edel Doherty, Emma Nicholson and paradigm of being reactive in favor of becoming proactive. Such a proactive approach may permit Deirdre O’Donnell anticipatory regulatory science research and ultimately shorten the elapsed time between market technology innovation and regulatory response. Received: 23 January 2021 Accepted: 4 March 2021 Keywords: public health; decision-making; evidence; knowledge; translation; tobacco regulatory Published: 16 March 2021 science; tobacco regulation; e-cigarette; e-cig; vape; Juul Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affil- 1. Introduction iations. The popularity of electronic cigarettes (e-cigarettes) in the United States has led to a startling rise in youth nicotine use [1,2]. E-cigarette use has acted as a gateway to the use of other tobacco or tobacco-related products in non-established cigarette smokers [2]. Since their introduction to the market in 2004, electronic cigarettes have become popular among Copyright: © 2021 by the authors. Licensee MDPI, Basel, Switzerland. both cigarette users and nonsmokers. This may be partly because of a misconception This article is an open access article that these products are a healthy alternative to cigarettes. While some studies report that distributed under the terms and e-cigarettes may lead to reduced harm compared to combustible cigarettes [3–8], others conditions of the Creative Commons contrast with these findings [9–12]. Whether e-cigarettes will yield an overall positive or Attribution (CC BY) license (https:// negative health impact compared to cigarettes remains unknown. ® creativecommons.org/licenses/by/ The Juul e-cigarette (Figure1) rapidly came to dominate the U.S. market within 4.0/). a year after its 2015 release and led the way in the immense popularity of rectilinear Int. J. Environ. Res. Public Health 2021, 18, 3067. https://doi.org/10.3390/ijerph18063067 https://www.mdpi.com/journal/ijerph Int. J. Environ. Res. Public Health 2021, 18, x 2 of 19 Int. J. Environ. Res. Public Health 2021, 18, 3067 2 of 18 The Juul® e-cigarette (Figure 1) rapidly came to dominate the U.S. market within a formyear factorafter its e-cigarettes 2015 release and and nicotine led the way liquid in the filled immense pods. popularity This e-cigarette of rectilinear represented form a significantfactor e-cigarettes change and from nicotine the prior liquid “cig-a-like” filled pods. and This “pen e-cigarette style” devices represented which a significant had thus far dominatedchange from the the market, prior “cig-a-like” and ushered and in “pen the new style” era devices of compact which high-nicotine had thus far concentration,dominated discrete,the market, easily and concealed ushered in “pod the new style” era devices. of compact The high-nicotine Juul® e-cigarette concentration, is composed discrete, of two easily concealed “pod style” devices. The Juul® e-cigarette is composed of two primary primary subassemblies: the disposable reservoir and power control unit. The non-refillable subassemblies: the disposable reservoir and power control unit. The non-refillable reser- reservoir contains nominally 0.7 mL of e-liquid composed of a mixture of propylene voir contains nominally 0.7 mL of e-liquid composed of a mixture of propylene glycol, glycol, glycerin, nicotine and, in some cases, other additives. The top of the reservoir glycerin, nicotine and, in some cases, other additives. The top of the reservoir integrates a integrates a mouthpiece, which the consumer draws puffs through. The interior of the mouthpiece, which the consumer draws puffs through. The interior of the mouthpiece mouthpiece includes a sophisticated fresh air mixing chamber and flow conditioning includes a sophisticated fresh air mixing chamber and flow conditioning pathways. The pathways. The heating coil is located in the bottom of the reservoir and surrounds a heating coil is located in the bottom of the reservoir and surrounds a wick to draw e-liquid wickinto tocontact draw with e-liquid the heating into contact coil. The with heated the ov heatingen region coil. of Thethe reservoir heated ovenis where region aerosol of the reservoiris generated is where by mixing aerosol fresh is air generated inlet from by the mixing bottom fresh of the air reservoir inlet from with the vaporized bottom of e- the reservoirliquid, and with drawn vaporized upward e-liquid, through andthe outlet drawn pipe upward into the through mixing chamber. the outlet Two pipe electri- into the mixingcal terminals chamber. on the Two bottom electrical surface terminals of the reservoir on the bottom(not shown) surface establish of the the reservoir electrical (not shown)connection establish to the thepower electrical control connection unit. The power to the control power unit control consists unit. of The an outside power case, control unitinterior consists carriage, of an a microproce outside case,ssor interior board, wire carriage, harness, a microprocessor 200 mAh lithium board, battery, wire and harness, sen- 200sor mAhgasket. lithium Sides A battery, and B of and the sensordisassembled gasket. PCU Sides are Aillustrated and B of in theFigure disassembled 1. A four con- PCU areductor illustrated USB wire in Figureharness1 .connect A fours conductorthe distal user-accessible USB wire harness USB port connects to the themicroproces- distal user- accessiblesor board. USB The port presence to the of microprocessor four conductors board. suggests The that presence the USB of four harness conductors has potential suggests thatboth the for USB power harness and data has potentialtransfer (+V, both ground, for power data and + and data data transfer -). The (+V, microprocessor ground, data + andboard data includes -). The battery microprocessor charging boardcircuitry, includes puff detection battery chargingcapability, circuitry, coil voltage puff control, detection capability,user feedback coil voltagevia light control, emitting user diode, feedback and da viata processing light emitting capability. diode, The and pressure data processing sen- capability.sor, used for The puff pressure detection, sensor, is evident used for on puff the opposite detection, side is evidentof the microprocessor on the opposite board. side of theWhen microprocessor assembled, the board. pressure When sensor assembled, is encased the by pressure the sensor sensor gasket is encasedto communicate by the sensorthe gasketflow of to fresh communicate air. Two terminals the flow connect of fresh the air. positive Two terminals voltage and connect ground the from positive the micro- voltage andprocessor ground board from to the the microprocessor coil. Juul Labs™ board Inc. tohas the branded coil. Juul the Labs reservoir™ Inc.