Engineering Ph.D. Program, Rochester Institute of Technology, Rochester, NY 14623, USA.
Department of Mechanical Engineering, Rochester Institute of Technology, Rochester, NY 14623, USA.
Int J Environ Res Public Health. 2021 Mar 16;18(6):3067. doi: 10.3390/ijerph18063067.
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.
电子烟在美国和全球的流行导致青少年尼古丁使用率惊人上升。 Juul 电子烟于 2015 年在美国市场推出，到 2017 年已占据美国市场约 13%的份额。与许多其他当代电子烟公司不同， Juul 电子烟的创始人在推出其产品时采用了传统高科技创业公司的方式，而不是烟草公司的方式。本文以美国监管行动为背景，介绍了 Juul 公司的企业和产品发展历史。本文的目的是展示政府策划档案作为领先指标的价值，这些指标可以 (a) 提供对新兴技术的洞察，(b) 为新兴监管科学研究问题提供信息。为了收集有关 Juul 电子烟及其周边公司的信息，我们使用了各种来源。这些来源包括政府机构、已发表的学术文献、非营利组织、公司和零售网站以及大众媒体。在将数据置于事件时间表之前，对其进行了去歧义、验证和分类。本文呈现了四个重要里程碑、十九份公司备案和事件、十二项美国监管行动、六十四项专利申请、八十七项商标申请、二十三项设计专利和三十二项与 Juul 实验室及其关联公司相关的实用专利的时间表，时间跨度为 2004 年至 2020 年。这项工作展示了专利、商标和 SEC 备案文献中发现的在为新兴监管科学研究问题建立前提方面的证明价值，这些问题可能尚未得到传统档案研究文献的支持。本文提出的方法可用于在产品实际进入市场之前识别新兴技术的关键方面；这种从被动反应范式转变为主动积极的政策制定和问题识别。这种积极主动的方法可能允许进行前瞻性的监管科学研究，并最终缩短市场技术创新和监管反应之间的时间间隔。
