5 minute read
FELDMAN
HOW DIFFERENT COUNTRIES REGULATE E-C GARETTES
on research by
ERIC A. FELDMAN
Deputy Dean for International Programs; Heimbold Professor of International Law; Professor of Health Policy and Medical Ethics; Co-Director, Center for Asian Law
As the popularity of electronic cigarettes rises in the United States and globally, countries have taken vastly different approaches to regulation: some have effectively banned e-cigarettes, while others hardly regulate them. In a new volume, The Legal Process and the Promise of Justice: Studies Inspired by the Work of Malcolm Feeley, published by Cambridge University Press, University of Pennsylvania Law School Professor Eric Feldman has authored a chapter analyzing the reasons for the significant policy divergence on e-cigarettes.
Feldman holds the Heimbold Chair in International Law and is also a Penn Professor of Medical Ethics & Health Policy and Penn Law’s Deputy Dean for International Programs. He is an expert on Japanese law, comparative public health law, torts, and law and society, and his scholarship explores the comparative dimensions of rights, dispute resolution, and legal culture in the context of urgent policy issues.
In the chapter, “Regulating E-Cigarettes: Why Policies Diverge,” Feldman examines the global landscape of e-cigarette policy through the lens of three countries that have starkly different approaches to regulating them: the United States, Japan, and China. The three countries have a number of commonalities, Feldman explains: “Each… has a robust tobacco industry, government agencies entrusted with protecting public health, an active and sophisticated scientific and medical community, and a regulatory structure for managing new pharmaceutical, tobacco, and consumer products. All three are signatories of the World Health Organization’s (WHO) Framework Convention on Tobacco Control (United Nations 2003), all are signatories of the Agreement on Trade-Related Aspects of Intellectual Property Rights, and all are members of the World Trade Organization.”
Nevertheless, their regulatory paths have diverged, with the United States regulating e-cigarettes as tobacco products, Japan regulating them as pharmaceutical products, and China treating them as ordinary consumer products. Feldman identifies three key factors that have contributed to the differences in e-cigarette policy in these three countries: first, a lack of scientific consensus on the potential harms versus benefits of e-cigarettes; second, distinct national economic and political interests that drive policy outcomes; and third, the roles of litigation and judicial decisions in shaping the regulatory landscape.
At their core, “all e-cigarettes are based on a common technology,” writes Feldman. “They include a rechargeable battery, a liquid (or in a few cases a chamber that can be filled with leaf) that generally contains nicotine, an atomizer that converts liquid into vapor, an LED light to simulate a burning cigarette, and a computer chip that senses inhalation and triggers the atomizer.” As the technology and aesthetics have continued to evolve, e-cigarettes have grown in popularity. In the United States, for example, the Centers for Disease Control and Prevention (CDC) reported that in 2016, “15.4 percent of adults aged eighteen years of age or older had tried e-cigarettes, and 11.3 percent of high school students had used e-cigarettes in the past thirty days.” By 2018, that number had increased to 20.8% of high school students.
Scientists studying e-cigarettes are conflicted about their potential harms and benefits. “If e-cigarettes are capturing the interest of youth, for example, who first vape and then turn to combustible cigarettes, long-running declines in tobacco consumption could level off or be reversed,” writes Feldman. “On the other hand, e-cigarettes might be helping current smokers quit, keeping youth from initiating smoking, and playing a key role in reducing tobacco-related morbidity and mortality.” The absence of a scientific consensus has left the door open to a range of interpretations and regulatory approaches, Feldman argues.
Differences in existing tobacco policy in the United States, Japan, and China have also contributed to policy divergence on e-cigarettes. In the United States, “the tobacco industry consists of a number of private companies, some of which have grown into the world’s most robust multinational corporations.” While these companies have worked to avoid regulation for decades, in 2009 the passage of the Family Smoking Prevention and Tobacco Control Act permitted the FDA to begin regulating certain enumerated tobacco products. In order to regulate e-cigarettes, the FDA had to ‘deem’ them tobacco products within the meaning of the statute — a process that took a number of years.
In contrast, the government of Japan has long held a monopoly on the cultivation, manufacture, and sale of tobacco products, and continues to own one third of Japan’s only tobacco company. Participants in the traditional tobacco industry did not welcome competition from e-cigarettes, and “the political and economic interests of the key players leaned clearly against a liberal regulatory posture” for such products. Thus, e-cigarettes were determined not to be tobacco products and are instead regulated as pharmaceuticals, which has effectively resulted in a ban on nicotine-containing e-cigarettes in Japan. In China, tobacco is an enormous industry that generates significant revenue: “With 300 million smokers (25 percent of all smokers globally) who consume 40 percent of the world’s cigarettes,” the political and economic impact of tobacco in China is enormous.” As a result, tobacco control policy is minimal and thus far the government has taken no action to regulate e-cigarettes.
Finally, Feldman notes, “there is only one jurisdiction in which the courts have powerfully influenced e-cigarette policy — the United States. In neither Japan nor China have the courts played even a minor role. In the United States, Smoking Everywhere v. U.S. Food and Drug Administration resulted in a decision holding that the FDA can only regulate e-cigarettes as tobacco products, and not as pharmaceuticals, sharply limiting the range of policy choices available to would-be regulators.
As Feldman’s comparative analysis explains, “[d]ivergence, not convergence, describes the landscape of e-cigarette regulation” for the three key reasons he identifies. “Although this [chapter] underscores the particular importance of these reasons, one can easily identify other possible explanations,” which additional research and observation might reveal.
