BETTER LATE THAN NEVER: ELECTRONIC CIGARETTES AND A FAILED FEDERAL REGULATORY RESPONSE.

• Author: Mccue, Cameron

1. INTRODUCTION

   On the morning of April 14, 1994, chief executives from the seven largest tobacco companies in the United States testified together before Congress for the first time. (1) Congressman Ron Wydcn of Oregon began his questioning of the executives rather bluntly: "Yes or no, do you believe nicotine is not addictive?" (2) One by one, each executive gave essentially the same answer: yes, they believed nicotine was not addictive. (3) History would not look too kindly on this testimony. (4) Just weeks after the famous 1994 hearing, a box of internal documents from the Brown & Williamson Tobacco Corporation was delivered to the University of California at San Francisco, with information revealing that the tobacco industry had long known their products were addictive and posed serious health risks. (5)

   Fast forward some twenty-five years to February 5, 2020, when Congress again heard testimony from top executives on the issue of nicotine and addiction. (6) This time, however, the executives were not before the committee to talk about conventional combustible cigarettes; they were there to talk about a new method of nicotine consumption exploding in popularity across the world--electronic cigarettes. (7)

   In stark contrast to the 1994 hearing, the five executives from the leading electronic cigarette manufacturers in the United States gave markedly different answers than their Big Tobacco predecessors on the question of whether they accepted that nicotine is addictive. (8) When asked this time whether nicotine is addictive, the executives responded with a resounding yes. (9) Congresswoman Diana DeGette of Colorado began her time by asking the executives, "Isn't it true that nicotine is addictive?" (10) K.C. Crosthwaite, CEO of Juul Labs, Inc.; Ricardo Obcrlander, President & CEO of Reynolds American Inc.; Ryan Nivakoff, CEO of NJOY, LLC; Antoinc Blonde, President of Fontem U.S.; and Jerry Loftin, President of Logic Technology Development, LLC, all answered in the affirmative, without hesitation. (11)

   Perhaps even more striking was their testimony regarding the health effects of the tobacco products of the past. (12) Crosthwaite, whose company Juul Labs was the leading electronic cigarette manufacturer at the time, testified: "Combustible cigarettes remain the leading cause of preventable death in our country and worldwide. More than 34 million Americans still smoke. Each year, nearly half a million Americans die from smoking-relatcd diseases--1 person every minute. The economic costs exceed $300 billion." (13) Clearly, these executives were not before Congress to deny the health risks of tobacco use--rather, they were there to try and change the increasingly negative public perception of the electronic cigarette industry and to show regulators that their products could actually produce a net benefit to public health. (14) Crosthwaite continued: "But research indicates that vapor products are substantially lower-risk than cigarettes and that many, if not most, adult smokers who try Juul products are able to successfully transition completely off of cigarettes to our products." (15) Time will tell whether their testimony was the beginning of a new era in the tobacco industry or if it was simply a revival of the forces that led Big Tobacco to unabashedly tell Congress twenty-five years ago that nicotine was not addictive when they knew that it was. (16) The rise of electronic cigarettes has put government regulators and public health practitioners in a precarious position. (17) Smoking continues to be the leading cause of preventable death in the United States each year. (18) On the one hand, there is a plausible argument that policymakers should welcome, if not encourage, technological innovations that might reduce the risks of conventional tobacco use, even if those alternatives fail to eliminate the risks altogether. (19) On the other hand, there are legitimate concerns over the dearth of research on the long-term health effects of electronic cigarette use (20)--not to mention the fact that plots by the tobacco industry to market new products based on unfounded health claims are nothing new. (21) As policymakers have wrestled over whether the rise of electronic cigarette use should be cautiously embraced or outright condemned, the market for these products has undeniably exploded. (22) Despite what efforts there have been from regulators to get a handle on the electronic cigarette market since the products were first introduced, Americans--adults and youth alike--have taken to using electronic cigarettes in astounding numbers. (23) The long-term public health repercussions that may stem from the rise of electronic cigarette use remain to be seen. (24)

   This paper will argue that the regulatory response--or lack thereof--to the electronic cigarette industry has put the United States in a dubious position, not far from where it was when the products were first introduced to the market over a decade ago. (25) The federal government has been inconsistent in its approach and too slow to respond to the rise of electronic cigarettes, and as a result, millions of U.S. youth have developed a nicotine addiction that could have been prevented. (26) It is time for the federal government to establish clear policy goals regarding electronic cigarettes and take decisive action to achieve those goals before it is too late. (27) Policymakers should work to prevent youth from ever using nicotine in the first place while remaining careful not to preclude adult smokers from potentially safer tobacco alternatives--albeit with hefty skepticism of unfounded health claims coming from actors inside the industry. (28) Part II will give a brief background on the rise of electronic cigarettes. (29) Part III will describe the attempts to address the introduction of electronic cigarettes to the United States market. (30) Parts IV and V will address public health issues that have grown out of the United States' disjointed and tepid regulatory response to electronic cigarettes and conclude by outlining lessons for the future of electronic cigarette regulation. (31)

2. BACKGROUND

   1. TOBACCO USE IN THE UNITED STATES

      In 2018, approximately 49.1 million U.S. adults reported they were currently using any tobacco product. (32) More than eighty percent of tobacco users reported using traditional, combustible tobacco products such as cigarettes and cigars. (33) Over the past fifty-plus years, the United States has experienced significant declines in rates of adult tobacco use, which has been hailed as a tremendous success of organized public health initiatives. (34) Despite these declines, tobacco use continues to harm public health, with roughly 480,000 Americans dying from smoking combustible cigarettes each year. (35) Widespread tobacco use has more than just mortality costs: it is estimated that every year medical costs and losses in economic productivity due to smoking-related illnesses cost the United States upwards of $300 billion. (36)

      Even though by the late 1950s medical science had established a clear link between smoking and the occurrence of cancer, (37) it was not until the beginning of the next decade that the American public first started to recognize and accept the potential adverse health effects of tobacco use. (38) Over the ensuing decades, private litigants brought hundreds of lawsuits against tobacco manufacturers seeking damages related to smoking-related illnesses, but most of these efforts largely failed. (39) Individual plaintiffs found it difficult to overcome allegations from the tobacco industry that smokers themselves were largely responsible for their poor health outcomes. (40) Plaintiffs did not start to see success in the courts until the 1990s when state governments began to bring lawsuits against tobacco companies. (41) One of the first major legal achievements against the tobacco industry came in November of 1998, when forty-six states, five U.S. territories, and the District of Columbia reached a settlement--"The Master Settlement Agreement"--with four major cigarette manufacturers. (42) The Master Settlement Agreement was the largest civil litigation settlement in United States history, requiring the defendant tobacco companies to pay the settling states billions of dollars in damages annually, in perpetuity. (43)

      While a detailed history of the lawsuits brought against the commercial tobacco industry is beyond the scope of this paper, many of the facts that emerged from that litigation animate the public skepticism that should be present in the emerging debate over electronic cigarettes. (44) The facts in United States v. Philip Morris, (45) a landmark case brought by the federal government alleging that tobacco companies had engaged in a decades-long conspiracy to cover up the risks of smoking, are particularly illustrative:

      The court found that Defendants engaged in a scheme to defraud smokers and potential smokers by (1) falsely denying the adverse health effects of smoking; (2) falsely denying that nicotine and smoking are addictive; (3) falsely denying that they manipulated cigarette design and composition so as to assure nicotine delivery levels that create and sustain addiction; (4) falsely representing that light and low tar cigarettes deliver less nicotine and tar and therefore present fewer health risks than full flavor cigarettes; (5) falsely denying that they market to youth; (6) falsely denying that secondhand smoke causes disease; and (7) suppressing documents, information, and research to prevent the public from learning the truth about these subjects and to avoid or limit liability in litigation. (46) Even with the billions of dollars paid out by Big Tobacco over the years to settle legal disputes, the industry continues to be profitable. (47) According to the Centers for Disease Control and Prevention, tobacco companies spent over eight billion dollars on cigarette and...