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On 23 June 2022, the US Food and Drug Administration (FDA) announced that after a thorough review of the application by JUUL—the most widely used vaping product from November 2017 to April 2022—it had determined to issue a Marketing Denial Order (MDO). The company was ordered to stop selling its products in the US market, and retailers had to stop selling them. In announcing its decision, the FDA declared that JUUL’s application “Lacked sufficient evidence regarding the toxicological profile (of its) products to demonstrate (the sale and use) of its products would be appropriate for the protection of the public health” (FDA news release, FDA Denies Authorisation to Market JUUL Products, June 23, 2022).

The ruling made clear that JUUL bore the burden of proof for establishing the safety of its products. Tthe comments of FDA Commissioner Robert M. Califf underscored the degree to which youth vaping defined the US policy debate over e-cigarettes. JUUL was one of the products that, he noted, accounted “for most of the U.S. market” and “played a disproportionate role in the rise in youth vaping.” At the same time, the agency underscored that “To date the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUUL pods.” In a clear reflection of the impact of the precautionary principle, the FDA made clear that the absence of evidence regarding harm was not sufficient to overcome the concerns raised in its review. Against the backdrop of public furore about allegations of JUUL having blatantly marketing to youth, the FDA came to rest on the position that despite the massive evidence that JUUL had submitted, it had provided “insufficient evidence to assess the potential toxicological risks” from using those products (FDA news release, FDA Denies Authorisation To Market JUUL Products, 23 June 2022).

For those who had pressed for years for a ban on e-cigarettes, the FDA ruling represented a triumphal moment for public health. Matt Myers, President of the prominent Campaign for Tobacco-Free Kids declared, “This would be the most significant action the FDA has taken to date to end the youth e-cigarette epidemic and stop tobacco companies from using these nicotine-loaded products to addict another generation of kids” (FDA Orders JUUL e-cigarettes Off the Market, Politico).

To those whose commercial interests were imperilled, the FDA determination was disastrous. The product was popular not only among youth—the product has had disproportionately higher youth rates compared to other brands—but also adult smokers (Wang et al., 2020). The president of the American Vapour Manufacturers Association denounced the decision as the “latest sorry example of the agency’s campaign of regulatory arson against nicotine vaping products that millions of Americans rely on as an alternative to cigarettes” (FDA Orders JUUL e-cigarettes Off the Market, Politico). But there were others, not driven by narrow economic interests, who were also profoundly distressed. There had been for years a cadre of public health researchers who saw in e-cigarettes an opportunity for harm reduction, an opportunity to dramatically limit the toll exacted by tobacco cigarette smoking. Kenneth Warner, the former Dean of the University of Michigan School of Public Health and founding member and former President of the Society for Research on Nicotine and Tobacco (SRNT), who for years had sought to underscore the need for careful analysis that balanced the risks and potential benefits of e-cigarettes, saw the future as bleak unless there was a reversal of the FDA’s June 23 determination. E-cigarettes would begin to disappear, “a black market for such products would emerge, fewer people would vape, more would smoke, more would die” (Kenneth Warner, interview 20 July 2022).

Yet within, a month both advocates and proponents were thrown into confusion.

On 24 June, the day after the FDA denial, the D.C. Circuit Court issued and administrative stay of the order in response to an emergency motion from JUUL. This stopped the MDO from going into effect until JUUL could file an emergency brief, which the court would consider along with the FDA response (Scribner, 2020). In their emergency brief filed 27 June, JUUL Labs, Inc. (JLI) claimed that the FDA review of their evidence had been insufficiently thorough and that the agency had capitulated to “unprecedented, inappropriate” “political pressure” from congressional representatives that “tainted the entire agency process.” Although the FDA had approved other e-cigarettes, JUUL was the 1000-pound gorilla in the room when it came to share of the US e-cigarette market. The FDA denial was, in the eyes of the company, “manifestly erroneous.” JLI argued, “As it has with other PMTAs, FDA should have evaluated the totality of JLI’s evidence, which conclusively established that the public-health benefits of JUUL products significantly outweigh any potential risks” (JUUL Labs, Inc., v U.S, Food and Drug Administration, 27 July 2022).

On 5 July 2022, the FDA announced a temporary stay of its own MDO, explaining, “There are scientific issues unique to the JUUL application that warrant additional review.” Although the agency stressed that the stay should not be misinterpreted as FDA authorisation, under the deeming rule all e-cigarette products were technically on the market illegally until they received formal marketing authorisation. Until the matter is resolved, then, business as usual will continue for JUUL (FDA news release, FDA Denies Authorisation to Market JUUL Products, 23 June 2022, 5 July 2022 update note).

Yet for JUUL, business as usual would have to be very different. On 6 September 2022, the company tentatively settled a suit brought by some three dozen states over its sales and marketing practices, which relied on launch events, social media campaigns that had a sizeable proportion of followers 17 or younger, youthful spokespersons, and what the Attorney General of Connecticut described as “porous” age verification processes (Jewett, 2022). Without conceding fault, the company was poised to pay a $438.5 million settlement. Nonetheless, the company had already begun to emphasise that its target market was adult smokers and had curtailed its advertising and removed key flavoured products (Beachum & McGinley, 2022).

With hundreds more cases against the company awaiting conclusion or pending (Larson et al., 2022), the FDA review reopened, and rates of youth vaping dramatically down among both high school and middle school students from a zenith in 2019 (CDC, 2022), the 15-year controversy involving science, politics, and the ethics of public health continues to hang in the balance.

1 First Encounters

E-cigarettes arrived on the American market in 2006. Two years later, in October 2008, the FDA detained a number of shipments of electronic cigarettes at the Los Angeles International Airport, claiming that they were in violation of the Food, Drug, and Cosmetic Act. The FDA believed the products were intended to be used as drugs—defined as something that affects the structure or function of the body—since they contained nicotine and could treat or mitigate addiction to combustible tobacco.

Importers and manufacturers, predictably, had a different view. By strategically avoiding claims about the therapeutic effects of e-cigarettes—as a treatment for nicotine withdrawal during smoking cessation, for example—they argued that their products could not be regulated by the FDA as combination drugs/delivery devices but should instead be regulated as tobacco products. Two e-cigarette manufacturers sued the FDA to end the detention of their products. Both a District Court and the US Court of Appeals, District of Columbia Circuit, in Sottera, Inc. v. FDA, sided with the e-cigarette manufacturers and importers (Sottera, 2010). The FDA could not regulate tobacco products as drugs or drug delivery devices unless the products were marketed with claims about their therapeutic effects.

In April 2011, in the aftermath of the D.C. Circuit’s opinion in Sottera, the FDA released a letter to stakeholders stating that “the government has decided not to seek further review of this decision, and the FDA will comply” (Letter to Stakeholders, 2011). Three years later, with U.S. sales of e-cigarettes rising meteorically, reaching $1.5 billion, the FDA continued to contemplate its options (Wahba, 2014). The agency’s inaction raised several questions, including what the FDA had the authority to do (the Family Smoking Prevention and Tobacco Control Act of 2009 had given the agency authority to regulate tobacco, but the act was not updated to extend authority to e-cigarettes until 2016), what it should do, and when it would act. They were operating in a grey area when it came to e-cigarettes.

In October 2013, the FDA submitted a draft Notice of Proposed Rulemaking to the Office of Management and Budget’s Office of Information and Regulatory Affairs in the White House. The FDA announced its intention to bring e-cigarettes and a variety of other products under its regulatory authority by “deeming” them tobacco products under the Tobacco Control Act (Husten & Deyton, 2013). The content of the proposed rules, including product manufacturing standards such as appropriate ingredients, provisions for testing, and limits on advertising, sales, and distribution, had yet to be determined. The absence of adequate data on the possible harms of e-cigarettes to users and to bystanders exposed to the vapour they emitted, as well as on the question of whether e-cigarettes were more likely to create new combustible tobacco smokers or ease current smokers away from their habit, made it extremely difficult for the FDA to base its regulations on epidemiological or medical evidence (the deeming rule would not go into effect until August 2016).

In the face of uncertainty, US anti-tobacco advocates took a precautionary stance, arguing that accepting lesser harms was akin to being wilfully duped by the industry and serving as little more than “naïve” pawns in a grand scheme to take back lost ground in the long battle over smoking (Chapman & Wakefield, 2013). Given the long history of tobacco industry deception regarding what it knew about the harms of smoking, such advocates asserted there was no room for compromise when it came to a product in which Big Tobacco had any financial interest. As the FDA moved cautiously, municipalities in the US were responding to the new challenge from e-cigarettes.

In 2011, Boston, Massachusetts health officials voted to treat e-cigarettes like tobacco products, banning their use in the workplace and restricting their sale to adults (BPHC, 2011). Boston would go on to ban all combustible cigarette smoking, including the use of e-cigarettes, in outdoor parks, squares, and cemeteries (Rousseau, 2014). New York City was the second major city to ban e-cigarettes in all of the places tobacco smoking was banned, including parks and beaches (Gay et al., 2013; Robertson, 2013). While the measure was not passed unanimously, it passed without significant controversy. Los Angeles unanimously passed an e-cigarette ban in March 2014 (Whitcomb & Gorman, 2014; Zahniser, 2014). Like New York, Los Angeles also banned smoking and vaping in parks and certain beaches.

Chicago, Illinois also banned e-cigarette vaping in public, but with some degree of controversy. On a first attempt in November 2013, the proposed ban received a chilly reception from city aldermen, who said their constituents were using e-cigarettes to wean themselves off of combustible tobacco products (Yellen, 2014). A second attempt in January 2014, aided by the advocacy of Mayor Rahm Emanuel, succeeded in prohibiting the use of e-cigarettes in bars, restaurants, and most other indoor public places in the city (AP, 2014; Byrne, 2014). In 2018, San Francisco passed a new ban on sales of menthol cigarettes and flavoured e-cigarette liquids, which was deemed to be the strictest municipal restriction on e-cigarettes sales in the nation (Hoffman, 2018b). By 2018, 12 states, including California, Massachusetts, New Jersey and New York, and the District of Columbia had laws prohibiting the use of e-cigarettes in otherwise smoke-free settings.

2 Harm Reduction Confronts Precautionary Thinking

In the context of tobacco, harm reduction—if not always by that name—surfaced in the mid-1990s. In 1996, the FDA approved Nicorette gum, which was nicotine-based, for sale over-the-counter. The next year it approved two forms of the nicotine patch, which delivered nicotine through the skin (Hughes et al., 1999). Over-the-counter availability of nicotine replacement therapies (NRTs) forced the medical, public health, and research communities to investigate the likelihood and consequences of long-term nicotine use (Fairchild & Colgrove, 2004).

In 2000, a Public Health Service panel, drawing on widely respected researchers across an impressive array of leading schools, institutions, and agencies, dramatically reframed tobacco dependence as “a chronic condition that warrants repeated treatment until long-term or permanent abstinence is achieved” (TCPGT Tobacco, 2000). The panel equated tobacco dependence with “high blood pressure, high cholesterol or diabetes.” Drawing an analogy to psychiatric patients, its chair explained that good practice sometimes requires “keeping them on medication for the rest of their lives because I know it saves their lives. We have the exact same circumstances here” (Barker, 2000). In framing the guidelines in this fashion, the panel offered long-term treatment using nicotine replacement as a companion to cessation (Clinical practice guideline, 2008; Fiore et al., 2000). This did not amount to a formal endorsement of tobacco harm reduction. It did, however, solidify the acceptance of NRT and established a treatment mindset with cigarette smoking abstinence as the goal.

One year later, the Institute of Medicine (IOM), a private, nonprofit institution renowned for its scientific advice,  released a report opening the door for endorsement of such products as a feasible component of a harm reduction strategy (Bondurant et al., 2001). The FDA, concerned about the safety and efficacy of emerging nicotine-laced and tobacco-based products, had commissioned the report from the IOM, which had on more than one occasion endorsed the concept of harm reduction in the case of needle exchange to prevent HIV transmission (Normand et al., 1995; Trussell et al., 2001). The 2001 IOM committee on smoking and harm reduction released its report after a year-long process of reviewing evidence on tobacco control and harm reduction. Key to the panel’s conclusion that harm reduction was “feasible and justifiable” was the observation that “approximately 10–15 per cent of the adults in the United States are expected to be regular users of tobacco in 2010, and they will continue to suffer the increased incidence of harmful and lethal consequences. Among this group are many who cannot or will not stop using tobacco, and it is to this group that effective programs and products of harm reduction should be directed” (Bondurant et al., 2001). This perspective was inevitably met by challenges that ranged from scepticism to utter rejection, in important ways recapitulating the history of responses to the evidence of the efficacy of needle exchange.

Underscoring the persistence of profound disagreement over tobacco harm reduction, on the heels of the IOM report the National Cancer Institute (NCI) issued its own analysis: Risks Associated With Smoking Cigarettes With Low Machine-Measured Yields of Tar and Nicotine (NCI, 2001). It fuelled enthusiasm for a  cessation-only approach. The NCI was decidedly hostile to less harmful tobacco products like smokeless tobacco (e-cigarettes were not yet on the scene) and raised provocative questions about the place of harm reduction within tobacco control. The NCI described its monograph as a complement to the IOM report, but its emphasis fell more heavily on discrediting low-tar cigarettes, once touted as safer, and underscoring the duplicity of the tobacco industry (Burns & Benowitz, 2001). The NCI report thus confirmed for many that the only reasonable objective remained total cessation: “If you are concerned about your health, quitting is your only choice” (American Lung Association, 2001; Davis, 2001).

3 E-Cigarettes Take the Stage

In 2009, the World Health Organization warned that e-cigarettes threatened bans on public smoking, which were key to tobacco control. In the US, long-time anti-tobacco champion Stanton Glantz, a prominent tobacco researcher at the University of California, and his colleagues raised similar concerns: “Given the substantial research demonstrating the effect of viewing smoking in the movies on adolescent smoking initiation, the addictive nature of nicotine and the lack of regulatory assurance of their quality or safety, it is important to keep Electronic Nicotine-Delivery Systems (ENDS), and other similar products, from being sensationalized through the use of celebrity promotion or product placement in movies or other entertainment media” (Fairchild & Bayer, 2016a, 2016b).

Glantz and others—a geographically dispersed group of researchers, many of whom had studied with him or looked to him for leadership—were alarmed by a flood of e-cigarette advertisements (Fairchild & Bayer, 2016a, 2016b). “Smelling like an ashtray is not the ideal aphrodisiac,” scolded talk-show host Jenny McCarthy, as she enjoyed her BlueCig. Actor Stephen Dorff, another Blu spokesperson and former smoker, added, “I’m tired of feeling guilty every time I want to light up.” He implied that public health messages were paternalistic: “We’re all adults here. It’s time to take our freedom back. Come on guys, rise from the ashes.” On Super Bowl Sunday 2013, an NJOY e-cigarette ad seen by 10 million viewers declared, “Finally, smokers have a real alternative. Cigarettes, you’ve met your match” (Fairchild et al., 2014). That the e-cigarette promotions also sought to stigmatise combustible cigarettes was of little consequence to those who saw in them a grim assault to the television promotion ban on tobacco advertising established nearly five decades earlier.

Although youth use of tobacco, understood as underaged use and typically meant to mean use in middle or high school but also inclusive of use by even younger children, continued its steady decline, dread was compounded by data from the Centres for Disease Control and Prevention: twice as many young people experimented with e-cigarettes in 2012 as in 2011 (Fairchild et al., 2014). The driving concern, at that time, was that e-cigarettes would prove to be a “gateway” or “bridge” product, leading to an increase in underage smoking. Invoking images of terrorism, two tobacco-control advocates claimed, “smoking bans and clean air advocacy are being hijacked” (Fairchild et al., 2014). Seeing in e-cigarettes a Trojan horse that would unleash a new epidemic of tobacco consumption, in September 2013, 40 US attorneys general, the chief legal officials in the states, called on the FDA to act swiftly to regulate e-cigarettes as tobacco products.

This group of alarmed scientists struck a decidedly precautionary stance, echoing the sentiments of the Wingspread Statement of 1998, one of the foundational documents in the history of precautionary thinking focused on preventing environmental threats. “When an activity raises threats of harm to human health or the environment,” the Wingspread environmentalists agreed, “precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically” (Visionary Science, n.d.).

By 2015, it appeared clear that a precautionary perspective informed the outlook of the Centres for Disease Control and Prevention (CDC). In October of that year the CDC hosted a public health grand rounds expert panel on e-cigarettes, during which speakers discussed background information and strategies for addressing the emergence of these devices. All five of the speakers, including CDC director Tom Frieden and Campaign for Tobacco-Free Kids president Matthew Meyers, focused on the health concerns associated with e-cigarette use. The Campaign for Tobacco-Free Kids, an advocacy organisation that was among the most vocal proponents of ever-more restrictive tobacco policy, was critically important because while other non-governmental organizations (NGOs) had emerged as sharply opposed to e-cigarettes (such as Action on Smoking & Health, known as ASH), Meyers’s organisation was the most influential and focused exclusively on youth. None acknowledged the potential role of e-cigarettes in reducing the tobacco burden on marginalised populations or in reducing health disparities (E-cigarettes, 2015). Overwhelming concern for the threat to youth and non-smokers set the parameters for the precautionary approach for US policymakers.

Challenging those whose precautionary perspective suggested a need for strict regulation, if not explicit outright prohibition, were vaping organisations, e-cigarette industry retailers, and a small but vocal group of academic experts on tobacco policy, whose disciplines included economics, epidemiology, psychology, and medicine. Most important at this juncture was the American Legacy Foundation.

4 The Contours of Opposition

The American Legacy Foundation, which in time would be renamed Legacy and then Truth Initiative, was a non-profit public health organization created by funds made available by the Master Tobacco Settlement, a civil litigation settlement with major tobacco companies. Organisationally, it would provide an ongoing commitment to policies that would counter the still powerful tobacco industry. The position that it would take on the emerging debate over e-cigarettes was signalled in a keynote address by its founding chief executive officer, Cheryl Healton. In 2008, she sought to locate that controversy in the context of public health challenges other than those posed by tobacco. “I think we really need to consider making that product more accessible to individuals so that they may choose to use that product in lieu of smoking” (Healton, 2008). Healton’s Board of Director’s included individuals who would emerge as strong proponents of harm reduction. Among them were Thomas Miller, the Iowa Attorney General who had led the effort to secure creation of the foundation as part of the Master Settlement Agreement, and Kenneth Warner, a Professor of Economics and former Dean of the School of Public Health at the University of Michigan, who had initially expressed scepticism over e-cigarettes. Healton also created an autonomous but affiliated research group, the Schroeder Institute, staffed by social scientists who would become among the most prominent proponents for making e-cigarettes available to those who smoked combustible tobacco cigarettes.

But the deck was hardly stacked in favour of e-cigarettes. Initially, the Schroeder Institute was hostile to the prospect of e-cigarettes as harm reduction. In a 2010 editorial in AJPH, Schroeder Director David Abrams wrote, “ENDS should be removed from the market and permitted back only if and when it has been demonstrated that they are safe, that their benefits outweigh their harms to overall public health, and that a comprehensive regulatory structure has been established under the appropriate FDA division. … Until then, health and safety claims based on assumptions are unacceptable” (Cobb et al., 2010).

As the evidence evolved, the institute cautiously opened itself to the harm reduction potential of e-cigarettes. By 2014, Abrams called the products “a disruptive technology that might give-cigarettes a run for their money”  (Abrams, 2014a). A year later Abrams expounded on this perspective in JAMA. “Applying overly burdensome, expensive regulatory hurdles to e-cigarettes could stifle innovations and favor the market domination of tobacco companies.” For Abrams the central question was whether e-cigarettes should be aggressively supported by tobacco control advocates. He described this as “an extraordinary opportunity to end the-cigarette century well before the 100th anniversary of the Surgeon General’s report on smoking and health in 2064” (Abrams, 2014b).

But it was a moment in which political controversy was mounting. Those who advocated for tobacco harm reduction found themselves under enormous political pressure. Over the years in the course of our formal research, the individuals we interviewed in both academic and government positions reported experiencing a variety of tactics that had become part of the anti-tobacco playbook to silence them or bring them around to the emerging public health anti-e-cigarette consensus (Pertschuk, 2001). Some were accused of taking funds from big tobacco. Pressure was put on supervisors to “muzzle,” fire, or deny tenure to individuals. Others did not need a direct threat, but it was clear to them that their jobs depended on aligning with anti-vaping messages coming from major NGOs and the CDC (Fairchild & Bayer, 2016a, 2016b).

At the centre of the heated controversy that had begun to inform the debate over e-cigarettes, Abrams wrote, “Policy making relies on science not dogma…It is not nicotine per se that kills people.... If nicotine can be decoupled from deadly tobacco smoke, adults and youth can be saved—The public health standard need not be weighed to favor youth prevention” (Abrams, 2014a).

It was thus no surprise, in 2015, that the foundation, now renamed  the Truth Initiative, published an extensive review of the literature that made clear the grounds for the role of e-cigarettes in harm reduction. The “Truth About: Electronic Nicotine Delivery Systems” sought to debunk what it deemed as unfounded assertions about the risks posed by e-cigarettes. A striking feature of the analysis was the extent to which it relied on the work of Public Health England, which had published the evidence base for UK e-cigarette policy. Truth’s report concluded, “If prudently regulated we believe ENDS hold promise as one means to move smokers to a less harmful product and reduce the devastating death and disease burden caused by combustible tobacco products” (The Truth about, 2015).

Cheryl Healton left the Truth Initiative in 2014. But her impact lingered for some time. In a 2015 letter to the acting commissioner of the FDA, the Truth Initiative reiterated its belief that “the overarching goal of …regulation must be to protect the public health. By maximizing ENDS benefits and minimizing ENDS potential harms…” (Udall et al., 2015).

In time, however, new leadership at the Truth Initiative did a dramatic about-face on e-cigarettes. A determination to focus exclusively on the potential risks to children was central to the radical shift. Reflecting the new orientation, the organization took all earlier public facing messages that embraced the role of e-cigarettes for harm reduction from its website. Asked to explain the new  stance CEO Robin Koval stated, “We have an epidemic of young people vaping. We know from an emerging body of science that these products are far from harmless” (Gunther, 2021). By 2018, the Schroeder Institute was absorbed into the Truth Initiative, losing its quasi-independent status. It is two most prominent scientists, who had been strong proponents of the role e-cigarettes in confronting the toll of smoking combustible-cigarettes, resigned.

With the radical turn on the part of Truth Initiative, there remained no strong institutional voice on e-cigarette policy that was firmly grounded in a commitment to harm reduction for current adult cigarette smokers. That voice was to be filled by what amounted to an ad hoc group periodically called together by Thomas Miller. Of note, a number of those who joined the group were formerly leaders in the no longer independent Schroeder Institute at the Truth Initiative.

Miller’s position as an advocate for the role of e-cigarette in combatting the toll of tobacco cigarettes was well-known. A public address he delivered in 2016 was titled, “E-cigarettes—A Harm Reduction Tool to Save Millions of Lives.” As he laid out his case, he underscored how poorly understood the evidence-based was. “What troubles me and bothers me a lot,” he concluded, “is that the American public does not realize that e-cigarettes are dramatically less harmful. The misconceptions are amazing and extremely troublesome. … People are going to die because they are misinformed” (Miller, 2016). It was that commitment to sharing unvarnished evidence that was to inform Miller’s ongoing efforts to address the public health challenge of e-cigarettes.

The FDA officially deemed c-cigarettes tobacco products on 8 August 2016 (FDA, n.d.). On 14 June 2017, in a letter addressed to recently appointed FDA commissioner Scott Gottlieb, Miller brought together a group of co-signers who laid out what was essential to a policy approach that would be committed, in deed as well as word, to harm reduction. Children had to be protected from nicotine addiction while adult smokers had to have access to e-cigarettes that protected them from the harms of combustible tobacco cigarettes. Further, the group urged, “It was necessary to have in place a regulatory framework for less harmful products.” While acknowledging that Gottlieb had spoken favourably about harm reduction, the letter asserted, “At this time we do not believe that the current regulatory framework for the low-risk nicotine products such as e-cigarettes and smokeless tobacco is appropriate or will deliver the substantial public health benefits we hope and expect FDAs oversight will bring” (Miller et al., 2017). The letter went on to lay out a broad set of policy proposals that would be familiar to those who had followed the arguments that had made clear by the early American Legacy Foundation stance and the publications of the research scientists at the Schroeder Institute.

5 Protecting Children: Harm Reduction Under Fire

Two weeks after the FDA’s deeming rule, on 28 June 2017, Scott Gottlieb announced a “new comprehensive plan for tobacco and nicotine regulation” under the Tobacco Control Act (TCA) (Gottlieb, 2017). Companies that hoped to market new e-cigarettes were required to submit to the FDA a pre-market tobacco product application, known as a PMTA. E-cigarettes that were already on the market when they were deemed tobacco products in 2016 also had to meet this requirement. To allow for both scientific deliberation and product innovation, the FDA initially set a deadline of August 2018 for those products to submit a PMTA (Lindbloom, 2020). In 2019, it extended that deadline to August 2022. At the heart of the change was what the agency described as “a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible-cigarettes” (FDA, 2017). Combusted tobacco was the most dangerous, followed by regular smokeless tobacco, low-nitrosamine smokeless tobacco, e-cigarettes, and, finally, nicotine replacement therapy. The FDA’s statement, followed by a strong rationale in the New England Journal of Medicine in September, 2017, recognised harm reduction as an appropriate public health strategy for curbing the tremendous morbidity and mortality toll of combustible tobacco (Gottlieb & Zeller, 2017).

Just months after its potentially game-changing summer statements, the FDA published a blog that suggested to many that it might, after all, hew to a more restrictive definition of harm reduction, harking back to its original position in which it tried but failed to treat them as therapeutic devices. On 29 November 2017, the agency announced the creation of a Nicotine Steering Committee charged with “re-evaluating and modernizing FDA’s approach to development and regulation of nicotine replacement therapy products that help smokers quit.” Alarming to some e-cigarette advocates was a new medical orientation: “FDA also sees compelling opportunities to explore additional opportunities for the development of new and improved products that could be sold as new drugs, typically as over-the-counter pharmaceuticals” (Gottlieb, 2017). For advocates of harm reduction, there had to be non-medical (e.g., recreational) alternatives for smokers who either wanted to quit or who wanted to enjoy nicotine without the terrible risks of combustible tobacco smoking.

The FDA’s more cautious course would come to rest on an evidence review that it commissioned from the prestigious National Academies of Science, Engineering and Medicine (NASEM, 2018). NASEM’s official charge was to analyse the research literature, identify the need for research to fill evidentiary gaps, and make judgments about the short- and long-term health effects of e-cigarettes.

The NASEM report affirmed the mounting evidence that e-cigarettes were substantially safer than combustible products: “There is conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes” (NASEM, 2018). But the report sounded an alarm when it came to the risks to children and bystanders, two of the weight-bearing pillars of the US approach to tobacco control.

NASEM concluded that since e-cigarettes contained and emitted potentially toxic substances, “using e-cigarettes in indoor environment may involuntarily expose non-users to nicotine and particulates, but at lower levels compared with exposure to secondhand smoke from combustible tobacco cigarettes.” On the heels of the NASEM report, the CDC stated in information for consumers, “E-cigarette aerosol is not harmless. It can contain harmful and potentially harmful substances, including nicotine, heavy metals like lead, volatile organic compounds, and cancer-causing agents” (NASEM, 2018).

When it came to children, the report advised, “There is substantial evidence that e-cigarette use increases the risk of ever using combustible tobacco cigarettes among youth and young adults.” While the report did note contradictory data, it determined that observational or ecological evidence could not provide a conclusive refutation of the risk to children. Only randomised clinical trials could meet that bar. And conclusive proof, for NASEM, was the standard when it came to vulnerable populations like children (NASEM, 2018).

Most important was how the head of FDA’s Tobacco Division, Mitch Zeller, read the evidence in light of the NASEM Report. “For kids who initiate on e-cigarettes, there is a great chance of intensive use of cigarettes. As the regulator,” he said, “we’ve got to factor that in” (Kaplan, 2018). How that evidence should be factored in was clear to Shannon Lea Watkins, a member of Stanton Glantz’s research team, which had long warned of threats posed by e-cigarettes. “It comes down to this tradeoff between definitely hurting kids and maybe helping some adults,” she said. “To me the tradeoff sounds quite clear” (Anapol, 2018).

How different the “trade off” might be understood was made clear by an analysis conducted by Kenneth Warner and his colleague Lynn Kozlowski. Citing evidence from large, cross-national studies, they argued that adoption of e-cigarettes as a harm reduction tactic “might come at the cost of additional new smokers among the younger generation. While unpleasant to contemplate, this cost must be compared to the far more immediate benefit in terms of health consequences that would be realized by adults quitting smoking” (Kozlowski & Warner, 2017).

With children at the centre of debate, harm reduction became a politically unpalatable approach. Said FDA Commissioner Gottlieb, “Innovations that could present an alternative to smoking—particularly as it relates to e-cigarettes—cannot, and will not, come at the expense of addicting a generation of children to nicotine through these same delivery devices” (Gottlieb, 2018).

In September 2018, the FDA launched a $60 million campaign targeted at adolescents who had used or might be tempted to use e-cigarettes. Employing graphic imagery, the campaign depicted hideous worm-like creatures crawling under the skin and into the lungs and brains of otherwise blemish-free teenagers. The ads sounded an urgent warning: “There is an epidemic spreading” and “vaping can put dangerous chemicals into your lungs.” The Agency’s “Don’t Get Hacked” campaign suggested that nicotine triggered a kind of wild-eyed mania or personality hacking, in which nicotine transforms teens into emotionless robots that lack the autonomy or charm of a chatbot. The imagery and language evoked the 1920s and 1930s, when narcotic crusaders framed drugs as “parasites” and addicts as little more that “The Living Dead” (Speaker, 2001).

Beyond the risk that e-cigarettes posed as a gateway to tobacco cigarettes, another danger informed the FDA’s posture. Increasingly, the argument became that nicotine, in and of itself, posed a threat to the developing brain of adolescents. This was all the more remarkable since decades of research on tobacco had never suggested such a threat. Indeed, the Surgeon General’s 1988 Report on Nicotine centred on the harms of addiction and the potential nature of the impact of nicotine on organ systems without mentioning the brain (Kandel, et al., 1994). But the 1988 Joe Camel controversy, centered on R.J. Reynold’s adoption of a cartoon character in its marketing, had sparked interest in nicotine’s impact on the brain (Fairchild & Colgrove, 2004). Both the Surgeon General and the director the CDC came to express alarm about the threat of nicotine exposure to the adolescent brain.

It is against this backdrop that JUUL—an inexpensive, trim, high tech device that looked like a long, elegant thumb drive—entered the market in 2015 without the legacy of having previously manufactured combustible products. Sales of JUUL kits increased 680 per cent and sales of refills increased 710 per cent between 2017 and 2018, according to RBC Capital Markets. JUUL quickly took command of the e-cigarette market. On 6 October 2018, Wells Fargo Securities attributed 74.5 per cent of e-cigarette market unit shares to JUUL (Craver, 2018).

JUUL, which in the US had a much higher nicotine content than in the UK, improved nicotine delivery to users, meaning that they got more nicotine, faster, than with other vaping products. Most products on the market used propylene glycol and glycerine as the solvents that allow the delivery of nicotine (Public Health Statement, 1997). Distinguishing JUUL was its use of nicotine salts, a mix of a nicotine base combined with a weak organic acid (NASEM, 2018). Nicotine salts allowed for absorption of nicotine in a fashion similar to combustible products. One 2018 study suggested that the nicotine hit from JUUL was also less harsh on the throat, which might produce a more pleasant experience for both seasoned cigarette smokers and people who had never smoked or vaped (Nguyen, 2018).

All of the features that made it appealing to adults also made “JUULing” a youth phenomenon. It was, in addition, easy to hide because it was small and produced little vapour. A Truth Initiative study found that, in a national sample of 1012 people aged 15–17, seven per cent reported ever having used a JUUL. Twenty-one per cent of this age group also recognised a photograph of a JUUL. Recognition (34 per cent) and past 30-day use (11 per cent) were higher among those in the sample who were more affluent. Adolescents who were just experimenting might not realise that JUUL delivered nicotine as efficiently as a combustible product, potentially increasing their risk of addiction (Willet et al., 2018).

In May 2018, the former chair of the American Academy of Pediatrics Tobacco Consortium weighed in on the side of peril. Dr. Jonathan Winickoff described JUUL in The New Yorker, a culturally sophisticated and politically liberal weekly with a generally affluent readership, as nothing short of “bioterrorism.” He declared JUUL “a massive public-health disaster” (Tolentino, 2018). Once again resisting the tide, Iowa Attorney GeneralTom Miller, continued to see promise in JUUL and other products that delivered nicotine electronically. Miller continued to argue that public health had an obligation to inform the public that e-cigarettes were substantially safer than combustible products. While Miller said that JUUL gave “cause for concern” when it came to kids, “it had not reached panic or epidemic stages” (Miller, 2018a).

6 The Pressure for Regulation Mounts

Deep concern about the malevolent intentions of e-cigarette proponents was fuelled when JUUL established an important financial relationship with Altria, the makers of Marlboro. “The union,” the New York Times reported, “would create an alliance between one of public health’s greatest villains and the start-up that would upend it. Particularly, alarming was Altria’s plan to invest “$12.8 billion for a 35 percent stake in JUUL, at a $38 billion valuation” (Richtel & Kaplan, 2018).

A review of newspaper articles, op-eds, and editorials from the New York Times, and Los Angeles Times makes clear that from 2010 onward, pessimistic pieces on e-cigarettes had come to over-shadow descriptive new accounts. Optimistic stances were all but eclipsed.

Nothing more tellingly underscored the prevailing tone of profound hostility to e-cigarettes, than the decision on the part of the New York Times to publish on its front page an investigative report detailing the horrific experience of an adolescent who quickly became addicted to nicotine through e-cigarettes, and his subsequent struggle to break free of the overpowering drive of his dependence. In what may have been an act of balancing, the Times published a less emotionally compelling account of a person who had successfully used e-cigarettes to free herself from tobacco. In mid-December 2018, the day that US Surgeon General Jerome Adams tweeted that he was “officially declaring e-cigarette use among youth an epidemic.” The Times returned to the theme of e-cigarettes use as a crisis, again in a front-page story (Vurthy, 2018). “Addicted to Nicotine, Teenagers Have No Clear Path to Quitting” was an account of parents, teachers and clinicians all paralysed as they observed teenagers falling prey to a brain and health threatening drug (Hoffman, 2018a).

Not just in the popular media were e-cigarettes characterised as a grave threat. In January 2019, the New England Journal of Medicine published the results of a major randomised clinical trial on efficacy of e-cigarettes. It concluded that e-cigarettes were more effective for smoking cessation than nicotine replacement therapy (NRT). After one year, 18.0 per cent of the e-cigarette group was “tobacco abstinent” compared to only 9.9 per cent of the nicotine replacement group (Hajek et al., 2019a). For e-cigarette users who were not tobacco abstinent, the problem of dual use remained. The journal’s senior editors published a formal commentary alongside the results of the clinical trial. They repeated the grim NASEM conclusions without ambiguity, “There is substantial evidence that e-cigarette used by youth increases the risk of smoking combustible tobacco cigarettes” (Hoffman, 2019).

Under these circumstances, the FDA history of delaying the PMTA process struck the mainstream public health community as inexcusable, leading many to conclude that it was necessary to challenge the agency in federal court. On 27 March 2018, after the PMTA deadline had been extended to 2022, major US NGOs including the American Cancer Society, Cancer Action Network, the American Heart Association, the America Lung Association, The Campaign for Tobacco-Free Kids, and the Truth Initiative filed a lawsuit in the Maryland Federal District Court claiming that the FDA had, in effect, violated its legal responsibility. “The FDA had effectively arrogated to itself…statutory forbearance that Congress had nowhere derogated to the agency” (Complaint, 2018). If it was following the law, in other words, the agency had no right to keep delaying.

One year later, on 15 May 2019, the court handed down a stinging decision. “Instead of addressing public health concerns associated with tobacco the August 2017 Guidance exacerbates the situation by stating in essence, that manufacturers can continue to advertise and sell products that are addictive and that target a youth market.” The Guidance “was clearly contrary to the Tobacco Control Act’s purpose” (Memorandum Opinion, 2019). The FDA, the court concluded, had “exceeded the authority granted to it by Congress” (Memorandum of Opinion and Order, 2019).

Two months later in a Memorandum of Opinion the Court imposed a 10-month deadline for PMTA submission and a one-year deadline for FDA approval. The 2022 deadline was unacceptable to the court. Yet, the onset of the COVID-19 epidemic set the stage for yet another move to extend the court’s deadline. On 30 March 2020, the FDA filed a request for a 120-day extension, a request the court agreed to. Hence, the new deadline was 9 September 2021.

In the midst of these legal manoeuvres, the FDA took a modest step. In November 2018, it declared that many flavoured e-cigarettes could be sold only in shops that had age-restricted entry or that set aside products in areas that were not accessible to those under age 18. Flavours like “gummy bear” or “bubble gum” had long drawn caustic critique from those who had fought so hard to combat efforts to make vaping appealing to youth. The FDA had thus not, as many had initially hoped, banned all flavours and all advertising. Rather, it took the approach of requiring exacting age verification controls on all sales, both in stores and online.

In a forceful op-ed in the Washington Post in response to the new FDA regulations, Tom Miller again weighed in. Sceptical of numbers that suggested plague-like youth uptake and hyperbolic concerns that nicotine could be injurious to adolescents he wrote, “To overreact and limit access to harm reducing tools means that adults die…. The FDA should be the last institution to strip the harm reduction potential of these products. The FDA should never act in a way to cause tens of thousands of Americans, perhaps hundreds of thousands, to die” (Miller, 2018b).

These events occurred against the backdrop of dramatic amplification of the already heated controversy. In August 2019, the CDC reported the emergence of a striking number of cases of life-threatening vaping-related pulmonary illnesses. A growing concern about the rising number of young vapers—15 per cent of cases were younger than age 18, and 37 per cent were ages 18 to 24—exposed to the risks of nicotine addiction had taken a dramatic turn with hospitalisations and fatalities from this condition (CDC, 2020). Confounding policy makers’ response to the new threat was uncertainty about what had caused the sudden outbreak of acute lung injuries.

News reports captured the emerging sense of alarm. On August 15, the New York Times published an update with the headline, “Dozens of Young People Hospitalized for Breathing and Lung Problems After Vaping” (Kaplan, 2019). Two weeks later, against the backdrop of 193 cases nationwide, the Times announced, “First Death in a Spate of Vaping Sicknesses Reported by Health Officials” (Richtel & Kaplan, 2019).

Over time, public health messages became ever starker. Following a death in Los Angeles, the county’s public health director stated, “Today we are issuing a warning to all residents ‘Stop vaping now’” (Christodoulou, 2019). In so doing, he echoed the position of the American Medical Association, which called vaping an “urgent public health epidemic” (Berg, 2018). To spur the adoption of local and state restrictions on flavoured vaping products, Bloomberg Philanthropies announced the funding of $160 million campaign over the next three years. Matt Myers stated that his organisation had mobilised to “transform what is going on” in “the battle over e-cigarettes” (McGinley, 2019).

Primed by long-standing fears that flavours attractive to adolescents were responsible for the steep acceleration in youth vaping, the new outbreak set the stage for more restrictive policy proposals. Indeed, total bans on e-cigarettes were being considered. In early September, Michigan’s governor announced an immediate ban on the sale of e-cigarettes. In California, the governor made clear while announcing a $20 million vaping awareness campaign that if he had the necessary legislation he would ban e-cigarettes. On September 24, Massachusetts declared a public health emergency and imposed a four-month ban on e-cigarettes.

By December 2019, four months after the initial CDC reports, both the CDC and the FDA confirmed that vitamin E acetate, a tetrahydrocannabinol (THC) product additive, was the likely cause of the US outbreak of lung injuries. Strikingly, although neither nicotine or flavoured vaping liquids were implicated and both CDC and FDA warnings focused on THC and products purchased off the streets, that new information did not reduce confusion about the source of the injuries in a context in which the youth vaping rate was increasing. Massachusetts, San Francisco, Ohio, and New York made immediate moves to ban either vaping products or flavours. The American Medical Association (AMA) called for a total ban on all vaping products. By 14 January 2020, there had been 2,668 cases and 60 deaths (CDC, 16 January 2020).

Political controversy continued unabated in 2020 as the FDA’s efforts were characterised as half-measures that failed to address the threat of e-cigarettes. In January, the FDA made its most substantial move against the sales of flavoured e-cigarettes. Although no e-cigarettes had yet received FDA authorisation through the PMTA process, the agency retained enforcement discretion and opted to “prioritizing enforcement” against flavoured products. Only tobacco-or menthol-flavoured e-cigarettes could continue to be sold. Further, it targeted manufacturers that targeted minors or failed to prevent access by minors to its products. In its press release, the agency stressed, “By not prioritizing enforcement against other flavoured ENDS products (e.g., tobacco and menthol flavours) in the same way as flavoured cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with consideration regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products.” In other words, although it did not shut the door on flavours other than menthol or tobacco, it drew a line in the sand when it came to kids: flavours like mint and fruit could no longer be marked without agency authorisation. It also determined to target enforcement against e-cigarettes, regardless of flavour, that had not submitted a premarket application (FDA finalizes, 2020).

This move drew sharp rebukes from those who believed the agency had retreated from what many took as a pledge by President Donald Trump to “sweep the market” of all flavours except tobacco (McGinley, 2020). Harold Wimmer, President and Chief Executive of the American Lung Association said the plan could “only compromise the health of our nation’s children” (Dasey, 2020). For Robin Koval of the Truth Initiative, this was nothing more than a Band-Aid when major surgery was called for (Dasey, 2020). Significantly, the ongoing hostility to e-cigarettes by Democratic law makers became ever more present. Patty Murray, the ranking member of the Health Education, Labor and Pensions Committee of the US Senate, attacked the FDA Commissioner as “having placed politics ahead of science, data and public health.” She like other Democrats saw this retreat on the part of the FDA as emblematic of the politics of the Trump Administration. After all, she said the President had said that vaping was a big industry and “we want to protect the industry” (Dasey, 2020).

Thirty Democratic Senators, in a letter to the Commissioner to the FDA, wrote that the “Newly announced e-cigarette flavour policy represent[ed] an alarming reversal from what the administration promised.” The policy, they said, was “weak and unlikely to have a meaningful impact on e-cigarettes use by youth” (Weixel, 2020). A month later Democrats in the House of Representatives passed a bill that would forbid the sale of flavoured cigarettes and e-cigarette liquids (Sheryl, 2020). The vote was 213 for banning and 195 against, and largely along party lines. “All but 5 Republicans voted against the bill. For them the measure represented overreach by a big government, liberal elites, telling adults what they can do.” A striking feature of this vote was the fact that some African American Democrats viewed the bill and its ban on menthol as “a targeted attack” rather than as a “value neutral health car policy decision” (DeBonis, 2020).

At the same time, the FDA’s effort was attacked by the vaping industry as a grave threat (DeBonis, 2020). Evidence suggested that vaping flavours with or without nicotine might appeal to youth, but flavours also appealed to adult smokers and might help them switch. Some evidence suggested that the vast majority of smokers who successfully switched completely from smoking combustible products to vaping did so—often after weeks, months, or even years of dual use—by transitioning from tobacco-flavoured or menthol-flavoured liquids, to other flavours and often to lower nicotine concentrations, or even to no nicotine in order to reduce the triggers that reminded them of their prior combustible smoking product (Abrams et al., 2018; Hajek et al., 2019b; McNeill et al., 2018; Russell et al., 2018).

In the next months, prior to the court-imposed deadline of 2021, the FDA followed through with its targeted approach. In April 2020, the FDA issued 10 warning letters to those who sold and produced or imported unauthorised nicotine delivery systems that were targeted to or were likely to promote use by youths. The director of the FDA’s Centre for Tobacco Products said of these warnings, “the public should really be outraged by these products.” He went on to say, “If you’re marketing or selling these products to youth, the FDA will not tolerate it” (FDA Warns, 2020). In July, the FDA again issued warning letters notifying 10 companies to remove their flavoured products from the market since they lacked premarket authorisation (FDA Warns, 2020).

The COVID-19 epidemic provided yet another occasion for pressure to mount for more aggressive regulation. A study published in the Journal of Adolescent Health suggested a dramatic increase in the risk of disease among those who vaped. The study leader stated, “In young people many believe their age protects them but the data shows that this isn’t true” (Digitale, 2020). This provoked a Democratic controlled subcommittee of the House of Representatives to send a letter to the FDA calling upon the agency to “temporarily clear the market of all e-cigarettes for the duration of the coronavirus crisis” (Howard, 2020).

The long-anticipated 9 September 2021 FDA regulations that would confront the challenges posed by larger companies involved in the production and sale of e-cigarettes was, as we have noted, met with an announcement that there would be yet another delay. While it had rejected the applications of 940,000 flavoured e-cigarette products, one careful observer noted, “they hadn’t made any of the tough decisions…I expected a little bit more” (Richtel, 2021). The American Heart Association, which had long called upon the FDA to reject the application of JUUL, expressed its disappointment noting that large companies involved in the vaping industry “had targeted our nation’s teens for years and contributed to the epidemic of tobacco use among youth” (Phend, 2021).

In August 2021, the depths of the division over policy was thrown into bold relief. The American Journal of Public Health published yet another appeal to consider the potential contribution that e-cigarettes could make to the goal of reducing morbidity and mortality associated with smoking tobacco cigarettes. “Balancing Consideration of the Risks and Benefits of E-Cigarettes” was co-authored by 15 past presidents of the SRNT, an international organisation with approximately 1000 members. Of the past presidents since the organisation’s founding in 1994, only seven had chosen not to join the effort that had commenced several months before the article’s publication (Balfour et al., 2021).

There was little that was new given the long-standing effort of  harm reduction proponents to press for a careful understanding of the evidence. What mattered most was an appeal to reason: “our objective is to encourage more balanced consideration of vaping within public health and in the media and policy circles.” Given the conclusion that e-cigarettes could contribute to smoking cessation it was essential that smokers “should be well informed about the relative risks of vaping and smoking and vaping’s potential to help quit smoking.” Acknowledging the need to carefully monitor the challenge of youth vaping, the authors lamented that “as public health groups, the media, policy makers and the general public focus[ed] on youth vaping, vaping’s potential to help adults quit smoking too often gets lost. That may come at a significant public health cost.” A final element of this appeal centred on the fact that a disproportionate number of African Americans, those with lower education, individuals with mental illness, and LGBTQ individuals smoked cigarettes. It was they who became ill in greater numbers; it was they who died from tobacco-related illness at higher rates. In short, this was a challenge to social justice (Balfour et al., 2021).

A contemporaneous statement by the Truth Initiative could not have been more different. Most strikingly in their September 2021 statement was the determination to embrace a very narrow interpretation of what harm reduction truly necessitated. Truth acknowledged the contribution of needle exchange to preventing the spread of HIV infection among drug users. But it went on to state, “We forcefully reject…the notion that [harm reduction] requires the further development of a huge commercial market in addictive nicotine products focused on youth and young adults. Instead, we argue that a genuine harm reduction approach requires a measured and careful deployment of nicotine alternatives that are tightly focused on helping smokers who otherwise would not quit smoking cigarettes…[We] reject the notion that unregulated or lightly regulated commercial markets in nicotine alternatives are equivalent to harm reduction” (Truth Initiative Statement, 2021). It was against this background that the FDA appeared, surprisingly, to side with those who had argued that e-cigarettes could indeed make an important contribution to the public health effort to reduce the toll exacted by smoking tobacco. On 12 October 2021, the FDA issued a long-awaited decision on e-cigarettes, permitting the sale of two nicotine flavoured cartridges manufactured by R.J. Reynolds corporation. In making the announcement, the FDA stated that the “potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth provided that [the company] follows post marketing requirements aimed at reducing youth exposure and access to [these] products.” In taking these steps, the agency noted that it had ordered the removal of more than 1,000,000 products “that lacked sufficient evidence that the benefit to adult smokers who used the flavored products would overcome the public health concern posed by the well documented and considerable appeal of the products to youth” (FDA Permits, 2021).

Left to a future moment was the question of menthol. On 29 April 2021, the FDA had made clear its intention to ban menthol in combustible cigarettes (FDA Commits, 2021). Menthol has long been the single most dangerous tobacco chemical flavour when it comes to both adult and youth smoking. Despite two FDA-derived reports that recommended a ban on menthol in combustible products, one internal and one externally commissioned, there has been policy paralysis in the face of appalling evidence: 52 per cent of all adolescents initiate smoking with menthol. But among African American youth, that figure is over 90 per cent (Villanti et al., 2017). The menthol burden on African American communities reflects a history of deliberate marketing. After the 1950s, as the evidence on the harms of smoking began to mount, industry shifted from marketing menthol away from women to Black Americans. Industry engaged in what historian Keith Wailoo calls “corporate race work” to target the urban market in Black communities. For marketers, “human crises (drug use, economic distress, fears of cancer, poverty) were opportunities” (Wailoo, 2021, p. 12). Although smoking rates dropped for all racial groups in the US, targeted marketing created disparities in consumption (and, as a result, death and disease) that have narrowed since the middle of the last century but not yet closed for Black men. In a context in which behaviours like smoking were increasingly viewed not as having structural causes but as being the result of bad choices, such disparities had consequences for stigma and discrimination in social and economic life as well as in access to care (MMWR, 2011).

Even though there is currently a renewed push to ban menthol in combustible products, it continues to remain unclear whether the FDA would extend such a ban to e-cigarettes. But in approving only tobacco-flavoured e-cigarette products in October 2021, it seemed more certain that e-cigarette flavours would be a thing of the past, shaped in large measure by the historical contours of debate over tobacco and youth in this US.

The decision on the part of the FDA was remarkable in that it had determined that the evidence supported a harm reduction approach to the human toll of smoking combustible tobacco products. In so doing, it hewed to a position that put it at odds with a well-financed campaign on the part of virtually the entire public health establishment in the US. At the same time, the agency rejected the claims on the part of e-cigarette proponents that a range of flavours other than tobacco could enhance the appeal of e-cigarettes to adult smokers.

It was not surprising that the FDA drew the ire of long-time antagonists to e-cigarettes who saw in them yet another ploy on the part of the tobacco industry. The national assistant vice president for advocacy of the American Lung Association stated bluntly “This throws young people under the bus. The industry has been waiting for the next big thing and they found it with e-cigarettes” (Richtel & Kaplan, 2021). A Democratic Congressional representative echoed the position that had characterised the party’s deep hostility to the tobacco industry e-cigarettes, stating, “The FDA has turned its back on the public health by approving high nicotine e-cigarettes” (Washington Post 10/2021), and accusing the agency of “ignoring the data” (Pietsch, 2021).

The decision was also castigated by e-cigarette proponents, who had asserted that a range of flavours made e-cigarettes more appealing to smokers seeking options that helped them transition away from combustible cigarettes.

It thus came as a surprise to many that, not ten months later, the FDA issued is Denial of Marketing Order to JUUL, noted at the start of this chapter.

7 Conclusion

On 23 June 2022, the FDA issued its ruling against the marketing of JUUL vaping products. For proponents of harm reduction, this seemed nothing short of a defeat, despite the willingness of the FDA to approve some e-cigarettes. It is thus important at this juncture to acknowledge the issues at hand have not finally been put to rest.

A huge, and apparently unbridgeable, gulf continues to separate the Truth Initiative, other major NGOs, and the core of the public health community from those who warned that overly restrictive measures would subvert the fundamental goals of public health by denying harm reduction as a viable approach for smokers. It would be naïve to imagine that evidence alone will resolve this debate with its deep historical roots. Fear of addiction, even benign addiction, remains a central concern for American policy makers. Youth, too, remain centre stage. Understanding and reckoning with these powerful frames will continue to shape the prospects for both those opposed and committed to tobacco harm reduction.