The summer of 2019 witnessed a dramatic amplification of the controversy in the United States over the potential threat to the nation’s youth posed by e-cigarettes. After years of festering debate, a summer outbreak of vaping-related injuries imperiled the idea that e-cigarettes could serve to advance the role of harm reduction for cigarette smoking.

We consider the responses in two countries that stand at opposite policy poles when it comes to tolerance for e-cigarettes as harm reduction for those who smoke combustible cigarettes. The context was one in which many assumed the outbreak might prove to be a policy game changer. Australia had adopted a prohibitionist policy on e-cigarettes, seeing in e-cigarettes the potential to roll back a half century of gains against smoking. The United Kingdom, convinced by a mounting evidence base that the population health benefits were substantial, embraced an openness to the potential role of e-cigarettes in tobacco harm reduction. In the US, antagonism toward e-cigarettes intensified even as it became clear that it was a product of the US regulatory landscape rather than a new risk related to vaping nicotine. In all three contexts, the outbreak of acute lung injuries thus served to reaffirm preexisting policy positions and divides.

Shockwaves Over E-Cigarettes

In August 2019, the US Centers for Disease Control and Prevention (CDC) reported the emergence of a striking number of cases of life-threatening vaping-related pulmonary illnesses. By January 14, 2020, there had been 2,668 cases and 60 deaths. A growing concern about the rising number of young vapers—15 percent of cases were younger than age 18, and 37 percent were ages 18 to 24—exposed to the risks of nicotine addiction had taken a dramatic turn with hospitalizations and fatalities from this condition. Confounding policy makers’ response to the new threat was uncertainty about what had caused the sudden outbreak of acute lung injuries.

In early September, the US Food and Drug Administration (FDA) identified vaping products containing tetrahydrocannabinol (THC, the main psychoactive constitute of cannabis) as the most probable cause of the outbreak while acknowledging the need for more information. Analyses of most samples of vaping products used by cases were found to contain THC and significant amounts of vitamin E acetate. The CDC, long skeptical of e-cigarettes, differed from the FDA in suggesting that vaping nicotine products themselves could be causative.

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.” 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.”

Focusing on the possibility that illegally obtained contaminants might have been added to vaping nicotine products, Scott Gottlieb, the former FDA commissioner who explicitly steered the agency toward tobacco harm reduction, said it’s “probably something new that has been introduced into the market by an illegal manufacturer.” Referring to the most popular e-cigarette brand on the market, he said, that it was unlikely “that the Juul brand was associated with the recent cases.”

Over time, public health messages became ever starker. On the occasion of a death in Los Angeles, the first in the nation, the county’s public health director stated, “Today we are issuing a warning to all residents ‘Stop vaping now.’” In so doing, he echoed the position of the American Medical Association, which called vaping an “urgent public health epidemic.” To spur the adoption of local and state restrictions on flavored vaping products, Bloomberg Philanthropies announced the funding of $160 million campaign over the next three years. Matt Myers, Campaign for Tobacco Free Kids president and longtime opponent of nicotine vaping, stated that his organization has mobilized to transform “the battle over e-cigarettes.”

Primed by longstanding fears that flavors 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.

Those who supported the strategy of tobacco harm reduction warned that these restrictive policies would undermine the possibility of using vaping devices to assist smokers who could not or would not give up the use of nicotine. They saw in the prohibitionist urge a panic-like reaction making reasoned evidence-based policy all but impossible. When San Francisco took the nation’s first step toward outright prohibition in June 2018, before the acute lung injury crisis emerged, Steve Schroder, a professor of public health, had stated “it’s ludicrous that we would ban e-cigarettes but permit the sale of tobacco and cannabis …. It’s really smart politics but dubious public health.”

Australia Responds: Warnings Realized?

Australian federal and state medical officers viewed the US crisis as compelling evidence of the wisdom of their own policy of prohibiting the sale to adults of e-cigarettes that contained nicotine. In a statement issued in mid-September, it declared, “All Australian governments are united in maintaining a precautionary approach to the marketing and use of e-cigarettes. There is growing evidence implicating e-cigarettes in a range of harms to individual and population health.” The statement cited the US cases as “evidence … of a possible link between the use of e-cigarettes and lung disease” and encouraged “individuals who had used e-cigarettes and had unexplained respiratory symptoms (cough, shortness of breath, chest pain) to seek medical advice.” The possible role of THC in the US outbreak was noted but downplayed by a statement that only “some” cases involved cannabis vaping. The statement also suggested that bystanders exposed to vaping might be at risk: The Australian Medical Association strongly supported this statement.

The Melbourne Age and Sydney Morning Herald (September 8, 2019) editorialized, “Australia has been wise in not bowing to the demands of lobby groups seeking to have federal and state governments ease restrictions on vaping. The cautious approach should be universally maintained until much more is known about the medical risks of electronic smoking.” The editors warned against what they saw as the faulty perception that vaping was “safer” than smoking cigarettes. Dismissed as well was the notion that e-cigarettes could serve as effective smoking cessation devices.

The British Respond: Reaffirming The Importance Of E-Cigarettes, For Public Health

The backdrop to the British response to the US “crisis” could not have been more than that which prevailed in Australia. Public Health England (PHE), a national agency established in 2013, embraced a tobacco harm reduction strategy in which vaping nicotine products represented a critically important opportunity to assist smokers who would not or could not give up combustible cigarettes. In early 2019, months before the US crisis took hold, PHE had issued a new evidence-based systematic review emphasizing the positive role that e-cigarettes could play in reducing tobacco-related morbidity and mortality.

Martin Dockrell, tobacco policy lead at PHE, drew a sharp distinction between policies in the UK and the US. “Unlike the US, all e-cigarettes products in the UK are tightly regulated for quality and safety by the Medicines and Healthcare Products Regulatory Agency, and they operate the yellow card scheme, encouraging vapers to report any bad experiences.” Action on Smoking and Health (ASH), an anti-tobacco advocacy organization, likewise underscored their distinct regulatory approach. ASH’s Deborah Arnott underscored, “In Britain, you can check on the Medicines and Healthcare Products Regulatory Agency website whether the product you’re using has been notified and can be legally sold.”

There were, to be sure, some tabloid press headlines that echoed US and Australian anxiety. Thus, for example, the Daily Mail reported, “Shocking scans show how vaping e-cigarettes left a 19-year-old’s lungs filled with solidified oil that looked like hardened bacon grease and left him unable to breathe on his own.” Yet, even at a point in which there was considerable uncertainty over the implications of the US outbreak, British public health officials maintained confidence in their longstanding evidence-based policy approach. The chief medical official, Dame Sally Davies, in a pre-retirement appearance before the House of Commons Science and Technology Committee, endorsed as the British approach, although she did, in fact, express some concerns: “E-cigarettes are clearly much safer than tobacco smoking, and they have become a much-liked way of stopping smoking. If they help people to stop, they are so much safer so I would like them to use them. I would encourage the NHS smoking cessation services to work with that.” Nevertheless, she continued, “I have concerns because we do not know their long-term side-effects. I would like us to be careful.”

While worded differently, sharp dissent from the official position was clear in some notable medical circles. An unsigned Lancet editorial attacked e-cigarettes in line with that journal’s previous position. “No solid evidence base underpins the marketing claims that e-cigarettes are healthier than cigarettes, or that they can support quitting.” In arguing that it was time “to align the public health approach to e-cigarettes with that of cigarettes,” the Lancet editorial suggested that vaping was as harmful as smoking, a position in clear variance with the consensus within policy circles.

Conclusion

By December 2019, four months after the initial CDC reports, both the CDC and the FDA confirmed that vitamin E acetate was the likely cause of the US outbreak of lung injuries. Strikingly, that new information did not reduce confusion about the source of the injuries in a US context in which youth vaping rate was increasing.

In the US, there were divergent policy responses. Some states and cities continued down a prohibitionist course, banning e-cigarette flavors or all e-cigarettes. Others, such as Massachusetts, rolled back temporary bans while focusing on what many described as an “epidemic” of youth e-cigarette use by targeting flavors. At the federal level, the White House, under pressure from lobbyists, waffled on vaping nicotine products and flavor bans. The FDA passed a long-urged federal mandate that limited tobacco and vaping sales to those 21 years of age or older and announced plans to crack down on underage sales and predatory marketing. It also issued a temporary ban on flavors other than tobacco or menthol in nicotine vaping products, noting that flavored nicotine products were in process of pre-market approval. Although the CDC struck an increasingly hostile posture on all vaping nicotine products based on the threat to youth and the threat of nicotine addition, the FDA continued to promote tobacco harm reduction and to consider approving applications for flavors other than tobacco or menthol.

Certainty about the cause of the acute lung outbreak also did little immediately to influence the policy debate in the UK and Australia. Existing policy positions were simply affirmed. Australia had long taken a precautionary stance on vaping and prioritized the most alarming evidence. Any risk served to trump arguments that vaping nicotine products, if properly regulated, could help smokers quit without undue harms to youth. In the UK, which had, from the outset, committed to a path of carefully weighing the full body of evidence in a systematic fashion on an ongoing basis, the outbreak was cause for concern but could not derail what it has viewed as a reasoned regulatory approach, which was considerably more stringent and wide-ranging than that which existed in the US.

The continuities and discontinuities underscore the power of regulatory path dependency in the face of uncertainty over what the outbreak of acute lung injuries implied.