It started with a plan to curb deaths from tobacco. In 2017, under then-Commissioner Scott Gottlieb, the Food and Drug Administration announced an ambitious comprehensive plan to address smoking and nicotine addiction.
At the heart of the plan were two key strategies. One was to render cigarettes less appealing by mandating that they contain extremely low levels of nicotine. This would make them less addictive for both new and existing smokers. The second was to ensure that smokers have a viable off-ramp to other, safer sources of nicotine, such as e-cigarettes.
Both aspects of the plan were essential. If nicotine was reduced in cigarettes without the widespread availability of safer alternatives, smokers might instead switch to other forms of combustible tobacco or seek cigarettes that are sold illicitly. “To be successful all of these steps must be done in concert and not in isolation,” Gottlieb said at the time.
Now, it appears we are poised to find out what happens when only half of the plan is implemented. The FDA recently announced a forthcoming ban on menthol in cigarettes; the agency is also finalizing rules to reduce nicotine in cigarettes to trace amounts. Theoretically, both moves would encourage smokers to quit or switch to vaping, thereby greatly reducing their exposure to harmful constituents in tobacco smoke. Yet the FDA is also ordering the most popular brand of e-cigarettes, Juul, off of the market.
Combined with a broad failure to authorize other brands of e-cigarettes—the agency has authorized only a handful, and none in flavors other than tobacco—these decisions reveal an agency that is eager to simply ever further restrict tobacco and nicotine products, rather than allow smokers and vapers to choose from the vast array of safer and enjoyable options that arose before the FDA’s regulations came into force. It’s certainly debatable whether the government should restrict the choices of adult nicotine consumers to this degree. But more than that, the breakdown in the “comprehensive plan” is likely to have unintended consequences both for public health and criminal justice.
Let’s look at the health aspect first. More than 480,000 Americans die every year from smoking. Persuading smokers to quit or switch to safer sources of nicotine would be a tremendous victory for public health; population surveys suggest that adoption of e-cigarettes has increased quit rates, and expert models predict substantial reductions in mortality if smokers switch. In recent years, advocates of harm reduction have been guided by the principle tobacco researcher Michael Russell laid out way back in 1976: “People smoke for the nicotine but they die from the tar.”
Early attempts to develop safer cigarettes were colossal marketing failures, but the innovation of e-cigarettes finally offered a workable solution. The health impact of vaping is still a contentious area of study, but e-cigarettes are widely considered to be far safer than smoking. The FDA itself has acknowledged that nicotine products fall on a “continuum of risk,” with combustible cigarettes being the most lethal kind. And while e-cigarettes might not be without risks, they outperform cessation products like nicotine gums or patches in randomized control trials. In other words, it’s not just about the nicotine: It’s easier to quit smoking with a device that has at least some of the feel of a cigarette.
Yet, as with other drugs, the fight for harm reduction in tobacco is an uphill battle. Many experts and activists in tobacco control prefer an abstinence-only approach to nicotine, aiming to eliminate its use entirely rather than to ameliorate the harms of smoking. Others worry about the appeal of vaping to young people. And lastly, the public perception of vaping suffered immensely due to an outbreak of lung disease in 2019. That turned out to be caused by additives in cannabis products, but the damage to the perception of all vaping products has persisted. Researchers at the American Cancer Society recently found that the percentage of adults who erroneously believe nicotine e-cigarettes are more harmful than smoking quadrupled from 2018–20. All of these factors likely contributed to the FDA’s decision to order all of Juul’s products off the market.
Allowing Juul to keep selling its products would have been politically fraught for the FDA for other reasons. Juul’s ease of use, appealing flavors, and often-dubious marketing made the brand synonymous with youth vaping. It makes sense to be concerned that a company that bought ad space on the websites of Cartoon network and Seventeen magazine is introducing nicotine addiction to kids who were never smokers in the first place. The company also sold a significant stake to Altria, the largest tobacco company in the United States and the maker of Marlboro cigarettes. All of this made Juul a particular target for politicians and activist groups. “It is hard to imagine the furor that would rain down on the FDA if they approved the marketing of Juul e-cigarettes, both from the public and from legislators,” says tobacco expert and prominent harm reduction advocate Kenneth Warner, of the University of Michigan.
But it’s not obvious that these factors justify removing Juul from the market. The company reformed its business practices, turning away from youthful imagery and social media, and removing all but its mint, menthol, and tobacco flavors from in-person retail channels. (The FDA later completely restricted nicotine cartridges not flavored with menthol or tobacco.) Youth vaping rates have declined substantially from their peak, and teens who do vape have largely switched to less-regulated Puff Bars. Most importantly, youth smoking rates have dramatically fallen to historic lows during the vaping era, contradicting fears that vaping would act as a gateway to more dangerous behavior.
Officially, the FDA contends that Juul failed to provide sufficient evidence for the toxicological safety of its vape pods. It’s arguable, however, that the FDA is undermining the aims of public health to punish the company for past misdeeds and avoid political controversy. “It looks like the FDA searched for a pretext for denying Juul’s products and this is the best they could come up with,” says Clive Bates, a former director of Action on Smoking and Health in the United Kingdom who now advocates for tobacco harm reduction.
The case of Juul captures the larger tension with harm reduction. The widespread appeal of its products makes Juul a target. Yet the fact that its products are so appealing is key to its potential to wean smokers from smoking and prevent premature deaths. It’s not entirely a bad thing that “Juuling” was seen as cool, especially when compared with smoking cigarettes. Other e-cigarette brands don’t get their names turned into verbs. By forbidding Americans from purchasing Juul products, the FDA makes it more likely that many vapers might revert to a far more dangerous habit.
The most optimistic outcome of all the new nicotine regulation is that smokers transition to legal e-cigarettes or even make the choice to quit nicotine entirely. But they will have another option: turning to black markets. The FDA is unwittingly setting up the conditions for illicit markets where menthol cigarettes, cigarettes with nicotine, and flavored e-cigarettes could thrive. We are already seeing this in states that have banned these products, such as Massachusetts. A recent report from the state’s Multi-Agency Illegal Tobacco Task Force takes note of multiple busts for flavored vapes and tobacco products. One accused seller faces five years in prison. In another instance, police staked out a Latin American clothing store to spot a customer leaving the shop with menthols; the owner was arrested. Extensive illicit markets for tobacco becomes a criminal justice issue.
Of course, it will take time for these regulations to take effect. It’s possible that the FDA will eventually authorize a more extensive array of products in Juul’s place. But barring a significant change in direction, the unintended consequences of banning Juul are look grim. Advocates of the FDA’s restrictions bristle at the term prohibition due to both its association with a past failed experiment and the fact that at least some nicotine products will remain on the market, but it’s an apt description of where American tobacco policy is headed. The FDA’s shambolic approach to banning combustible tobacco products while refusing to authorize safer alternatives is leading ineluctably to a future in which the potential for harm reduction is undermined, tobacco products and e-cigarettes are sold on illicit markets, and Americans are imprisoned for selling contraband cigarettes and vapes. Would it not be easier to allow consenting adults to take a puff from a Juul?