Scott Gottlieb's FDA Is Moving Toward a Stealth Ban on Cigarettes and Cigars
The Food and Drug Administration can't ban cigarettes outright. But the agency appears to be planning a workaround.
Earlier this month, Food and Drug Administration Commissioner Scott Gottlieb announced sweeping new rules governing e-cigarettes and tobacco in the United States. The most striking change is a ban on the sale of most flavored e-cigarettes in retail locations that admit minors, which will limit most in-person sales to specialty retailers like vape shops and tobacconists. The FDA also announced its intention to eventually ban menthol cigarettes and all forms of flavored cigars.
More worryingly, these moves may pave the way for even more radical regulations that would, in essence, make it illegal to sell the combustible tobacco products favored by cigarette and cigar smokers throughout the United States.
The new vaping rules fall short of the stricter interventions favored by many anti-smoking activists. But even though Gottlieb is a former fellow at the American Enterprise Institute who was appointed by Donald Trump with the expectation that he would champion deregulatory policies, his longer term plans align the FDA with the most strident anti-smoking groups. In addition to banning menthol cigarettes and flavored cigars, Gottlieb is steering the FDA toward mandating low nicotine yields in combusted tobacco, a regulatory intervention that would effectively outlaw most traditional tobacco products.
Paired with his support for e-cigarettes, the policies evolving at the FDA break down the standard framing of debates within tobacco control, which typically pits advocates of harm reduction against abstinence-only hardliners. The newly emerging division is between those who embrace a liberal, dynamic approach to regulation and aggressive interventionists who advocate technocratic central planning of the tobacco market. Despite his intellectual ties to free market think tanks, Gottlieb increasingly looks like a radical restrictionist out to ban the sale of smoking products as we now know them forever.
How creeping interventions could lead to a federal takeover of the tobacco market
Gottlieb announced his intentions in July of last year as part of a comprehensive plan to transition cigarette smokers to less dangerous forms of nicotine delivery. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts," he said.
Technically, the FDA is forbidden by law from requiring the complete elimination of nicotine in tobacco. But it could mandate that nicotine be reduced to near zero. The FDA says it is considering the pros and cons of "lowering nicotine in cigarettes to a minimally or non-addictive level through the creation of a potential nicotine product standard." The idea is that new smokers would never get addicted, and current smokers would be forced to quit or turn elsewhere for their fix.
In this scenario, cigarette smokers would switch to e-cigs or similar devices. Realistically, however, many of them will choose to stick with actual tobacco, sourcing it on the black market or buying it in other legal forms such as roll-your-own, pipe tobacco, small cigars, and premium cigars.
Therein lies the threat for people who enjoy smoking any of those products. Cigarette smokers who switch to these instead of e-cigarettes would offset the gains of regulation, inviting further interventions. A rule that began by targeting only cigarettes could end up affecting all forms of combustible tobacco, including premium cigars.
This is no idle speculation. Anti-smoking organizations are actively and explicitly pressuring the FDA to mandate low nicotine yields across the board. According to comments to the FDA signed by a bevy of anti-smoking groups, "There is no rational basis for reducing nicotine levels in cigarettes, while leaving cigars highly addictive. …Exempting cigars from a reduced nicotine standard is likely to lead current cigarette smokers to switch to cigars or use both cigarettes and cigars to satisfy their need for nicotine." The FDA's own analysis similarly concludes that extending its authority to all forms of tobacco would be necessary "to rectify an institutional failure in which tobacco products that are close substitutes are not regulated by the FDA in a like manner."
Whether Congress ever intended for the commissioner of the FDA to wield such power is debatable. The Family Smoking Prevention and Tobacco Control Act, the 2009 law that gave the FDA the authority to regulate tobacco products, prohibits it from banning entire classes of tobacco products or requiring the removal of all nicotine. Mandating near-zero nicotine yields would accomplish essentially the same thing, perhaps complying with the letter of the law but ignoring its spirit.
"By continuing to advance this measure," Carrie Wade and Clive Bates argue in a policy study for the R Street Institute, "the FDA takes Congress literally but not seriously, and the agency would do well to recognize that Congress expects to authorize rulemaking of this significance." If an unelected agency head took such drastic action, it would arguably represent an anti-democratic power grab, substantially affecting millions of stakeholders without accountability.
If nicotine is essentially prohibited in cigars and other tobacco products, the act of smoking them would be fundamentally changed–a real cost to consumers who enjoy them. Anti-smoking groups implausibly deny this, contending that this wouldn't result in any loss of utility for cigar smokers because they would still be allowed to obtain nicotine from patches, gums, or e-cigarettes.
"To the extent that smokers derive pleasure from smoking apart from satisfying their need for nicotine, they will continue to be able to purchase cigarettes and other combusted products," they argue in their comments to the FDA. "Having access to both nicotine and combusted tobacco products, it is questionable whether smokers will experience any loss of consumer surplus, even assuming that such surplus is generated by smoking."
Yet the argument might persuade the FDA. The agency has struggled for years over whether to treat premium cigars differently from other tobacco products, likely because any threat to them would meet organized political resistance. It's possible that premium cigars would be exempt from new nicotine requirements, at least initially. But this special treatment would survive at the whim of future FDA commissioners, who might be inclined to revoke it for the sake of consistency or in response to cigarette smokers who turn to cigars as the last legal source of tobacco with nicotine. Sooner or later, Scott Gottlieb's proposal could end up affecting all traditional tobacco products throughout the United States.
The new debate over tobacco pits dynamism against technocracy
The increasingly aggressive moves by Gottlieb's FDA reveal the biggest divide in today's tobacco policy debate. On the one hand, there are people who favor an open, classically liberal approach to regulation that expands the range of choices. On the other, there are advocates of top-down, technocratic planning to reduce it.
Both groups recognize that nicotine products exist on a continuum of harm, with some substantially more dangerous than others. The liberals want to see cigarettes, the most dangerous product on the continuum, suffer creative destruction by voluntary means, with smokers choosing for themselves to take up safer alternatives. Educational campaigns, targeted advertising, and preferential tax treatment could provide additional nudges. The technocrats seek not to nudge but to shove, urging the FDA to manage the market from above by banning some products entirely and coercively rendering others less appealing.
In this new framing, Scott Gottlieb looks increasingly like a central planning wolf in deregulatory sheep's clothing. His early actions at the FDA protected the open market for e-cigarettes with the aim of promoting harm reduction, fending off restrictions that critics might portray as "nanny state" interference in the choices of consenting adults. His plans going forward suggest that the agency's hands-off approach is coming to an end. That will inevitably create conflict between regulators and the producers and consumers of the products they seek to remove from the market.
Part of the challenge is that the harm reduction argument sows the seeds of its own destruction. It's easy to see the benefit when an actual smoker switches to vaping. But if e-cigarettes are effective, then the population of smokers will fade away as they switch, quit, or never take up smoking in the first place. As the gains of harm reduction are realized, the underlying questions of consent and coercion that have always surrounded nicotine and tobacco use will come roaring back. What happens to the small minority of people who continue to smoke cigarettes in spite of everything? What about those who smoke for pleasure, perhaps with cigars or pipes? What about nonsmokers who take up vaping? Inevitably we'll have to confront the fact that people are smoking or using nicotine and the question of what, if anything, to do about it.
Mitch Zeller, director of the FDA's Center for Tobacco Products, raised similar questions in an article published last month in Nicotine and Tobacco Research outlining the agency's concerns. "How comfortable are we with long-term, or possibly permanent, use of less harmful nicotine delivery mechanisms by adults, if they help keep currently addicted smokers from relapsing to combustible tobacco products?" Zeller asks. "Given the potential health impacts of dual use of tobacco, how acceptable is a short period of dual use while transitioning to less harmful nicotine-containing products? What if many current smokers engage in dual use on a long-term or permanent basis?"
Who is the relevant "we" and why should their determination of what is acceptable or comfortable be decisive for everyone else? One struggles to find any indication in the statements of FDA leaders that the preferences of individual smokers are viewed as a constraint on their actions. As Gottlieb noted in a recent interview with Reason, he is guided by a mandate to reduce smoking rates. The entirety of tobacco policy is reduced to one metric—the maximization of public health—at the expense of any other interests.
This approach, culminating in the plan to require near-zero nicotine yields, is thoroughly technocratic. It micromanages the flow of products on and off the market and places ever more restraints on adult behavior in pursuit of a single goal.
An alternative approach would embrace dynamism, a concept journalist and former Reason editor Virginia Postrel elucidated in her 1998 book The Future and Its Enemies. Technocrats, in her telling, advocate for a "one best way" determined by politically empowered experts. Dynamists, in contrast, "permit many visions and accept competing dreams…Their 'central organizing principle' is not a specific outcome but an open-ended process. A dynamic future tolerates diversity, evolves through trial and error, and contains a rich ecology of human choices."
E-cigarettes owe their evolution to that very sort of dynamism, arising from a messy, bottom-up process with minimal regulatory oversight. Had the FDA imposed its heavy-handed regulations a few years earlier, the tools the agency now sees as essential for harm reduction might not exist.
Yet to judge by his public comments, Gottlieb has faith in the power of technocratic authority. Once feared by progressives to be an unabashed deregulator, he has settled comfortably into the role of central planner when it comes to tobacco. He speaks of "on-ramps" and "off-ramps" to nicotine addiction that he believes he can manage from above to optimize public health. Even that road metaphor understates his top-down mindset. The job of traffic engineers is to help people get to where they want to go; Gottlieb wants to choose their destination too, insisting on abstinence from combustible tobacco as the only acceptable aim.
In contrast, a dynamic approach to tobacco regulation would empower smokers by giving them safer options while respecting their right to choose what goes into their bodies, whether it's drags from a cigarette, hits off a vape pen, or a cigar on special occasions. The millions of smokers who do want to quit could be aided by streamlining and clarifying the FDA's approval process for e-cigarettes, freeing manufacturers to speak truthfully about their products, and targeting advertisements to existing smokers.
The ultimate pattern of use that would emerge from such an open market is impossible to predict, but it would likely lead to longer, healthier lives for millions. Recent modeling published by health researchers in Tobacco Control projects that even with residual smoking rates of 5 to 10 percent, a large-scale transition to vapor products would prevent 1.6 to 6.5 million premature deaths between now and 2100.
In place of the aggressive central planning currently being contemplated by the FDA, a dynamist could look to the examples of Sweden and Norway. Residents in both of these countries have shifted consumption away from cigarettes and toward snus, a form of oral tobacco that presents much lower risks than familiar American-style chewing tobaccos. Sweden, which made the transition to snus earliest, now has phenomenally low rates of smoking, with superior health outcomes to match. The transition was driven by consumers from the bottom-up, largely without planning or approval by health authorities.
Academics differ about the extent to which snus has directly contributed to this success, but one lesson from the Nordic experience is that significant gains in health can be made by persuading people to give up smoking even if they don't give up tobacco and nicotine altogether. Swedes and Norwegians can still buy cigarettes and cigars, but given access to safer alternatives, the vast majority of them choose not to.
Harm reduction isn't always liberal
Scott Gottlieb has said he is committed to the idea that transitioning smokers and potential smokers to a safer form of nicotine delivery would prevent much of the harm caused by cigarettes. It's a compelling case, and we know from countries like Sweden and Norway that it can work.
But how we achieve that outcome matters. Harm reduction is typically viewed as the more liberal approach to tobacco control, but harm reduction itself comes in liberal and illiberal varieties. The proposal to ban flavors and eliminate nicotine in tobacco marries illiberal harm reduction to the so-called "endgame" strategies favored by the most radical wings of anti-smoking activism, guaranteeing conflict over who decides what products adults have access to. This technocratic vision allows for anything but a rich ecology of human choices. Its one best way is the extinction of combustible tobacco use in all its forms, and the pervasive assumption of its supporters is that this goal is universally shared.
That's a self-serving illusion that erases the preferences of many smokers as irrelevant obstacles to the ideological aim of achieving a smoke-free society. Today's anti-smoking technocrats are not so far removed from the early-20th-century prohibitionists like Lucy Page Gaston, who dreamed of a "smokeless America by 1925" and refused to let the autonomy of consenting adults stand in the way of it.
Gottlieb may have come from the deregulatory right, but he now embraces technocratic central planning of the tobacco market that may lead inexorably to the elimination of everything from cigarettes to premium cigars in their traditional forms. If he brings that about, it will be a loss for those who view the preservation of individual choice as a good on its own—and an ironic legacy for an FDA commissioner who was expected to be a skeptic of overreaching government.