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.