The FDA Is Set To Unintentionally Push Quitters Back to Smoking

Instead of trusting the science, the FDA will treat adults like children.


The week ahead will be hugely consequential for the future of tobacco and nicotine in the United States. On September 9, the Food and Drug Administration (FDA) must meet a court-imposed deadline to decide which electronic cigarette and vapor products will be allowed to remain on the market. The agency's decisions will affect more than just the livelihoods of small business owners and big vaping companies; at stake are the rights of millions of current and former smokers to access a safer alternative that could literally save their lives.

American news coverage of vaping has tended to focus on its downsides, particularly the use of e-cigarettes among teens and adolescents. Legislators and activist groups have raised the alarm about youth vaping to encourage the FDA to enact de facto prohibition of flavored products. In the popular imagination, vaping seduces youth into dangerous addiction and renormalizes tobacco use, justifying bans on the sale of e-cigarettes even to adults.

The story is considerably more nuanced among experts in the field of tobacco control.

Advocates of harm reduction do not dismiss genuine concerns over youth use of nicotine products, but they also focus on the long-term goal of preventing deaths caused by smoking. They note that the best available evidence suggests that vaping is far safer than smoking cigarettes, that it is more effective than nicotine patches or gums at helping smokers quit, and that the health benefits of encouraging smokers to switch outweigh the harms of vaping under almost all circumstances.

Kenneth Warner and David Mendez, both of the University of Michigan School of Public Health, illustrated this in a study last year that simulated 360 different scenarios for how vaping could impact American health through the end of the century. In 99 percent of those scenarios, the outcomes were positive for life-years saved. Similarly, modeling published by David Levy of Georgetown University and other researchers in the journal Tobacco Control projects that widespread switching from smoking to vaping would prevent between 1.6 million and 6.6 million premature deaths by 2100.

That transition to lower-risk sources of nicotine will only occur if smokers are provided with accurate information about vaping and if adults are allowed to buy products appealing enough to compete with cigarettes. Unfortunately, alarmist news coverage and prohibitive policies are consistently failing smokers. The situation is sufficiently dire that Warner and 14 other prominent experts in tobacco control, all of them past presidents of the Society for Research on Nicotine and Tobacco, issued a joint article in August warning that the opportunity to save lives through harm reduction may be missed.

"We believe the potential lifesaving benefits of e-cigarettes for adult smokers deserve attention equal to the risks to youths," they wrote in the American Journal of Public Health. They noted that the public has a distorted view of the risks of vaping, with many falsely believing it to be equally as harmful as smoking, and that adults are increasingly denied access to flavored vapor products that can help them quit. "The singular focus of US policies on decreasing youth vaping," they wrote, "may well have reduced vaping's potential contribution to reducing adult smoking."

While policies should seek to discourage youth vaping, it's important to keep that problem in perspective. Rates of use are already declining from their peak. Most vitally, youth smoking (a far more dangerous behavior than vaping) has fallen to the lowest rates in modern American history at the same time that vaping has risen in popularity, contradicting fears that vaping will be a gateway to cigarettes. Research evaluating the effects of a ban on flavored e-cigarettes in San Francisco suggests that it may have unintentionally increased the use of combustible tobacco among teens. Challenging tradeoffs like these are inherent to tobacco control and policies that do not take them seriously will often fail to achieve their intended aims.

That brings us to the difficult decisions the FDA must now make about the future of vaping. The law the agency is tasked with enforcing was passed in 2009, years before the unanticipated rise of e-cigarettes. Backed and negotiated by tobacco giant Philip Morris, the Family Smoking Prevention and Tobacco Control Act was designed for a more stagnant market. It grandfathered in nearly all tobacco products that were sold before 2007 while subjecting newer products to an onerous and costly process of regulatory review. In practice, that means that lethal cigarettes continue to be freely sold, no questions asked, while lower-risk e-cigarettes are threatened with prohibition.

The FDA has struggled with how to apply this poorly designed law while balancing the potential for harm reduction with public demands for strict regulation. Given the scope of the market and the complexity of the issues, the FDA itself sought more time to develop a sensible regulatory framework. Under former Commissioner Scott Gottlieb, it would have delayed the deadline for applications until August 2022, but a misguided lawsuit brought by health groups forced an acceleration of the schedule.

Submitting testimony to court in 2019, the director of the FDA's Center for Tobacco Products warned that enforcing rapid compliance would eliminate many products from the market and drive smokers back to tobacco: "Dramatically and precipitously reducing availability of these products could present a serious risk that adults, especially former smokers, who currently use [e-cigarettes] and are addicted to nicotine would migrate to combustible tobacco products."

That is precisely the outcome that will occur on September 9 if the FDA takes a hardline approach to vapor product applications. The agency has already rejected 4.5 million applications from a single company for lacking environment assessments; more ominously, it also rejected 55,000 applications from manufacturers of flavored e-liquids last week and at least another 800 applications on Monday, reportedly all for products in flavors other than tobacco or menthol. Close watchers of the industry fear that this portends disaster for independent "open system" products that allow vapers to choose the flavors, nicotine concentrations, and physical components that work best for them.

It appears that the FDA's decisions will ultimately be determined less by the actual risks of the products involved than by the question of which companies have the resources to conduct expensive scientific trials. An ironic result of this would be that the e-cigarette brands most likely to survive this winnowing are those that are at least partially owned by "Big Tobacco" companies, who stand to gain massively from the anti-competitive effects of banning their smaller competitors.

It should be obvious that this is an irrational way to regulate vaping given that the relevant comparison is to lethally dangerous cigarettes, which remain widely available and essentially unchanged after 12 years of FDA regulation. Yet because the anti-smoking lobby has spent years encouraging moral panic about vaping and decades denigrating the rights of tobacco and nicotine consumers to make their own decisions, the pointless prohibition of a wide swath of far safer nicotine products will likely proceed without much protest from anyone but the small minority of vapers themselves.

The FDA's own incentives tilt toward appeasing anti-vaping groups and reducing its workload by setting an impossibly high bar for smaller e-cigarette and e-liquid companies, but in doing so it will perpetuate smoking. The more humane option would be for the FDA to use its discretion to keep many more products on the legal market, including open systems and nontobacco flavors, by recognizing the abundant evidence that vaping is driving down rates of smoking, helping smokers quit, and rendering the conventional cigarette obsolete.

Despite making tremendous progress to curb smoking, 34 million Americans still smoke and more than 400,000 of them die prematurely every year. The habit is disproportionately ingrained among the least well off, including those with low incomes, low levels of education, and mental illness. These smokers deserve better than the moral panic and demands for abstinence that dominate the discourse around nicotine use. For many, access to safer and more appealing options is a matter of life and death. To take that away from them would be a tragedy, one the FDA can avert by choosing harm reduction over prohibition.