FDA Commissioner Scott Gottlieb ended months of speculation about the future of vaping with his Thursday announcement of sweeping new regulations on e-cigarettes, flavored cigars, and menthol cigarettes. The new rules are a response to what he has taken to calling an “epidemic” of youth uptake of e-cigarettes, particularly those produced by the brand Juul, whose wide range of flavors, sleek design, and unique nicotine delivery have made it popular among both youth and adults.
The most immediate impact is a crackdown on flavors besides tobacco, menthol, and mint. Everything else—including offerings such as mango, cucumber, or crème brulee—will no longer be permitted for sale outside of age-restricted, in-person locations. That means they won’t be available in most convenience stores, and buying a flavored e-cigarette will instead require a visit to a specialty retailer such as a vapor shop, tobacconist, or a store with separate areas reserved for adults. (In a separate action announced before Gottlieb’s decision, Juul went even further, removing its non-tobacco and mint flavors even from vape shops. They will now only be sold online.)
The exemption for mint and menthol flavors mirrors the law for combustible cigarettes, for which all flavors except menthol are forbidden in the United States. Yet that, too, may be changing. Though the rules will take longer to implement, the FDA also announced plans to pursue eventual bans on menthol cigarettes and all forms of flavored cigars. This has been a longtime goal of hard-liners in tobacco control, who argue that flavored tobacco makes it easier for youth to initiate use and become addicted.
The announcement marks a striking departure from Gottlieb’s tenure at the FDA so far. A former fellow at the conservative American Enterprise Institute, he was widely expected to champion deregulatory policies on e-cigarettes—which are, it’s worth saying, essential harm-reduction tools. One of his first significant actions was to delay overly burdensome rules that could have forced thousands of e-cigarettes off the market, imposed impossibly high costs on manufacturers, and subjected all remaining products to an opaque process of pre-market review. This was widely viewed as a victory for harm reduction, winning praise both from free-market libertarians and many public health advocates. In contrast, the policies revealed on Thursday are unlikely to please anyone: They fall short of the complete ban on flavored e-cigarettes that some anti-tobacco groups have championed, but make it harder for adult vapers to access the products they want.
The perverse irony of the new rules is that while many e-cigarettes will now be banned from convenience stores, perfectly lethal combustible cigarettes will still be right there on the shelf. To many advocates of tobacco harm reduction, this represents a striking misunderstanding of the harms posed by each product. “Every argument that the FDA is making in justifying a ban on the sale of electronic cigarettes in convenience stores and gas stations applies even more strongly for real tobacco cigarettes,” writes Michael Siegel, a professor at the Boston University School of Public Health and a former tobacco researcher at the Centers for Disease Control and Prevention, on his blog. “I believe this action will have a net negative impact on the public’s health because it will almost certainly result in many ex-smokers returning to smoking as their products disappear from convenience store shelves.”
The FDA justifies this unequal treatment by referencing new data allegedly showing Gottlieb’s “epidemic” of e-cigarette use among youth. The data comes from the latest National Youth Tobacco Survey, which has been annually tracking middle- and high-school use of tobacco since 2011. The FDA says this survey justifies its actions, but it’s also released only a fraction of the data, and it has done so in a way that makes it difficult to accurately judge the problem’s scale.
According to the FDA, “overall tobacco product use increased by 38 percent among high school students,” rising from 19.6 percent in 2017 to 27.1 percent in 2018. That sounds alarming. But it’s debatable whether lumping all forms of tobacco together in one figure is a useful metric. (It would also be more accurate to refer to them as “nicotine products,” since e-cigarettes don’t contain tobacco leaves.) As Gottlieb has stressed throughout his time at the FDA, nicotine consumption now exists on a wide continuum of harm, with products like combustible cigarettes presenting a far higher risk than vapor products. (The Royal College of Physicians estimates the risks of e-cigarettes at about 5 percent that of the real thing.) The overall statistic doesn’t provide any information about which type of nicotine products students are using or how often they’re being consumed, but occasional or experimental vaping has radically different health implications than daily smoking. By omitting this crucial information, this statistic obscures as much as it illuminates.
The FDA released more specific data about the number of students who report using an e-cigarette at least once in the past 30 days. This did increase sharply in the past year, rising from 11.7 percent to 20.8 percent. This is obviously concerning, but the more relevant figure is arguably the proportion of high school students who use e-cigarettes on a regular basis, defined in the survey as on 20 or more of the past 30 days. Oddly, the FDA’s press communications do not directly provide the figure.
Instead, the FDA reveals that among high school students who have tried vaping at all in a 30-day period, the proportion of them that vape on 20 or more of those days has increased from 20 percent to 27 percent in the last year. That sounds alarming, but the figure is misleading: It’s not saying that 27 percent of students regularly vape. The more logical way to present the data would be as a proportion of students overall. Doing the math, this comes to about 5.8 percent of high school students regularly vaping.
Is that cause for concern? Absolutely. But could this be believably portrayed as an epidemic justifying aggressive intervention in the market that restricts access for adults too, many of whom are switching from cigarettes to these much-safer alternatives? Possibly not. (Also worth noting: Despite this year’s press coverage about the youth Juul epidemic, figures for frequent vaping among middle schoolers didn’t increase by a statistically significant amount.)
From a public health perspective, smoking actual tobacco is still much more worrisome than vaping. Discussions that neglect that context inevitably miss the full picture. The good news is that cigarette use among high schoolers has fallen by half in less than a decade, from 15.8 percent in the 2011 National Youth Tobacco Survey to 7.6 percent in 2017. (Results from 2018 have not yet been released, but leaks suggest a statistically insignificant increase to 8.1 percent.) This is the same period in which the popularity of vaping has risen substantially, undermining the scary narrative that e-cigarettes are seducing kids into actual smoking.
Ideally, of course, high schoolers would abstain from nicotine entirely. Realistically, there’s no way to provide access to safer forms of nicotine for adults that won’t have at least some spillover to youth. As suggested by Siegel, a better approach would have been to deal with Juul directly. The company’s products have been the most visibly popular among young people, and their earlier lifestyle marketing undermined the message that e-cigarettes should be primarily used by existing smokers. But rather than negotiate, Gottlieb has taken on the role of a stern parent threatening to turn this car around. “I could take more aggressive steps,” he warns, noting that he could end enforcement discretion and remove vapor products from the marketplace entirely. The e-cigarette industry—and more importantly, the people who have turned to a safer alternative to smoking—would bear the brunt of that overreaction.
Gottlieb claims to believe in the potential of harm reduction to address the devastating health effects of tobacco. If that’s truly the case, he still has many options at his disposal. Most importantly, he could streamline the FDA’s confusing pre-market approval process, bringing clarity to producers about the types of products that may eventually be permitted for sale. He could lift restrictions on targeted advertising to existing smokers that currently forbid e-cigarette companies from truthfully communicating with consumers. Enforcement against retailers who sell to youth could also be increased, with different approaches tried and evaluated at state and local levels—the beneficial kind of experimental federalism that one might expect a former fellow of the American Enterprise Institute to embrace.
Instead, the best we can say for now of the FDA’s new regulations is, “They could be worse.” And if the agency continues to give in to pressure from the most strident anti-smoking groups, they probably will be.
