Yesterday for Slate I wrote a long article on current regulations surrounding e-cigarettes, their potential for harm reduction, and teen use of Juul and other vapor devices. So naturally this morning the FDA announced major changes to its policies and secretive new data. (In an email to my editor this weekend I’d said, “Let’s try to run it soon, just because you never know when the FDA might announce something that would force re-writes.” I’ve been down this road before.) I’ll use this post to talk about both my article and the new announcement.
First, my article in Slate. The gist of it:
Teenage use of e-cigarettes is a legitimate concern to address, but it’s important not to panic. The media’s alarmism obscures a wealth of good public health news: Smoking rates are lower than they’ve ever been, they’re dropping fastest among young cohorts, and young adults actually have a better understanding of the relative risks of conventional and electronic cigarettes than do their elders.
This is all still accurate and much of the piece expands on this with data. Polling among adults shows that beliefs about e-cigarettes are still wildly out of touch with the developing consensus that they are much safer than conventional cigarettes. In addition, many people erroneously believe nicotine to be a primary disease-causing agent in tobacco. Media alarmism and the FDA’s marketing restrictions both contribute to the spread of this misinformation.
I also write a bit about the Swedish and Norwegian experiences with snus, a form of oral tobacco that imposes fewer risks than both smoking and American-style chewing tobacco. The Swedish success is fairly well-known at this point, the Norwegian one less so. Snus use eclipsed smoking in Norway for the first time last year, with the shift in consumption most pronounced in young people. Smoking rates in both countries, especially among young cohorts, are now remarkably low.
The last part of the article gets into the fundamental approaches to nicotine regulation. The debate is usually portrayed as between two camps: those who want to eliminate nicotine use entirely and those who focus on harm reduction. I suggest that a deeper divide is between technocrats and dynamists, the latter term borrowed from Virginia Postrel:
[Allowing] adults to make informed choices about nicotine frightens regulatory gatekeepers. The abstinence-only and harm reductionist camps have different visions for combating smoking, but both believe that their visions should be imposed via legislation or through agencies like the FDA. They share a technocratic approach that tolerates change only when it’s tightly managed. As Virginia Postrel described technocracy in her insightful 1998 book The Future and Its Enemies, “Technocrats are ‘for the future,’ but only if someone is in charge of making it turn out to plan.” That there must be a plan is never questioned: “The issue isn’t whether the future should be molded to fit one static ideal. It’s what that static ideal should be. There must be a single blueprint for everyone.”
Opposition to technologies like Juul must be understood in part by the ways that they upset that static vision. Technocracy depends on central planning and top-down control. E-cigarettes, in contrast, are all bottom-up and unruly. They arose in vape shops and strip malls hacked by users mixing flavors, components, and nicotine concentrations to meet their individual needs. This messy disorder made room for an evolutionary process that refined innovations that worked and discarded those that didn’t. While no one could have predicted the spectacularly sudden rise of Juul in particular, it’s not so surprising that the leading e-cigarette company turns out to be a total newcomer rather than one of the pharmaceutical or tobacco companies that have profited from decades of stasis.
Which brings us to today’s announcement from FDA commissioner Scott Gottlieb. When he delayed enforcement of the agency’s pre-market review requirements last year, I wrote approvingly that this signaled a lighter touch at the FDA that recognized the potential of harm reduction. A year later, armed with new data and perhaps motivated by a summer of media stories about teens addicted to Juul, he’s threatening to roll this back:
[In] view of the accelerating use among youth, we’re actively considering whether we will enforce the premarket review provision earlier, when it is apparent that these products are now subject to widespread youth use.
One factor we’re closely evaluating is the availability of characterizing flavors. We know that the flavors play an important role in driving the youth appeal. And in view of the trends underway, we may take steps to curtail the marketing and selling of flavored products. We’re now actively evaluating how we’d implement such a policy.
[We’re] seriously reconsidering our compliance dates for the submission of product applications when it is apparent that there’s widespread youth use of the product. We’re especially focused on the flavored e-cigarettes. And we’re seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.
In addition, the FDA is stepping up enforcement at the retail level and launching a campaign to deter e-cig use among youth. If implemented properly, these latter two initiatives are entirely appropriate responses to youth uptake of e-cigs. Juul as a company has also been justifiably criticized for its lifestyle marketing (though the FDA makes advertising as a harm reduction tool virtually impossible). But bringing back the agency’s notoriously burdensome pre-market review and banning flavors (which are preferred by many adult users) threatens to undermine the potential of e-cigarettes to reduce conventional smoking.
According to Dr. Gottlieb, this reversal is justified by data that the agency is not ready to make public:
We have good reason to draw this conclusion based on the trends and data that we’ve seen, some of which is still preliminary and will be finalized in the coming months and presented publicly.
I’m certainly curious to see this data. Based on the latest publicly available figures, this is what I wrote for Slate:
The 2015 National Youth Tobacco Survey, for example, found that nearly 38 percent of high school students had ever tried an e-cigarette. That sounds alarming, but very few of them (2.5 percent) reported regular use—and regular use is particularly rare among non-smoking youth. The latest available figures also suggest that use of e-cigarettes among high schoolers is down from its peak in 2015. That’s no reason to be complacent about teen use of Juul or any addictive substance, but the most current data available suggest that nightmare stories of a vaping-to-cigarette pathway are the exception, not the rule.
I’d considered adding an obvious disclaimer that the next release of statistics might show youth use increasing again due to the popularity of Juul, and in hindsight I wish I’d included it. This morning I asked the FDA about both the source of the data and more specifics about what they show, but their press officer was unable to provide any further information so we’re stuck evaluating the FDA’s announcement in the dark. If we did have access to the data, I’d want to know the degree to which increases are in experimentation, occasional use, and regular use.
What’s notably absent from Dr. Gottlieb’s remarks is any mention of youth smoking. While teenage use of e-cigarettes or any addictive product is worrisome in itself, the chief fear is that teens who try e-cigs will move on to take up the real thing. Unsurprisingly, teens who experiment with one forbidden product are more likely to experiment with another, so many young people report having tried both. But thus far the rise in e-cigarettes has been accompanied by a fall in smoking. The 2017 youth smoking rate was 7.6%, a record low, down from 12.7% in 2013. In terms of actual health outcomes, avoiding cigarette use remains by far the most important aim. If the FDA has new survey data, it’s reasonable to guess that it asks about both vapor products and cigarettes. An increase in the use of the latter would bolster the case for the agency’s new course of action, so the omission of any remarks about youth smoking is curious. I asked if their new data indicated anything about trends in youth smoking, but once again their press office was unable to provide additional information.
As with any controlled substance, it’s challenging to balance an open market for adults with the need to prevent uptake by youth. But it’s vital not to shut down innovation in the market for cigarette alternatives. The FDA says it still believes in the potential non-combustion products, but today it’s a very open question whether its actions will reflect this. As Jacob Sullum remarks at Reason:
The federal government is threatening to eliminate that alternative even while tolerating conventional cigarettes, which are far more hazardous and also end up in the mouths of people who are not old enough to buy them legally. If underage consumption does not justify a ban on tobacco cigarettes (and I don’t think it does), it cannot possibly justify a ban on competing products that are much safer.
The narrow questions about flavors and lifestyle marketing are a preview of the debates to come. The abstinence/harm reduction divide is gradually going to become less salient than the technocracy/dynamism divide. Harm reduction advocates have been focused on the benefits of shifting consumption from cigarettes to much safer forms of nicotine delivery. This is entirely correct, but the achievement of this goal will bring other questions to the fore. What’s the best approach for people who continue to smoke cigarettes in spite of everything? What about people who smoke for pleasure, perhaps with cigars or pipes? What about non-smokers who take up vaping because they like it?
Scott Gottlieb has taken a looser approach than his predecessor, but the FDA is still committed to central planning. The agency has already noted that it intends to mandate lower nicotine yields in cigarettes, and if history is any guide then it won’t be long before this rule is extended to other forms of tobacco. The pervasive assumption is that bringing tobacco and nicotine use down to zero is a universal goal that everybody shares. Gottlieb speaks of “on-ramps” and “off-ramps” to nicotine as if he’s a city planner optimizing traffic patterns. But we’re not all headed to the same destination. As the gains of harm reduction are realized, the underlying questions of consent and coercion that have always surrounded tobacco will coming roaring back.
In my Slate piece I briefly quoted an interview with Karl Lund, a senior researcher at the Norwegian Institute of Public Health. Here’s a longer excerpt from that interview that gets to the point:
I think nicotine will become a more accepted drug if delivered without severe health risks. The tobacco control community will eventually have to accept that we have to separate nicotine from tobacco. In the 1990s the strategy was to warn against the axis of evil; cigarettes – nicotine – tobacco industry. Now we are paying the price for this merging. The goal should be to reduce tobacco-related deaths, not to make the society nicotine-free.
I think much of the opposition against THR and novel nicotine products comes from the fact that health side has been on the outside and not in the driver-seat of its development. These innovative products have emerged without their control and approval. This is a consumer-driven process. It is difficult for us to realize and accept that these products may have greater potential to make smoking obsolete than the regulations many of us have spent a lifetime fighting for.
Reducing tobacco-related deaths is a noble goal, but there are limits to what planning can achieve without crushing personal liberties. The dynamic approach to tobacco regulation empowers smokers by giving them safer alternatives to the cigarettes. Like Scott Gottlieb, I’m optimistic that many of them will take them and eventually quit using nicotine altogether. But the purpose of government should not be to impose the preferences of regulators onto everyone else by micromanaging the market and placing ever more coercive restraints on adult behavior. It’s too often forgotten by authorities in tobacco control, but the aim of a liberal society is to give people the space to pursue their own ends, not to insist that they conform to ours. An open market in nicotine products will indeed lead to healthier outcomes than the status quo, but the ultimate patterns of use are not ours to control.