British American Tobacco (BAT) and its American unit, R.J. Reynolds, are undoubtedly having a very good week, but the same cannot be said of the public health sector, never mind the tobacco control community. While the former are reveling in the just announced U.S. Food and Drug Administration (FDA) authorization of their Vuse Solo e-cigarette and two if its accompanying tobacco-flavored pods, the latter are left positively reeling at the decision.
This is the first time the U.S. FDA has approved an Electronic Nicotine Delivery System (ENDS), an umbrella term for products also commonly referred to as e-cigarettes, vapes, or vape pens. For those who are not familiar with the heated vaping debate, the Juul propelled youth vaping craze or the fact that the United States was home, in 2020, to some 3.6 million youth e-cigarette users, it’s worth enumerating why permission to market Vuse Solo has public health policy practitioners mentioning Pandora’s boxes.
Lest it be publicly presented with data that would paint its decision as particularly egregious, the FDA insists that it “considered risks to youth when reviewing these products” and also claims that it is “aware” of and “takes very seriously” specific evidence, including the 2021 National Youth Tobacco Survey (NYTS). Conducted annually by the Centers for Disease Control (CDC), this school-based survey found that approximately 10 percent of high school students who currently used e-cigarettes named Vuse as their preferred brand.
Though cited, the NYTS data did not inspire the FDA to embrace the precautionary principle—err on the side of caution when a new product poses risk—because, as the agency fully concedes, it was largely informed by specific evidence provided by the RJR Vapor Company. According to the FDA, the company submitted significant data demonstrating that marketing Vuse products would be “appropriate for the protection of the public health”; that the benefits to the whole population would outweigh any risks to youth; and that tobacco flavored Vuse products could help addicted adult smokers cut down on or quit combustible cigarettes.
The FDA is not required to disclose its decision-making process, nor is it mandated to share the evidence on which it draws. Still, given both its track record on e-cigarettes—it waited two full years before demanding that Juul document its marketing, research, and sales efforts toward youth—and the tobacco industry’s reputation as an unreliable narrator, a bit more information on how this all came to be is most welcome. For example, what specific studies did RJR conduct to determine that the risk to youth is low? How exactly did RJR conclude that Vuse is effective for smoking cessation? Did it only conduct studies in clinical settings, or did it also ensure that findings manifested in the real world, too?
Absent answers to these questions, we are left speculating about the future and pondering when officials meant to protect us might learn from the past.
Before it was acquired by the rivaling BAT in 2017, RJR Reynolds was a prominent tobacco player in its own right. And both companies are, of course, part of an ignominious industry whose product claims almost 500,000 deaths each year in the United States alone. Fifteen years ago, in her groundbreaking 1600 plus page ruling, U.S. District Judge Gladys Kessler noted that for more than fifty years, cigarette companies had “lied, misrepresented and deceived the American public, including smokers and the young people they avidly sought as ‘replacement smokers,’ about the devastating health effects of smoking.”
To its credit, the FDA appears to have learned part of the lesson from the Juul fruity flavor fiasco—parents and public health rightly experts argued that these directly targeted youth—that occupied much per-pandemic periodical real estate. The agency issued 10 marketing denial orders for Vuse’s other flavored ENDS products, but in authorizing both the vaping device and tobacco-flavored pods, we must question both whether young people will seek out this flavor in the absence of others and if the agency needs a refresher course in how a $15 billion industry has come for kids before.