Refining the Food and Drug Administration’s Public Communications, Research Priorities, and Policy Evaluation

The US Food and Drug Administration (FDA) must take care that its research priorities, public communications, and product bans do not cause more harm than good. Most Americans now perceive vaping as no safer, if not more dangerous, than smoking.^1,2 A majority also think, incorrectly, that nicotine is the principal reason cigarettes cause cancer.³ And most Americans blame nicotine vaping for the 2807 hospitalizations and 68 deaths linked to e-cigarettes since last year⁴ even though the actual cause in almost all cases was illegally produced, tainted THC (tetrahydrocannabinol, the principal psychoactive constituent of cannabis) vape cartridges. FDA leadership bears substantial responsibility (albeit not so much as the Centers for Disease Control and Prevention’s leadership) for this pervasive and growing disparity between public perceptions and the truth.

One particularly egregious example occurred in September 2019, when the FDA publicly castigated Juul for promoting its e-cigarette as a less harmful alternative to combustible cigarettes.⁵ Expert observers understood that Juul was being criticized for having failed to obtain official approval before making such a claim, but the public could only have assumed that the FDA believed that Juul’s device was just as dangerous as combustible cigarettes or of no help in quitting smoking.

Miscommunications of this sort tragically undermine what should be the overriding goal of getting 34 000 000 smokers to stop while dissuading young people from smoking combustible tobacco products. Meanwhile, abundant evidence from the illicit drug education field suggests that deceiving and even lying to young people about the relative risks and dangers of particular drugs may produce promising results in the short term but backfires over the long term.⁶

The guidance also demonstrates naivete regarding potential harms and growth of a dynamic illicit market. It fails to note, oddly, that the EVALI (e-cigarette or vaping product use-associated lung injury) hospitalizations and deaths overwhelmingly were caused by cartridges produced and sold illegally. The guidance then expresses overconfidence in the FDA’s ability to manage the illicit market consequences of banning products used by millions of people.

It is worth observing that the prohibition on marijuana, which similarly was justified in terms of protecting youths, did little to reduce availability of marijuana to young people even as tens of millions of people were arrested, millions incarcerated, and vast sums expended on behalf of enforcement efforts. E-cigarettes differ in important ways from marijuana, but the FDA would be foolish to underestimate the resourcefulness of both criminal entrepreneurs and motivated consumers.

FDA guidance repeatedly references its desire to balance the potential harms of e-cigarettes to young people with the potential benefits of this disruptive technology for adults trying to quit smoking. One finds, however, remarkably few references to how and why smokers succeed in quitting with e-cigarettes, or even how many have done so. (Rough estimates for the United States range between 2 and 5 million.) This failure likely reflects not just the skewed research funding priorities of the FDA and associated agencies but also powerful ideological and political biases among gatekeepers to that funding. Talented researchers are deterred and excluded and obliged to choose among three options—refraining from seeking funding, skewing their research agendas to satisfy funders’ biases, or seeking funding from sources associated with the tobacco industry—with all the downsides of professional and social ostracism and skepticism that follow.⁷

The FDA cannot possibly accomplish its balancing objectives so long as its research funding priorities and decision-making remain so unbalanced. Most striking to me is the virtual absence of ethnographic studies using in-depth interviews of former smokers who now vape e-cigarettes, many of whom view their transition not as a matter of lifestyle but rather one of life or death.