By Erik Sass
TES Editor
One of the more confounding mysteries of U.S. public health regulation in recent years has been the crackdown on new forms of nicotine delivery, including e-cigarettes and vaping. On the face of it these new technologies, though still bad for human health, are vastly preferable to regular cigarettes, with their well-known and dire consequences: while still delivering addictive nicotine to users, the new devices are estimated to present a mortality risk that’s just 1% of traditional combustible tobacco. So why has the FDA put the new delivery systems under the regulatory gun?
It’s a complicated question with a complex answer, hardly rendered more intelligible by the opaque decision-making process of government regulators. But according to a presentation at the European Resource Bank’s conference in Chisinau, Moldova on March 30, 2019, the basic cause is regulators’ refusal to update longstanding anti-tobacco public health policies, due either to institutional inertia, moral judgments, or some combination of the two. What is definitely not part of the decision matrix is harm reduction – ostensibly the whole purpose of public health regulations in the first place.
Paul Blair, director of strategic initiatives for Americans for Tax Reform, noted that the U.S., like many other countries, has “pursued the precautionary principle because the way regulations have generally governed their treatment of the tobacco industry is aimed at prohibition.” According to Blair, a key component of this prohibition-focused policy has been making obtaining approval of new tobacco-related products as arduous as possible: “If you have a product you want to introduce on the market in the future, you have to get government permission to do so, and the process was essentially designed to end in failure. The process was not designed to bring new tobacco products to market.”
This strategy may have made sense when nicotine equaled cigarettes, full stop, but it becomes less coherent in the current technological landscape, when e-cigarettes and vaping could offer millions of smokers ways to transition to a significantly less harmful way to deliver their nicotine fix (which is, again, undoubtedly addictive and damaging to health in its own right, but far less so than cigarettes).
Describing this incoherence, Blair noted that FDA’s stated reason for cracking down on e-cigarettes and vaping was an “epidemic” of youth usage. On that note, according to the CDC in 2018 around 3.6 million teens, or 20.8% of high school students, reported having used the new products at least once in the previous 30 days. But at the same time, the CDC estimates roughly 34 million American adults are still regular smokers, while 16 million are living with a smoking-related disease, and 480,000 die from smoking-related causes every year.
The cost-benefit calculation just doesn’t add up: in order to prevent American teens from using a markedly less dangerous form of nicotine, the FDA seems content to allow around half a million American smokers die annually, while tens of millions more continue playing Russian roulette with cigarettes. And the irrationality of this policy is fully reflected in the incoherent regulatory approach, Blair added: “In the U.S we have tens of thousands [of new nicotine products] currently on the market that by 2022 will be illegal… What’s interesting about this process is that cigarettes are still protected.” As a result of cigarettes’ widespread availability, teens who might have experimented illegally with vaping or e-cigarettes can still smoke cigarettes, also illegally, instead.
It’s hard to find any rhyme or reason behind this approach – as opposed to, say, a two-pronged strategy that combines legal sales of the new devices to adults with a full-on public health advertising campaign targeting teens with messages about the negative health consequences of nicotine addiction, whatever its delivery form. Still grasping for explanations, we’re left facing the simple fact of regulatory inertia, abetted by a more nebulous moral motivation grounded in the old puritanical religious concept of vice as a simple moral failing. Rather than pragmatically pursuing harm reduction, this Manichean worldview presents adults already addicted to tobacco with a stark either-or choice: quit cold turkey or die. Here Blair noted: “The very innovations that could reduce these harms are being discouraged by the same public health groups… which refuse to embrace the fact that there is a continuum of risk.”
Blair concluded: “It’s a baffling question because if millions of adults transition away from cigarettes… the public health benefit so far outweighs youth experimentation that we are clearly moving away from an evidence-based approach to regulation, and pursuing a moral crusade.”
