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There appears to be something of a disconnect in US public health policy.
In many ways that is not surprising, given the government is in the middle of a handover that will result in a massive shift in philosophical outlook on myriad issues.
But even putting that aside, the recent proposal for a rule to limit the maximum nicotine content for the vast majority of combustible tobacco products still represents something of a major change from years, or even decades, of prior decisions.
The proposed rule places a heavy emphasis on the role of alternative nicotine products in the future market of very-low-nicotine combustible tobacco. These categories of products are meant to not only provide an off-ramp for current smokers who can no longer get their nicotine from cigarettes or the like, but also be a bulwark against the developing of an illicit market.
Officials at the US Food and Drug Administration (FDA) say in the notice of proposed rulemaking (NPRM) that they think the presence of alternative nicotine products with higher levels of nicotine will help prevent the development of an illicit market for products such as regular-strength cigarettes.
The trouble with this is, due to the FDA’s actions (such as the rejection of specific science behind vaping products as not being up to its standards, and applying the premarket tobacco application (PMTA) process for products already widely available on the market), pretty much all of the vaping products on the US market are there illicitly, while many of the other nicotine products available are – at best – operating in a regulatory grey area, recent approvals of all US-sold lines of Zyn nicotine pouches notwithstanding.
How does the FDA really feel about nicotine?
It seems a remarkable volte-face to deny the vast majority of vaping products attempting to be on the US market legally by going the PMTA route and then say it is hoped the presence of these products will help smokers transition to safer nicotine products and prevent them from seeking out illegally made or imported conventional cigarettes.
The move also seems to show a disconnect over nicotine as a substance. Throughout the NPRM, the FDA reiterates that nicotine itself is not particularly harmful. It is all the other carcinogens found in combusted tobacco that are the true killers. The agency also laments the current state of harm perception in the US, with many believing nicotine itself causes cancer.
Yet the FDA has been at the forefront of the mob hounding vaping companies for getting young people addicted through nicotine-containing vaping products. If nicotine itself is OK, why all of the previous outrage?
The FDA’s main claim for its concern over nicotine and youth is because of the potential effect nicotine has on brain development. There was also the dubious gateway theory that youth vaping would later lead to youth smoking. And the FDA still maintains that young people and non-smoking adults should not take up nicotine use if they are nicotine-naive.
But the agency cannot spend years fuelling outrage over nicotine-containing vaping products in schools and then stand around wringing its hands and lamenting that everyone now seems to think nicotine itself is evil.
The FDA may not have been directly responsible for much of the anti-vaping propaganda that has been produced over the last few years. But it also did nothing to limit critiques about adolescent brain development and could very much be said to have actively contributed to many other mountain-out-of-molehill concerns about vaping, such as nicotine poisoning, lung damage or heavy metal contamination.
The unpredictability of whether the rule will survive
The proposed rule is a bold move that would 100% lead to improved health outcomes even in the FDA’s worst-case scenario in terms of illicit market growth, non-compliance and failures on models for quitting or switching to alternatives.
Several public health advocates appear to have taken a “why bother?” attitude to the rule. They suggest it has little chance of passing. There is a high likelihood the incoming administration under president Donald Trump will nix it for no more reason than it is a holdover proposal put through by the previous regime (despite Trump’s having toyed with the idea himself during his first term in office).
Trump support is not out of the realms of possibility. He has a well-known distaste for smoking, and the main beef that Robert F Kennedy Jr., his presumptive health secretary, has with existing public health experts is about vaccines. Kennedy has not commented very much on tobacco-related issues, but the rule would potentially fit in with his broader beliefs around improving the overall health of the US – even if it may clash with pro-consumer choice sentiments he holds.
Even if Trump does support the proposed rule, detractors say, there would be significant further barriers. They point to continued fights on issues such as graphic warnings. Lawsuits have held up imposing more graphic warnings on conventional cigarettes long enough to make the US an anomaly in terms of developed, western countries.
Given that, how long will challenges against a rule capping combustible tobacco nicotine at minuscule levels last? But that in itself is not a reason to give up before even starting. The FDA has anticipated some obvious objections. It is not calling for a full ban on conventional cigarettes.
Nor is it reducing nicotine content to zero, which it is prohibited from doing by US law – a move driven by prior lobbying. In many ways, then, this could be viewed as the next step forward in a fight between public health regulators and tobacco companies. In such a scenario, further lawsuits are nothing more than future battles in the same war, and their burden should not be considered when deciding whether to take this current step.
– Freddie Dawson ECigIntelligence staff
Photo: Gilberto Parada
