Hysteria over vaccines in the US is introducing incoherence into all levels of public health policy to the detriment of tobacco control. Changes in leadership and staffing, coupled with a desire to bend science to political will at the US Department of Health and Human Services (HHS), is undermining the ability of federally supported elements to perform tasks essential to the execution of public health policy in all areas – not just those surrounding vaccines.
To the surprise of no one following recent general political discourse, the primary objective of the HHS under president Donald Trump’s administration is overturning mandatory vaccination programmes and generally putting the screws to vaccination theory.
HHS secretary Robert F Kennedy Jr. may have obfuscated and outright lied during nomination hearings when he said he would let the science guide him and would be open to learning about facts supporting vaccination. But the primary public health objective of those working for the Trump administration has become clear.
It is to undermine and roll back vaccination programmes as much as possible, even if leadership has thus far lacked the courage to outright say it. However, efforts to weaken vaccination in the US have been incoherent, while also weakening other aspects of public health – including tobacco control.
A chaotic, top-down approach
That incoherence starts at the top. President Trump recently said he supported many vaccines that “pure and simple worked”. He would later come back with statements more in line with those of the vaccine-sceptical wing of his supporters (who are more concerned with vaccines than other Americans).
The contradictory statements on a topic that is meant to be so important to many of his supporters suggest that Trump is unconcerned with vaccines and public health policy in general. He has elected to delegate this non-priority issue to secretary Kennedy to run as he likes.
Kennedy has been consistent in his stance on vaccines for some time. But his approach to bedding in anti-vaccine sentiment at HHS public health departments has been disjointed. For example, the attempted personnel cuts at the HHS are largely linked to the anti-vaccine sentiment of the HHS leadership.
They primarily target the scientific basis supporting and justifying the use of vaccines as part of public health policy to remove impediments from the path of bringing in further personnel supporting anti-vax views. A secondary list appears to be largely for political reasons, with both Democratic appointees and any perceived benefactors of diversity, equity, and inclusion programmes allegedly being targeted.
For example, the leadership of the US Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) was eliminated, having been appointed during previous Democratic administrations – though many in the nicotine alternatives sector would like to believe it was due to their mishandling of the premarket tobacco product application (PMTA) process.
Conflicting justifications for cuts
The cuts had a secondary objective of refocusing the primary aim of organisations such as the Centers for Disease Control and Prevention (CDC) back on their primary mission. In the case of the CDC, this is meant to be the prevention of infectious diseases, something that opposition to vaccines – with no lack of irony, though a degree of incoherence – undermines.
The cuts could also be said to be part of a wider Trump administration policy to cut government spending. In this case, the idea would be the elimination of part of the federal workforce leading to a proportionate reduction in federal budget. Some of the cuts were purported to be for duplicate roles across departments that administration leadership felt could be handled centrally – for example, human resources and media relation roles. This disregards the specialist knowledge such positions would likely require. For example, there is a marked difference in knowledge required to be able to recognise characteristics for experts or discuss important details of work in progress in areas as diverse as as oncology and medical device approvals.
Again, there is a lack of coherent policy here, as the reduction in budget through the elimination of a few thousand federal workers would be miniscule in the grand scheme of the federal budget.
Legal challenges
Outside the aim and impact of the cuts seemingly not being fully thought through, the actual execution of the dismissals has also been incoherent. There has been not one but multiple occasions where cuts were announced before later being rescinded.
Official reasons for recantations were not always given (nor for the dismissals in the first place in many cases, with some inclusions being admitted to be simply in error). Those reasons for dismissals being rescinded that could be ascertained included because staff being dismissed were essential to the day-to-day running of departments, were otherwise essential to the execution of tasks mandated by law (for example, freedom of information requests), or were found to be not paid for by the federal budget so could continue fulfilling their roles without impact on larger fiscal reduction objective. This was the case for those dealing with medical devices who were recalled. But not for those dealing with tobacco products, despite both being funded by the fees paid by companies being regulated.
Those orchestrating the cuts have also been ill-served by legal advice. The process has been beset by legal challenges, the largest of which remains unresolved more than half a year after initially being filed.
Several other personnel decisions are likely to result in their own lawsuits. For example, last month the CDC rescinded the ability of employees with disabilities or other health issues to work from home. The decision was widely believed to be another attempt to increase pressure on employees to get more to tender their termination. But it is also widely believed to be in violation of various employee protection laws – the sort of rules the Trump administration has generally been contemptuous of and worked hard to remove. But notwithstanding, still laws of the land as things currently stand.
Political approval over science
And all of this incoherence and chaos has had a detrimental impact on the execution of tobacco policy in the country. It was suggested by former heads of the CTP – generally not considered friends to the alternative nicotine sectors – that the sole purpose of the cuts and dismissals, including their scattershot nature, was to simply sow confusion among the federal workforce and lower morale so more choose to leave of their own accord.
But merely collapsing the morale and spirit of the federal workforce is not an objective in itself. And the resultant disruption has not proven to be great for the regulation of tobacco products or the monitoring of various important tobacco-related health statistics.
What it has done is made it easier to install personnel okay with taking direction from political overlords. Demoralised staff are more likely to be grateful to still have jobs and less likely to kick up any sort of fuss with superiors.
Once more, this plays into the demolition of vaccine science and policy by creating an atmosphere where political will can triumph over scientific direction. But such a situation is equally detrimental to other areas where politics and science collide – such as theories of harm reduction.
Both Trump and HHS secretary Kennedy have previously promised to let the science lead and to follow scientific best practice in all decisions taken. This has quickly been shown to be a lie – vaccines are universally supported by science as a net boon for public health.
It has also led to multiple resignations and reappointment of nominees among public health leadership. Last month, Susan Monarez, who was fired in August as CDC director, told senators she was forced out because she refused to bow to pressure on vaccine mandates and political appointments. Monarez said she faced significant pressure from secretary Kennedy to both support administration policies on changing the childhood vaccine schedule – despite this being against scientific advice – and to back changes to high-level personnel involved with US vaccine policy.
This included firing senior scientific staff and backing appointments handpicked by Kennedy – many of whom either did not have scientific backgrounds or, if they did, supported fringe scientific theories that were not backed by facts. Monarez also said Kennedy told her all major public health policy decisions across the HSS would require prior political approval.
Mixed signals on harm reduction
All this suggests there is not going to be any sudden coherent policy on tobacco control. For one, the conflation of science and politics has proven damaging to support for theories of harm reduction. Kennedy has, at times, expressed support for harm reduction. His pick to head the FDA, Marty Makary, has largely taken a prohibitionist stance on nicotine products.
Wider policy appears to be going negative on harm reduction in favour of prohibition as well. For instance, the administration recently threatened to withhold funds from supervised consumption sites or even looking to charge them with aiding drug taking for not promoting abstinence.
This, once again, suggests incoherence at the top level of policy creation. Either an administration believes in harm reduction or it believes in prohibition. It either lets science dictate policy or it lets politics do it.
Similarly, the lack of appointment or even nomination of new leadership in the CTP coming up to a year through the administration also suggests no coherent tobacco control policy from the Trump administration and that the area is not a priority for this government. It could be that tobacco control is being lumped in with other various areas of public health, where the administration believes control should be passed to the individual without government interference (with the notable exception of reproductive health).
A pouch-first strategy
Such a scenario would theoretically benefit nicotine alternatives at first glance. The assumption would be that if tobacco control decisions were more of an individual choice and less down to government public health restrictions, this would mean consumers would be free to choose from a wider array of flavours, strengths and other options among alternative nicotine products.
However, taken further it would also mean the relaxation of restrictions on conventional cigarettes, which would, at the very least, cut down on the desire to switch among the remaining smoking population. In worse scenarios, it could also lead to backsliding back into smoking among those that have already converted or quit.
The lack of priority for tobacco control and smoking cessation public policy is demonstrated through other aspects as well. There was hope a pilot programme for rapidly approving nicotine pouch PMTAs would be the first indication of a general support for harm-reduction alternative nicotine products. But it is becoming clear that the nicotine pouch pilot will not be extended to cover vaping products.
Kennedy has suggested that pouches are the best alternative nicotine product for smokers to switch to, and it appears the administration will back them as the primary non-prescription cessation solution. This appears to be linked to the belief there is a lack of youth interest in pouches. This is already a statement starting to wear thin as more evidence of youth use mounts. It will only continue to deteriorate if enforcement takes away cheap, flavoured vaping products.
For now, though, administration leadership continues to believe this lack of potential for youth uptake outweighs both potential benefits to cessation and dangers of longer-term potential health consequences (with both further determinants currently favouring vaping). This suggests it will continue to prioritise and favour pouch PMTAs over those for vaping.
Exacerbating the processing bottleneck
There is a further theory that the FDA will now only increase the difficulty in achieving a marketing granted order (MGO) for a novel nicotine product going through the PMTA pathway. The suggestion is that further products will have to prove they provide a net benefit to public health beyond that of what is already on the market.
In other words, they will have to prove they offer even better cessation potential and smaller youth abuse or interest potential than comparator novel nicotine products on the market. At the same time, the continued reductions in staffing at the CTP – which again have no impact on federal budgets – make it harder for applications to be reviewed and processed.
There is an element of thinking among industry members that the dismissals are just desserts for incompetence so far, which certainly has some truth to it. Delays in assessment got so bad even tobacco companies, which have generally enjoyed decent responses from the FDA on PMTAs for their vaping, pouch and heated tobacco products elected to sue the FDA over its lapses.
But reducing the workforce is not going to help speed up any review process. Of course, the FDA could hire new CTP personnel. But this would go against the current overall trend of reducing the federal workforce (regardless of whether payment for it comes out of the federal budget). And even if the HHS was to buck the general trend and hire in new CTP staff to process applications, who exactly is it going to find with the very narrow sector specific experience required to do the job?
The industry’s answer would be “from the industry or academia”. But hiring tobacco industry personnel to regulate tobacco products would be a non-starter for public relations purposes, if nothing else. Those involved in academia may have the experience to perform the assessments, but how many would be willing to trade in the positions they worked for to take anonymous federal workforce staffing jobs – particularly given what has happened to their immediate predecessors?
Altogether, it gives no great optimism for the alternative nicotine and vaping sectors or suggestions of joined-up thinking for public health policy. Instead, it appears obsession over vaccines has dragged the entire US federal approach to public health down with it, leaving tobacco control and public health smoking policy no better off a year into the Republican Trump administration than it was under previous Democratic ones – and, in some cases, significantly worse.
Freddie Dawson TobaccoIntelligence senior contributing editor
Image: AI-generated
