Is regulation keeping up with the evidence?
As the European Union considers the future regulation of non-combustible tobacco and nicotine products, an important question emerges: is the available scientific evidence being assessed fully, consistently and transparently?
In this Science Lab presentation, Carrie Wade examines the EU’s Better Regulation Framework and the evidence used in the recent evaluation of the Tobacco Products Directive (TPD). She argues that sound regulation requires a broad and balanced evidence base—including quantitative and qualitative data, expert input, stakeholder perspectives, uncertainties and conflicting findings.
Transcription:
GFN Science Lab 4 — Carrie Wade
2026-06-05 · 11:30-13:00 (Europe/Warsaw) · Global Forum on Nicotine 2026
Barnaby Page 0:00:10
Let me hand over to our first speaker, who is Carrie Wade from BAT. Well, Carrie works in scientific engagement with BAT, will be a familiar face to many people who've been to GFM before. If we could have Carrie's video, please.
Video 0:00:27
As we work to understand the public health impact of non-combustible tobacco and nicotine products, one principle becomes essential. We cannot reach sound conclusions if we begin by restricting the evidence base. And yet in parts of scientific and regulatory landscape, we increasingly see attempts to do just that.
Today, I want to explain why this approach is scientifically unsound, inconsistent with the European Commission's better regulation framework, and ultimately harmful for public health decision-making. The Commission's better regulation guidance aims to create legislation that achieves its objective while being targeted, effective, and easy to comply with.
Under this approach, a robust assessment integrates quantitative data, qualitative insights, stakeholder input, and findings from earlier evaluations and scientific expert advice and explicitly reflects uncertainties and data gaps. Importantly, better regulation recognizes that evidence is rarely perfect.
Data can still be incomplete, information can still be biased, and some evidence may have limitations but still provide meaningful insights. What matters is not perfection, but fitness for purpose, transparency, balance, and traceability of how evidence informs conclusions.
A high-quality evaluation must make the evidence to conclusion chain transparent and traceable, explain why each type of evidence is appropriate, describe how it was gathered and analysed, show how conflicting evidence was handled, including triangulation, identify biases, limitations, and uncertainties, and explain their effect on the confidence in the conclusions.
In other words, better regulation explicitly requires breadth, completeness, and balance, not selective curation.
In the recently published TPD evaluation report, the Commission briefly outlines the health risks associated with non-combustible tobacco and nicotine products, such as e-cigarettes, heated tobacco, and nicotine pouches, relying primarily on a joint research center report, which acknowledges that this has important implications for tobacco control policies and strategies aimed at reducing the burden of tobacco-related diseases in the EU.
The question is whether both of the evaluation reports and its use of the JRC analysis meets the Commission's own standards for high-quality evaluation under the Better Regulation Framework.
Overall, our final assessment suggests that the evaluation report relies predominantly on hazard-based framing, which does not sufficiently contextualize how these products operate in real-world settings, including their potential role within tobacco harm reduction.
In his publication, Health Outcomes Associated with the Use of E-Cigarettes, Heated Tobacco Products, and Nicotine Pouches, which forms the basis of the Commission's evaluation reports related findings, the JRC assessed 32 reports from government, academic, and public health institutions that were published between 2014 and 2024.
Twenty-five reports included assessments on e-cigarettes, five on heated tobacco, and only three on nicotine pouches, a significant asymmetry that already limits the strength of any comparative conclusions.
In the final evaluation report, tobacco harm reduction is mentioned only two times with regard to snus and heated tobacco, with the Commission stating that there is insufficient evidence to support their role in tobacco harm reduction.
However, the JRC report presents more nuanced assessment, including statements from the US and UK public health institutions that support exactly such a role. Unfortunately, in some instances, failure to accurately reflect the underlying evidence base also applies to JRC's own report.
One noteworthy example from the JRC report is a selective quotation of the publication from the German Cancer Research Center in which the JRC removed a sentence outlining a potential benefit of switching to e-cigarettes. This particularly noteworthy example concerns the selective quotation of the German report in the JRC synthesis.
The original report notes that switching to e-cigarettes suggests short-term improvements in lung function, a sentence that is omitted in the JRC extract relied upon in the evaluation, despite being directly relevant to tobacco harm reduction comparison analysis.
These examples demonstrate a systematic narrowing of interpretation, rather than a neutral appraisal of the evidence base. Most importantly, while the evaluations assessment of non combustible products is framed largely as a hazard based assessment. Focusing on intrinsic risks it omits critical elements required under better regulation, which is comparative context.
In the European Union, where the average smoking prevalence remains around 24%, with member states ranging from approximately 8% to 37%, assessing alternative products without explicit comparison to cigarettes significantly weakens policy relevance.
There is no shortage of scientific assessments from industry, government agencies, and academic institutions that add to the knowledge base of how these products compare to cigarettes, intoxicant exposure, short-term health impacts of switching, and how these products are used, including whether these products act as a gateway to smoking.
Excluding or marginalizing this body of evidence prevents meaningful triangulation and undermines public health goals. For example, BAT studies have demonstrated a reduction in toxicant emissions across our product categories, where emissions are reduced between 90 and 99%. This translates to reduced toxicity responses between 90 and 99% when compared to cigarettes.
Such findings warrant critical scrutiny, but not blanket exclusion under better regulation principles. When broad streams of evidence, such as comparative risk assessments, are excluded or marginalised, public health goals are weakened.
This isn't consistent with better regulation and risks producing conclusions that are overly precautionary insufficiently substantiated, and potentially detrimental to adult smokers seeking reduced risk profile alternatives.
A credible evaluation of noncombustible tobacco and nicotine products must consider all relevant evidence, assess it against transparent methodological criteria, and integrate it through genuine triangulation. Only then can regulation be proportionate, scientifically defensible, and aligned with the EU's public health objectives. Thank you.
Carrie Wade 0:07:21
Thank you. I would just like to add or emphasise from the, I have nothing new to add because it was obviously perfect, but no, I just want to add and emphasise that when we looked at the EU's TPD's evaluation report and the underlying reports that supported the final evaluation report, what struck us at BAT was really that it's a hazard-based assessment.
And that does not take into account the actual real-world risks associated with these products, which is super important when you do have a smoking rate of 24% across the EU.
And what you can also see is that when you look at the different countries, 8% to 34% or 37%, sorry, you can see that some of those countries where it's lower at 8%, you're looking where they're switching away from different, from smoking to different products such as nicotine pouches and snus. And I think that is really an underappreciated finding.
that is largely ignored in the evaluation report. The other thing I would like to add is we're looking at a situation where the TPD is now going to include explicit references to nicotine pouches and heated tobacco products, and there are not enough reports that we're feeding into that evaluation report.
I mean, you're looking at 10 years of evidence that they were looking at, and only three reports included nicotine pouches, yet they're gonna use those three reports to create a regulatory framework, and if you're looking at what they say about nicotine pouches, you're looking at comments in the evaluation report suggesting that These products are not useful to display smoking.
These products contain nicotine, which is dangerous. Well, so do cigarettes. So I think these are the two things I would absolutely highlight.
As far as industry science goes, I mean, we can speak for days and days and days and probably perhaps years about whether or not it's appropriate to include industry science, but I do think in this context it is important because we do know so much about these products and that evidence does come from industry.
It warrants critical appraisal, of course, but it being filtered through other government reports and kind of biased I think is inappropriate in a context where you still have 24% average smoking rates. So that's what I would like to highlight and emphasise, but I'm happy to take questions.
Barnaby Page 0:10:01
I've actually got a couple of questions I'd like to ask you, Carrie, so I'll kick off. They're kind of related, so I'll put them together. First of all, you used a great phrase there, selective curation, which is a very polite way of putting it, and I'll remember that one and use it again. I wanted to ask you, how much do you think that is...
deliberate, and how much is that born out of ignorance? Clearly, some cases, such as the omission of the sentence about lung health, can only be deliberate. In other cases, it's simply down to a misunderstanding or an ignorance.
And then the other question I wanted to ask you, which is kind of related, is, of course, if you compare this upcoming TPD3 with TPD2, since then we've had over a decade of scientific output on reduced-risk products, and there's a huge body of work, particularly on vaping, on e-cigarettes. So how does the situation now compare with the situation then?
Is the science treated better, as it were, valued more, valued less? Has it become more or less politicised?
Carrie Wade 0:11:04
So to answer your first question, I think, I hate to say that I think it's quite deliberate. I mean, in the evaluation report and in the Joint Research Committee's report, I think I got that C right, I can't remember. But in those two reports, they do explicitly refer to the Cochrane reviews that show that e-cigarettes are effective for quitting smoking.
But their conclusion is entirely the opposite. And I don't know how you could claim that that is just a misunderstanding of the science. The Cochrane reviews explicitly say that that is their conclusion. It is ignored in how that's fed into the reports.
Other areas of the cardiovascular risks of nicotine, well, I think that that might be more of a a bit deliberate but more of a misunderstanding of the acute impacts of nicotine on the cardiovascular system versus the chronic delayed risks that are largely associated with smoking. But I do think it's an important context. The second question, I can't remember, I'm sorry.
You're gonna have to repeat that.
Barnaby Page 0:12:15
Sorry, it was about the way that science is treated or regarded by regulators now compared to the way it was a dozen years ago with TBD2.
Carrie Wade 0:12:25
So I'm very new to the role within Europe. And so I'm afraid that I'm not super familiar with TPD2 and how that science is evaluated. But I just see it as a general statement. I think science has become more politicized rather than less politicized and more contextualized.
And I think particularly with this idea that as the evidence base grows, the arguments become more of a hazard-based assessment rather than a risk-based assessment. So that's kind of the trend I see.
I can't really speak to TPD2, but in general with other regulatory frameworks that are being set out or when you're looking at, particularly with WHO statements, you're looking at more of a decontextualized evidence-based
Barnaby Page 0:13:11
Sure, thank you. I think we have a question over here.
Andrew Manson 0:13:14
Yeah, I think it would be useful if, you know, you showed that map there with the smoking incidents. It would be very useful to have two maps side by side. One showing smoking incidents and the other the availability of legal alternatives to cigarettes because they would... I've not seen that. I'd like to produce it myself, but I don't have the resources to do it.
It would be really useful to have that contextually because...
I think that's actually a really good point.
Carrie Wade 0:13:59
Thank you. And I hadn't really thought about that before. One thing that did strike me reading the different JRC reports that came out, there were three. One was on the health risks. One was on the use patterns. Another was really on cigarettes. There may have been a fourth.
But what struck me about the use patterns was so much of the framing around the health risks from new products, as I said four times already, it's a hazard-based assessment, but when you're looking at the use patterns, I mean, we're talking about 24% smoking rates, which is well-established health impacts from smoking, negative health impacts from smoking.
and the use patterns of other alternatives, you would think 100% of people in the EU are using them. But it's really like 1% or 2% or 3%. So I think having that contextualized would also be important, having that side-by-side comparisons that we can really get a full understanding of the whole landscape.
I just think these reports like this that only focus on one thing is completely taking out of context the entire tobacco landscape. And you have to consider it all within the framework.