Samuel Hampsher-Monk (ARAC), explores how person-centered thinking applies to the global nicotine and tobacco policy landscape. He explains how effective harm reduction depends not only on the availability of safer alternatives but also on consistent, evidence-based public health messaging. #GFN25ScienceLab
Transcription:
00:05 - 00:28
[Garrett McGovern]
OK, I'm going to move on to our next speaker, which is Samuel. You're getting two for the price of one here, because he's going to do the two videos. And you've plenty of time, Samuel. You'll be happy to hear us. You're not going to be rushed. So over to you, and we'll play Samuel's video.
00:38 - 10:10
[Video]
And welcome to AREC's GFN5's video presentation titled Person-Centered Approaches to Sensory, Behavioral, and Consumer Research and Analysis. So let's dive in. My first question is for Dr. Jessica Zudynak. What exactly do you mean by person-centered approaches and how does this concept apply across sensory research, behavioral science, and consumer insights? That's a great question, Allison. When we talk about person-centered approaches, we refer to focusing our work with the individual first and then turning to how the individual makes up the whole. This can be a lens that is applied as we do to all aspects of our work, whether it's product development and innovation, our work in the regulatory sciences, population modeling, or even the expansion of products to new markets. We rest on the basic psychological phenomenon known as the ABC approach. We have seen really great success using these approaches in the nicotine and tobacco industry, where we consider affect, the A, which are someone's feelings, behavior, which are actions, things we see or hear, and then cognitions, which is the C, our thoughts and our perceptions. of each and every individual and person. And then we consider how these factors for each individual make up the totality, make up the population. More recently, you may have known this as the iceberg effect. And as you can see on the screen, what we see, again, which can be behavior, our tone, our gestures, or the things that we say, that part really is just a little bit of what is actually going on with a person, as you can see, which is underneath the water, which are the things that you can't see. If you fail to study all of what is under the surface, you really miss out on the true answer. So imagine applying this to product development and you take a cohort of, say, 20 individuals or 40 individuals in a new segment that you want to launch a product into, and you only ask, surface level behavioral based questions. Do you like this product? Does this seem to be a product you would use right now? What do you think about the packaging? Is this a product that you would pick up on the shelves? If you only ask what is on the surface and you don't dig into their thoughts, their initial reactions, their biases to certain images, to certain colors, how their past experiences have led them to have those biases. Or you're not considering their fundamental beliefs and personal norms and cultural norms that go into an individual and the way they act. You're missing out on all of that. Or what about their future selves? We all have a part of us as an individual that sees ourselves in a certain light in the future. If you're not asking a consumer, in a new market potentially, what would happen if we took away product A, B, and C? If you're not asking these types of questions that go way beyond the surface level, you are going to miss out on the true key, which is what their future selves will do once that product is on the market. So honestly, you can follow the regulatory guidelines and frameworks of any individual market or country all you want. And you can conduct the best regulatory science that is needed for an application to receive authorization. And in fact, you can even receive authorization to put a product on or in a new market. But if you haven't aligned your product development, your business strategy with the individual and everything that encompasses a person, your product will likely fail once in the market. And we've actually seen this several times. Products that meet consumer preferences, individual preferences, are more likely to drive switching, gain market traction, and ultimately succeed through regulatory review. And as I mentioned, we've seen this firsthand. Products that are informed by sensory and behavioral science, they not only meet FDA expectations, they exceed consumer expectations because we focus at the individual level. That's a sweet spot. That's where we've helped businesses succeed. And in today's environment, the ability to effectively strategize, innovate, and comply, it's not optional and it's what defines success. Please go ahead and scan this QR code to connect with ARAC today and we look forward to seeing you in June 2025 at GFN. And welcome to AREC's GFN5's video presentation titled Person-Centered Approaches to Sensory, Behavioral, and Consumer Research and Analysis. Now thinking about this concept that individuals, persons make up the whole, how would you describe the global landscape within the nicotine and tobacco industry? Sam, as VP of Global Regulatory Strategy, you analyze how international markets regulate within this space. How do the individuals within these markets fare when it comes to harm reduction opportunities? So think about smoking cessation as the sum of thousands, well, hopefully millions of individuals making healthier choices. These choices are predicated on lots of different factors. What people know or believe about the products they use and their risks, price mechanisms, regulatory controls, peer and environmental influences. And everyone's unique. So what works for some won't necessarily work for others. Safer alternatives add additional options. That's why we see more smoking cessation as the demand for, for example, e-cigarettes increases. There's a group that, for whatever reason, was left behind by the traditional tobacco control policies, but with the right alternatives is now able to stop smoking. But again, it's not only about the alternative products and their features, it's also about what the consumer knows about them. And that's largely a response to messaging that they receive, both explicitly from public health agencies, but also implicitly from policymakers. Take the US, for example. On the one hand, we have the FDA approving at least some reduced risk products, concluding after extensive scientific review that their marketing is appropriate for the protection of public health. But federal law prevents the manufacturers from making health relevant claims about them, even when their marketing authorization was predicated on verifiable evidence. At the same time, we've got some states and localities bringing in new regulations, taxing and restricting the sale of safer products, while the status quo for cigarettes remains largely unchanged. And overwhelmingly, the US public health messaging on reduced risk products emphasizes risk. That's an attempt to deter youth experimentation. But no wonder the majority of smokers are confused about safer nicotine. The truism that there are no safe tobacco products masks the salient reality that some are much, much safer than others. Telling people that switching isn't quitting fear mongers people into continuing to smoke. If people don't understand that reduced risk products are indeed safer, that it's combustion and not nicotine that makes cigarettes dangerous, how can we expect more people to choose safer options? And we also need to correct misinformation among other groups too. When healthcare professionals or the friends and family of people who smoke are misinformed about nicotine, we lose opportunities to inspire and facilitate quitting attempts. Even where smoking is declining dramatically, led as it is in Japan and the US by substitutions to safer alternatives, the potential public health benefit is far larger still because the overwhelming majority of smokers doesn't understand that it's not nicotine that's responsible for smoking-related cancers. So we need to do a better job at aligning health communication and policy to communicate a more consistent message. And the UK is actually a good example of this. There, the NHS advice leads with nicotine vaping is less harmful than smoking. It's also one of the most effective tools for quitting smoking. Now, that advice still communicates that vaping isn't completely harmless. It acknowledges the uncertainty about long-term health effects and reiterates that children and non-smokers shouldn't vape. But crucially, the opportunity is front and centre. And that nuanced but clear message is also reinforced with a set of policies that increases the relative appeal of safer products. For example, we haven't seen flavor bans on e-cigarettes in the UK. And safer products like e-cigarettes have also been exempt from the high taxes that are levied against combustibles. So these key regulatory differences communicate to the public the different risk profiles of each product class. The UK has even announced plans to give free e-cigarette starter kits to disadvantaged smokers. And programs like this signal the government's support for THR in the right context, reducing stigma and skepticism. As a result, while there are still misperceptions about nicotine in the UK, these are markedly lower than in other countries. So from a global policy perspective, the lesson learned here is that in addition to having THR products available, we need to align medical advice, public health information and policy messaging to inform product selections that facilitate smoking cessation. Please go ahead and scan this QR code to connect with ARAC today. And we look forward to seeing you in June 2025 at GFN.
10:12 - 10:16
[Garrett McGovern]
That's great, Samuel. You can come in now.
10:16 - 16:51
[Samuel Hampsher-Monk]
Thank you. So obviously, only one of those voices is mine. My colleague was going to be here to present with me, but unfortunately, you've got me to present both. Since I've got a little time, I'm really grateful to GFN for giving me the opportunity to speak about a subject that's near and dear to my heart. I think GFN is always a highlight of my conference calendar because more than any other conference it gathers advocates with researchers, practitioners and industry who are here to have a conversation about the consumer. The consumer voice often gets short-thrift in this discourse. It's often assumed or presumed that the consumers are a homogenous group. At ARAC we see every day that successful behavioural change interventions are successful. And by that, I'm including the introduction of THR products. They are successful when they recognize and respond to the differences between different individuals regarding the barriers and facilitators to smoking cessation. So the first video that we just saw there speaks to why it's imperative to utilize a person centered focus approach to product development, sensory studies, behavioral studies, and how using that approach, ARAC can help our clients bring safer products to the market in compliance with regulation. And then my video spoke to the fact that the efficacy of reduced risk products is contingent not only on the features of the products themselves, but also the details of the regulatory environment that they are in. That's because consumers respond to the signal from regulators, signals them by policies, as do the people around them. So we need reduced risk alternatives. We need them to be sufficiently appealing that they gain traction and facilitate transitions to safer alternatives. And then we need regulations that unequivocally communicate that kind of relative risk profile. Now, as I mentioned, both consumers and non-consumers are informed by a broader conversation about THR. And because of that, because of the differences in the details of regulations, there's wide variation in how effective THR actually appears to be between contexts, between countries, between jurisdictions, and for different groups. So that has implications for both public health outcomes, but also equity outcomes. Looking at the picture as a whole, I think the overriding theme that I observe is that it's interventions that provide options to consumers, recognizing people as individuals that achieve the most. So with products, as with policies, blunt one-size-fits-all approaches don't work. And in that regard, a scalpel is a better tool than an axe. Understanding the differences between contexts, between groups and individuals is going to make the difference between understanding how to make THR more effective as an approach in the future than it has been in the past. Perhaps I can speak a little bit about what this means in terms of those who are trying to bring products to the market that not only comply with regulations, but also actually drive switching. So to start, regulatory compliance isn't optional. legally, practically, commercially. Our clients want to be regulated. They're calling for regulations because they understand that ultimately it's regulated products that will win market share, that will win sales. Yes, there is an illicit market. In the US, where I live, the illicit market is huge. I think I'm right in saying that less than 2% of the e-cigarette products that are used by regular adult consumers has a marketing authorization, or at least that was true when it was published in 2024. and if anyone needs that citation I can provide it to them. So there is an illicit market, but better regulated markets, more mature markets, see that most consumers shun illicit products, even where regulated ones carry a tax-driven price premium, because regulated products are available, they're appealing, they're trusted, and it's regulation that fosters consumer confidence. So regulatory compliance isn't optional. My advice is that the person-centered approach is not optional either. The public health literature emphasizes safety and efficacy, and each country has their own evidentiary standards. In the US, the APPH standard, Appropriate for the Protection of Public Health, requires the consideration of risks alongside benefits. But to be effective at transitioning people who smoke towards a safer alternative, that product needs to be sufficiently attractive and appealing as well in the real world. So again, it starts and ends with the people engaging with the product. If you design a product purely around maximizing uptake, you're certainly not going to get an authorization. But if you design a product disregarding the consumer appeal, the authorization won't matter. It won't get the traction that you need in the marketplace, and it certainly won't do what it might otherwise do in terms of reducing the harm to which consumers are currently exposed. So the manufacturer, and actually, The regulator, too, want to see both consideration of the risks and the benefits at the population and at the individual level. And that's where ARAC excels. So I briefly mentioned earlier that there's the heterogeneity in the consumer demand. Different consumers want different things. Different things work for them. They experience different obstacles. And so that means that from ideation forward, the consumer needs to be front and center in product development. But let me just add that the person-centered approach that Jessica spoke to is pragmatically essential as well. Understanding the gap in the market, what the consumers need now, what they're going to need in the future. Populations that are not being served by the available offerings, that validates that there is an opportunity in the market that would then justify the expenditure of producing evidence to support a marketing authorization, which is not insubstantial. Thank you very much, Samuel.
16:51 - 17:08
[Garrett McGovern]
We have plenty of time for questions. Anybody got any thoughts? I'm going to bring the mic down. This gentleman here, Carolyn, has a question. Anybody else? Just two at the moment. That's good.
17:10 - 18:01
[Pascal Michel]
Thank you, Pascal Michel, Canada. I was fascinated by how you would land patient center and the regulatory approach. So thank you for the additional comments at the end. So recognizing heterogeneity, and Canada is a good example of this, where a puzzle of so many different entities coming together. If I take the principle of when you've got a lot of criteria in your model, you can either stratify or you can layer this. So from a fiscal and regulatory approach, what are you really saying or getting at? Should we regulate at a smaller scale, or should we layer the regulation with additional context? Basically, I was just wondering where you're gonna land that kind of a specificity of small groups within a fiscal and regulatory framework, so thanks.
18:01 - 20:02
[Samuel Hampsher-Monk]
That's such a good question. So Canada's actually a fascinating example, and part of the reason why it's a difficult question to answer. is because of the challenges of the illicit market, which in Canada are quite substantial, even in this space. The presence of First Nations communities, which are taken advantage of by organized crime to produce historically combustible tobacco products but also now illicit versions, analogues of next generation products mean that when Health Canada or the provinces introduce regulations, those are obviously able to be undermined. Canada has regulations of next generations products at the federal level and also at the provincial level so since 2018 they've been a series of First the nicotine limit then flavor bands of various descriptions The federal tax was was brought in and then Canada allowed the provinces to double that as well So that has all informed consumption one of the things that certainly in the US challenges Again, the efficacy of those interventions is the differential between jurisdictions. So being able to bring a product from a First Nations reservation, the US, one Canadian province to another, limits that. But there's another challenge too that I want to speak to, which is just the signal, the introducing restrictions specific to safer products, at a time when we're not also introducing or increasing the restrictions on more dangerous products, communicates to the public that this is something to be rejected. That's not the right message that Canadian smokers need. I'm not picking on Canada, just because you mentioned it, but certainly there are other nations that experience the same challenge. I don't know if that answers your question.
20:03 - 20:15
[Garrett McGovern]
That's great. Great question. Carolyn? Thank you.
20:15 - 20:30
[Carolyn Beaumont]
Just a quick one. So regarding your regulatory studies, how does AIRAC ensure that your person-centred research, which I can imagine can have many variables in it, also meets strict scientific rigour and reproducibility?
20:33 - 24:14
[Samuel Hampsher-Monk]
Another great question. So my colleague, Dr. Jones, shared an anecdote with me that I'll share with you. In the 1940s and 50s, the US Air Force was trying to develop fighter planes, cockpits, aircraft. And so they decided to basically develop a kind of an aggregate model of the average fighter pilot. identified their criteria and built what was kind of an archetype US pilot. And it turns out that across the 10 most important criteria, the actual fighter pilots look nothing like the model, not within 15% on any of the relevant dimensions. So effectively, if you've got a cockpit designed for the aggregate, that's actually designed for no one. It's not everyone. It's no one. And I think there's a model there in THR as well We talk about meeting people where they are, and so if we recognize that everyone's different, then we need to tailor the interventions and tailor the products, and tailor the evidence supporting the authorization of those products to really understand the community that they're for, rather than appealing to a hypothetical abstract. So in practice, you talk about operationalizing this. This has implications across the product development cycle from ideation forward. Understanding the target subgroup, the consumer, what motivates her, specifically as an individual, what would help her, what hinders her from quitting tobacco. Losing that signal in the noise, or not losing that signal in the noise of the aggregate, is really going to be crucial for either commercial success or for actual harm reduction. And the person-centered approach is relevant later on in the pipeline too. So for example, with sensory studies or panel testing, optimizing the design features so as to refine sensory characteristics, attributes, maximizing the appeal and liking, again, to that target consumer, the group, is vital. And then when we're thinking about conducting tests to support marketing authorization, Remember that the effects of randomization or randomizing participants to SKUs or groups might actually mute the effects that in the real world we would like to see. Consumer preferences, the availability of choice, that's going to impact selection, uptake, and ultimately efficacy. So let me give you an example. So imagine I have a preexisting aversion to mental, and I'm a study participant. That's going to limit my propensity to engage with a study product under clinical settings. In the real world, the ability to choose from a portfolio, I think this is what Layla's study was speaking to, might create a situation where there's a different story to tell. So one of the things that ARAC is really good at is using the data to tell the story. Sometimes that's gonna involve certainly randomized controlled trials, that's what's robust and reliable, that's what the regulator requires. But the actual use studies also inform the determination of an APPH standard. And exploratory analyses as well add nuance and depth. So all of those are kind of a piece of the whole. I think that answers your question.
24:18 - 24:39
[Garrett McGovern]
Yeah. OK. That's great. Any further questions on Samuel's talk? If not, does anyone want to ask any questions before we close this session to any of the speakers? Okay. Oh, we have one. Sam, yeah.
24:46 - 24:56
[Attendee]
Sam, I'm quite shocked about the statistic of the number of people who are using the legal vape. So ones that do have a marketing granted order, 2%.
24:56 - 25:05
[Samuel Hampsher-Monk]
Let me get you the citation for that. I don't think it's 2% of the total market. I think it's 2% of the adults who frequently use e-cigarettes.
25:05 - 25:39
[Attendee]
Okay, so a slight nuance there. So my question is around why. So if, if there are products that have gone through the FDA process, they've been given that marketing granted order. Why aren't people buying them? Why are they seeking? Is it, is it an accessibility issue? Is it that people just prefer other flavors that aren't menthol or tobacco? Do you have any data or any insights on what might be driving that quite incredible statistic?
25:41 - 27:04
[Samuel Hampsher-Monk]
There's going to be several things going on. I think the availability and the visibility of product um, illicit product, uh, is going to be driving consumer choice. I think we're not doing, uh, enough as an industry to differentiate between, uh, the regulated product and the unregulated product, the illicit product. Um, you know, I mentioned, you know, and I was kind of in my head referring to, referring to alcohol, like, you know, I think about, you know, Jack Daniels and people not drinking moonshine and because, you know, okay, that's a much more mature market. Um, you know, the different sets of regulations that apply. But nonetheless, we've got to a point where the consumer trusts the regulated product to the point where they will bear an increased price point for it, pay taxes on it. Maybe they understand that there's No one's going to go blind at a wedding by drinking Jack Daniels. But that is nonetheless where we have to get to. We need to reclaim market share from the illicit space. There are other industries that are trying to do the same thing. And that is about signaling value to the consumer. We have to create products that are appealing, that the consumer trusts, and we have to make them available and accessible. So I think those kind of four categories, whatever is going on, it will fall into those buckets.
27:06 - 27:13
[Garrett McGovern]
That's great, Samuel. Okay, any other thoughts, final thoughts before? Yep, if you bring the mic down.
27:21 - 27:46
[Attendee]
Again, the question is for Sam. So in the graph that you showed about Japan, that it's 50% not knowing about the cause of the cancer, that it's not nicotine, it was interesting for me as we know that 40% of the share of market using keto tobacco, and it's still 50% not having the idea about that. Any comment on that?
27:49 - 27:50
[Samuel Hampsher-Monk]
We can't pull it out, can we?
27:53 - 28:01
[Garrett McGovern]
Yeah, I don't know if we can. We'll try and get the slide up.
28:01 - 29:23
[Samuel Hampsher-Monk]
Just to address that, maybe we can, maybe we can't, but I think one of the interesting things in Japan is that given the regulatory environment doesn't do a good job at differentiating between products on the basis of risk, the government doesn't tax heated tobacco products differently to regular tobacco. There is still a massive reduction in the aggregate demand for combustibles that coincides with the uptake of heated tobacco. So that's a huge public health win in terms of, you know, it's an example of THR in action. The caveat to that is that if you look at Japanese consumers' cessation rates, they haven't declined as quickly as would be suggested by a comparable decline in aggregate consumption looking at ends in the UK or the US. So rather than switching, yes, they're smoking less, they're buying cigarettes less, but they're not fully quitting. And we know that the health benefit comes from complete substitutions. I can't substantiate this, but I certainly think that it's an interesting framing to suggest that that's a result of the regulations or the lack of regulatory differentiation. And it does suggest that there's an opportunity for more harm reduction that's being left on the table.
29:26 - 29:31
[Garrett McGovern]
That's great, Sami-Lini. We have Norbert just here.
29:35 - 30:24
[Norbert Schmidt]
on the question why consumers don't buy the American products, the authorized products. I've seen some of the products and it's a bad joke, as a consumer. Part of them are already out of production, some, and those that still are produced are not usable for hardly anybody. So it's no wonder that nobody uses them. And especially the lack of flavors is very, very severe, a severe deterrent for consumers.
30:27 - 30:48
[Garrett McGovern]
Yeah, thanks. Anybody wants to make any comment? If not, I'm going to bring this session to a close. I've learned a lot today, four really excellent presentations, videos, and a really stimulating Q&A session. That only leaves me to give a round of applause to all the speakers.