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Hear how science drives the development of reduced-risk nicotine products at BAT, one of the world’s largest tobacco companies. And learn how it uses science to help ‘seal the deal’ with regulators.

DR. Summer Hanna
VP Scientific Regulatory Engagement, BAT


Hi everybody, I'm Brent Stanford and welcome to another edition of RegWatch on GFN.TV.

We're here in Warsaw, Poland for the Global Forum on Nicotine, the annual conference on

safer nicotine products and tobacco harm reduction, celebrating its 10th anniversary.

And joining me today is Dr. Summer Hanna from BAT.

Summer, thanks for coming on.

Thanks for having me.

So you are, and I'm going to get this straight because it's one of those combined things,

you're the head of science and regulatory engagement at BAT.

So scientific regulatory engagement.

So why the two together?

What we find is, so how we're structured internally is we have teams, we have a very large government

affairs team who's dedicated to regulatory engagement broadly.

Within that, we have some areas where you're a bit more specialized.

So for example, we have a team that's dedicated to fiscal affairs and trade.

So they're very well versed in finance and the nuances around that.

Within my team, we are very honed in on the science.

So my entire team are all classically trained scientists, including myself.

So we all have R&D backgrounds, we've grown up in the R&D infrastructure as part of our

overall training and professional careers.

What we find is that in a lot of regulation, there's scientific underpinnings.

It may not be the driving force.

It may not be the primary engagement topic, but many decisions that regulators are coming

up with have science backings, nicotine limits, for example, around considerations of toxicity

or exposure, the comparison of products and the backing and the idea of the risk continuum.

That's all underpinned by scientific concepts.

And so to have a team within our government affairs function that can bridge those worlds.

So we are all very, we're competent and fluent in the science, but we can also speak the

language of regulation, helps us be more effective in our job.

Is that unique, do you think, to other, just to your company, or is that?

It sort of depends.

So from my understanding, everyone has science engagement in some capacity.

Everybody does it a little bit differently.

So there are some companies that they have scientists who are just dedicated to science

engagement, full stop.

And then teams who run in parallel who do regulatory engagement, full stop.

And they may have individuals who run across, maybe they're a product focused individual

or something else, while there are other companies that do have very similar structures, particularly

if you think about the U.S., you see a lot of scientific regulatory engagement teams

there across the landscape who do that kind of work as well.

In a way, science seals the deal.

I like to think so, yeah.

So tell us about BAT's approach to tobacco harm reduction.

Is that something that you believe in?

Absolutely, yeah.

I mean, you look at the history of the science, you look at the product offerings, and you

can see there's a consistent narrative there.

When I started with the organization, so I started as a Reynolds employee in the U.S.,

and at that time we were a total tobacco company.

But underneath that, we were thinking about what are those tobacco products that might

deliver on that promise of harm reduction.

It was very well understood that the dangers associated with tobacco products were associated

with smoking cigarettes.

If you can eliminate that combustion, you know, in the Reynolds world we had Premier

and Eclipse.

And I understand that they're not the products we see today, but they're definitely the foundation

of today's Glow and ICOS.

Looking at those ideas of how you remove that combustion, we had, when I started with

the company, Camel Snooze was just being launched in the U.S., and that idea was very much relying

on looking at the Swedish experience and understanding that story, those positive health outcomes

within Sweden.

And now, you know, we're talking about Sweden hitting below 5% smoking prevalence, which

is amazing.

And how you can deliver on those kinds of strategies across your portfolio.

You know, we fast forward today and we run the whole gamut of product offerings, which

I think is great in terms of consumer choice and the options that we provide to move away

from smoking.

You know, I grew up in a very tobacco-heavy sort of area, heavy in tobacco growing, very

prevalent in smoking incidents, all of those things.

And to see the positive impacts, you know, in my local community where I grew up and

having those conversations with smokers and saying, you know, there's so many options

and things you can do, to see that firsthand and the positive impact that that brings to

people's lives, absolutely, I believe in that.

What are the BAT products?

And we like to keep things around the vaping side because they're, you know, they are big

and the ones under assault, actually, I believe, by regulators.

What are the products that BAT have created?

What have you worked on?

Yeah, so our product offerings, so, you know, we have our traditional portfolio, both in

FMC and traditional smokeless products in the U.S.

Then you move into our reduced-risk category products, which is really where my primary

focus has been professionally throughout my career.

I'll work, you know, across Glow, our tobacco heating product, and so we work in major brands


So Glow being the THP, Vuze for our vapor product, Velo for what we refer to as our

nicotine pouches.

And so Vuze would be our primary vapor offering.

How has it been doing in the marketplace?

It's been doing really well.

So we see globally that, you know, consumers, they really love the brand.

In the U.S., it's the number one vapor product in the market.

So it's doing really well.

Now Vuze got a marketing order.


You know, but it's only tobacco.



So we, you know, we're still waiting to hear back on decisions for other products.

And so, you know, we'll wait and see what happens.

So what can you tell our viewers with regard to the science then that might support a decision

by the FDA to allow another flavor beyond just tobacco?


So just to clarify, I don't work in the U.S. team, but I do know having worked there previously

that the science that underpins all of our FDA submissions, you know, it reflects our,

what we refer to as our best-in-class science approach, you know, our commitment to international

harmonized test methods, all of those kinds of quality systems in place across all of

our research.

The science that's been done is extensive to support the products and, you know, we

believe in the work that we've been doing.

So outside of the U.S. because of course we're here in Warsaw.

So the Vuze product, are flavors sold, you know, in many markets across the world or

are you as constrained elsewhere as they were in the U.S.?


So we're not as constrained as we are in the U.S.

We do have a variety of flavor offerings in the Vuze portfolio outside of the U.S.

So what does the science, now pulling out of the U.S., just overall, what does the science

say about flavors?

Obviously, clearly in some markets it's okay.

We actually just recently published a study on the toxicity of flavors in vapor products.

What we saw was that across the board when it comes to the toxicity of flavors in e-liquid

compounds that, you know, there's no increased risk in the toxicity of those flavored products,

particularly compared to a traditional cigarette.

So the flavors that you see, the flavor offerings, they're not increasing the risk of the use

of the product.

We believe in the role of flavors and the importance that they have for adult tobacco

consumers, providing them with that array of choices and helping them on that journey

away from smoking.

So then is the concern really all about the youth use and is that scientific?

I think when it comes to the concerns around youth tobacco product use, obviously we only

advocate for adult tobacco consumers to use our products.

We have a range of age verification processes in place.

But we do see that that's a concern.

We're working to be responsive to that and, you know, we continue our commitment to underage

youth prevention.

What about the debate around vaping?

It seems that it's focused on the science in some cases and in other cases it may be

focused on more emotional issues around youth.

When it comes to the science, is there a debate around the science?

I don't think that there's a debate around the science.

I think it's very clear that when it comes to vapor products and the science that backs

them, that there's in no uncertain terms, they are a better alternative compared to

smoking cigarettes.

It's very clear that with the use of those products that you see biomarkers of exposure.

So those are the different markers within the human body that after use they indicate

potential disease, you know, damaging effects to the body.

We see those values reduced with the use of vapor products and in many instances you'll

see reduction in those biomarkers almost equivalent to quitting tobacco product use completely.

In some instances, never tobacco user outcomes.

So I think that the science has a very clear compelling message that these products are

a positive move away from smoking.

Well, I mean, certainly Reg Watch since 2015, we've had well over 150 epidemiologists on

our show.

Only a small fraction of those were ones that, you know, had a real issue when it comes to


But yet, there just seems to be such a strong anti-vaping within this epidemiological community

at least, right?

Yeah, and I think, you know, I don't think any epidemiologist is probably going to be

satisfied until we're 30 years on the other side of the phenomenon of vaping.

Any scientist always wants a perfect answer and a perfect study and a perfect data set.

And the ultimate answer with epidemiology is those, you know, 30, 40 year longitudinal

studies in line with what you'd see tracking across the Swedish experience.

But in the meantime, we can still use those early indicators through things like biomarkers,

our clinical studies at specific points in time to start to point to indicative moves

in terms of the positive health impacts of vaping.

Yeah, so from what I understand with the biomarkers is that, you know, you're not going to see

cancers and all of this kind of stuff, but you will see some of the...

How do you...

Yeah, so you might see reduced inflammation.

You might see reduced different markers that associate typically with disease outcomes.

So, you know, just a chemist, so don't quote me on everything here, but, you know, you'll

have different indicators typically that are used in disease outcomes.

And so what we see is the reduction in things, you know, COPD, heart disease, those kinds

of markers.

And then if you think about how you can mimic that in the real world is then you can start

to look at things like in Japan, hospitalization rates after the introduction of tobacco heating


And you can start to correlate the reduction in biomarkers, the reduction in hospitalizations

associated with the specific disease outcome, track that against the introduction of a product

in market, and you can tell a pretty compelling story based off of that.

And so all of that together, while we don't have 30 years of data, that's a pretty compelling

story in terms of positive health outcomes.

That sounds like it should be right up an epidemiologist's alley.

I think so.

So what kind of pushback is there that you can think of?


I mean, I can say in terms of my own personal experience when it comes to science engagement

for regulatory purposes, one of the things that I've experienced at BAT, for example,

is a regulator may say, well, BAT's produced this data.

Obviously, they have a conflict of interest.

We're considering this, you know, with Article 5.3 in mind.

And given that, we can't even look at this.

So that's kind of those kinds of things where it's not really a conversation about the science

that's the problem.

It's the other elements that are coming into play that get in the way of things.

The other side of that is that I've also seen in regulatory engagements that when you're

coming into a discussion about the scientist with the scientists that are making the decisions

and you stick true to that, that you often have really productive conversations.

And so that's really what we aim to do in my team is focus on those science engagements

for specific regulatory purposes, but staying true to who we are and the message that we're

trying to deliver based on the data that we believe in.

Dr. Hanna, what is BAT's promise in terms of moving the business over to reduced risk products?

So our goal is 50 million consumers of reduced risk products by the year 2030.

So we're really committed, and you see that in the infrastructure in R&D, our product

development focus around reduced risk products, that we're working to deliver on that.

And we're committed to it.

Now looking at the Tobacco Transformation Index, the most recent one now, it showed

a considerable amount of financial investment on your part.

Absolutely, yes.

So we employ over 1,500 scientists globally who are dedicated to the development of reduced

risk products, the substantiation of those reduced risk products.

And it's definitely something that we believe in, and it's part of who we are.

You know, Article 5.3 impacts people like us, too, because we're industry supported.

It's interesting sometimes the things that I think we encounter, and it's definitely

something that when you look at the intention of 5.3, it's not for media.

It's not for scientific publications.

It's really around the limitations on regulatory engagement.

And I think that that's something that we have to continue to fight for and advocate

for in the spaces that we occupy.

Does it feel like sometimes that tobacco control doesn't want to allow big tobacco companies

to redeem themselves?


Yeah, absolutely.

I think that it's a challenging space to occupy.

I think about that a lot in terms of what I do, the conversations that I have about

what I do.

All of us.

I don't think anybody who's joined our company has joined with the aspiration to, you know,

this thing.

That certainly all took place for me before I was even born.

And so I find it often frustrating to be pulled into a category of ways of working, professional

behavior, ethics, with people that I've never met and never worked with and, again, wasn't

even alive for.

And to be told that you can't be anything different, I think, is very frustrating.

I see the things that we do as an organization, KBIO, for example, the opportunity when the

Ebola outbreak happened that KBIO stepped in and worked with the federal government

and brought in an emergency use sorter for a vaccine that saved the life of a scientist,

of a health care professional.

That's huge.

That's a transformational story.

And to discount the motivations of people to try to do good, I think, is disappointing.


It is.

Well, and then didn't this happen with PMI and the vaccine?



And their vaccine as well.

Approved for use, I believe, in Canada.

And then to be unplugged that way, it says that you can never be anything different.

And I think that's kind of a limitation, not just of an industry, but as individuals and

your ability to evolve in any capacity.

That's got to take a toll.

You know, you do the best you can with what you have, and you do the best job that you


You're committed to the mission.

You believe in the work that you do.

You believe in the work of the people around you.

And for me, the thing that I think about a lot is I started Reynolds as a summer student.

So I'm in grad school.

It's shortly after the financial crisis.

No one has jobs.

So I'll, yes, I'll take this internship.

I have a PhD with no work experience.

Somebody hire me.

And there was a professor who worked across the hall from me.

That's where his lab was.

And I went to grad school at Wake Forest, which is right across the street from RJ Reynolds

Research and Development.

So long history between the campuses.

And he pulls me aside, and he says, Summer, you're going to be really impressed with the

science that you see.

And I said, what are you talking about, Dr. Noftal?

And he said, you don't, you think it's simple.

He's like, but you're going to be impressed by the quality of the research and the quality

of the scientists that you work with.

And that has stuck with me the entirety of my career.

And it is 100% true.

I am so proud to work with the people that I work with every day.

They inspire me with their creativity, their commitment to not just tobacco harm reduction,

but to our consumers, to the business, to our external colleagues.

And it makes me proud to do what I do.

And it's why I get up every morning.

When you look at the Global Forum on Nicotine, how important is that to the effort?

I think it's critically important.

For me, being a scientist, most of my career has been spent in very technical meetings

with other scientists talking about relatively dry material.

I really like this meeting because of how many consumers are here.

It's a group that where I sit, I don't normally get a ton of exposure to in this way.

Having so many consumer advocates who believe in the purpose, who it's touched their lives,

and they aren't just willing, but they have embraced and taken on that mantle to really

advocate for that, I absolutely love it.

It brings so much unique perspective to the meeting.

And the dialogue here, the exchange of ideas, I think it's so different than a lot of the

other meetings that you see, and just creates such a positive experience.

So coming up later this year, in Panama, is COP10, the WHO's Framework Convention

on Tobacco Control and the Conference of the Parties.

If you had the opportunity to send a message to the delegates, what would that be?

Ooh, that's tough.

I mean, I think, the thing that I think about the most is the elaboration of harm reduction

in Article 1D.

That was, I think it was discussed yesterday.

Every country agreed to that, and that's a promise to be followed up on, to figure

out what's the opportunity to say, we've got these products here, we've got that.

We've got that opportunity for harm reduction.

And that opportunity is a wide variety of consumer choice-centric products to move away

from smoking.

And that's how we deliver on our smoke-free ambitions globally.