Prohibition cannot eliminate consumer demand. It’s an iron rule of free markets. As lower-risk nicotine products remain stuck under FDA review, illicit products proliferate to fill the void. Shot on location at GFN 2026 in Warsaw, Poland, Altria’s Dr. Mohamadi Sarkar argues that slow authorization decisions have left regulators playing enforcement “whack-a-mole” while adult smokers wait for more FDA-authorized alternatives.
Featuring:
DR. MOHAMADI SARKAR
Regulatory Science & Engagement, Altria
Affiliate Prof., Clinical Pharmacology, VCU
@AltriaScience
Transcription:
GFN interview — Mohamadi Sarkar on FDA product authorisation
Global Forum on Nicotine 2026
Brent Stafford 0:00:05
Dr. Sarkar, tell us, how difficult is it to get a product authorized in the US?
Mohamadi Sarkar 0:00:12
Well, so FDA relies on science and evidence to make an authorization decision. But quite honestly, it takes too long for the review process. In order to make the decision, FDA has to be convinced that the product is appropriate for the protection of public health. And we generate substantial levels of evidence to demonstrate that.
And essentially, the way we go about it is we have a scientific framework that's actually grounded in the regulatory framework. And there are three pillars to that. One is, you know, we demonstrate constituent reduction, that there is individual health risk reduction, and the third is population harm reduction.
And under each of these pillars, there are several studies that are done. So, for example, you know, product characterization, making sure that the levels of the harmful constituents, HPAC as they're called, are substantially reduced compared to cigarettes, making sure that we can manufacture these products consistently.
And then in terms of individual risk reduction, we carry out a very systematic product stewardship programme which essentially is to ensure that the ingredients that are used are not going to increase the toxicity. We do a range of toxicological assessments to ensure that the toxicological profile of the product is substantially lower than that of a cigarette.
And then we look at human studies to measure nicotine exposure. Sometimes we also measure exposure to the constituents. And then for the population harm reduction, we have to demonstrate that both users and non-users have an accurate perception that these products are not risk-free, but are a lower risk.
We look at their intentions to use, and then after this comprehensive scientific evidence package, we then integrate it all to show that there is a net benefit to the population.
As part of the population harm reduction, we also do an assessment of the likelihood of use by non-users, including youth, and demonstrate whether, you know, there's a low likelihood that these products are not going to be found to be appealing to kids. Now, you know, all that evidence gathering takes a while. There's a lot of studies that we have to do.
But then, you know, when we submit this to FDA, it takes them, you know, a very long time. I'll give you a specific example. So our on nicotine pouches, the original on nicotine pouches, has been sitting with the FDA for now six years. And that's a long time.
And that's in the face of FDA acknowledging the continuum of risk and acknowledging that nicotine pouches are lower than the continuum of risk. So we think that there is an opportunity for FDA to develop a more sensible and pragmatic approach in reviewing the applications.
And one of the challenges is that this long, drawn-out process has created an avenue for illicit products to be entering the market.
Brent Stafford 0:03:45
Right. Well, and that is actually the topic of this conference this week is prohibition and public health. I wonder, do they go together, prohibition and public health?
Mohamadi Sarkar 0:03:58
Well, you know, it's interesting because we have seen over and over again that prohibition just does not work. You cannot ban consumer demand. So if the regulated products are not coming into the market, consumer demand shifts to unregulated products because, you know, they are looking for alternatives and the illicit manufacturers are very happy to fill that void.
And at least in the US, we have found that there is a proliferation of thousands of illicit products in the marketplace. And that's because FDA has not been very efficient in authorizing not only more, but faster review of applications.
Brent Stafford 0:04:45
We use the term safer nicotine products, and I know that that's not something that necessarily everybody can use, but for those products, what of these alternative nicotine products does Altria have on the market that's been authorized?
Mohamadi Sarkar 0:05:03
So we have had, you know, nicotine pouches authorized as part of this recent expedited review process. We were one of the first ones to get the ONN plus nicotine pouches that were authorized. We also have authorization of our N-Joy e-vapor products. Now, that was one of the first tobacco and menthol flavoured product that was authorized.
And right now, there's still several applications in the queue. And I think FDA is in the process of trying to figure out how best to straddle this. They seem to be concerned about flavours.
And, you know, that brings back to the discussion we were having at the conference about, you know, most of the bans that are taking place are on flavours and in some instances even total ban of smoke-free products. And the biggest concern is youth use. And look, to be clear, nobody wants youth to use any tobacco products.
And if you kind of just step back and look at the numbers, the National Youth Tobacco Survey, NYTS, clearly shows that youth use of tobacco products continues to decline. As a matter of fact, smoking rates are the historical low. And even if you look at evapour, the rates of the prevalence of evapour use amongst middle and high schools is like 5.
2, which is a 70% decline than its peak in 2019 from 20%. And nicotine pouches has continued to remain low in 2024 was 1.8%, 2025 numbers are 1.7%. So if you just look at the big picture, youth use of smoke-free products is continuing to be low. So I just fail to understand why there's these prohibitions and bans that are taking place.
I mean, look, we have to be vigilant and we have to continue to monitor that. But right now there is no indication that there is a high increase use. On the contrary, actually today we had a panel discussion and one of my colleagues presented some interesting findings. And what we see is that in states that implement these bans, there's a lot of cross-border proliferation.
And while the restrictive policies limit the availability, but then from the neighboring states, the products are just coming through. And of course, illicit products fill the void, right? And so the net result of these bans is that they are being essentially ineffective in curbing the use, which is what has been touted as one of the reasons for the flavour bans.
Brent Stafford 0:08:14
You're a man of science, correct? Yes. Fill our viewers in a bit about your background and what brought you to Altria and how Altria handles that intersection between science and regulation.
Mohamadi Sarkar 0:08:27
Sure. Well, I can talk about it for quite some time. I have had an interesting journey. I'm from India and trained as a pharmacist, and then came to the US to get advanced training in clinical pharmacology. And I got the teaching bug. I was teaching for many years. And I was happy as a tenured professor.
Actually, my research was on smoking and health, and I did a lot of cessation studies amongst cancer patients. And it used to be painful for me, Brent, that many of these smokers, after getting a diagnosis of cancer, would still not be willing to quit. And I would struggle to find ways to get them to stop smoking.
And right around the time, somebody from Altria heard me talk and they made me aware of harm reduction. And I had never in my wildest dream imagined that I would leave my tenured job and come work for corporate America, let alone work for a tobacco company. But I have never looked back. I've never regretted my decision.
And I'm very happy that I'm in a place where I can make a direct, meaningful impact on those same people that I was trying to convince them to quit smoking. Right now, we are in a position to have a lot of options for smokers.
And if FDA were to increase the pace of authorization, we'd have a lot more products on the marketplace that have been reviewed by FDA and are under the watchful eye of FDA for, you know, any likelihood of potential unintended consequences, which is not what's happening because with the proliferation of the illicit products, we've seen that in the data from the NYTS survey that a lot of the kids who are using vapes are using illicit vapes.
You know, 60% of the middle and high school students are using these illicit vapes.
Brent Stafford 0:10:33
Right. But as you said, though, the number of middle and high school students that are actually using the vapes has gone down by almost 70% since 2019. So if there was a vaping epidemic of any sort that still exists, you've got all this more availability, all the more products that are out there, you would think that the use would be going up higher. But it's not.
Mohamadi Sarkar 0:11:00
What's happening is that with these illicit products, there is no control of youth access. So youth are actually easily being able to access this, as opposed to if you have a regulated product, that's being done in a more responsible way. The marketing is done using responsible marketing practices. So that limits the ability of kids to get access to these products.
But on the other hand, these illicit products are being sold in venues and in locations. They don't have a stringent age verification barrier for kids to buy these products. I mean, of course, one of the things that has happened, which is a good thing, was to raise the minimum age to 21-year-old.
And of course, because the responsible manufacturers ensure that there is appropriate age verification, that's not happening with the illicit products. So the illicit products are being widely used. And the other thing is that these products come in a range of appealing flavours that range from cotton candy. Some of them have cereal-like flavours like Cap'n Crunch, Fruit Loop.
There is no proper attention being paid into how these products are being brought to the marketplace.
Brent Stafford 0:12:25
Yeah, FDA just put out their newsletter, which they do quite often, highlighting, and I'll put them up on the screen here as we're talking, products that look disturbingly like candy and cereal and so forth. That's a good thing that the FDA does that. I just wonder, though, how much of that really represents the amount of product that's out there.
Mohamadi Sarkar 0:12:48
I think the best way to help the people, adults who are looking for alternatives, is to have a range of FDA authorized products that have gone through the proper rigor of the science and evidence. Because I'm saying that FDA should not compromise on the science and evidence.
But, you know, if FDA has reviewed them and has been comfortable that these products are appropriate for the protection of public health, then they will be appropriate for adults to switch, and they'll be appropriate safeguards to prevent youth use.
On the other hand, you know, these illicit products, they are, you know, if you just go to a vape shop, you'll see a wall of or products with flashy neon color products and wide range of flavours that seem to be very appealing to youth.
Another thing that I do want to raise that's important is that there was actually a very interesting research being done by some health economists, a researcher by the name of Abigail Friedman from Yale University.
She and Mike Pesco from University of Missouri have done some similar work, and they've consistently shown that in the presence of some of these bans, there's actually increased product substitution to cigarettes. In fact, in the recent paper, they showed that for every pod not used because of the, which I think their math was like 0.
7 mils, that's not used, there's about 11 to 15 more cigarettes purchased. That's not good for public health, right?
Brent Stafford 0:14:35
That's totally not. And we've had Dr. Pesco on the show many times and recently just to talk about that research you just mentioned, which is which is stunning because basically they're saying that flavours matter in a good way. And when they're banned, it pushes people back to smoking.
Mohamadi Sarkar 0:14:56
Yeah. And it pushes them back to smoking and to unregulated products. We don't know what's in them because they have not been as fully characterized as I described about the scientific framework. The vast majority of the products that are currently available have not gone through the FDA review, have not gone through the rigor of the science and evidence.
And they are widely available.
FDA has the responsibility to enforce and making sure that you know that has been you know clean up the market and the best way to get products in the hands of the 30 million adults who are smoking that have gone through the rigor of the science that are you know, appropriately monitored by the FDA is to clean up the market of illegal products and have a wide array of authorized products.
And that's one way we can address the fact that, you know, this constant tug of war between, you know, this is almost a whack-a-mole. These companies are suitcase companies. Well, if FDA gives them an enforcement letter, they'll just probably do a name change and come over again. So they're always playing whack-a-mole.
And the other bodies, and I commend FDA for putting together this task force of multiple agencies. but just they have not been effective in cleaning up the market. And on layer on top of it, there haven't been as many products that have been authorized.
If there were a lot more products that were authorized, it will naturally kind of give the smokers the options to choose from products that have gone through this review process.
Brent Stafford 0:16:47
We always hear people talk about the smoker. And of course, you know, it's why we're in this business, right? But what I don't hear enough of, and it worries me, are the millions of people who are no longer smokers. And they got that way because of using smoke-free products, which are on the verge of being enforced out, right?
What do we do about, because there's 25 million Americans who currently have switched or are in the process of switching, and they're no longer a smoker, technically, in this case, and they are using alternative nicotine products right now. And so if we rip out all these products that they're using and give them 41 products of tobacco-flavoured, this can't be right.
That can't be the right way to go.
Mohamadi Sarkar 0:17:43
Right. And that is exactly why I think it's important that, you know, FDA has a more pragmatic approach. And look, the science and evidence, if you think about it, is very clear. It is very subtle that nicotine pouches are one of the lowest risk products in the marketplace.
And even with e-vapors, you know, Public Health England has been saying this for quite many years, that e-cigarettes are far less risky. So if FDA uses a more balanced approach and, you know, keeping up with the science and evidence says that keeps you warm, because one size does not fit all.
And if they make more faster decisions if the pace of authorization is is increased that will make available products that have been well characterized right now we don't know what's in these other products i'll give you an example there's you know there's some research that has shown that some of these illicit products don't even have the same level of nicotine that's claimed on their package.
They have constituents that have not gone through the recovery. And I talked about our scientific framework. We make sure that we look at each and every ingredient and show that there is no harm or hazard associated with it. We are very diligent. And that's what you get with an FDA regulated product.
But what's happening right now is that FDA is taking so long that it can't even keep up with the innovations.
Brent Stafford 0:19:15
Well, by law, they're supposed to take only 180 days, and here you are six years from the original law.
Mohamadi Sarkar 0:19:23
Right, right. Well, we hope that, you know, FDA will, you know, has been saying that, you know, they are about science and evidence, and we want them to be basing the decisions on science and evidence. But the science and evidence clearly shows that nicotine pouches, for example, are, you know, far less risky.
They have themselves in actually in our own plus authorization that FDA just issued last year in December. They said that these products are the lowest on the continuum of risk.
So given that there is enough evidence that products are low risk, do they need to have so much time to review the the scientific studies and make a decision so i i think that's where the biggest disconnect is that you know if fda could bring these allow these products to come on the market at a faster pace that will naturally give consumers options in a variety of flavours, in a variety of formats, so they can make decisions for themselves.
Look, as I said, there are 30 million adults who are smoking. And many of them have made quit attempts and have failed that. So if we can present to them a wide range of options that are available. Another thing that I don't know whether we have a chance to talk about it, but is Many of them will continue to smoke because they have deeply rooted misperceptions.
And these misperceptions are linked together. There's a product risk misperception and there's a nicotine harm misperception. And those are kind of two interlinked. We have shown from our analysis of the POTS survey that more than 90% of these adult smokers who are exclusively smoking cigarettes believe that e-cigarettes are equally or more harmful than cigarettes.
Brent Stafford 0:21:24
Well, and that's something we've been tracking for quite some time, you know, exactly that. They believe that e-cigarettes are as harmful or more harmful than smoking. How do they get that impression if it not be from media and public health?
Mohamadi Sarkar 0:21:42
Right. And look, and if you layer on top of that, these bans don't help either. Because when legislative authorities or public health push for banning flavours, the impression that the smoker gets is, oh, they're banning it because it may be bad for me. So they revert back to smoking.
And I think that's where the biggest opportunity lies, is that we need to figure out solutions in a way in which we can correct these misperceptions. Because not only are they product risk misperceptions, nicotine misperceptions.
And those nicotine misperceptions that nicotine causes cancer is not only amongst smokers, but also the general public, as well as well-informed, educated folks like the healthcare providers.
Doctors right now, 80%, I mean, you may be familiar, your audience may be familiar that 80% of physicians think that nicotine causes smoking-related disease like cancer and COPD and cardiovascular disease. The evidence is clear.
In fact, the International Association Agency for Research on Cancer, IR, has looked at the evidence and come to the conclusion that nicotine is not a carcinogen. It's not risk-free, but it is far less risky than combustible cigarettes. In fact, FDA itself has on its website that nicotine is not the reason for the major smoking related diseases. Your viewers know this.
It's the combustion that causes the harm.
Brent Stafford 0:23:22
Here's the issue is that tobacco control in Western countries over the last 40 years since starting pretty much in Canada in the 80s, it was really started in Canada, has successfully placed into legislation and tobacco laws that you can't make statements publicly in the television news media, like in terms of you can't buy a 30-second ad that says, hey, safer nicotine products.
You can't make that claim. And we wonder why there's so much misperception. Because it's only the one side of this debate has any access to any of the tools to communicate to the public.
Mohamadi Sarkar 0:24:01
Right. And I'm very passionate about correcting these misperceptions. And I've been thinking about this a lot, and others in my company and my colleagues. Look, I think that there are three potential avenues. Of course, industry now in the US industry has the ability to communicate to the consumer, but it can only do that through an MRTP pathway, right?
So we have to go through this whole series of evidence generation, and then it takes forever for FDA to review and make a decision. But, you know, public health authorities and FDA, they are the trusted voices that smokers will listen to. They had the opportunity to correct us and inform smokers about the facts.
In fact, FDA says that on the website, but that does not reach the consumer. No average consumer is going to go digging for that information on the website. FDA can proactively make a PSA to the public, and for adults only, and ensure that they know the accurate facts.
One of the core principles of harm reduction is, meeting people where they are, and then giving them the accurate information and letting them make informed decisions on their own. You can't move them by pushing them in one direction. That's what these bands are just trying to push them in a direction. That does not work.
Give the agency, the 30 million adults, It's a statistics, but behind that there is an individual. Each individual has their own perspective, their own consequences. Let's treat them like adults and let's give them the facts and let them make a decision on themselves. So I'm coming back to the ways in which we can correct misperceptions. FDA can certainly say that.
Another opportunity, I think, is healthcare providers. Because healthcare providers are somebody that everybody would trust them. We've done surveys and shown that 80% of smokers would treat their doctors as a trusted messenger on health information. Unfortunately, doctors also have this misperception about nicotine and product risk.
So that's where we can correct the misperceptions amongst the physicians so that they can provide the information to their patients about making the decisions that is right for them. They can make informed decisions.
Brent Stafford 0:26:36
But you can't reach the doctors because the doctors and healthcare providers, they largely are impacted by the traditional media and what they hear in the media just like anybody else. That's where they get the misperception from.
So if you can't communicate through traditional media and media forms, then the only other way to do that is through the medical training kinds of things, so every doctor and so forth has to do a certain amount of training as a part of their profession each year. Now, you could, and this has been done, Dr.
Brad Rodu, who's been almost 35 years in the space of tobacco in nicotine research and Dr. Sally Sattel, for instance, and both of them participated in creating a 10-part module course to teach doctors just about tobacco harm reduction, not to push your advocate, and they got slammed. I know. by public health so hard. The journal, the blowback was immense.
So this is all pie in the sky. And I agree with you. We could get FDA to do it, but they refuse to acknowledge the continuum of risk publicly. And Campaign for Tobacco-Free Kids certainly isn't pushing the FDA to do that. Neither is Truth Initiative. And then the doctors, yeah, sure, let's try to reach them.
But as soon as people put together any kind of programmes to reach them, they get hammered. Yeah. What do we do?
Mohamadi Sarkar 0:28:08
So I have a solution. It is not a silver bullet, but it's a potential solution. So there is a very time-tested process called the Delphi process. The Delphi approach has been used in other disciplines, and the Delphi is originated from the Greek thing about the oracle of knowledge.
So in this Delphi approach, the way this works is that you assemble a small group of stakeholders, so in this case it would be physicians, and present them with the evidence. Look, physicians are all about evidence-based decision making. So let them look at the scientific evidence and let them come to their conclusions on their own.
I was blown away by the fact that some of the research that came out of Dr. Del Nomo's group in Rutgers, they did a survey amongst physicians. And most physicians don't even know that FDA regulates tobacco products.
The other thing is that they didn't even know that the Cochrane Review, which you and your audience may be familiar with, has shown consistently that e-cigarettes are far more effective than NRTs in cessation. Dr. Rigotti did a commentary that it looks like we have reached a tipping point. Doctors should have this in their cessation toolbox.
They are going to be reluctant to make that recommendation because it's not in their ethos through the guidelines that come across. But let each one of them look at the science, look at the evidence, and come to their own conclusion. And then that can truly be proliferated in other health care providers. And look, it's just not the primary care physicians.
But dentists, for example, you know, smokers often make frequent visits to the dentist because of the staining of their teeth from smoking. And they get dentists and the dental hygienists get their undivided attentions for sitting in the dental chair.
And if they are educated and they are informed about the science, then they can make their recommendations and just give them the facts. Often with nicotine pouches, what often gets stated that, oh my God, this is gonna increase my risk of oral cancer.
And there is substantive evidence from Sweden on snus, which is a similar product as nicotine pouches, that the risks of oral cancer are minimal, are actually not very high compared to never use, and definitely much lower than that from cigarettes.
So, and we just did, we did a really nice study where we looked at smokers who had switched to nicotine patches and we followed them for a period of six months and we found that their gingival inflammation actually goes down. So, I mean, once you start showing healthcare providers the hard, solid scientific evidence.
We all think that science will ultimately carry the day amongst people who base their decisions on the science. And once they kind of start recognising that, that would, I think, make them aware and at least not have a negative view of somebody who is vaping or using nicotine pouches. They are told, no, no, you should stop doing that.
Essentially, that encourages them to continue to smoke.
Brent Stafford 0:31:52
So if you're a smoker in the US and found yourself in a position to use vaping to quit, let's say it's in 2019, you know, seven years ago, and you feel that it saved your life and you feel that you did everything that public health told you you had to do. You had to quit. And you did quit. But the manner in which you quit is not what public health is hoping for.
And boy, I think that somewhere in there is something that needs to be fixed. Because public health feels they didn't quit. They feel like they did quit. And there's a huge battle that's going on that's kind of focused on that kind of issue there. Does that make sense?
Mohamadi Sarkar 0:32:50
Yeah, I think, look Brent, I think the fundamental problem is that many in tobacco control believe that people who use tobacco products should quit all tobacco products. And there's this disconnect that within the spectrum of tobacco products, there are some products, like cigarettes, that are most risky. And then you have other products. We kind of depict it as a risk cliff.
On top of the cliff is the most risky product, and then you have lower risk. I mean, look, that goes back to the fundamental principle of harm reduction, that moving people away from minimizing the risk from some behaviours that they're causing, not abstinence only.
And many in tobacco control would like to see complete abstinence from all tobacco products, including safer nicotine products. You may be familiar with the famous quote from Michael Russell in 1976. He said something which was so pointed that smokers smoke for nicotine but die from the tar.
And I think somewhere along the line, public health, the ones in tobacco control, have lost sight of that. If we can get people off combustible cigarettes, get them off these thousands of chemicals that they're inhaling. Cigarette smoke has got 7,000 chemicals, 70 of which are carcinogens. Imagine they're inhaling this every day, 10, 20 times a day for decades.
If we can get them to drop that and move to safer forms of nicotine, that can make a real meaningful impact in the lives of these individuals. Because, you know, they are There's some people who want to just continue to use nicotine. They're just unable or unwilling to quit. And is it quit or die? Or is it giving them options that are less harmful?
And that's why I think it's important that we recognise that in order for them to make the switch, We'll have to give them a range of products, inhalable, heated tobacco products, e-vapor, nicotine-positive, because one size does not fit all. And you have to give them the option to find the product that meets their needs.
When we do our studies, for example, with the nicotine pouches, we have a range of nicotine flavours. And when they start to study, they usually kind of experiment with different nicotine levels, different nicotine levels and flavours. And eventually, very quickly, they find a product that meets their needs. And then they kind of gravitate towards that.
Brent Stafford 0:35:39
So final question, if you could change anything about the regulatory environment, what would that be?
Mohamadi Sarkar 0:35:46
If I had the empowerment to make that decision. I would say that, you know, we need a clear understanding of what are the requirements, what are the scientific studies that would be needed to demonstrate the APPH construct.
And we really need FDA to take a hard look and make quick decisions and to be clear on science and evidence, but make quick decisions and a lot more decisions that we have a open range of products for consumers to choose from and do them within the 180 days that's required in the Tobacco Control Act framework.
And another thing that I would do is make sure that adults are well informed about the differential risk of products, about the harm that nicotine does not cause, the harm, the misperception they have.
So correcting the misperceptions and making available a range of FDA regulated products would really make a meaningful impact on individual consumers, on public health, and it's good for everybody.