Shaping Vaping Transcript
May 8, 2025

Featuring Jim McCarthy, Joe Gitchell, and Kevin Schroth

Jim McCarthy: Good morning, it's Jim McCarthy with American Vapor Manufacturers, back for another installment of our Shaping Vaping podcast, a sizzling, scintillating, hopefully informative conversation on nicotine and THR policy. We're going to be joined today, as ever, by our special guest, Joe Gitchell from Pinney & Associates. And on today's show, we also have a very special guest. Let me try to pull him in. Joe, good morning. Can you hear me?

Joe Gitchell: I can hear you great, Jim. Thank you.

Jim McCarthy: That's great. Well, I should point out to our listeners that Joe and I had a nice chat in person yesterday at the Global Action to End Smoking gathering in Midtown Manhattan. And there were a lot of terrific advocates and thinkers and researchers there. And it was great to see you in person, Joe.

Joe Gitchell: Same.

Jim McCarthy: And we've got on the show today, who I think will be patching in shortly, a very special guest. But Joe, since you lassoed the guest and since you're doing all the booking and lifting and lassoing, why don't I let you introduce our guest today? Because I think it's a terrific chance to have an ecumenical conversation, let's say. Oh, there he is right now. I'm going to invite him to speak. Can't quite hear you, Joe. So let me perhaps tee this up for us. On the show today, we've got Kevin Schroth from Rutgers, longtime thinker and researcher and specialist in tobacco science. And I want to let him introduce his bio. There you are, Joe. Hey, can you hear me?

Joe Gitchell: Yeah, I'm sorry. I had headphones on and they betrayed me. So there was so much scintillation that I was contributing that you couldn't hear. Yes, and I would suggest maybe a different verb than lasso.

Jim McCarthy: Is that pejorative?

Joe Gitchell: It's not so much as pejorative, but it's really not what's going on. I'm extending invitations and we're fortunate that there are people who share a sentiment of let's actually have an exchange of ideas. Here's the notion.

Jim McCarthy: I endorse that heartily. I forgive me for lapsing into my Wyoming high country colloquialisms.

Joe Gitchell: Well, and if you ever saw me try to deal with a knot, you would easily know that lassoing and me are not concepts that fit credibly together. So Kevin Schroth is a professor at Rutgers in the Institute of Nicotine and Tobacco Studies and has a distinguished history in more of the applied area of health, law and science, and we can let him, since he is fully endowed with the mellifluous voice, to give listeners a bit more background on him.

Jim McCarthy: Welcome, Kevin. Kevin, welcome to the show. Can you hear us?

Kevin Schroth: Thank you very much. I can. Can you hear me?

Jim McCarthy: We got you fine. We got you fine. Yes. I'm delighted to have you. Why don't you just give us a little summary of your distinguished CV?

Kevin Schroth: Sure. But first I just wanted to point out that I heard a little bit of a debate over whether the word lassoed was appropriate. I think hogtied might be better.

Jim McCarthy: That's great. Well, hopefully I won't get, I won't be dragged around the castle walls like Achilles later in the show.

Joe Gitchell: No, it was Hector.

Jim McCarthy: Hector. Oh, forgive me. Forgive me. Thank you. Kevin, please give us a little background on your work.

Kevin Schroth: An astute correction by the learned Joe Gitchell.

Joe Gitchell: That's like the only time that's happened that I've caught Jim on some classics thing that he was wrong on. And notice how gracefully he accepted the correction. We're trying to model the behavior that we seek in all of us, welcoming constructive criticism in the spirit that it was intended.

Jim McCarthy: Joe is our resident fact checker.

Kevin Schroth: The real question is whether Joe got that from watching the movie or from reading ancient Greek text in black. Does it matter though? I don't think so. So anyway, yeah, my name is Kevin Schroth. Many thanks for the invitation. I'm happy to be here. I am a professor at Rutgers University. I work at the School of Public Health and the Institute for Nicotine and Tobacco Studies. I teach a public health ethics and law class there. Before joining Rutgers, I worked in the New York City health department where I was essentially a director of the New York City health department's policy during periods that included the Bloomberg administration and the de Blasio administration. And in that role, I helped craft a number of tobacco control laws that came out of the health department though. So I wasn't, I certainly wasn't a legislator. But I helped develop policies that then went to City Hall. And then after getting approval at City Hall, moved on to City Council and became city law. And before working with the New York City health department, I worked in private practice as a lawyer.

Jim McCarthy: Got it. And you know, a question occurs to me Kevin, as Joe and I went to the Global Action to End Smoking gathering in Midtown yesterday, and there was such an interesting and wide range of advocates there. Some had come out of public health institutions like Truth Initiative. And others were working with THR on the front lines. I'm thinking of our good friend, Helen Redmond, for example. And, you know, maybe a fanciful thought occurred to me that if there's a notion of the continuum of risk, there's also, it seems to me, a kind of continuum of advocacy in the nicotine space. There are wild-eyed wing nuts like myself on maybe an extreme end, and then on the far other pole, perhaps hardline prohibitionists, and there's a wide range in between too. And you know, please tell me if you think that's an unfair way to think of it, but I'd be curious, your sense of where you fall on that spectrum, if it exists.

Kevin Schroth: Yeah, there certainly is a broad spectrum. And I, you know, this might sound a little bit like a dodge, but I really try to focus on the science and the literature. And I know a lot of people can say that and still fall into very opposite ends of that spectrum, right? But I feel like I don't fall into either end of the spectrum. I do think that it's important to recognize the continuum of risk. It's important to recognize that nicotine is approved as a cessation product in a number of forms by the FDA. And it's important not to demonize nicotine partly for that reason, but also because nicotine can be sold in less harmful forms. I mean, let's be clear. The most dangerous commercial product in human history is the combustible tobacco product, specifically cigarettes and cheap cigars come right behind premium cigars. You know, we can get into a little bit of debate about whether usage patterns are a little bit different, but combustible tobacco products are incredibly dangerous. They kill people when they're used as they were intended to be used. And that's a problem. That's a defective product. If you're looking at a product from a legal products liability perspective and FDA-approved nicotine devices for cessation are on the other end of the spectrum. And then the question that you're getting at is where do these other products fit within those two ends of the spectrum? And there's a lot of evidence that shows that a lot of e-cigarettes that have been studied don't have nearly the same number of ingredients that are harmful or potentially harmful when they're compared to combusted tobacco products.

Jim McCarthy: Well, let me, if you don't mind, let me pressure test it a little bit, because if we're on what you would call broadly the THR side of that spectrum, I think within our world, there's another dividing line between whether or not people can and have the right and ought to be able to use nicotine for hedonistic purposes, for their own enjoyment, or simply because they wish to. So where do you, you know, as opposed to people who think that products like vaping ought to be used only in a cessation context and maybe for a limited duration, where do you fall on that question?

Kevin Schroth: Well, yeah, that's a good question. That gets to the issue, I think, a little bit more directly. I think nicotine products should be regulated, right? I mean, that's what the Tobacco Control Act of 2009 was about; Congress said that products should be regulated. And I think that we should be working towards creating a market where those regulations are meaningful and are recognized and followed. And we're not there. The FDA has been working to try to regulate the product, but, you know, we're not close to where I think we could be or should be.

Jim McCarthy: Yeah, right. Well, it's interesting. You know, I read an interview you had done some months back where you, and correct me if I'm characterizing this wrong, please. I'm trying to be good faith to what you had said. But on the one hand, you said the state should seriously consider, speaking to the state of New Jersey here, adopting an alcohol-like model for e-cigarettes by restricting sales to a finite number of licensed standalone specialty shops. And then on the other hand, you praised the state of New Jersey for enacting a sweeping ban on flavored vaping products. And I guess that's where I struggle to see, it seemed to me a little bit at odds. I mean, I too would wish for a system of specialty shops, that's our AVM members after all. But you know, if you go into any one of those alcohol specialty shops in the state of New Jersey, there's flavored alcohol products galore. So if you favor a system like that, why also wish to restrict flavors?

Kevin Schroth: So, first off, I absolutely think that it's important to create a licensing system so that we can establish who's selling products and regulate them so we can make sure that they're playing by the rules. But I don't remember exactly what I said during that meeting, but I do remember one thing, and that was that if states like New Jersey are going to have flavor bans, they should prioritize the most dangerous products on the market as a first step. And that's starting with menthol cigarettes and then flavored cigars. Frankly, they should both happen at the same time. New Jersey didn't do that. New Jersey went forward with a ban on flavored e-cigarettes. I think it's far more important for localities to prioritize flavored combustible tobacco products.

Jim McCarthy: Well, did you, I mean, let me ask you a question about your work then in the administrations with mayors Bloomberg and de Blasio, which from where I sit seems to stress a pretty heavy emphasis on law enforcement on all sorts of products, including the ones you're describing, but also on vape products too. Do you think that those policies went too far in their, you know, what a lot of folks thought were crackdowns on vape retailers?

Kevin Schroth: I was not there when New York City passed a ban on flavored e-cigarettes. I was there when New York City established a licensing requirement for e-cigarettes that included a system to try to cap and reduce the number of retail outlets. So I'm more supportive of getting a handle on where products are being sold and then trying to manage that as opposed to trying to prohibit all types of products. Now, on whether flavored e-cigarettes should be prohibited, I'm not drawing a hard line there. I like what New York State did where they said that flavored e-cigarettes should be banned unless they have PMTAs from the FDA. I think that's an interesting strategy because that offers flavored products an opportunity to get on the market so long as they abide by certain regulatory requirements.

Jim McCarthy: And somehow overcome the million-to-one against odds of getting that approval.

Kevin Schroth: Well, I’m not necessarily passing judgment on the FDA’s practice or the way the FDA has carried out enforcement. I don’t think it necessarily should be a million-to-one odds, and that’s what it turns out to look like. Cause we’ve got 34 products and we’ve got, I don’t know, 25 million applications. There’s different ways of trying to determine exactly how many applications there were, because I guess sometimes they were grouping and bunching applications.

Jim McCarthy: But, sorry to interject, but elsewhere, I noticed you favored product standards and said that might be an alternative way for the agency to manage those applications. And, you know, that’s something we’ve urged as well. Do you still see that as a potential workaround to this bottleneck?

Kevin Schroth: Well, I’m not sure that it needs to be a workaround to the bottleneck. I think that there ought to be a way for the FDA to improve its practices. I do think there’s a lot of potential for product standards. I just don’t know what we’re talking about because the FDA hasn’t really taken any positions on a product standard for e-cigarettes. The only product standards that we know of are the low nicotine rule for cigarettes and the flavor ban for menthol cigarettes and flavored cigars.

Jim McCarthy: If I may, let me switch the frame to the consumer side here. Because there are, you know, I think—

Joe Gitchell: Yeah, please. Did you want to swear the witness in, or are we having a genteel conversation?

Speaker 4: Did I get the ball out of the fairway?

Joe Gitchell: No, no, no. I just couldn’t resist a little good-natured needling.

Speaker 4: I sent you your nouns and verbs present.

Joe Gitchell: Okay. Sorry to interrupt.

Jim McCarthy: No, please. I want to let you jump in here too, Joe, because you are far more learned in the literature and the policy, as Kevin is, than myself. So I promise I’ll let you jump in here in a second, but I want to ask Kevin about a consumer-side, maybe practical dilemma to this, which is, okay, yes, the FDA ought to do better, and yes, various jurisdictions should fine-tune their policies from a science-based perspective. But in the meantime, there are by last count more than 20 million Americans that are using flavored vaping products. And there is a robust and thriving, growing black market in states like New Jersey and New York with a whole laundry list of harmful aspects to that. And I joke with Joe, there’s this special guest I want to get on this podcast in coming weeks, which is my friend who runs the local bodega here on Lexington Avenue named Fabiola. And you can walk into her store and buy black market cigarettes of every type, disposable vaping products of every strength and variety. And it seems as if the enforcement efforts that we’re talking about here run into that iron law of economics, that there’s a black market and that those 20 million Americans are going to seek those products out. Not least because, you know, it’s helping to save their lives. I mean, do you ever, I guess, belabor it, Kevin, but does that phenomenon give you pause when you’re thinking about the enforcement strategies and how states and the federal government ought to set these policies? How do you factor that in?

Kevin Schroth: Well, the illicit market I think is a significant problem. And I know that flavors are important to people. I’ve witnessed dozens of people come to testify when New York City was proposing various types of laws that would restrict licenses or restrict indoor vaping. And I think that there’s a way to have both, I think there’s a way to satisfy everybody involved here. One is for the FDA to process applications and to clearly, you know, if the FDA is going to change its protocol or its standards, given the new administration, what evidence would help, what would be required to satisfy the appropriate public health standard, you know, I want to know what they’re going to do. But right now, we have a certain amount of evidence. We have a limited number of products that have PMTAs, and that’s where we are right now. I mean, back in 2018, the FDA could have tried to clear out the market of e-cigarettes completely, and it didn’t do that. In 2020, it established guidelines that dramatically limited the prospects for manufacturers selling cartridge-based e-cigarettes, something that Joe’s very familiar with. And what cropped up after Juul took some of its flavors off the market was this Puff Bar and then other e-cigarette-dominated market where we have these thousands of products coming in from China that aren’t even trying to play by the FDA’s rules, and they’re dominating the market. They’re everywhere; they’re over 80% of the market, this disposable-dominated portion of the market that isn’t, as far as I can tell, even trying to get PMTAs, and that needs—

Jim McCarthy: to stop. You know, we sent a letter, Kevin, AVM did, five-plus years ago before the synthetic nicotine standard was put in place giving the FDA authority on synthetic nicotine. And we warned them explicitly. I’ll repost this letter in the thread, but we warned them explicitly about these exact kinds of outcomes, you know, black markets and the kind of products that you’re describing and indifference to the regulations and all the rest of it. And it was, you know, we heard nothing back from them but crickets, and incredibly, both the agency and a lot of the press that cover it, to my immense frustration, continue to insist that they were caught by surprise. This is unforeseen outcomes. I mean, aren’t the kind of dynamics you’re describing a direct and utterly predictable result of regulatory policies that restrict the market too tightly?

Kevin Schroth: I was with you until the very last half of your last sentence. I think there was a grave error in 2020 when the FDA guidance targeted cartridge-based products like Juul based on the evidence that they were popular with young people and carved out a number of exceptions. They carved out an exception for tank-based systems based on evidence that they were popular with adults and hadn’t caught on with young people to the same extent. And then they carved out an exception for disposable products, I think based on a general lack of data, but the disposable products, unlike the tank-based products, had all the same characteristics that led to Juul holding like 70, 75% of market share by 2018. So that carve-out did not make sense. And that carve-out led to the problem that we have right now.

Jim McCarthy: Let me ask you, sorry, Joe, this is the last question, and I promise I’ll lob it to you. Let me ask about a policy prescription that you’re recommending. In fact, I think it was just today, your Rutgers put out a release headlined “Lawsuits could choke off the candy-flavored vape pipeline,” urging more litigation against distributors of products. And obviously, I’d be keen to hear your view on that. But I’d also like to know whether you think that kind of initiative would contribute to the black market effects we’re talking about.

Kevin Schroth: I’m not talking about contributing to the black market effects we’re talking about. I’m trying to rein in the black market. What you’re referring to that was published today was essentially a summary or press release related to an article that was published about a week or two ago in Tobacco Control. And that was titled “How state and local affirmative litigation can rein in illicit flavored e-cigarettes.” And the general idea of that is that attorneys general were the main drivers of a number of major accomplishments in the tobacco control movement, most notably the Master Settlement Agreement in 1998. And that happened right after the FDA tried and failed to regulate tobacco products. There was a 1996 effort that was struck down by a Supreme Court ruling in 2000, and the states took it upon themselves to try to rein in the tobacco industry. And they did, not perfectly, but in a pretty monumental way. And what I’m proposing is that state attorneys general should get involved here because the FDA can’t do it alone, and I wrote the article before April 1st, 2025, when the FDA was gutted by the current administration, so the FDA was incapable before April 1st. And now we don’t even know, I don’t personally know, what’s left of the FDA and its enforcement division to either process PMTA applications or enforce its regulations that are prohibiting these products that lack PMT authorizations from being on the market. So my suggestion is that attorneys general should not go after the retailers per se, but should go after the distributors, the master distributors that are taking these imports from China and then circulating them around the country. So going higher up in the food chain to try to cut off the distribution system of these illicit products.

Jim McCarthy: And I guess this is where I part ways with Joe and the approach you’re describing, which is all centered on ways of either using law enforcement or litigation to crack down on vape sales. And to my mind, these are approaches that inevitably, demonstrably, and have always led to black market effects. I mean, for every company that you might bankrupt with that approach, they will be replaced. And I commend to anyone the article that was in the Sunday Times, the UK Times, this past week about the black market that exists in that country. And it just absolutely shocks the conscience when you look at it up close; it involves Kurdish hitmen and snakehead triads and bounties on drug sniffer dogs and arson and even human trafficking. I mean, the effects are horrendous. And to my mind, the Irish colloquialism is, you know, it attempts to plow the sea. And I just don’t know. It really troubles me that this was echoed by Dr. Califf and Dr. King in their recent webinar, Kevin, I imagine you might’ve seen, in which they’re describing the new nicotine standard that they proposed, a lowered nicotine rule. They wanted to see, and when asked about the black market, they just shrugged it off as if it probably won’t be that bad. And, you know, we’ll cross that bridge when we get to it. Well, let me hand off there, Joe.

Joe Gitchell: Okay. This has been a great discussion, and I was teasing you, Jim, about your, I would say friendly but firm inquiry, and Kevin, I appreciate your thoughtful responses. I would maybe dial us back to a discussion, maybe more of ends, insert hashtag day job, and means, including the surgeon general nominee, hashtag day job. What are we trying to accomplish with any of these initiatives? And that is a question for you, Kevin. What, if you had your druthers and given the available resources, the authorities, the staffing, the realities of our various federal, state, local regulatory systems, so you’re constrained by that, what do you want the nicotine marketplace to look like in five years?

Kevin Schroth: I would like to see a nicotine market where people can walk into a store selling e-cigarettes and have options before them that have passed the FDA’s regulatory requirements, that have PMTAs. And it would, you know, I think it would be great if there’s quite a bit more than 34 products for people to choose from. So that’s where I want to get. I know we’re not going to get there anytime soon.

Joe Gitchell: Well, why is that? Why can’t we get there anytime soon? And I gave you five years. So is five years too soon? I mean, I hope I’m still alive.

Kevin Schroth: It is. I mean, if you look at the time it takes for law enforcement to really change a marketplace, we’re talking years. I mean, my idea of attorneys general getting involved, they’re not even focused on this yet. New York State filed a very thorough, comprehensive complaint earlier this year that targets distributors. And the paper that I wrote earlier, I guess in April, was with an attorney from the New York City Law Department, Eric Krushansky, who prosecutes affirmative litigation on behalf of New York City, and he wasn’t as involved in the lawsuit that was filed against Magellan, Bape, and other distributors that goes back a year prior. So New York City was getting involved. New York State is now involved. The states of California and Illinois have lawsuits that are also going after e-cigarette distributors, but on a smaller scale than New York State. My point is just that this is something that is kind of percolating and on the radar screen for attorneys general, but it’s not something that is anywhere close to Master Settlement-type interest or even the level of the Juul attorney general lawsuit that took place several years ago, and that involved at least 34 different attorneys general. So my point is just that it will take a while just for the attorneys general to decide if they want to take this up, and if they did, then litigation has its own pace, and it takes a couple of years for a major lawsuit to go through and come to some type of conclusion that could change marketplaces. So that’s why I think, even in a best-case scenario, it would take years. Plus, we have turmoil going on in the FDA; we don’t know what their next steps will be and how long it’ll take once they come up with a game plan.

Jim McCarthy: Let me just put a fine point on this. If I may, let’s say that unfolds as you just described and are urging, and those distributors are hauled into court, admonished, and bankrupted. Are you saying that you think that’s going to curtail or even eliminate the sale of those products in the state of New York?

Kevin Schroth: I think it could have a significant effect. When you look at the volume of business that’s going through these distributors and when you consider that these are products that are being sold in the open on the streets. It’s not that even if other distributors try to occupy that space that might be left when a major distributor or a number of major distributors disappears, somebody else tries to occupy that space. It’s not that hard for law enforcement to go into a retail store and put pressure on that retailer to find out who the supplier is. So basic law enforcement effort, if there is interest, can be used to work up the chain and figure out who the new distributors are, and if there’s sufficient interest, I think there could be significant progress made. Now, but the point that you get to is there is always demand, and there has to be some way of satisfying the demand. And that’s where I do think that having an FDA that’s processing PMTAs could help. It’s not going to happen. The attorney general piece isn’t going to happen overnight. The FDA piece isn’t going to happen overnight, but perhaps the FDA can approve more products as more evidence is accumulated, and we get closer to the promised land that I’m envisioning.

Jim McCarthy: You know, I think back to Joe and I did a series of conversations on the podcast called Backfired, which got a lot of national attention, which was a deep dive into all these dynamics of nicotine and vape policy. And one of the things, examples that really jumped out at me in that show was how the host did a ride-along with the New York City task force, law enforcement task force that tries to crack down on vape retailers, that’s just part of what you’re describing there, Kevin, pressuring them to find out about distributors and so forth, and also, you know, handcuffing them and seizing their inventory and shutting down their store. And what struck me was what the law enforcement officers themselves said after they had done such a raid. And they said, these guys that run this store are going to be open again down the street in three days or three hours. And they thought that approach was not only pointless, but like, you know, taking them away from other more important law enforcement duties in New York City, which, you know, as a New York City resident, I’m here to tell you are pretty acute. I mean, I don’t know. I just, the approach you’re describing, doesn’t that overlook the example of the most stringent law enforcement efforts that are going on or, I don’t know, marijuana policy, for example, or any other attempt at stringent litigation solutions?

Kevin Schroth: So you’re talking, you’re confusing two different law enforcement bodies in New York City. You were describing something that would be done by the New York City Sheriff’s Office, as opposed to the New York City Police Department. This is not NYPD. NYPD is appropriately going after criminal laws. And this is something where the New York City Sheriff’s Office is charged with dealing with— the New York City Sheriff’s Office is part of the Department of Tax and Finance or Department of Finance. And they do work that’s, you know, 15 years ago or 10 years ago, their number one responsibility was trying to work against cigarette tax evasion. And that’s why they know where all these retailers are that are licensed, and they have regularly done that type of enforcement operation. And now that e-cigarettes have licenses, they’re involved in that as well. But it doesn’t take away from law enforcement, but it gets to one of the points that I’m advocating for. And that’s that if you’re targeting primarily the retail level, you’ve got thousands of retailers in New York City that are selling electronic cigarettes, trying to go to 3,000 or so retailers is not a cost-effective way to try to enforce the law. But if you go to the warehouse, if you go to the master distributor, I mean, they’re not even trying to play by the rules. They’re not trying to follow the FDA’s rules. And they know very well that they’re openly breaking the law. If you go into that warehouse, that’s where you can have a law enforcement impact that makes sense.

Jim McCarthy: This is reminding me, Joe, of the discussion we had a few weeks ago about the lowered nicotine standard. And that’s, I think, of a piece with something you had, I believe, advocated, Kevin, which is to eliminate menthol cigarettes. And Joe, I guess I’ll just hand it off for your thoughts too. I mean, I am just baffled that the notion that those policies will not lead to explosions in the black market. I just, I mean, I don’t know how much more plain as day that outcome could be.

Joe Gitchell: Well, let me go back to my effort to bring us to a little higher level, though. Kevin, thank you for that instruction on the various authorities of law enforcement in New York City. Walking on 43rd Street this morning, I saw a law enforcement officer, and his badge read something like “Hybrid Threat Team.” And I was like, you know, I thought hybrids were good cars, but maybe, I don’t know, times are changing. But you described a better world as a person could walk into a store and have a broader range of options, presumably non-combustible nicotine options, from which to choose. And that was one of my points in the rapid response to your commentary that may still yet appear, Kevin, that it seems as though these approaches really need to work in tandem. And the idea of enhancing and increasing interdiction efforts without radically changing the licit supply is actually making the likelihood that Jim is correct about something painfully likely. And given how averse I am to that idea, I would urge you to maybe comment more on, you know, yes, there’s uncertainty, there’s turmoil, there’s change. But we know a lot more now than we did in 2018, than we did in 2020. And it feels like having more expression like your colleagues Del Nevo and Werner wrote in JAMA in December to say, essentially, CTP’s got authorized some pouches, seems like CTP’s got authorized some vapes that would be at least close to competing with the products that people are buying now.

Kevin Schroth: You know, I can’t explain why, before April 1st, 2025, I couldn’t really explain why CTP has not processed more applications. And so, I mean, I think it would be great if there were more applications that were granted. But I also don’t understand why a lot of applications have been lagging, and there just haven’t been decisions. Well, do you have a theory?

Joe Gitchell: I don’t have a theory, but I do, something that you said, I just wanted to point back to, and I think it’s important and I think it’s valuable. If you go back to the days when Scott Gottlieb was the commissioner of the FDA, he announced his policy on nicotine harm reduction and this plan to lower nicotine in cigarettes on one hand, and on the other hand, provide time and ability for e-cigarettes to submit PMTA applications to create a better marketplace so that when a low nicotine rule goes into effect, there would be a better e-cigarette market with PMTA, FDA authorization out there to help people to transition. I like that plan, and we got away from it a long time ago based in large part on the spike in e-cigarette use in the 2018, 2019 period. But I do think that that plan had a lot of merit, and it would be nice to get back on track with something to that effect.

Jim McCarthy: Well, Kevin, let me offer a thought on that. You know, I went back and re-listened to the terrific interview you did with Brent Stafford on Reg Watch some months back, and we’ll put a link to that in the thread too, and you touched on this question and said that you’re not convinced that the FDA is making decisions with politics in mind. And I stuck on that because, you know, an anniversary just passed a couple of days ago, which is the Juul PMTA is now more than five years in limbo at FDA, although it is one of the most in-depth and rigorous and voluminous applications, maybe of all the ones that have ever been put forward. And it’s just, as you point out, really inexplicable that that remains circling the airport. And I can’t help but think, as the Reagan-Udall audit indicated, that they do feel political pressure and more than just political, they feel advocacy pressure too, a lot of which comes from your old colleague, Michael Bloomberg, who’s put hundreds of millions of dollars into that advocacy. I mean, I don’t know. It just seems inescapable that that plays a huge factor in FDA’s process.

Kevin Schroth: I wonder, Joe, if Joe has a theory or has any thoughts on this? I mean, I don’t know exactly what’s happening inside the FDA. So I’m trying to find out as well.

Jim McCarthy: Well, let me ask it a different way. And then I’ll let Joe weigh in here. The terrific journalist Mark Gunther did a piece a year or so ago about zeroing in on that advocacy and the way that Bloomberg Philanthropies has funded and helped coordinate a lot of these groups that are opposed to nicotine vaping writ large. And what was striking about it was that there was a long list of a couple of dozen of the leading thinkers in tobacco science, some of the names that we’ve mentioned on this chat here, including David Abrams and Cliff Douglas, Ken Warner, among others, asking for a private, confidential Chatham House conversation with Mr. Bloomberg and his team about the latest science, which I think the three of us all agree ought to be a preeminent part of the discussion. And they wouldn’t even sit down with them. Wouldn’t even have that dialogue. I mean, are you troubled when you see stuff like that, Kevin?

Kevin Schroth: Well, first off, I think it’s important to distinguish Michael Bloomberg, the individual, from Bloomberg Philanthropies, from Bloomberg, the mayor. I worked in the New York City Health Department, and he was the mayor when I was there, and as far as I was concerned, having a mayor that prioritized public health was great because we felt like when we had science-driven ideas, we could try to work them up the food chain. And he was, you know, his reputation as a businessman is deserved. I feel like he would listen to the facts and the evidence and make decisions in an efficient way. So I appreciated that as a city employee. And I think you referred to him as my colleague. He wasn’t quite my colleague. I had a couple of occasions to meet him, but I don’t think he would remember me. And Bloomberg Philanthropies is a totally separate organization that funds a lot of the work done by Tobacco-Free Kids and others. And I don’t, if you’re trying to get a meeting with Michael Bloomberg, I don’t know what your chances are, but if they were trying to get a meeting with people at Tobacco-Free Kids or Bloomberg Philanthropies, that’s another matter. And I think they ought to have meetings with people that have a range of views, and they ought to recognize the scientific evidence that shows that e-cigarettes are not at the most harmful range of the spectrum. But they’re advocates, and they’re doing their thing.

Jim McCarthy: Their thing is pretty big, though. I mean, again, I keep coming back to the sheer scale of that advocacy, the money that’s going in, and what strikes me as the obvious influence that’s having on federal vape policy. I mean, a lot of those groups, TFK, Vital Strategies, and others, had recurring, repeated meetings with FDA leadership on these policies. I mean, Hell’s Bells, the CTP was shoveling money out the door themselves to some of those groups. And none of that was publicly disclosed.

Kevin Schroth: Of course, the meetings, I mean, and well, I don’t know, just the industry is having lots of meetings with the FDA and the White House as well, right?

Jim McCarthy: Well, it’s one thing to be called to the living room and another thing to be called to the woodshed.

Joe Gitchell: Well, let me, I did almost pass up an opportunity to speak, and I wouldn’t want that to actually happen. I do have kind of a broad-brush theory about the challenge that the Center for Tobacco Products at FDA faces, which is different, I think, in a qualitative way than the challenges confronting the other centers at FDA. There are pitched struggles and debates confronting biologics, devices, drugs. But there are no real, and there’s an asterisk with this, but there aren’t credible voices saying we don’t want any of these, and the struggle I believe that CTP confronts is there’s a pitched battle with the most credible voices saying we don’t want any of these, and that puts CTP in a real pickle. And I think I know what it would take to resolve it. It would take things like statements from leading legislators to the effect of, I’m not in a position to judge the merits of these applications. That’s why we granted resources and authorities to you, HHS and FDA, but we’re tired of waiting, make some decisions. We will not second-guess them, but we will not wait any longer. That would be a very different environment than what we have now.

Jim McCarthy: Right. And I think you’re touching on an important point, Joe, not only is there frustration in the academic and research and policy communities, but there’s also that deep frustration among ordinary vapers. I mean, you know, again, at AVM, we interact and work with these folks all the time. They are customers. And when they hear technocratic solutions, and it may take years, and if only we changed this spark plug and not that air filter and made the brakes a little tighter, and five years down the road, we’ll see what shakes out, I mean, people get, I mean, blood pressure goes through the roof. I mean, I’m here to tell you that the vape customers are in a kind of mindset of revolt. Their view is, I’m going to use the products that helped me quit cigarettes, I’m going to seek out and use the flavors that I prefer. I am not going to wait until Brian King or Dr. Califf or anyone else comes to Jesus.

Kevin Schroth: Well, we’re in a new administration now. I’m curious if you have any thoughts on, I know I’m not sure if I can ask you questions, but please, please do.

Speaker 4: Yeah. Yeah.

Kevin Schroth: I’m wondering if you have thoughts on what might be next with the new administration. We’ve got RFK Jr. in charge of HHS, Brian King’s no longer the head of CTP, Califf is no longer there. So what’s next?

Jim McCarthy: Yeah. And I worry about this all the time, Kevin, and, you know, there’s a range in these stakeholders I’m talking about. There’s a wide range from optimum optimism to guarded optimism to pessimism and horror. And I lean a little bit, I hate to say, on the darker side of that, because, you know, a lot of the very few pronouncements you hear from the new officials that are going into those offices, to my ears, lean very heavily on authoritarian enforcement solutions and talk about guns and door-kicking and crackdowns. And it’s all of an authoritarian piece; this time it might have an R behind it instead of a D, but it’s all the same kind of drug war reflexes that are going to prolong and worsen and wrench this policy outcome in different but equally bad directions. Now, I fervently hope I’m wrong. I’d love to see a more enlightened policy and a more efficient way of regulating, for sure. I mean, I think we all share that North Star, but I can’t so far see a whole lot of reason for optimism. Joe, how do you see it?

Joe Gitchell: I actually, my optimism doesn’t let me say that I agree. I can certainly see and understand where you’re coming from. However, I had the good fortune to attend this New York Times Well Festival yesterday and had a chance to talk to another attendee who’s more involved with trying to deal with smartphones and adolescence. And we got to talking about how there’s some kind of similarities here. And they expressed the sentiment of, yeah, it’s actually kind of exciting. There’s a broad spectrum of support for these notions. It’s like a bipartisan thing. And then I said, well, you know, the support to crack down on non-combustible nicotine products has a very profound bipartisan nature too. It’s just that literally everyone is wrong. And I’ve been thinking about this notion of shared truths. And I’m now realizing we do have shared truths in this arena. They’re just not correct. It’s like the Mark Twain quote: It ain’t what you don’t know, but what you think you know that just ain’t so. That’s where we are.

Jim McCarthy: And let me meet Kevin halfway on a shared truth. Cause he pointed out a moment ago that there’s influence coming from tobacco companies. And in this new administration, that’s plainly true. You’re right, Kevin. The two of the single biggest contributors to the Trump campaign were RJR and Altria. And guess what? They’re up there in DC, as we speak, urging policy prescriptions that would also crack down on disposables. And that’s also heavy enforcement, stresses heavy enforcement. Of course, they’re doing it to protect their market share. It’s a regulatory capture strategy, which I abhor. But all of that, whether it’s Matt Myers meeting behind closed doors with Dr. Califf and urging a prescription or the lobbyists for RJR doing it with RFK’s office, I mean, that, to my mind, is all wrong. That all betrays the American public. It is not the way that the federal government ought to set policy. That should be strictly science-based. It introduces, it turns all of the stakeholders in this space into competing, jockeying factions for who’s going to be able to curry the most favor and who has the most financial clout. And that’s where I think we can meet halfway, Kevin. And if I had my way, all of that would be forbidden and rebuffed.

Kevin Schroth: Yeah. I think we can meet halfway there. I’m not a fan of that type of influence. I mean, people should have opportunities to speak. I don’t appreciate the perception that these backdoor meetings are having an undue influence on policy decisions.

Jim McCarthy: I wonder, though, I mean, take the Juul delay, though. How to understand that? Is it because they got off on such a terrible foot in their early interactions with the agency and are therefore in a kind of de facto penalty box? I mean, what could possibly explain a five-year delay on that?

Kevin Schroth: That, I really don’t know. But when you look at the Juul product and consider that Juul has really taken a turn in trying to market its products responsibly. And when you look at the constituents, it’s now a product that’s been studied very thoroughly. It seems like one of the credible, less-harm, harm-reduction products on the market. And I can’t explain why it hasn’t been given a decision yet.

Jim McCarthy: Well, we’re getting close to our wrap-up time. So I want to, before we go, I want to give you a hopefully amusing anecdote, Kevin, which is that I too have a connection to Michael Bloomberg because he and I are members of the same golf club in Bermuda. And I often see him there in the men’s grill, where there’s a microcosm of tobacco policy, because me and other members like to vape in the men’s grill, much to his honor’s consternation. And so I share that as a weak attempt at levity. Joe, what have we, what can we squeeze on Bermuda law? I know it’s a little to my chagrin there; they are, despite their British history, a little more liberty-loving than the American golf clubs I go to. Joe, what thoughts should we wrap up on? What are you thinking about as we go forward? And I want to hope that, Kevin, the conversation has been good enough that you might consider coming back. There’s a lot we could, should talk about, and I want to see what Joe thinks we could maybe pick up another time.

Joe Gitchell: I agree. I do hope that Kevin will forgive you for your trespasses, which were pretty wild. No, where my mind went is I would read the heck out of anything that Jim McCarthy and Kevin Schroth could coauthor. And I know that’s setting an expectation, you know, you got to believe it to achieve it, whatever, but that would be fascinating because I suspect there would be more, yeah, I could meet you halfway or this, and gosh, we are not going to make forward progress unless we start coming together with where we can actually see a compromise. That’s literally the way things work in a democracy. And I hope we continue to live in one.

Jim McCarthy: Well, let me suggest an idea, Kevin, that I’ve been thinking about. My friend Eugene Volokh started a terrific legal blog, you may be familiar with, called the Volokh Conspiracy. And the function of it is for a variety of lawyers, mostly in appellate law, to get together online in a single-threaded platform, and they converse and share ideas and put questions to one another and have an ongoing, evolving conversation in their field of legal expertise. And what’s so great about it is you get, as you say, Joe, a variety of those perspectives, and they can share ideas and challenge one another. And it’s a good, civil, high-minded way to do it. And it also benefits the readers too, because it chronicles that whole conversation. So I’m tempted to try to organize something like that. And I wonder if you two would consider doing that if we can get it rolling.

Kevin Schroth: I’ll certainly look into it. I’m not familiar with it. You said the Volokh Conspiracy?

Jim McCarthy: Yeah, spelled V-O-L-O-K-H, the Volokh Conspiracy. And essentially, it’s just a way for a group of thinkers in a particular topic to kick around policy ideas as they evolve and unfold and have an ongoing convo. It sort of centralizes the conversation among disparate thinkers in a space.

Joe Gitchell: Cool. Excellent. Yeah. That sounds like a really cool function.

Jim McCarthy: All right. Well, I want to say thanks, especially to Kevin, for joining us. You’re one of the most serious thinkers in this space and alive with a lot of experience too, and you’re gracious to make time for our humble podcast. And Joe, I want to thank you for including me at the GAES event last night. I felt a little awkward rolling in as a notorious wingnut on the topic, but everyone treated me graciously, and I hope I behaved myself. And so here’s hoping we can have more ecumenical conversations like this.

Kevin Schroth: Thank you very much. My pleasure.

Jim McCarthy: I’m glad to have you. All right. We’ll put links in the thread. Kevin, I encourage you to jump in there too, if anything occurs to you or you want to present any links to the work that Rutgers put out this week that we touched on. And in the meantime, thanks for listening, and we’ll see you next week for another episode of Shaping Vaping. Thanks, gents.

Kevin Schroth: Thank you.

Joe Gitchell: Thank you.