Explainer Episode 61 – FDA & Flavored E-cigarettes – Discussing Triton v. FDA

The approach the FDA has taken to regulating e-cigarettes and vape products, particularly those that are flavored, has been the topic of conversation for some years. Experts debate the best methods for review, risks and benefits involved in such products, and the means by which the FDA reviews such applications. Jeff Stier joined us to discuss a recent Fifth Circuit decision (Wages and White Lion Investments, L.L.C., doing business as Triton Distribution v. FDA) concerning the FDA’s approval (or lack thereof) of flavored cartridge e-cigarettes –the state of the flavored e-cigarette market, the facts of this case, the existing circuit split, and the potential ramifications of this decision moving forward.


  • Jeff Stier, Senior Fellow, Consumer Choice Center


Although this transcript is largely accurate, in some cases it could be incomplete or inaccurate due to inaudible passages or transcription errors.

[Music and Narration]


Introduction:  Welcome to the Regulatory Transparency Project’s Fourth Branch podcast series. All expressions of opinion are those of the speaker.


Chayila Kleist:  Hello, and welcome to this Regulatory Transparency Project podcast. My name is Chayila Kleist, and I’m an Assistant Director of the Regulatory Transparency Project here at The Federalist Society. Today, we’re delighted to host Jeff Stier for a discussion on the recent Fifth Circuit decision related to the Wages and White v. FDA case, a case concerning the FDA’s approval processes of flavored vape products. Mr. Stier, thank you so much for being with us today. We appreciate you taking the time.  


Jeff Stier:  Thanks for having me on, Chayila.


Chayila Kleist:  For our audience, Mr. Steir is a senior fellow at the Consumer Choice Center. He is also a senior fellow at the Taxpayers Protection Alliance, and a policy advisor at the Heartland Institute. He is widely quoted in the media and has written health policy op-eds for the Wall Street Journal, the Los Angeles Times, USA Today, the New York Post, the Washington Examiner, FoxNews.com, and the National Review online, and has been interviewed by several other news sites. 


Additionally, Mr. Stier has testified at state and local legislatures throughout the U.S., at FDA scientific hearings and at the Office of Management and Budget, and at hearings of the United Nations and Israel’s Knesset. Now, there’s more to say, certainly. In the interest of time, I’ll cut it there. Although, if our listeners would like to read his impressive full bio, you can do so at RegProject.org. With that, however, we can turn to our discussion. 


I’d love to start with the facts and how we got here. We can talk details later. But, for now, as we’re heading into the discussion, can you give me the 60 seconds on what this case is and just a little bit of background. And then we can get into definitions and everything else. 


Jeff Stier:  Sure. So, about a decade ago, Congress gave the Food and Drug Administration authority to regulate tobacco products. About six years ago, ballpark, the FDA said, “We are going to deem e-cigarettes as tobacco products. And, therefore, under the law, we will have authority to regulate e- cigarettes,” which, especially back then, were a very novel product. 


The FDA developed regulations about how it was going to regulate them using the standards that were set out in the law, and, over a number of years, developed the regulations that would require a company who wanted to bring a new, novel “tobacco product” to the market, a process for how that would happen. And they’re called the “premarket tobacco applications.” And when the FDA was developing these rules, there were lots of questions over what would be in the requirements for a premarket tobacco application. 


And, having been following this topic very closely over the years, I participated in some of those meetings with the FDA where they’re going back and forth with the industry and with public health groups to decide how is the agency going to weigh an application. What is it going to look for? So, here we are. Those rules came out. Industry complained it didn’t really know what the FDA wanted out of them. 


There was a deadline to submit an application. That deadline had been pushed back a little bit. But when the deadline finally came, companies submitted their applications. The FDA has been ruling on those applications. Of the million or more applications that the FDA received, 23 of the applications received an authorization for marketing. The FDA is very clear they’re not approvals, because the FDA doesn’t want people to think that the agency approves of e-cigarettes as if it’s some sort of moral issue. So, they authorize an application. 


And the rest of those applications, almost all of them have been denied. There were marketing denial orders, which is what happened in the Wages and White Lion case known as Triton. The marketing denial orders mean you cannot bring your product to market. You can’t keep it on the market. It must come off the market. It is being illegally marketed. 


And, of the 23 authorizations that the FDA did give, they were all for tobacco-flavored e-cigarettes and none of them were for flavored e-cigarettes, be it menthol flavor or other sweet flavors that adult smokers have said that they need to maintain their cessation of smoking.  


Chayila Kleist:  Got it. Okay, so with that background, then, the conversation on vaping and vaping products clearly is nothing new. But this case is particularly addressing a subset of the products in question. Is it just about flavored vape products? Or is it about vape products as a whole? 


Jeff Steir:  So, the way the FDA set up the application process is they are on a case-by-case basis and it is dependent upon the application. So, Company A may have a cherry-flavored e-cigarette that they’re marketing to adult smokers and Company B may have a very similar product, similar nicotine levels, same type of flavor. And Company A submits a very robust application. And Company B, with a very similar product, submits a much weaker application. 


The FDA could decide to authorize Company A’s product and issue a marketing denial order for company B’s product, even though the FDA had access to Company A’s application and the science behind it that would apply to Company B as well. It could even be — get this — that the Cochrane review, which is a very well-established scientific analysis, they do meta-analysis of different studies — it could be that the Cochrane review comes out with a study that says e-cigarettes are more effective than nicotine replacement therapy that’s been approved by the FDA. And, by the way, that happened this week. 


The FDA would not look at the independent Cochrane review, the most reputable independent science out there. It would only look at the four corners of what’s in the application. And if you did not put your reference to the Cochrane review in your application, the FDA wouldn’t consider it. The FDA is not seeking out the truth here. They are seeking out the validity of the application. And the FDA, in its deeming regulations in subsequent guidance based on the Tobacco Control Act, says that in order to authorize an application we have to be persuaded that the marketing of this particular individual product is “appropriate for the protection of public health.” 


Now, the FDA has not defined what that means. There have been discussions about it. And, basically, it’s a weighing of the risk to the public health in that youth may start vaping, in that the product itself may be dangerous, in that a smoker who might have quit using nicotine completely will now vape instead of not use anything. So, they’re assuming some risk versus the benefits, which are quite obvious that if you quit smoking cigarettes completely and you switch to vaping, you will significantly reduce the harm. 


Because, as I think too few people know, nicotine is the addictive component in a cigarette, but it is not particularly the harmful component. The real danger of smoking is the products of combustion, of burning tobacco. And in e-cigarettes you get the nicotine which satisfies your addiction with very few other problems. And even if there are some troubling constituents in those problems, they’re far, far, far lower than you would get from smoking a cigarette. 


So there is a scientific consensus that if you’re going to use nicotine, you’re better off using it from an e-cigarette than from a combustible cigarette. So, if you can quit smoking, as many people do — particularly if they have access to the flavors that they say are important to them to make it palatable and enjoyable — then switching from smoking to vaping is a huge health benefit. 


And the FDA presumably would say, “Well, what’s the benefit of smokers quitting using this particular individual product versus the risk introduced by this product on a population level of other people who may not even have vaped or smoked before now using this appealing product? And how do you weigh those against each other?” 


And the FDA never gave specifics. There was no algorithm that it shared with potential applicants who needed to put it in the application. Because, again, the FDA was only looking at the application for the individual product. So, in this particular case, in the Wages and White Lion or Triton case, the FDA only looked at that application. And the ruling was only about that product. But, as we’ll discuss later, the implications could be far more broad reaching.


Chayila Kleist:  Got it. So, it’s a little less about the product itself, more about the application process and how the FDA is reviewing the applications that are coming before it. You mentioned the FDA doesn’t provide, necessarily, a formula for this. But I do believe they provided guidelines — at the beginning, throughout the process — and then amended those. What did the FDA initially say it was going to look at in reviewing applications for e-cigarette products? 


Jeff Stier:  Sure. So, what the FDA said in guidance — and there has been a lot of criticism about the FDA, as well as other federal agencies, sidestepping the regulatory process by regulation by guidance, and that’s something that I’m sure our listeners are very familiar with — the rules for issuing a regulation require notice and comment. Purposefully, it is a laborious process, and time consuming. 


And, rather than, as it did with the deeming rule, go through that notice and comment period, it did a lot of informing potential applicants about what would be required through draft guidance, or, even less, the FDA would often speak at an industry conference and drop some clues as to how it might rule. But it never issued those clear standards of “In order to convince us that your product is appropriate for the protection of public health, we will need to see a study of this type. We will need to see, for instance, a longitudinal study about your product.” 


The FDA never said that. Well, actually, when the deadline came and passed for an application to be submitted, the FDA dropped a very big hint that it would want to see a longitudinal study. Now, longitudinal study, if you think about the word, the first few letters are L-O-N-G. It takes a long time to do a longitudinal study. And when the FDA suggested that it would really want to see those studies in an application, the deadline had already passed for submitting the application. 


It would have been impossible for a company to say, “Oh, we just heard in something a little bit less formal than draft guidance that they want to see a longitudinal study.” It’s too late. You would have missed the deadline to apply in order to keep your product on the market. So, the FDA did give some hints. And one of the hints that I heard the most was that the FDA, because it was concerned about youth vaping, wanted to see the marketing plans of these companies. 


In other words, what are you going to do, when you bring this product to market, to sell it? Are you going to do flashy ads with young models, being read in magazines by 20-year-olds or being advertised on websites that young people visit? Or will you be reaching out to adult smokers who the FDA wants the audience to be? And the FDA said that those marketing plans were critical to the FDA’s evaluation of the application. 


Chayila Kleist:  Got it. Okay. So, with that background of what this process is, what’s at question, moving to the case itself, what were/are the issues at stake? Because, obviously, it is decided by the Fifth Circuit. It could still have an appeal. Who are the parties in this particular case? And what were the arguments they made?


Jeff Stier:  So, the FDA was defending its rule, defending its application of the rule and its review of this particular product’s application. And the plaintiffs, like almost a million others, had received a marketing denial order. They were told that, despite their application, they did not have robust information. Particularly, they didn’t have a longitudinal study. And the FDA said, “Your data was not robust enough for us to conclude that your product” — there were, actually, I think, two products — “that your products would be appropriate for the protection of public health.” And they challenged that, saying, “You never told us we needed to do this, we needed to do those studies. You told us we needed to provide critical information about our marketing plan.” 


And what the FDA did, and this came out in a Freedom of Information Act law request that the FDA instituted something that was called the “fatal flaw analysis.” It looked at the applications, particularly for flavored e-cigarettes, which the FDA was concerned would appeal to kids. And, therefore, if they appealed to kids, they wouldn’t be appropriate for the protection of public health because it would do too much public health damage, even when weighed against the potential of adults quitting smoking completely. The FDA was pummeled by applications. It was surprised at how many applications it received. 


Now, it’s important to note the FDA’s own deeming rule, which laid the groundwork for the application process, made it clear that if Company A had an e-cigarette that had four different flavor options, and those four different flavor options each had four different levels of nicotine that you could choose from, rather than submitting one application for those products, the company would have to submit 16 applications: one for cherry at the low level, one for cherry at the medium, etc. So, different applications for each individual product and every variation in that product. 


So, perhaps it should not have been a surprise to the FDA when it received some million applications that it was going to have to review, individually, each time, on a deadline, which it missed. So, in this case, the FDA was reviewing two applications. And, because the applications contained flavors and because the FDA felt stretched for, pressured to come up with a ruling on these, out of a million applications, they instituted the fatal flaw analysis, which simply meant — and it didn’t tell the public about this, it came out in the FOIA — that “We are going to categorize these. All these flavors are going to go in one big pot. And we’re going to search for whether they did the longitudinal studies, for whether they had the type of science we want to see.”


And all of the applications that did not have those studies were deemed to have a fatal flaw and were issued marketing denial orders. And what came out in the Fifth Circuit case that we’re talking about today is that the FDA acknowledged that it did not even read the marketing plan, which the FDA itself said was critical to the application, and, instead, relied on the fact the study the FDA wanted wasn’t in there, even though the FDA never put a requirement for those types of studies in the rule, or even in the draft guidance, prior to the time that the application was due.  


And that’s why the court found the FDA’s approach to be arbitrary and capricious, which is that standard for a court to overturn an agency’s decision. Obviously, the courts give great deference to the experts at the agency and will only overturn a decision if the courts find it to be arbitrary and capricious. The court will never second-guess the expertise of the agency. But, in a fact pattern such as this, where the FDA said, “We want to see your marketing plan. That is critical,” and never said “We wanted to see the type of science that the agency asked for” until it was too late, and then never read that critical marketing plan, and then issued denial orders without even reading the critical marketing plan, the court said, “That is a violation of the Administrative Procedures Act. It’s arbitrary and capricious.” 


And the court went even further. And I will say it may not have been a ruling, but the court made an observation that because the FDA has refused to authorize any flavored e-cigarettes, other than the tobacco flavor itself, that the court — I’m not going to say “found” — but the court observed that it appears that the FDA actually has a flavor ban, a de facto flavor ban in place because it wasn’t even looking at the applications for flavors, so long as they didn’t have what the FDA later decided it wanted. 


And a de facto flavor ban would, again, be another example of the FDA circumventing the regulatory process and the notice and comment period, because there is no flavor ban in the rulemaking. The flavor ban came about in a de facto manner by simply issuing marketing denial orders for every single flavored product that the FDA had an application for, even without reading the application. And that is a violation of the Administrative Procedures Act to circumvent the notice and comment period and just have a de facto regulatory policy. And that’s what the Fifth Circuit found here, in this particular case. 


Chayila Kleist:  Excellent summary of the case and the decision. I would love to move on to effects in a moment.  But, before we do, rounding up the facts of the case, who/what are Wages and White, acting as Triton? What is the particular complaint in this case?


Jeff Stier:  They are a manufacturer of flavored e-cigarettes: e-cigarette liquids, particularly. And they are just one company. I would call them a mid-sized, relatively small e-cigarette company. But they took a stand here. There are other companies that have, in other circuits, challenged the FDA’s opinions. They have failed. I think there were five other circuits that ruled that the FDA did not act arbitrary and capriciously. But here in the Fifth Circuit, with this medium-sized e-cigarette company, the court found otherwise, similar to how the Eleventh Circuit found. 


And Triton, I think, is making itself a bit of a hero for the rest of the vape industry. There are a lot of people concerned that all of these other applications — the Fifth Circuit case right now only applies to Triton, to this one company. But they are being seen as a hero in the community of people who used to smoke and quit smoking because they used flavored e-cigarettes. Most smokers have no interest in tobacco flavored e-cigarettes, which is why the 23 products that have been authorized by the FDA have very little market share. 


Smokers don’t want to go to the black market for their products. They want to go to a regulated market where they know the product has been tested and authorized by the FDA, knowing that it doesn’t have any unknown contaminants in it that you might get if you had to go to the black market. But many smokers, or many former smokers who have now quit smoking using flavored e-cigarettes, are willing to go to the black market only because they have to. Because they see this as a life and death issue. They understand smoking is deadly.  


They finally found a way to quit smoking. And they are concerned that the government is taking away their ability to protect their own life by banning these products, by issuing marketing denial orders for products like the Triton e-cigarette flavors. So, this is a really strongly held view by many people that the FDA has taken away their life-saving products. 


But when you see how the FDA went about taking away those products in what an earlier decision from the Fifth Circuit in this case called a “surprise switcheroo,” the surprise was “We need to see these studies.” And it was a switcheroo because they told you to do the marketing report, and they never looked at that. And then, they did say they want the longitudinal studies, which they never told the companies about before they submitted their application. So the court called it a surprise switcheroo of the rules. So, this particular company, while not a major player in the industry, is having an outsized impact by having challenged this case in the Fifth Circuit. 


Chayila Kleist:  Well, that transitions us nicely into the effects of this decision. You’ve mentioned there’s a circuit split. And this case only changes the immediate future for Triton. But what are the possible potential impacts of this for either the applications that have already been denied or applications coming in?


Jeff Stier:  So, Chayila, you’re right. This ruling only applies to this particular case, to Triton. But the implications could be much larger. You’re right to say there’s a circuit split. As our listeners know, the Supreme Court is not likely to take a case until you’ve reached that point where the different circuits have split on it. Well, now we’ve got, I think, five circuits that sided with the FDA. And this is now the second circuit, after the Eleventh Circuit and now the Fifth, that have shot down the FDA’s approach, at least in a particular case. 


And the FDA, until now, has not been willing to accept a challenge from the companies that got a marketing denial order. So they’ve only turned them down. And the FDA, just last week, turned down an unrelated but similar case regarding a California flavor ban. But now, we are really set up, potentially, for the Supreme Court to take this case. However, we have to understand that the FDA may recognize that the current makeup of the Supreme Court may not look kindly upon the surprise switcheroo that it did. And the FDA may say, “Well, we’ve won in a lot of other circuits. We’re going to accept the ruling of the Fifth Circuit.” 


And the main weakness that I see in that Fifth Circuit very strongly-worded opinion is that the remedy that it chose was simply that the FDA must go back and consider Triton’s application again, even though the agency — and I’ll quote the court here — “Second, and most disturbingly, FDA argues that its capriciousness should be forgiven as harmless because the agency promises to deny petitioners’ applications even if we remand to make the agency follow the law.” Wow.


So, in the arguments, the FDA said, “Oh, it was a minor error, the fact that we didn’t look at their marketing study. We were going to reject it anyway, even if we had read it.” Well, the court said, “No, you’ve got to go back. You’ve got to consider it. And you better be careful in how you do so.” The FDA might — and based on its previous actions, particularly with regard to the Juul case, a much bigger case. A leading market company, Juul was the most popular e-cigarette. 


And when the FDA denied Juul’s application, there were court challenges. And the FDA eventually said, “Okay, we’re going to take another look at it.” And it’s been well over a year, and the FDA is still looking at it and hasn’t authorized it. So, it may be that the FDA says, “Okay, we’re going to take it again. We’re going to sit on it for a while. We’re going to deliberate and we’re going to deny it again.”


And that may be a wise strategy for the FDA to take to kind of limit the impact of this case, of this very strongly-worded critique of the FDA’s arbitrary and capricious review and regulatory process and kind of just nip it in the bud. Now, if that does happen, if the FDA doesn’t challenge it, it’s really going to be up to the industry to go to the Fifth Circuit and rely on this ruling in their case and get their own marketing denial order shot down. 


And the FDA is going to have to review a lot more cases. And it’s going to buy the industry a lot more time to maybe do the studies that the FDA wants. Because a fair review of the application, if you want a longitudinal study, would require giving the company time to do the longitudinal review before ruling on an application and, therefore, before requiring a deadline for that application. So, it’s a fraught issue. 


The FDA, on the one hand, could say, “No, we weren’t arbitrary and capricious. We’re going to fight this to the Supreme Court. We have a whole bunch of other circuits that side with us.” In this case, the FDA argument was shot down by the court and said that the law is not made up by nose counting, by counting how many circuits agreed with you. We, the Fifth Circuit, feel strongly about this. And the Eleventh Circuit agreed with us. It’s only up to the Supreme Court to sort that out, if it comes to that. 


So, the FDA may choose to say, “Look, we don’t want to have to expose ourselves to thousands of people coming through the Fifth Circuit wanting another fair shake at it; or a first fair shake at it, a second chance, but a first fair one.” And the FDA may say, “Well, we’re going to challenge it, because we don’t want a flood of new applications relying on this Fifth Circuit ruling. Or the FDA may say, “Well, we do want to challenge it because we don’t want to do all that.” 


And then, how will the Supreme Court rule? Will they even take the case? That’s something that we’re all going to be watching. So, it really depends. In terms of the impact of this case, we don’t know yet. We don’t know the impact of this case. It depends on how industry responds. And it depends on how the FDA responds. If the FDA does challenge, it will depend on whether the FDA appeal to the Supreme Court is accepted, if the Supreme Court is willing to hear it. And then, of course, how it rules on that. It’s important to note that this decision did not throw out the entire regulatory process. It simply said the company gets to go back and do another application. 


So, a remedy that would have been stronger might have said the entire regulatory process around e-cigarettes was arbitrary and capricious because it didn’t set clear rules, clear standards, clear guidelines of what the FDA wants to see in order to be persuaded that a product is appropriate for the protection of the public health. But the court did not do that. As strongly as its opinion was worded, the remedy itself was narrow and it leaves open lots of strategy from both sides before we can determine what the outcome will be from this case. 


Chayila Kleist:  Got it. So, potential future litigation at a variety of levels, a potential for future studies, as there’s time to look into what these products do, and an actual real chance for Triton to take a second stab at it. Is there anything that would be worth watching, either in this space or in the FDA’s approval processes of products more broadly, moving forward, given how this case shook out? 


Jeff Stier:  That’s a great question because how does industry respond? How does the FDA respond in this case? But the FDA still has premarket tobacco applications sitting in front of it that it has to decide on, particularly for flavored products, and particularly for menthol-flavored products, which some have seen as not as bad as cherry-flavored products. There are menthol-flavored cigarettes. 


So, just like the FDA has authorized tobacco flavored e-cigarettes, maybe it will authorize menthol flavored e-cigarettes, particularly because, early this year, the FDA has said it is going to ban menthol combustible cigarettes. So, if the FDA takes away the legal combustible menthol cigarette, it might want to give those smokers a lower-risk place to go, and authorize a menthol e-cigarette. 


We mentioned Juul before. Juul recently submitted a premarket tobacco application to the FDA for a menthol-flavored e-cigarette that has hardware built into the e-cigarette that prevents unauthorized users from vaping it. In other words, it has technology that would prevent youth usage, which is the FDA’s primary concern. So, we are in a new environment now that the FDA, which has never authorized a menthol e-cigarette, can now say, “Well, you’ve got this technology that addresses our concerns.” 


And this menthol e-cigarette by Juul — who the FDA doesn’t like very much, because the FDA blames Juul for what it called “an epidemic of youth vaping” — the FDA may now come back and say, “We authorize this hardware that has age verification technology in it,” even though it may not be 100% foolproof. It can be hacked. I’m sure youth could figure out how to do it. But it will tamp down youth usage. And the FDA could authorize this flavored e-cigarette and go back to the Fifth Circuit. Maybe not go back to it but make the argument to other cases. “There was no de facto flavor ban,” the FDA would say. 


“In fact, we just authorized the first product that had age verification hardware built into it. It wasn’t that there was a de facto flavor ban. None of the applications had the technology that we wanted to see. Now that Juul has age verification software for a menthol e-cigarette, we’re going to prove to you there’s no de facto flavor ban. We’re going to authorize this product at a time when we’re banning menthol cigarettes. And it will give those smokers a place to go to lower their risk.” That would be a wise move for the FDA to do, especially in light of these continuing allegations of a de facto flavor ban.


Chayila Kleist:  Well, thank you. That answers the other question I was going to pose, which is there has been a lot of conversation on one side of this; what are the arguments in favor of the FDA? And I think they’d say, “Hey, here’s where we’re at. Here’s how you can move forward.” And it will be interesting to see what the FDA does and how this industry moves forward. Are there any — 


Jeff Stier:  And can — 


Chayila Kleist:  Sorry, go ahead.


Jeff Stier:  Yeah. We at The Federalist Society like being balanced. And you’re correct to ask what the FDA’s position is. I think the court in this Fifth Circuit case addresses what the FDA’s argument was. I read a little bit of the second one. But the court wrote in this decision, “FDA justifies its behavior with two principal arguments. First, FDA argues that its years’ worth of regulatory guidance was not worth the paper it was printed on because it was hedged with cautious qualifiers and never guaranteed that any particular submission would be granted.” 


Now, that’s true. The FDA never said “If you submit a marketing order, if you submit a marketing plan and we review it, then we’ll approve your application.” In its defense, the FDA never said that. The FDA said it’s critical. But the FDA never promised that even if you submit a longitudinal study, as some companies have done, that, therefore, the FDA will authorize the product. It just said, “There are things we’d like to look at.” It never said, “You must have this.” 


So, the court, obviously, wasn’t satisfied by that, at least in the Fifth and Eleventh Circuits. The other circuits did side with the FDA. And that reasoning from those courts was it doesn’t matter that the FDA didn’t look at the marketing plan, which it acknowledged it didn’t through this fatal flaw approach that was a way to get through a whole lot of applications at once. If you didn’t have the longitudinal studies, we’re throwing you out. 


The courts in those cases said, “These applications, even if the FDA had read the marketing plans, those applications clearly would not have been authorized anyway because it didn’t convince the FDA that the product was appropriate for the protection of public health. So these failures to read the marketing plan were harmless. And, therefore, because they were harmless errors, it won’t affect the outcome. 


And that’s really where the split was. And if we do see this going to the Supreme Court one day this year or next, it may really hinge on if the FDA tells you what you have to do and you do it, and then the FDA wants something that it didn’t tell you to do, is that a harmless error or not? I think that’s really what a future Supreme Court case may hinge on. 


Chayila Kleist:  Well, that will be an interesting case if it ever comes up. In the meantime, are there any last thoughts or comments you want to give on this topic?


Jeff Stier:  Well, like I just said, it will be important to watch and see the next steps, both from industry, whether they try to get a lot of applications reviewed, based on the Fifth Circuit decision. And it will be important to see if the FDA challenges the Fifth Circuit here or is willing to live by it. And it will be important to see, prospectively, how the FDA handles applications still before it, based on this decision. 


The FDA is always going to try to tailor its future behavior to be in line with what the court said. So that’s why I think the Juul application for a menthol e-cigarette that has the age verification technology built into it may give the FDA an out by authorizing a flavored product, saying there was no flavor ban. 


It’s just that the million applications we received until now, it’s not that we were arbitrary and capricious. It’s just that none of them had the level of evidence and the type of technology that we wanted to see. And now that we have that in this Juul application, we’re going to authorize that. That’s my prediction of how the FDA can kind of dig its way out of the mess it regulated its way into. 


Chayila Kleist:  Interesting. Well, we can wrap it there. Mr. Stier, thank you so much for taking the time out of your day and lending your expertise and insight. We really appreciate it.  




Conclusion:  On behalf of The Federalist Society’s Regulatory Transparency Project, thanks for tuning in to the Fourth Branch podcast. To catch every new episode when it’s released, you can subscribe on Apple Podcasts, Google Play, and Spreaker. For the latest from RTP, please visit our website at www.regproject.org.




This has been a FedSoc audio production.

Jeff Stier

Senior Fellow

Consumer Choice Center and Taxpayers Protection Alliance

FDA & Health

The Federalist Society and Regulatory Transparency Project take no position on particular legal or public policy matters. All expressions of opinion are those of the speaker(s). To join the debate, please email us at [email protected].

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