Explainer Episode 31 – The Regulation of E-Cigarettes and Vapes

Health policy expert Jeff Stier joins the podcast to discuss all things concerning the regulation of e-cigarettes and vapes: How did the FDA get the authority to regulate tobacco in the first place? What is synthetic nicotine, and what might its developement demonstrate about the interplay between federal agencies and their statutory authority? What are the most recent FDA actions in this area, and what is likely to come next?

In June Jeff narrated an Explainer video on the same topic, which you can view here.

Transcript

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.

 

Jack Derwin: Welcome to the Regulatory Transparency Project’s Explainer Podcast, part of RTP’s Fourth Branch Podcast Series. My name is Jack Derwin, and I’m Assistant Director of RTP at The Federalist Society. Today, I’m excited to be joined by Jeff Stier to discuss the state of play for the regulation of e-cigarettes and vapes. Jeff is a senior fellow at the Consumer Choice Center, a senior fellow at the Taxpayer’s Protection Alliance, and a policy advisor to the Heartland Institute. 

 

Jeff has testified on health policy at FDA and OMB hearings, as well as in front of state and local legislatures across the country. His writing on health policy has appeared in a number of outlets, including The Wall Street Journal, Los Angeles Times, The New York Post, and National Review Online

 

Before we jump in, I’ll also note that Jeff narrated a great animated Explainer video on this topic back in June, to which this podcast will serve as a follow-up of sorts. So we’ll link to that in the description below and definitely encourage listeners to check that out as well. 

 

With that, Jeff, let’s dive right in. Thanks so much for joining me today.

 

Jeff Stier:  Thanks for having me on, Jack.

 

Jack Derwin:  Of course. So to start us off, can you orient our listeners by laying out the basic landscape and history of e-cigarette regulation?

 

Jeff Stier:  Sure. Thanks, Jack. Well, I’ll go even further back than that. It’s really the history of tobacco regulation in the United States, and I think it kind of illustrates some important ideas about regulation and how it’s developed and implemented. Cigarette smoking is the number one preventable cause of death in this country and has been for a long time. And the question is, how do we prevent that? I think people with all sorts of political sensibilities and ideologies want to address that problem. The question is how best to go about it? 

 

And the FDA commissioner in the Clinton administration decided he could solve the problem, at least modestly begin to address it, by having the FDA, the Food and Drug Administration, the real health regulator in our country, try to tackle the problem of youth cigarette smoking. And we could all be against youth cigarette smoking, but the problem is he did that on his own — the agency tried to do that on his own. And as much as he properly pointed out that youth cigarette smoking is terrible and we shouldn’t have it in this country, he tried to solve the problem with the agency’s regulation. I think regulation that he tried to put forward was very modest. The problem is the Food and Drug Administration never had the authority to regulate cigarettes, as bad as they are for kids to smoke. 

 

Eventually, the U.S. Supreme Court came in and said, “No, FDA, you can’t, on your own, regulate tobacco products. You don’t have the authority. That authority needs to be given to an agency, an executive branch agency, by Congress.” And that wasn’t the Supreme Court saying it’s okay for kids to smoke. It was just saying, “We’re a nation of laws, and these laws need to be passed by Congress, not by the executive branch.” And eventually, we got to the point where Congress said, “Okay, we hear you. We have to do this, and we have to give authority to an agency to tackle a problem.” And that’s exactly what happened. 

 

It took a long time, though. Is Congress going to ban cigarettes? What are we going to do about it? How are we going to give the FDA that authority? And it took many years but, eventually, Congress eventually stepped in and said, “Okay, well, we do want cigarettes to be regulated. We want tobacco to be regulated.” The FDA, Congress said, was the agency to do it. And following the outline of what the Supreme Court said is, “Yeah, this is a problem, but FDA can’t do it on its own.” Congress gave the agency that authority, but Congress didn’t just say, “Hey, FDA, you’re in charge of regulating tobacco.” They didn’t want to give the FDA all of that authority. They gave the FDA specific authority. 

 

It took years for this legislation to come about and lots of negotiation. And eventually, the Tobacco Control Act was passed. That act is what gave the FDA the authority to regulate these products. It did not give the FDA carte blanche to do whatever it wanted. It said, “You must do certain things. You may do certain things. Here’s how these things ought to be regulated.” It was very specific.

 

And following that FDA v. Brown & Williamson Tobacco Corp. Supreme Court case from 2000, Congress gave very specific instructions about what it wanted done. For instance, Congress said, “FDA, you must ban flavored cigarettes, like strawberry flavored cigarettes. FDA, you have to ban it. Congress is telling you that there’s no question about — you have to ban that.” 

 

Whereas, on issues like menthol cigarettes, which are a popular version of cigarettes, while they’re flavored, Congress could not get its act together and say we’re going to ban these or we’re going to allow these. And Congress held up for a year on passing this legislation until it could figure out what to do with menthol cigarettes. And what Congress did is it punted, and it said to the FDA, “We’re not banning menthol cigarettes. We’re giving the FDA the authority to ban menthol cigarettes if doing so would benefit the public health.”

 

So it kind of scopes out, “Here’s what you must do, here’s what you may do, using your expertise.” And it also said — Congress said there are certain things FDA could not do. For instance, “We, Congress, have decided we’re not going to ban cigarettes in this country. So the FDA can’t ban cigarettes, and the FDA can’t even zero out nicotine from cigarettes.” Nicotine, of course, as we’ll get into more later, is the addictive component, but it’s not particularly harmful to adult smokers. It’s addictive, absolutely, but the harm from cigarettes comes from burning and inhaling that tobacco. 

 

Congress laid out a whole bunch of things, and then the FDA had the authority to implement that legislation, and that’s kind of where we began. At the time, e-cigarettes didn’t really widely exist. There was a concept out there, at the time, when this legislation was being developed and, in fact, Congress did contemplate the idea of a lower-risk product––whatever that may be––and allowed for innovation and set specific standards on how the FDA will allow lower-risk products into the marketplace. So all of this was, in one way or another, contemplated by Congress, and the FDA had that authority. 

 

As the FDA began to implement the authority that it was given by Congress, it did all sorts of things. It banned flavors like strawberry and chocolate-flavored cigarettes. It didn’t yet decide on what to do with menthol cigarettes. And as the implementation was happening, e-cigarettes became a very big deal. And as most of our listeners know, e-cigarettes are a way to deliver nicotine to somebody who’s addicted to cigarette smoking, wants their nicotine, but is able to do so in a way that is less harmful because you’re not getting the products of combustion that come along with burning tobacco and inhaling it in a cigarette. 

 

So companies eventually were able to apply for what’s called a — what Congress called a premarket tobacco application. If you want to bring a new product to market, you have to go to the FDA first and get permission. And the FDA is allowed to grant marketing authority to a new tobacco product if the FDA finds that that product is appropriate––and this is important language––is appropriate for the protection of public health.

 

And that’s kind of the standard that Congress gave to the FDA in order to approve a new product or authorize a new product. The FDA doesn’t want to be seen as approving any of these products, but authorizing a product has to be for the appropriate — for the protection of public health. And that really sets the stage for the beginning of the regulation of e-cigarettes. 

 

But there was one important legal decision that came about right around the time this legislation was going into effect before it was really implemented. The FDA, apparently not learning from its mistake, decided it was going to ban the importation of e-cigarettes into the United States in a case called Sottera. If you’ve heard of the NJOY e-cigarette, that’s the parent company.

 

And the FDA said, “We’re no longer allowing the importation of e-cigarettes into the country. We’re going to solve this problem before it starts. And how are we going to do that? Well, these new e-cigarettes deliver nicotine, and we know nicotine has an effect on the body, so nicotine is a drug, and we, the FDA, have authority to regulate drugs.” It’s also a device, and the FDA said that e-cigarettes are a combination drug device. “They’ve got the nicotine being the drug and the device being the e-cigarette, and we, FDA, don’t need any authority, other than what we already have, to regulate drugs and devices, so we’re going to stop them from coming into the country.” 

 

And then the Court, in that Sottera case, said, “Actually, FDA, you already have authority to regulate tobacco products, and tobacco products are defined in the statute as anything that is derived from tobacco. So a tobacco leaf in a cigarette is a tobacco product, obviously, but anything else that is derived from a tobacco product –.” 

 

For instance, the nicotine in an e-cigarette comes from tobacco leaf. So if the FDA wants to regulate e-cigarettes, it needs to do so under the tobacco regulation authority, not under the drug and device authority, so long as the company isn’t treating that product as a drug or device. So if, in fact, Sottera or NJOY or another e-cigarette marketer would have said this is a smoking cessation device that will help you quit smoking and, therefore, made a medical claim, then the FDA could regulate it as a drug or device because it’s a smoking cessation device.

 

But the companies never did that. It was the name of the company, NJOY — it was for people to enjoy. It wasn’t a medical product. And the FDA said, “Therefore, you’ve already got this emerging regulatory control to regulate these products, not as drugs, but as tobacco products, and use the framework that Congress set out for you, the FDA, to regulate these products.”

 

Jack Derwin:  Thank you for that. I think that really sets the stage for the rest of our conversation here. And something we haven’t touched on yet is the relatively recent development of synthetic nicotine. What exactly is synthetic nicotine, and why is it so important in the regulatory context?

 

Jeff Stier:  Well, Jack, that’s a cutting-edge issue right now, and it’s probably one of the most interesting that we’re facing. So we’ll get into some of the discussions over how the FDA is handling the regulation of e-cigarettes under the law. How is it implementing the statute? And there’s been some very recent case law on that, including this week. There have been briefs filed by the FDA to the U.S. Supreme Court on this issue. 

 

But what happened over the last couple years is the FDA has been removing e-cigarettes from the marketplace out of concern for youth vaping, youth using these products. And obviously, just like the 2000 Brown & Williamson case, it’s a real problem of kids vaping, just like it was a problem of kids smoking. So a lot of the marked products, the FDA said — especially the flavored products — remember, Congress said that the FDA must ban flavored cigarettes. It didn’t say you have to ban flavored e-cigarettes. It probably didn’t even really contemplate that. 

 

So the FDA said, “We’re going to ban, through the regulatory process, through the authority that Congress gave us — we’re going to ban a lot of these flavored products because we’re concerned that kids are using them.” And to the extent that these products need to be appropriate for the protection of the public health, the FDA seems to be coming out and saying these flavored products are too much of a risk of youth initiation. And when you weigh that risk of youth initiation and the harm that comes with that against the benefit of e-cigarettes being in the legal marketplace so that adult smokers can dramatically reduce their risk and quit smoking, the FDA said we’re not going to authorize these products; not okay. 

 

So a lot of the products came off the market through threats from the FDA, threats of more legislation, and the products came off the marketplace. The problem is you can’t really solve a societal problem exclusively through regulation. We kind of learned that when it came to alcohol and prohibition. So what happened was, the predictable outcome is that there would be an illicit market. And there’s, absolutely, a strongly developing illicit market for flavored e-cigarettes, which don’t really have much of a legal pathway right now through the FDA. 

 

But we talked earlier about the NJOY and Sottera decision where the Court said these products, these e-cigarettes, are derived from tobacco, therefore, Congress gave the FDA the authority to regulate a tobacco product. But what happens if you make an e-cigarette, and instead of deriving your nicotine from a tobacco leaf, you get your nicotine elsewhere? There’s very little bit of nicotine in a tomato plant, in an eggplant, so, theoretically, you could make a tomato e-cigarette. It would be very costly and inefficient.

 

But you could also synthesize it. You could make it in a lab. You could make nicotine in a lab, and none of those ingredients for synthesizing it in a lab come from a tobacco plant. And in that case, the FDA cannot extend its regulatory authority over that product, at least, we think, because it’s not a tobacco product. So the market engaged and said, “Well, if you can’t have legal e-cigarettes that are flavored, we’re going to sell an e-cigarette with nicotine that is synthetically developed, that didn’t come from a tobacco plant and, therefore, the FDA cannot extend its reach into this — under the Sottera decision, can’t extend its reach over a synthetic nicotine product.” 

 

And that’s where just earlier this — I guess it was in late summer or during the fall, the FDA said some very interesting things when presented with this emerging issue of synthetic nicotine being used to, I don’t want to say evade FDA authority, but in some way get around it because the FDA ought not to have authority to regulate this product under the Sottera decision. But the FDA relied on earlier court cases challenging the regulation of e-cigarettes and said nicotine liquid derived from tobacco is a tobacco product, but the FDA also has authority to regulate products that are intended to be used together with a tobacco product.

 

For instance, an e-cigarette device, the hardware, if you will, didn’t come from a tobacco plant. It’s not a cigarette. But according to the law and according to the Court’s interpretation––and the law is pretty clear, any product intended to be used together with a tobacco product is also a tobacco product under the law––you haven’t given the FDA authority. 

 

So what the FDA said with regard to synthetic nicotine, is it said, “Well, the synthetic nicotine is being used with e-cigarette hardware, and we’ve already established that that hardware is intended to be used with a tobacco product, nicotine.” So the FDA says, “Well, maybe we do have the authority to regulate synthetic nicotine because it’s being used with a tobacco product.” Basically, it’s like that game of electricity. “We have authority over this, so, therefore, we have authority over that, and, therefore, that gives us authority with something else that’s used with it.”

 

I don’t know whether that will actually work, but there’s a very easy fix for that. And that is Congress to say, “Okay, FDA, you also have the authority to regulate synthetic nicotine.” But the key point here is — the concept is that the FDA just doesn’t have authority to do things unless Congress gives it that authority. And if Congress doesn’t scope out, “Here, you have authority to do this,” and especially if that is an area that’s already very well regulated, then FDA can’t, on its own, extend its regulatory reach and say, “We do have authority for some strange and imaginative thinking.”

 

Jack Derwin:  Well, speaking of statutory authority and its limits on the FDA, earlier you mentioned that Congress explicitly does not allow the FDA to zero out the nicotine in cigarettes but recently, here in the last couple years, the FDA has floated the idea of limiting nicotine to levels so low that they would be barely registered. What’s going on there, and what lessons might that teach us about administrative law more generally?

 

Jeff Stier:  Well, it’s another fascinating issue here. We could have just banned cigarettes and solved the problem, but we learned the problem with prohibition; maybe it wouldn’t work. But there has been this idea out there in public health that we can lower nicotine levels because we all know, we all agree, as contentious as these issues are, we know that nicotine is what makes these products addictive. There’s some debate over the harm, but they’re not really — the main source of harm is the combustion. Nicotine, the FDA has said, is really the source of all of the issues here. If we could get people — adult smokers don’t want to harm themselves. What if we could just get them off of nicotine? And if we could get kids not to become addicted to nicotine, we would solve this problem. 

 

Four hundred thousand Americans die every year from cigarette smoking, and it’s not from nicotine. It’s the nicotine that addicts them. So the FDA — or even before the FDA said anything, there was this idea out there in the public health community, what if we gradually reduced the amount of nicotine, what makes it addictive, and over time, we would have no nicotine left, or very little nicotine left, and it wouldn’t really matter because people wouldn’t become addicted to these cigarettes because there’s so little nicotine in them. 

 

The problem with that idea––and this was born out in medical journal articles––was it created a problem that scientists call compensatory smoking. I think the best example, and, actually, a pretty apt example, is if you wanted to get off caffeine—and caffeine, like nicotine, is addictive—and you said, “Okay, well, I’m going to drink half regular coffee and half decaf; and I’m going to cut the caffeine in half; and every little bit, I’m going to drink a little bit less caffeine.”

 

The problem is, especially for something that you decide how much you’re going to get and take, if you’re smoking for the nicotine or if you’re drinking coffee for the caffeine, if you lower the amount of caffeine or nicotine, your body is going to react by saying, “I need more to get this nicotine level, to get this caffeine level,” and you’ll drink more coffee. And coffee drinking isn’t necessarily so harmful in moderation, but cigarette smoking is harmful. And so, why would we reduce the amount of caffeine or nicotine in the product, causing people to smoke more if smoking is really the problem, not the nicotine? And public health kind of came to a consensus, “We ought not to do this.”

 

Congress was contemplating this when it was developing the legislation, and Congress said, “We, as a country, we believe in freedom. We are not going to ban cigarette smoking. We are not going to make nicotine illegal.” So while this idea was out there about reducing nicotine, Congress, I think, said, “If the FDA thinks it’s the right thing to do, we’re going to leave that to FDA. But you can’t ban cigarettes; you can’t zero out nicotine.” And the idea was pretty much dead because people knew it wouldn’t work because if you gradually reduced nicotine, it would have an undesirable effect of getting people to smoke more. 

 

Then the FDA came out with a different idea using the authority that Congress gave it when Congress said you can lower but can’t zero it out, and everyone knew lowering wouldn’t really be a good idea. FDA came up with this idea not to lower nicotine, but to dramatically lower nicotine, recognizing the problem of compensatory smoking, saying, “Yes, compensatory smoking’s a problem, and it would undermine this approach, but what if we lowered the nicotine so much that it would no longer satisfy somebody who wanted nicotine? It would no longer be enough nicotine to create addiction in young users, and without zeroing out nicotine, we’ve solved the problem.”

 

And the FDA and the Trump administration actually decided it was going to do this. And it moved forward with the regulatory plan that we are going to dramatically lower nicotine, and the FDA was buying concept cigarettes that were very low nicotine to pass this idea along.

 

And the FDA did something very interesting. It announced its intention to dramatically reduce nicotine in legal cigarettes––not e-cigarettes, but combustible cigarettes––and it said, “We are going to do this because it will save all of these lives, and we are also going to develop the science to back that up.” Now, that’s strange because I always thought what you do is you develop the science, and you build policy around it. The FDA was very sloppy here. It said, “We’re going to take this policy approach and then develop the science to support it.” And sure enough, the regulators did just that. 

 

They came up with a model. A lot of people have been talking about modeling with coronavirus. Well, modeling, in science, is a pretty simple idea. You plug numbers in. You put in a calculation, and you come out with some outcome that, all of a sudden, is science. But as we’ve learned, if the numbers that you put in — no matter how good your equation is, if the numbers you put in are garbage, your end result is still going to be garbage.

 

And what the FDA, when it said, “We’ve got this bias; we want to lower nicotine to dramatically low levels and then do the science,” it put in numbers into its model, for instance, the concept that there’s not going to be a significant black market, that there’s not going to be illicit sales of high-nicotine cigarettes. We’re going to live in this imaginary, modeled world where nobody can get nicotine cigarettes. And in that world, we’re going to save a lot of lives. Well, that science eventually was scrutinized and put to bed at the end of the Trump administration. And FDA decided not to pursue that. 

 

But in this democracy, the Biden administration came around, and they said, “You know what we’re going to do? We’re going to have very low nicotine e-cigarettes” — I’m sorry, “very low nicotine combustible cigarettes.” And that policy proposal is back on the table, and I would expect to see it early next year. Or sometime next year, the FDA is going to put forth that plan for very low nicotine cigarettes, not e-cigarettes but combustible cigarettes. And the FDA is going to say, “We’ve got the authority to do this because Congress gave us the authority. Congress contemplated this, and they said you’re allowed — it’s one of those things you’re allowed to do, FDA, as long as you don’t zero it out.”

 

And I think we’ll see that next year. I think it’s a — potentially a very dangerous experiment on the American public. We don’t really have real-world science. We’ve just got these FDA models, but I think it goes back to some of the interplay between Congress developing legislation and saying, “Here’s what you can do, here’s what you may do, here’s what you must do, and here’s what you can’t do.” Congress, I think, responsibly said, “You can’t zero it out. We, as a country, have decided we’re not doing that. But as long as you don’t zero it out.” 

 

So what regulators can do is they can push the limits of their regulatory authority and, I think, appropriately, in this case, while I have a problem with the science, I think they’re reading legislation and their authority properly and say, “As long as it’s not zero we can do it. So we’re going to make it 0.00001; that’s not zero. If Congress wanted to say you can’t bring it down to below a certain threshold, Congress could have said that.” Now, of course, Congress didn’t imagine this idea of very low nicotine because nobody had discussed it. It wasn’t an idea that was out there. The idea that was out there was lowering it gradually. 

 

So that’s where we are right now. And if I were somebody writing legislation on the Hill and I was giving authority to an agency, regardless of the area, I think the lesson here is you’ve got to be very specific in what authority you’re giving because if you don’t want them to do something like dramatically lowering nicotine, you actually have to say that in the statute. 

 

And to say, “You can’t bring it to zero,” you have to imagine that a regulator — and this is — we like to play both sides ideologically. This is something that Democrats and Republican executive branches are guilty of. All regulators always push to expand the scope of their regulatory authority. And if Congress leaves any bit of wiggle room for something you can’t even imagine, eventually, that agency may try to push that authority.

 

And I think the lesson for those of us who believe in strict constructionists is, “Hey, constructionists, when you’re constructing, be very clear, and put in there absurd ideas, and let them say to you, ‘Oh, they’ll never do that.’” Oh, well, if they’ll never do that, let’s put it in the law. Let’s not leave it up to regulators later. 

 

Jack Derwin:  It’s a fascinating example of the interplay between agencies and their statutory authority and Congress. That’s really interesting. It’ll be interesting to see how that plays out. And speaking of what’s next, do you have any thoughts on what we might see over the next couple years and the regulation of cigarettes and e-cigarettes more generally?

 

Jeff Stier:  Well, right now, we’re in this interesting situation. I teased it earlier that the Supreme Court is tiptoeing into this issue. The big issue these days, everyone’s talking about e-cigarettes. And we know that the regulatory process is played out pretty far, and the FDA has received millions of applications for these premarket tobacco applications where companies say this product is appropriate for the protection of public health.

 

And everybody knows that the balancing test Congress is using is how much benefit will there be to public health by helping adult smokers quit, weighed against the risk of kids using these products, weighing the risk of adults who quit smoking now going back to a nicotine product and taking on some risk from that lower risk nicotine product. And you put everything into the mix in terms of the risk, everything into the mix in terms of the benefit, and you weigh it all out. And if it’s appropriate for the protection of public health, then the product’s going to be authorized. 

 

Well, companies have submitted these applications under a court order. The deadline was last September. And the companies did that, and almost all of those applications were denied. Products have been coming off the market like crazy, at least the legal market. And that helped lead to this rise in the synthetic nicotine market.

 

But this September, 2021, was the deadline for FDA to rule on those applications, and the FDA had developed these rules for what needs to be in an application. And companies complained, “We’re not really sure what you want to see. What science do you want to see to make this — to be able for us — and we’ve got the burden –.” An applicant has the burden to show the FDA that the product is appropriate for the protection of public health. The FDA didn’t give applicants, companies applying for authorization, specific, “Here’s what you need to show.” It did say, “You need to list the chemicals. You need to do all sorts of things.” But it didn’t actually give specifics on what you need to show. 

 

Now, the FDA did authorize a couple products: one Vuse e-cigarette that’s tobacco flavored, not flavor flavored, but a tobacco flavor. There’s a big question what FDA is going to do with menthol e-cigarettes. Are they going to authorize them because they’re going to help menthol cigarette smokers get off cigarettes and switch to menthol e-cigarettes, or is the FDA going to say, “No, kids like menthol and, therefore, we can’t authorize these products.” 

 

But what happened in the courts was there had been a number of challenges to the FDA’s approach to dealing with e-cigarettes, and none of those challenges were successful up until very recently. I think the courts, appropriately, will say the agency has authority, and it hasn’t abused that authority because the products actually hadn’t been pulled from the market yet. 

 

But there had been a handful of cases where products that have now, over the last few months, been pulled from the market have sued. Those companies have sued, pointing out that the FDA didn’t give these clear instructions of what needs to be in an application. And without any sense of irony, days before the September 2021 deadline for the FDA to decide about these applications, the FDA issued final rules of what needs to be in the application for that product deadline a year earlier. And what the Fifth Circuit Court of Appeals said in one of those cases when it issued a stay of the ban, it said that the agency pulled off a surprise switcheroo. 

 

What was that switcheroo? It was days before the application was meant to be ruled on, a year after the application deadline. FDA said, “You know what we need to know that a product meets this public health standard, that it’s appropriate for the protection of public health? We need to see longitudinal studies, long-term studies, that help us figure this out. Those need to be in the application.” Well, the agency didn’t tell us that when the deadline came to pass, and a longitudinal study, you could tell by its name, takes a long time to do. 

 

You can’t take a product off the market under new rules. I mean, imagine playing a football game, and in the middle of the game, you change the rules and say, “We’re playing Canadian football now. The length of the field is different.” You can’t do that when you have laws governing this. So the Fifth Circuit said, “You know, we’re going to hold off on this FDA ban.” 

 

In one case, one company sued the FDA when its products were denied authorization. And the FDA said, “Well, you didn’t put in the longitudinal studies.” And that’s being challenged because that’s where the switcheroo was. But this company said, “Wait a second, we did put in the longitudinal studies, and you denied us anyway, and you said your reason you denied is because we didn’t have the studies there.” 

 

And that really raises questions about whether the FDA’s review of these products is arbitrary and capricious. And we all know that the standard — agencies, once they have the statutory authority, can do a lot. It’s up to them. They’re the experts. But the one idea is those decisions can’t be arbitrary and capricious. And if you change the rules of the game after the game is over, after the application deadline, yeah, that’s arbitrary and capricious. And if you state in an application––in a denial of an application––that you weren’t approved because you didn’t play by rules that we just made up and it turns out that the applicant actually did play by those rules––it went the extra mile and did these studies––that it raises real questions about the arbitrariness and capriciousness of the FDA’s application of this authority that it does have.

 

So I think we’re going to see that play out in the coming months. The Fifth Circuit kind of sided with industry. The Sixth Circuit Court of Appeals said, “No, this is fine. The FDA put out lots of publications. The FDA left itself some wiggle room and said, ‘Well, we’d like to see these studies, but you don’t necessarily have to have them.’” So I think this will play out in the — just this week, the FDA responded to that appeal in the Sixth Circuit, and the FDA said, “Well, that company wasn’t legitimate anyway because its products weren’t on the market at the time they had to be.”

 

So I think the facts of the case right now of that one case that the Supreme Court is looking at in terms of its shadow docket, I don’t think it’s really going to go anywhere. But I think over the next couple of years, we’re going to see whether the FDA acted appropriately. 

 

But the real public health question is will we be — and this is what we — in that video you referred to, we talked about is how do regulators, under the statute, allow for lower-risk products which, clearly, the FDA wanted to allow to help migrate addicted adult smokers to lower-risk products without the unintended consequences of too many kids using those products? And I think that’s really the balancing test. How well did Congress do? How well is the FDA going to do in implementing that statute to actually benefit public health?

 

Jack Derwin:  Well, we really appreciate you taking the time to join us, Jeff, and with the way — the speed in which this issue is developing, I’m sure we’ll have to have you back on soon.

 

Jeff Stier:  Well, I’ll be staying tuned, and you could follow me on Twitter @JeffaSteir. I’ll keep everyone up to date in between podcasts.

 

Jack Derwin:  Great. And as mentioned, we’ll link to that Explainer video in the description below, so definitely encourage listeners to check that out. And thank you to our audience for tuning in to this episode of RTP’s Explainer Podcast. You can subscribe to the podcast at any major podcast platform, and check out our website at www.regproject.org or also on social media at fedsocrtp to learn more. Thank you.

 

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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.

 

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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 rtp@regproject.org.