[00:00:00] Speaker 04: Case number 21-1201 et al. [00:00:03] Speaker 04: Prohibition Jews co-petitioner versus United States Food and Drug Administration. [00:00:08] Speaker 04: Mr. Navar for the petitioners. [00:00:10] Speaker 04: Mr. Kennedy for the respondent. [00:00:13] Speaker 04: Mr. Navar, good morning, and please proceed. [00:00:17] Speaker 02: Your honors, and may it please the court. [00:00:21] Speaker 02: Jared Navar for petitioners here. [00:00:23] Speaker 02: FDA's denials of the marketing orders requested were arbitrary and capricious and contrary to law. [00:00:30] Speaker 02: They were arbitrary and capricious first because of a lack of fair notice. [00:00:34] Speaker 02: And fair notice, as you know, is a fundamental principle of administrative law. [00:00:40] Speaker 02: If FDA changed the standard after the fact, the standard of evidence, then black letter law requires the court to remand these orders for reconsideration. [00:00:50] Speaker 02: And here, so the question is, did they change the substantive standard after the fact? [00:00:56] Speaker 02: And I believe the record here [00:00:58] Speaker 02: definitively shows that the FDA did change the standard. [00:01:02] Speaker 02: And the first thing I would point to is, as we've shown in the brief, if you compare the guidance, which FDA also points to in their brief, they said, you know, we didn't change anything. [00:01:16] Speaker 02: The petitioners had the benefit of our 2019 guidance document, which is in the record appendix, starts at 104. [00:01:25] Speaker 02: And it's about a 50 page document that's providing guidance on the standards of evidence and what kind of testing the FDA is requiring for these PMTAs. [00:01:38] Speaker 02: But if you can read that document in detail, and you will never see the specific statement of substantive standard, the evidence year standard that was stated in the denial orders to petitioners requiring this hyper narrow comparison [00:01:53] Speaker 02: between the applicant's flavored products versus the same applicant's tobacco flavored e-liquid juices. [00:02:01] Speaker 02: And in fact, the 2019 guidance definitively repudiates the FDA's argument here because when you read it, as my clients were charged with knowledge of what's in that document, you read it and it affirmatively gives the applicant's discretion to choose the relevant comparator products. [00:02:23] Speaker 02: In other words, it clearly leaves discretion to them to choose which products to compare. [00:02:30] Speaker 02: And it actually says to choose products in some places that are the most similar to the product that you want to get approval for, including in one place, it refers to flavor type. [00:02:43] Speaker 02: So the notion, you know, revealed later that you're supposed to compare flavored products with the same applicant's tobacco flavored products just is nowhere in that document. [00:02:56] Speaker 03: Go ahead. [00:02:57] Speaker 03: No, no, you go ahead. [00:02:58] Speaker 03: If you put aside the guidance document for a moment, [00:03:03] Speaker 03: for your notice argument. [00:03:06] Speaker 03: Just straight out arbitrary and capricious comparing the agency's reasoning to the statutory standard. [00:03:16] Speaker 03: What's wrong with their reasoning, which is that there's this one subcategory of e-cigarettes that has a [00:03:25] Speaker 03: distinctively high danger to kids and therefore the showing that they will require on the benefit side of the equation should be distinctively high. [00:03:37] Speaker 03: That seems pretty reasonable. [00:03:41] Speaker 02: Well, two responses to that, Your Honor. [00:03:43] Speaker 02: And the first is that we're not in a world where, so if [00:03:51] Speaker 02: My clients might have a different issue to deal with if they had been required to file PMTAs, these applications, without the guidance having been issued. [00:04:02] Speaker 02: In other words, if the FDA just said, here's the statutory standard and we're going to judge it according to that. [00:04:06] Speaker 03: I understand that. [00:04:07] Speaker 03: I'm trying to disentangle a little bit the fair notice slash reliance idea flowing from the guidance and just the [00:04:19] Speaker 03: What to me is the putting that aside, the basic reasonableness of the FDA's reasoning here. [00:04:29] Speaker 02: Well, I mean, I think they would, again, it's hard to compare because that would have been a different situation. [00:04:36] Speaker 02: But certainly, we're not arguing the FDA does not have discretion to flesh out the statutory standard. [00:04:44] Speaker 02: That's their job. [00:04:46] Speaker 02: but they have to be held to the guidance that they put out after they put out guidance. [00:04:52] Speaker 03: Fair enough, but I guess where I'm going with this is if the reasoning is otherwise permissible and consistent with the statute and your argument really comes down to the guidance, what they said in the guidance, [00:05:10] Speaker 03: I would think you have to show that in some respect, the guidance was affirmatively misleading. [00:05:18] Speaker 03: And I look at it honestly there's a little bit. [00:05:25] Speaker 03: There's something in it for everyone. [00:05:27] Speaker 03: You have a lot of statements in there that seem favorable to you. [00:05:32] Speaker 03: On the other hand, it's a pretty carefully hedged document and they say a lot of other things that seem favorable to the FDA. [00:05:41] Speaker 03: You generally will need studies and a lot of weasel words in here. [00:05:48] Speaker 03: So the question is just, can the final order be reconciled? [00:05:54] Speaker 03: with the guidance. [00:05:57] Speaker 03: I don't know. [00:05:57] Speaker 03: I think you have a tough case on that point. [00:06:00] Speaker 02: Well, that's a fair question. [00:06:02] Speaker 02: I appreciate the question because it gets right to the heart of this issue. [00:06:05] Speaker 02: If the problem is that the FDA left sort of almost a blank slate. [00:06:13] Speaker 02: I mean, there's some that you're right. [00:06:15] Speaker 02: It's very amorphous. [00:06:16] Speaker 02: It's still very weak. [00:06:17] Speaker 02: It's still if we were just arguing under the guidance document itself. [00:06:21] Speaker 02: It would we would potentially have an argument that it's it's vague it's it's hard to understand there's really nothing to hold on to there, but the problem is that the FDA didn't. [00:06:32] Speaker 02: They stated a new standard of review in their scientific review documents and these technical review reports, they said here's the scope of review by which we're reviewing these and it's very narrow question. [00:06:44] Speaker 02: which is just a very, it's one of the many types of comparisons that a petitioner could have thought, okay, well, we can try to do this test to meet the FDA's guidance. [00:06:56] Speaker 02: And then after the fact, once the game has started, the FDA adopted this hyper narrow standard. [00:07:02] Speaker 03: It's not that narrow. [00:07:05] Speaker 03: I mean, looking at the world in 2021 or 2020 to 2020, [00:07:13] Speaker 03: draw a distinction between flavoured and unflavoured, given everything that's happening in the world with kids, that doesn't seem hyper technical. [00:07:23] Speaker 02: Well, no, but it says draw a distinction between this applicant's flavored products versus this applicant's tobacco flavored products. [00:07:33] Speaker 02: And again, I accept the premise of the question that that would have been a reasonable comparator that makes sense. [00:07:39] Speaker 03: Flavored versus unflavored, given what they know about youth smoking. [00:07:45] Speaker 02: Well, right. [00:07:46] Speaker 02: And to go to your original question, Your Honor, the other point I wanted to make is that [00:07:51] Speaker 02: Another is that the FDA, which is part of our second argument for arbitrary capricious action, is that they've ignored the material distinction between device type. [00:08:04] Speaker 02: And that is not consistent with administrative law for them to, so they've tried to extrapolate because children migrated or high school students essentially migrated in the most recent survey from [00:08:19] Speaker 02: from cartridges and pod systems to disposables. [00:08:23] Speaker 02: They've tried to extrapolate that and apply the same rule to these open tank systems. [00:08:29] Speaker 02: But they want to ignore the relevant distinction there, which is that disposables and cartridge systems [00:08:40] Speaker 02: appeal, particularly to youth, because of certain device type features, which FDA acknowledges in this brief here again, which is that they're easy to use and to conceal. [00:08:50] Speaker 02: And if you look at the 28 J letter that the government filed last week, I believe, citing the migration to puff bar, I would welcome the court to look at that Wall Street Journal article, because at the front of it, there's a photograph of what a puff bar is. [00:09:05] Speaker 02: And in the 2021 survey, [00:09:07] Speaker 02: Puff Bar is one of the disposable type of products, which is just a world away from my clients' open tank systems. [00:09:17] Speaker 00: Can you just sketch that out a little bit more where in the record it's a world away? [00:09:24] Speaker 00: I'm not that familiar with these products, but I imagine it's the difference between a ballpoint pen and a fountain pen with a cartridge and a fountain pen that you actually have to stick into an inkwell. [00:09:36] Speaker 00: And not that many people use the very last. [00:09:39] Speaker 00: And is that the fair analog that [00:09:44] Speaker 00: once the fountain pen with the disposable cartridge is unavailable, will people really migrate to the one where you have to dip it in the inkwell? [00:09:53] Speaker 02: Well, that's exactly the point. [00:09:54] Speaker 02: And in the record, so for an image of what the easy to conceal type products look like, Puff Bar is one, which is in the Wall Street Journal article cited by the government. [00:10:07] Speaker 02: It's not in the appendix, but it's part of the administrative record at FDA to. [00:10:11] Speaker 02: And we've I was at the at the very beginning of that document it's a large document with a bunch of studies. [00:10:19] Speaker 02: In the administrative record, but one of the first ones, if you have some photographs, the first photograph in there is of an open tank system. [00:10:27] Speaker 02: which is similar to the e-juices that my clients manufacture would be used in those kinds of systems. [00:10:33] Speaker 00: And once it's just to describe for us today, because I don't have that administrative record in front of me, once it's filled, it's bigger, bulkier, different from the cartridge ones or the disposable ones? [00:10:48] Speaker 02: Well, even even before it's filled your honor because what so it's it's got a it's got a big battery and atomizer and you know contraption at the bottom of it and the top of it there's a there's a glass usually glass or plastic tank. [00:11:02] Speaker 02: And so it you know I mean it's it's it's a large contraption as Commissioner Gottlieb referred to it. [00:11:08] Speaker 02: just always, whether it's filled or unfilled. [00:11:11] Speaker 00: Got it. [00:11:12] Speaker 00: So I wanted to ask you a couple of questions about the marketing plans and the agency's failure to consider them. [00:11:21] Speaker 00: The FDA now takes the position that it's harmless error that they didn't consider your marketing plans because you don't propose any novel measures to control youth access that have not already been tried and failed to [00:11:39] Speaker 00: prevent the uptick that we've seen in youth use. [00:11:44] Speaker 00: So setting aside the formal question, which I understand is a central one for you, whether it's error for the FDA to have quite candidly said they didn't even consider the marketing plan, you haven't contended that the plan you submitted that wasn't read contained any novel control measures, have you? [00:12:10] Speaker 02: My response to that argument, Your Honor, is that the FDA is not allowed to engage in post hoc rationalization in the first place. [00:12:18] Speaker 00: Right. [00:12:19] Speaker 00: I understand that. [00:12:20] Speaker 00: Absolutely. [00:12:21] Speaker 00: And I'm just trying to bracket that for purpose of the question, as you've identified that as a defect. [00:12:27] Speaker 00: If they looked at it, what would have changed their mind? [00:12:34] Speaker 02: Well, I believe in our brief, Your Honor, and I'll try to flip through it while we're talking if I can find the citation. [00:12:39] Speaker 02: But I think we outlined the bullet points for each petitioner here, some of the particulars of their particular marketing plan. [00:12:51] Speaker 02: And FDA has said basically, we've never seen anything before that we thought would work. [00:12:58] Speaker 02: But it's hard to understand where that [00:13:00] Speaker 02: judgment was made if they issued the same NDO to all petitioners. [00:13:04] Speaker 00: Well, so I take it the things that I read your marketing plan, and I take it the things that you point to are the agechecker.net, that the products are designed and really targeted and intended for people over 21. [00:13:19] Speaker 00: As you characterize them, the colors are not bright, although black with purple [00:13:26] Speaker 00: kind of graffiti-like lettering. [00:13:30] Speaker 00: I don't know. [00:13:31] Speaker 00: That could be seen as kind of youth cool. [00:13:34] Speaker 00: But anyway, so the things that you point to are we're really trying to prevent under 21s from getting on our website. [00:13:43] Speaker 00: Our marketing plans are to people who are addicted to combustible cigarettes. [00:13:49] Speaker 00: We're not packaging our stuff as juice boxes and the like. [00:13:55] Speaker 00: qualitatively different from that. [00:13:59] Speaker 02: Well no and I found that your honors page 39 of our brief, which I'm sure you've seen great but right no my response to it first if we're addressing the substance of the question is. [00:14:11] Speaker 02: is that FDA unreasonably, impermissibly stack the decks from the first step of this process because they said they applied the same heightened evidentiary standard to all products, disregarding the material relevance of device type. [00:14:28] Speaker 02: And so they're holding our marketing plans to a higher standard than should be. [00:14:35] Speaker 02: If you go back and look at their guidance and where they specifically refer to, and this is around [00:14:41] Speaker 02: appendix page 133 to 140 or so, 145, they repeatedly emphasize the relevance of device type in terms of health risk to various populations. [00:14:55] Speaker 02: But they ignore those distinctions and apply this heightened evidentiary standard to everybody. [00:15:00] Speaker 02: And for that reason, they say, because there's this appeal to youth, we don't have to read your marketing plans. [00:15:05] Speaker 02: And that was impermissible. [00:15:07] Speaker 00: So you're saying that's that's helpful because I haven't seen the two things as as intertwined in that way on in your brief I mean the government does say marketing is relevant because if you had marketing mechanisms that could really bring down the youth risk. [00:15:24] Speaker 00: then a smaller amount of benefit to adults might suffice, right? [00:15:31] Speaker 00: So they're drawing a connection. [00:15:32] Speaker 00: And I guess you're also drawing connection. [00:15:34] Speaker 00: You're saying that the reason your somewhat traditional set of marketing measures was considered insufficient was because of this heightened evidentiary standard. [00:15:47] Speaker 00: Is that fair? [00:15:48] Speaker 02: That's, that's exactly right and we say that at least in two places in the brief I believe it's in the summary the argument and it's also when it's in the argument itself, but where we do say that they stack the decks impermissibly from the beginning by by applying this height height and evidentiary standard, which is premised on they're ignoring the device type distinction. [00:16:08] Speaker 00: Right, so let me ask you. [00:16:10] Speaker 00: You sort of flip that if we disagreed and we haven't decided and we haven't conference, but just for purposes of argument, if we disagreed with your view that they had imposed a heightened evidentiary standard, do you still have a standalone claim based on the failure to consider the individual marketing plan that you submitted? [00:16:37] Speaker 02: Well, sure, because the FDA made their bed, so to speak, with the guidance that they put out. [00:16:46] Speaker 02: And they have to lie in it. [00:16:47] Speaker 02: What happened later is they got far more applications than they wanted to review or could review within the period of time that they wanted to. [00:16:53] Speaker 02: And so they came up with this way, announces new narrow standard as a way to wholesale deny these applications. [00:17:03] Speaker 02: Our position is that, you know, as they say in the guidance and as they say again in the final rule, this is supposed to be a holistic review. [00:17:13] Speaker 02: And you're supposed to look at the particular product. [00:17:15] Speaker 02: The FDA has no evidence from any survey or anywhere else reflecting that a single youth has ever reported using any of these petitioners' products. [00:17:23] Speaker 02: And so it's supposed to be a holistic review. [00:17:26] Speaker 02: That should [00:17:27] Speaker 02: that should inform the burden. [00:17:29] Speaker 00: So let's say, and again, this is just hypothetical. [00:17:32] Speaker 00: Let's say the FDA at the beginning had said only longitudinal studies and randomized control trials, period. [00:17:40] Speaker 00: You might have a challenge to that, but let's say they said that and that that's what they applied and they held that your product failed and you thought, well, the standard is unfair, but they're right that my product fails under that. [00:17:56] Speaker 00: and they refuse to look at your marketing plan. [00:18:00] Speaker 00: In that case, would your marketing plan be enough for us to grant the petition and remand? [00:18:09] Speaker 02: Well, I would say no, because but in that case, they would have made clear from the beginning that you need this particular type of study. [00:18:17] Speaker 02: And the problem here is that not only is it and I want to be clear on this point because [00:18:22] Speaker 02: We're making the argument that the fatal flaw that they applied here was not merely requiring RCTs or longitudinal cohort studies as a type of study, but the substantive question that whatever evidence they reviewed is supposed to address was a new standard that was announced for the first time in this July 2021 memorandum. [00:18:45] Speaker 04: All right, anyone have any more questions? [00:18:49] Speaker 00: Judge Casas? [00:18:51] Speaker 03: All set. [00:18:51] Speaker 00: Just one thing, just to pin down, I had asked you about the novelty or not of your marketing measures. [00:19:00] Speaker 00: And the FDA says none of them, in fact, looking back, was novel and that the error was harmless. [00:19:09] Speaker 00: And the gray brief doesn't dispute that. [00:19:11] Speaker 00: It doesn't dispute that none of the measures was novel and it doesn't dispute that the error standing on its own was harmless. [00:19:19] Speaker 02: Right. [00:19:20] Speaker 00: That's your position, because it's really about the connection between that and the raised standard that you argue, raised and narrowed, that you've been arguing. [00:19:30] Speaker 02: Right. [00:19:30] Speaker 02: And the fact, I mean, there's a ton of information in these PMTAs, and we have to respond to what the FDA has done here. [00:19:39] Speaker 02: And so our response to that is that [00:19:42] Speaker 02: they can't retrospect, they can't post-hoc look back and say, well, it wouldn't have been, it would have been insufficient if we had looked at it because they never looked at it in the first place. [00:19:51] Speaker 00: I understand. [00:19:52] Speaker 00: That's helpful. [00:19:53] Speaker 00: Thank you. [00:19:54] Speaker 04: All right. [00:19:55] Speaker 04: Mr. Nabow, we'll give you a couple of minutes in reply. [00:19:58] Speaker 04: Mr. Kennedy, good morning. [00:20:03] Speaker 01: Good morning and may it please the court, Scott Kennedy for the Food and Drug Administration. [00:20:08] Speaker 01: I'd like to begin by addressing something that counsel said a few moments ago. [00:20:11] Speaker 01: I think he asserted that in a part of the analysis, FDA didn't offer any evidence relating to whether or not these particular products are used by youth. [00:20:20] Speaker 01: And I think this is an important issue because it flips the statutory burden. [00:20:24] Speaker 01: To be clear, the Tobacco Control Act requires FDA to deny an application to market a new tobacco product [00:20:31] Speaker 01: unless the applicant can demonstrate that the marketing of that product would be appropriate for the protection of public health. [00:20:37] Speaker 01: Now, the petitioners in this case manufacture a type of tobacco product that is especially likely to attract and addict kids, specifically flavored liquids that are used in e-cigarette products. [00:20:47] Speaker 01: And they come in names like gooey butter cake and root beer float and bubble gum, to name a few. [00:20:52] Speaker 01: Now, in attempting to show that those products were nonetheless appropriate for the protection of public health, the petitioners submitted two categories of evidence to the agency. [00:21:00] Speaker 01: One was summaries of the general publicly available literature on e-cigarette use generally, not specific to the products in this application. [00:21:09] Speaker 01: And they also submitted some point-in-time surveys of customers that were distributed to customers at vaping shops and that solicited those customers' views on things like [00:21:19] Speaker 01: perceptions and feelings about these products. [00:21:23] Speaker 01: The FDA rejected this evidence and determined the petitioner's applications had failed to induce sufficiently strong evidence of a public health benefit in terms of helping smokers quit to offset these products, particularly high risk to youth. [00:21:38] Speaker 01: So with that I'd like to address for just a moment why FDA reached the determination and how it reached the determination that these products present such a high risk to youth. [00:21:47] Speaker 01: One of the things I think that's key that FDA pointed to, in addition to the fact that flavors not only encourage kids to start using e-cigarettes and kids not only have a strong preference in the marketplace for flavored e-cigarettes, [00:22:00] Speaker 01: but also the flavors in these e-cigarettes actually reinforce the addictive properties of nicotine by encouraging more puffs, more frequent using of the products, deeper inhaling. [00:22:10] Speaker 01: This is discussed at A40 in the record in the Decisional Memorandum. [00:22:14] Speaker 01: Beyond that, there are a lot of harms associated with these products for kids beyond just their addictive properties. [00:22:20] Speaker 01: This is also discussed in the Decisional Memorandum. [00:22:22] Speaker 01: Nicotine exposure can have permanent effects on the developing child's brain, including deficits in kids' attention, [00:22:28] Speaker 01: learning and memory and kids who use e-cigarettes are much more likely to end up using combustible cigarettes further down the road. [00:22:36] Speaker 01: This was of paramount concern both to Congress in passing the Tobacco Control Act and to FDA because the vast majority of users of tobacco products start using when they're young and the vast majority of kids, over 90% according to one study, that use e-cigarette products say they started with flavored e-cigarettes. [00:22:53] Speaker 01: So the risk here is substantial and enormous to kids and FDA was looking for evidence [00:22:58] Speaker 01: sufficiently strong to offset that risk of a substantial enough benefit in terms of helping adult smokers quit to offset the substantial risk to youth raised by these products. [00:23:13] Speaker 01: So just returning one more time to petitioners' evidence and to what they submitted [00:23:17] Speaker 01: Again, there's two buckets here there are snapshot consumer surveys that were administered in vaping shops and FDA rejected those because it explained that in the decision memorandum here that point in time surveys like petitioners can't satisfy the standard because they don't evaluate behavior change. [00:23:35] Speaker 01: over time. [00:23:37] Speaker 01: And they also weren't specific, at least there wasn't evidence that they were specific to the products in the application. [00:23:42] Speaker 01: Also, consumer perception surveys like this focus on what FDA called precursors to behavior, things like perceptions of the user, which also don't reliably indicate actual changes in behavior. [00:23:54] Speaker 01: They're questions about what do you think about these products? [00:23:57] Speaker 01: Do you like flavored products? [00:24:00] Speaker 01: Do you think they help people quit? [00:24:01] Speaker 01: Do you think they help you quit? [00:24:02] Speaker 01: That doesn't actually track a behavior change over a period of time which FT determined is critical, consistent with its earlier guidance. [00:24:10] Speaker 01: Also, the publicly available literature now again the other bucket of evidence that was offered by the petitioners here to FDA were summaries of the general. [00:24:19] Speaker 01: publicly available literature on e-cigarette use and its effects generally in society. [00:24:25] Speaker 01: Now FDA reviewed, canvassed the body of publicly available literature, discussed it in the Decisional Memorandum, and determined that on the question that's really key here, whether or not flavored e-cigarette products [00:24:38] Speaker 01: confers some benefit, some differential benefit that's substantial enough over unflavored tobacco flavored comparators, that the publicly available research is inconclusive on that question and quite mixed, as FDA put it. [00:24:52] Speaker 01: And importantly on this question, Prohibition Juice, their survey of the publicly available literature reached the exact same conclusion. [00:24:59] Speaker 01: It said, quote, there is not enough evidence from well-designed studies [00:25:03] Speaker 01: to determine whether e-cigarette flavors aid in smoking cessation. [00:25:08] Speaker 00: Mr. Kenny, what about Mr. Navar's point that you've effectively treated their open systems as if they were closed system, disposable, or cartridge? [00:25:22] Speaker 01: Well, two points about that your honor the first is that FDA discussed the device type issue and the distinctions between these device types, specifically in the decisional memorandum and the key determination FDA made here is that having reviewed the evidence, particularly from the last few years in the market trends in the last few years. [00:25:39] Speaker 01: It became apparent to the agency that youth preferences for device types and all the different attributes of device types was fluid and tended to change, whereas the youth appeal, the youth attraction to flavor and the youth preference for flavor is constant across all of the device types. [00:25:55] Speaker 01: And it reached this conclusion by looking at the fact that, for instance, historically, youth had preferred a particular device type was cartridge based devices to be specific. [00:26:03] Speaker 01: But they had initially exhibited a preference for that kind of device type. [00:26:07] Speaker 01: Once that device type became less available on the market, kids didn't stop using e-cigarettes. [00:26:12] Speaker 01: What they did instead was migrated, flooded towards a different device type that was previously unpopular with youth. [00:26:19] Speaker 01: And that was [00:26:19] Speaker 01: originally the disposable device types. [00:26:21] Speaker 01: And FDA essentially found that it was playing whackable with this approach, that you couldn't just focus on one particular device type because the youth migration further underscored, in addition to the evidence I discussed earlier, that flavor is the fundamental thing driving youth appeal of these products. [00:26:39] Speaker 01: So that's the key finding here, that these differences between device types at this point and based on the evidence, including all of the marketing trends over the last couple of years, revealed [00:26:48] Speaker 01: that youth will migrate towards any remaining available device type that delivers flavored products to kids, even if the other device types that were previously popular are taken off the market. [00:27:00] Speaker 01: That was the conclusion. [00:27:01] Speaker 00: Penny, what would be the correct remedy if petitioners win? [00:27:07] Speaker 00: If we were to vacate the denial order, [00:27:12] Speaker 00: Would their products remain off the market because they haven't yet gotten an approved marketing order? [00:27:19] Speaker 00: Or would they get another grace period while their application is pending? [00:27:26] Speaker 00: Or is there some other reason why it would make a difference to their ability to market? [00:27:36] Speaker 01: Well, to be clear, the products at issue here were illegal ever since the deeming rule took effect, the deeming rule that brought them within the ambit of the TCA and its prohibition. [00:27:46] Speaker 00: But then the FDA put an enforcement withholding order into effect until the Maryland federal court ruled. [00:27:56] Speaker 00: And then I gather the FDA [00:27:59] Speaker 00: scrambled and has very quickly dealt with a flood of applications. [00:28:03] Speaker 00: But I'm just wondering what the status quo is, because frankly, and I know this is not in the record, but I believe that a lot of these products are available online today. [00:28:13] Speaker 00: And so I'm a little bit, it makes me think I'm missing something about the status quo. [00:28:21] Speaker 00: And then I also am unclear about what would happen if we were to grant [00:28:26] Speaker 00: the petition and how that so I'm unclear about the status quo as a practical matter and a legal matter and I'm unclear about what would happen as a remedial matter if the if the petition were granted and either or both of you might be able to shed some light on that. [00:28:43] Speaker 01: Yes, you're starting with the last question in terms of the remedy here. [00:28:46] Speaker 01: If well, the appropriate remedy under the APL start with this would, of course, if the court found some error would be simply to to to set aside the agency decision and remand for further proceedings consistent with that decision. [00:29:00] Speaker 01: But, you know, along those lines, the agency would then be obliged to proceed consistent with the court's opinion, depending on the nature of the issue the court had identified. [00:29:09] Speaker 01: Again, the default for these products is that they are illegal in the marketplace and the period of enforcement and discretion that FDA had exercised previously no longer applies to these products. [00:29:22] Speaker 01: So it remains true that they are illegal in the marketplace and that that was true even since 2016, since the deeming rule took effect, but it is true now and they could be subject to enforcement for that reason. [00:29:36] Speaker 00: They're being sold. [00:29:38] Speaker 01: Well, I don't have specific information about which products are and aren't being sold. [00:29:41] Speaker 01: There are some that have been approved, to be clear. [00:29:43] Speaker 01: There are some tobacco-flavored e-cigarettes that have been authorized to enter the marketplace. [00:29:48] Speaker 01: There may be other products that are still being sold, for instance, illegally and that they could be subject to enforcement actions. [00:29:55] Speaker 01: So it may be true that there are that category in addition to the ones that have been authorized. [00:30:00] Speaker 01: But there have been 11 products authorized to date for tobacco-flavored e-cigarettes that also remain lawfully on the market. [00:30:06] Speaker 00: If I were a manufacturer and I had distributed some inventory of my product, would it be unlawful for the distributor then to sell? [00:30:17] Speaker 00: Where does the enforcement, where is it directed? [00:30:22] Speaker 00: Is it just the manufacturers? [00:30:25] Speaker 00: What about retailers, distributors? [00:30:28] Speaker 01: Your honor, I don't have that specific information as to what the distinction between retailers and distributors would be. [00:30:34] Speaker 01: I mean, the Tobacco Control Act makes it illegal to market these products absent a marketing grant order from the FDA. [00:30:41] Speaker 01: So that is what's clear from the statute. [00:30:42] Speaker 00: So no one can market them as a retail matter. [00:30:45] Speaker 00: If I had, during the grace, the enforcement discretion withholding period, if I had bought a garage full of Prohibition Juice [00:30:58] Speaker 00: refills, I couldn't be lawfully selling those today. [00:31:02] Speaker 01: That's correct, because you would need a marketing grant order from the Food and Drug Administration in order to do that under the statute. [00:31:10] Speaker 01: And there's one other thing I'd like to return to that was discussed in the opening line of questions. [00:31:15] Speaker 03: Can I ask just on the nuts and bolts of how these things work? [00:31:21] Speaker 03: I'm [00:31:22] Speaker 03: puzzle trying to absorb some of the numbers associated with the case. [00:31:28] Speaker 03: I think you got 50,000 applications for 6 million products or some freakishly large set of numbers like that. [00:31:37] Speaker 03: So how do you think of the relevant product [00:31:44] Speaker 03: in a way that produces numbers like that. [00:31:48] Speaker 03: I would have thought that the number of manufacturers is, I don't know, maybe in the dozens and the number of flavors per manufacturer is maybe in the dozens and that doesn't come anywhere close to 6 million. [00:32:04] Speaker 01: Well, if I understood your question correctly, Your Honor, there's two things to clarify there. [00:32:08] Speaker 01: One is you're correct that there is a very large number of individual flavors and individual products that have been subject to marketing denial orders, but the actual number of applications, meaning, you know, an application from a manufacturer. [00:32:23] Speaker 01: For instance, in this case, you know, you could say that we have four applications. [00:32:27] Speaker 01: from each of the four petitioners. [00:32:30] Speaker 01: The most up-to-date knowledge I have, this isn't in the record, but the most up-to-date knowledge I have is that there have been over 250 applications for flavored e-cigarette products denied to date. [00:32:39] Speaker 01: So it's a much smaller number, but some of those applications do include a lot of individual flavored products. [00:32:46] Speaker 01: So those numbers can get pretty large. [00:32:49] Speaker 03: And I guess the reason I ask, I was [00:32:54] Speaker 03: I'm curious to hear your views on the point that the government failed to consider the marketing plans, which to me is the strongest argument on the other side. [00:33:09] Speaker 03: And what I'm just trying to think about is what a marketing plan [00:33:19] Speaker 03: might look like? [00:33:21] Speaker 03: Is it something that's going to sort of read the same way regardless of all the permutations? [00:33:29] Speaker 03: They just say, well, our marketing plan is we're only going to sell to licensed vendors or something. [00:33:36] Speaker 03: Or is the marketing plan going to reflect this to me surprising level of detail with [00:33:46] Speaker 03: You might have this flavor or that flavor and this kind of product. [00:33:53] Speaker 03: How specific are the marketing plans and what's your best shot at why the government can just stop reading them as you quite candidly said you did? [00:34:05] Speaker 01: Well, I think starting with your second question first to be clear FDA did consider the effect of advertising and sales access restrictions and found them to be insufficient to mitigate the substantial risk to kids from flavored e-cigarettes in part because kids do obtain these products from friends and other social sources. [00:34:22] Speaker 01: So I think this has been acknowledged in the earlier portion of the argument that was discussed [00:34:26] Speaker 01: in the April 2020 guidance that was issued by the agency. [00:34:29] Speaker 01: And that document was referenced repeatedly throughout the Decisional Memorandum here. [00:34:34] Speaker 01: It's an integral part of the regulatory history of these products. [00:34:37] Speaker 01: The applicants were well aware of it. [00:34:39] Speaker 01: And I'll add that even in the Decisional Memorandum, FDA did expressly say that there were no known types of restrictions along these lines that were sufficient to mitigate the risk to youth. [00:34:49] Speaker 03: And there, FDA was referring to- None that you had seen based on the plans that you reviewed. [00:34:56] Speaker 03: and then you said you just stopped reviewing them. [00:35:00] Speaker 03: If I get 20 Title VII cases in a row where the plaintiff hasn't made a sufficiently strong showing, I don't stop reading the briefs on the 21st case. [00:35:18] Speaker 01: Well, there were two statements, I believe you're referring to a footnote in, Your Honor is referring to a footnote in the Decisional Memorandum. [00:35:24] Speaker 01: And subsequent to the statement where FDA emphasized its review of prior applications, FDA also said that there are no known or FDA is unaware of any restrictions along these lines that are sufficient. [00:35:34] Speaker 01: And I think there FDA was referring to its experience more broadly. [00:35:38] Speaker 01: That experience includes the 2020, the April 2020 guidance document, [00:35:42] Speaker 01: and everything that it discussed. [00:35:44] Speaker 01: So it's broader than just the applications that were reviewed. [00:35:47] Speaker 01: And to be a little more concrete about that, in terms of what was in the 2020 guidance, that document really canvassed the known universe of restrictions along these lines. [00:35:56] Speaker 01: It was actually quite specific and quite detailed. [00:35:58] Speaker 01: It discussed things that have been attempted by manufacturers in conjunction with FDA, including sophisticated age verification technologies. [00:36:07] Speaker 01: Just to name one example, [00:36:08] Speaker 01: the very kinds of measures and also contractual penalties for retailers that don't comply with these age verification requirements, among many other things. [00:36:18] Speaker 01: Those are the very sorts of things that petitioners highlighted on page 39 of their brief. [00:36:24] Speaker 03: This is in, I guess it's Roman numeral, footnote Roman numeral 19 of the denial order, correct? [00:36:34] Speaker 01: Yes, I believe that's the case. [00:36:36] Speaker 03: It's theoretically possible that mitigation efforts could adequately reduce clearly reasonable thing to say is a general matter then you report that today. [00:36:50] Speaker 03: None of the applications that FDA has evaluated have proposed restrictions that are good enough. [00:37:00] Speaker 03: That's a statement about past cases that you've adjudicated. [00:37:05] Speaker 03: And then you go on to say, but so for the sake of efficiency, we are just not going to evaluate marketing plans and applications at this stage of review. [00:37:17] Speaker 03: Which I think is more or less [00:37:22] Speaker 03: what I said earlier, which is you saw a bunch of plants that weren't good enough in past cases, and so you just stopped looking at them in the cases before you. [00:37:34] Speaker 01: Well, there's one thing I'd like to add to that, which is, again, the sentence after the one that mentions prior review of applications, FDA said, we are not aware of restrictions that to date have been successful. [00:37:44] Speaker 01: And again, in the 2019 guidance, the conclusion was actually quite broad. [00:37:48] Speaker 01: It was that categorically, as a category, these kinds of restrictions were not sufficient. [00:37:54] Speaker 01: The way FDA put it at one point is focusing on how the product was sold [00:37:58] Speaker 00: would not be sufficient to address youth use of these products and quote that's at a 94 on the record so Mr Kenny let's imagine and counterfactual that my company or that prohibition has come up with a technology that requires a fingerprint ID and [00:38:16] Speaker 00: You can only buy if you're, you know, on some database that confirms like driver's license that confirms that you're over 21, that it's proprietary they haven't announced it publicly, they put it on the application they want to get out ahead of the curve. [00:38:32] Speaker 00: And because the FDA, which I understand as an expert engaged in this area, has been monitoring these kinds of age gating technologies, is unaware of this. [00:38:44] Speaker 00: And it comes through with this crush of applications. [00:38:49] Speaker 00: Isn't the FDA's position, well, it's good enough for us not to even look. [00:38:54] Speaker 00: Whoops, we didn't find out that there was this really cutting edge technology because we didn't even look. [00:39:00] Speaker 00: Why is that not, as a matter of administrative law, a reason that we would have to grant the petition here? [00:39:09] Speaker 01: Well, two reasons, Your Honor. [00:39:10] Speaker 01: First of all, it's not actually even hypothetical, and Your Honor may be aware of this, but there are three applicants that are known to date to have proposed this kind of novel restriction. [00:39:20] Speaker 01: There's only one kind of restriction that prevents or helps to try to prevent youth access to these devices that FDA is aware of that goes beyond and proposes something new [00:39:31] Speaker 01: beyond what was addressed in the 2020 guidance document. [00:39:33] Speaker 01: And that's what's called device access restrictions. [00:39:35] Speaker 01: So these are the very sorts of things your honor was referencing. [00:39:38] Speaker 01: One example could be, you know, a fingerprint scanner that attaches to a device and locks it unless the authorized user is using it. [00:39:45] Speaker 01: And with respect to those products, again, only three applicants to date have been known to propose those kinds of measures. [00:39:51] Speaker 01: Those applications are still in further scientific review. [00:39:54] Speaker 01: So FDA is still considering [00:39:55] Speaker 00: How do you know this isn't one, or at least at the time of the disputed action, which is what we look at under Chenery, how would you know this isn't one of those if the agency is not looking at this time, even looking? [00:40:14] Speaker 01: Well, first of all, the three applicants that proposed those actually discussed them even outside the confines of their application and outside the confines of the marketing plan. [00:40:23] Speaker 00: I mean, you know that the ad law precedents that bind us and that we do require that our decision making be made on the record. [00:40:34] Speaker 00: You referred to harmless error. [00:40:35] Speaker 00: I wonder if encompassed within that would be, for example, a remand without vacatur. [00:40:43] Speaker 01: Well, actually, first, your honor, and that's the second point I'd like to make. [00:40:46] Speaker 01: The petitioners in this case do not claim to have proposed anything along these lines. [00:40:51] Speaker 01: So as your honor correctly identified in the earlier questioning, you know, petitioners have not identified or even suggested that there was anything novel or materially different in any way from the kinds of measures that FDA had determined to be insufficient in the 2020 guidance. [00:41:05] Speaker 01: And along those lines, there is no basis and no suggestion on the part of petitioners that they've proposed any kinds of vice access restrictions like this. [00:41:14] Speaker 00: Right. [00:41:14] Speaker 00: That's a bit post hoc. [00:41:15] Speaker 00: So your position on remand without vacatur? [00:41:20] Speaker 01: I'm sorry. [00:41:20] Speaker 01: Could you clarify? [00:41:21] Speaker 00: Well, if we were to find that it was an error not to consider the marketing plan at all, but it was an error that we are confident, given the record, would be easily corrected on remand, would it be appropriate for us [00:41:38] Speaker 00: Again, hypothetically, were we to find that to be error? [00:41:43] Speaker 00: Instead of, you propose that we treat it as harmless error, and I understand that argument, take that. [00:41:51] Speaker 00: Would it equally be appropriate to rement the agency without vacatur? [00:41:57] Speaker 01: I don't believe it would be equally appropriate because to the extent that there is no harm that flows from the error that the court identified in its analysis, there wouldn't be any basis for any relief on the basis of that. [00:42:11] Speaker 01: Because if there is no harm, there is no remedy that's appropriate. [00:42:14] Speaker 01: I think the court has the option short of, if it identifies an error, short of setting aside and remanding, it could remand without vacator. [00:42:25] Speaker 01: I think that is an option that's available to the court. [00:42:27] Speaker 01: as an intermediate option, but I think the more appropriate relief there would be no relief because if the error is harmless, which we assert that it is, there's no basis for a remedy and no need for a remedy there. [00:42:37] Speaker 00: I'm curious about, in the footnote where the FDA says it's not going to consider, it says we're not evaluating at this stage a review, and I was just curious what that [00:42:50] Speaker 00: means? [00:42:51] Speaker 00: Is there a later stage or is this referring to the stage of sort of the review of the bulk of PMTAs or what? [00:43:02] Speaker 01: It's an important question because there are a number of applications for flavored e-cigarettes that are in that further stage of review, further scientific review. [00:43:10] Speaker 01: There's different terms for it, but undergoing further review to determine whether or not the products could be appropriate for the protection of public health. [00:43:17] Speaker 01: So [00:43:17] Speaker 01: FDA has been clear that these marketing restrictions are necessary, but not sufficient to render a product appropriate for protection of public health and for them to enter the marketplace. [00:43:28] Speaker 01: So there would need to be review of the marketing plan at FDA's position. [00:43:33] Speaker 01: before any product could be authorized and before any marketing grant order would be issued and that marketing grant order could include requirements that certain marketing proposals and certain marketing restrictions be adopted and as an example of this, this is not hypothetical, in the context of tobacco flavored e-cigarettes, a number of which have been approved, as I mentioned earlier, [00:43:53] Speaker 01: FDA has determined that in that context, tobacco flavored e-cigarettes, they can be appropriate for the protection of public health, given their lesser risk to use under certain circumstances, and those circumstances would necessarily include things like specified marketing restrictions. [00:44:10] Speaker 01: that can be agreed to or imposed upon the manufacturer before or when a marketing grant order is issued so it would be necessary to review the marketing plans, and they are necessary they're just not sufficient to establish the appropriate for the protection of public health standard at this stage and because there was no other evidence [00:44:30] Speaker 01: substantial or sufficient evidence in the applications of a substantial amount of benefit for these products in terms of helping smokers quit, particularly as compared to tobacco flavored e-cigarettes, then that is why FDA determined here that it was not appropriate for the protection of public health to authorize these products and they were denied. [00:44:49] Speaker 03: But in the application, with respect to the applications before us on review, those were final agency [00:45:01] Speaker 03: action as to which there are no further administrative proceedings? [00:45:08] Speaker 03: Those were denied outright. [00:45:12] Speaker 01: They were denied outright and they are final agency action. [00:45:15] Speaker 01: There have been further administrative proceedings, one of which was mentioned in a Rule 28J letter that we filed with the court last week. [00:45:21] Speaker 01: However, they were final agency actions and are the subject of this appeal now under review. [00:45:28] Speaker 03: Right. [00:45:29] Speaker 03: So the statement in the footnote that for the sake of efficiency, we will not review the marketing plans at this stage of review is really a head scratcher. [00:45:49] Speaker 03: And I mean, the most plausible explanation is that this is just [00:45:55] Speaker 03: of a cut and paste. [00:45:59] Speaker 03: Your general position is you haven't seen one that's good enough yet, and that's the basis on which you're proceeding in all these cases. [00:46:13] Speaker 01: Well, no, Your Honor, to be clear, when that footnote said at this stage of review, it was saying that because there had not been enough evidence in the applications of a substantial enough benefit, the application would be denied on that basis. [00:46:24] Speaker 01: That was essentially dispositive. [00:46:26] Speaker 01: However, there are other applications for flavored e-cigarettes that remain under review and that have gone through to that further stage of review and before any marketing grant. [00:46:35] Speaker 03: But if you just read the footnote within its four corners, [00:46:43] Speaker 03: It seems like the agency is approaching this problem in a way that would be, well, it's approaching it in a way you're saying you're pushing to a later stage of proceedings, review of individual marketing applications, which [00:47:13] Speaker 03: of suggests that at some point you have to review the marketing applications and you're just backloading a time intensive issue for the sake of efficiency as you say. [00:47:27] Speaker 03: Which might make perfect sense if there's a later stage of proceeding when you are actually going to look at the plan that the manufacturer has submitted [00:47:41] Speaker 01: Well, again, it is true your honor that they would look at it at a later stage of the review process prior to issuing any market grant order but the reason not to look at it at this stage was because FDA had already found a dispositive issue, it had already found that there was an absence of a substantial enough benefit. [00:47:56] Speaker 01: And in the 2020 guidance as discussed, there was nothing about marketing proposals and restrictions that would be sufficient to tip the balance by themselves in favor of granting these products and finding their appropriate protection of public health. [00:48:08] Speaker 01: So because there was already a dispositive basis here to deny or to deny the applications, that ended the analysis. [00:48:17] Speaker 01: But again, to the extent that these applications had submitted additional evidence, [00:48:22] Speaker 01: they would have gone through to that for the review. [00:48:24] Speaker 03: So in terms of the agency's reasoning, that last sentence is just kind of harmless surplusage is your position. [00:48:35] Speaker 03: That for the sake of efficiency, we're going to actually read these things at some later stage of proceedings. [00:48:42] Speaker 01: Well, the way I actually view it, Your Honor, is a little bit like when a trial court, for instance, issues a dispositive decision on a case based on a sole issue like standing, for instance, and therefore does not proceed onto other issues where it would have to proceed to those other issues if it had not disposed of the case on standing. [00:48:59] Speaker 01: But because it did, there was no need to proceed to those other aspects of the application. [00:49:05] Speaker 01: It doesn't mean they're irrelevant and it doesn't mean they would never be analyzed. [00:49:08] Speaker 01: It just means because you've identified [00:49:09] Speaker 01: a dispositive issue, that can end the analysis right there. [00:49:13] Speaker 01: And there's no way for the marketing proposals to tip the balance and establish that these products are appropriate for the detection of public health for all the reasons FDA explained in the April 2020 guidance. [00:49:23] Speaker 00: Although it seems like it's a little bit more complicated that because the agency itself, as Mr. Navar points out, has said that marketing is really important and it can make a difference. [00:49:35] Speaker 00: And if it can make a difference, then it seems like you need to look at it to see how good it is to see whether it makes a big enough difference. [00:49:43] Speaker 00: So I think your analogy would have to be more like [00:49:46] Speaker 00: You're at a summary judgment stage. [00:49:49] Speaker 00: There's a piece of evidence that raises a very complicated evidentiary question about admissibility or not, let's say. [00:49:56] Speaker 00: And the court says, even if that evidence were admitted, it's not gonna tip the balance because the other evidence makes it clear which way this is going. [00:50:09] Speaker 00: So we're just gonna pre-dermate consideration of that evidentiary question. [00:50:13] Speaker 00: We might need to in a case in which the other evidence were closer, but here it's not even close. [00:50:18] Speaker 00: The delta is not gonna be made up by that evidence, so we're not gonna go there. [00:50:23] Speaker 01: Well, I would disagree that the evidence was predetermined in this case, because again, the 2020 guidance categorically surveyed and canvassed the entire universe of these types of restrictions as categories. [00:50:33] Speaker 01: It looked at all of the different kinds of restrictions that are out there. [00:50:37] Speaker 00: So you're saying, assuming the best. [00:50:39] Speaker 00: on the open question, assuming that this evidence is brought in and that it's totally believed, in my analogy, it's still not going to make up the difference. [00:50:49] Speaker 00: So that's what you're saying. [00:50:49] Speaker 00: You're saying we knew, even if they had the best, they had contractual, I can't remember what you called those, but that all our distributors have to have some age verification. [00:51:00] Speaker 00: And we're doing some kind of electronic, even if they had everything known to [00:51:07] Speaker 00: marketing control against youth access, that still wouldn't be enough in this case? [00:51:12] Speaker 00: Is that what differentiates this case from a case that's further along an evidentiary review where the marketing plans will be looked at? [00:51:20] Speaker 01: Yes, I think that's right, Your Honor, because for instance, there have been other applicants that submitted additional evidence in the form of, for example, randomized controlled trials that do compare their flavored products to tobacco flavored comparators to assess whether or not they have an added benefit over those comparators. [00:51:35] Speaker 01: in terms of helping smokers quit. [00:51:37] Speaker 01: And so those applicants and those applications are in that further scientific review stage now. [00:51:43] Speaker 01: And again, if any of them were to be issued a marketing grant order, and we don't know yet, they're still in review and FDA is still assessing the strength of their evidence and the applications. [00:51:52] Speaker 01: But before FDA would issue any marketing grant order, it would assess the marketing plans in order to ascertain whether or not they're substantial enough as part of the overall equation. [00:52:04] Speaker 01: But again, they're necessary, but they are not sufficient. [00:52:07] Speaker 01: And here, the applicants did not submit any evidence of a substantial enough benefit for their products to justify the authorization in this case. [00:52:18] Speaker 01: So the benefit side of the equation was too empty for any marketing restrictions to tip the balance because of what FDA had determined in the 2020 guidance document. [00:52:30] Speaker 04: All right, if there are no more questions, thank you, Mr. Kennedy. [00:52:33] Speaker 04: And Mr. Navar, why don't you take two minutes? [00:52:37] Speaker 04: And in addition, I have a feeling my colleagues will have questions for you. [00:52:44] Speaker 02: Thank you, Your Honor. [00:52:44] Speaker 02: And sure. [00:52:45] Speaker 02: So just to try to go through a few points quickly in response to the argument. [00:52:53] Speaker 02: So in going back to Judge Katz's original question, [00:52:59] Speaker 02: You know, as you know, I mean, under the ad law precedent, that's a reasonable person standard in terms of fair notice. [00:53:07] Speaker 02: What you know what a person in this is discussed in pH h cork versus CFPB and the part of the opinion I know that went on Bach, but the part of the panel opinion that was reinstated discussing This issue. [00:53:21] Speaker 02: I've cited in the brief, but [00:53:24] Speaker 02: It's a reasonable person standard in terms of fair notice, and a petitioner would be held or a regulated entity is held to knowledge of even unofficial statements by public officials that go into what the standard is for an application like this. [00:53:45] Speaker 02: That's in PHH, it's in General Electric, et cetera. [00:53:49] Speaker 02: And so it but that has to work both ways. [00:53:52] Speaker 02: And so when the FDA issues a guidance document that says basically do some studies and choose some comparisons that you think are relevant. [00:53:59] Speaker 02: They can't then, you know, change the rule to say, well, I know you did some stuff, but it actually didn't address this particular question, which now we're making clear that that's the problem we've identified. [00:54:11] Speaker 02: And so when [00:54:12] Speaker 02: when the FDA and the argument just now, I think it's an appropriate post-hoc, but it's also inappropriate to rationalize why the evidence that was included in our applications was not sufficient. [00:54:26] Speaker 02: Because even if they looked at the evidence, they only looked at it, as we said in the brief, for this particular narrow question that was retroactively announced. [00:54:36] Speaker 02: And that's clear, by the way, from the text of the July 2021 memo itself as well, which says the FDA has determined [00:54:42] Speaker 02: that such and such is the standard, that they don't cite any prior documents. [00:54:47] Speaker 02: That document is the first one that announces that narrow comparison that they want presented. [00:54:53] Speaker 02: And just a real quick point on the statutory burden. [00:54:58] Speaker 02: I don't think that Mr. Kennedy's argument makes it sound like the FDA's position is that it's stacked against the petitioner. [00:55:08] Speaker 02: It's our burden. [00:55:10] Speaker 02: But if you read the statutory standard, it actually, I think it's neutral. [00:55:16] Speaker 02: It just says the FDA shall deny an application if it finds X. So the question is still, does it find X? [00:55:23] Speaker 02: And the last point is that, again, so it's hard for the FDA to explain how they can approve views [00:55:37] Speaker 02: which 10% of high school users of vapor products have admitted is their preferred brand when they don't have any evidence that any of my petitioner's products are used by a single use. [00:55:49] Speaker 02: And so they can't draw these distinctions that ignore the relevance of device type. [00:55:56] Speaker 04: All right. [00:55:57] Speaker 04: Well, I guess there are no questions. [00:55:58] Speaker 04: OK. [00:55:59] Speaker 04: Thank you, gentlemen. [00:56:00] Speaker 04: And Madam Clerk, if you'd give us an adjournment, please.