commissioner godley the head of the agency have repeatedly made themselves in fact in this very room making in this very room making the demon the f d a says quote that you believe that the inhalation of nicotine recognize that switching completely from combusted cigarettes to easier it may reduce the risk of tobacco related disease for individuals those are quotes from this very woman similarly the head of the agency just one more  repeatedly but we are precluded from saying the same truthful information to the public although we are not precluded from selling the product of the on the conventional version of the doctrine that ought to be subject to strict scrutiny but in our little bit unclear what conduct exactly your clients are seeking to engage in and therefore what exactly we need to rev is it your position that if someone associated with one of your client companies wanted to speak on our panel about the relative risks of the cigarettes or write an o somewhat of a red herring is that having to ask permission is a first amendment injury itself and i understand that that's your sort of leading position and i think the difficulty is you know you start with the promise that these are lawfully sold and used and that the only restriction is a restriction on what can be sad but under the tobacco control arc i mean isn't that just a product of the time delay for the modified risk product clearance and or the tobacco product pre market review so if you if you look at the got at the baseline as you can't sell a tobacco product be it of modified risk product  or a conventional tobacco product under this act unless and until there's been pre market review then that's a different baseline from the one that you started from ok i understand again you know the question and this is you know that the illegal to sell to the public then the claim of any speech issue would fail under the first level and perhaps and because the product would not be legal to sell having said we will give you several years to continue selling you know the product under the market aspect of this then the product is legal to sell into central hudson and the only question under the speech issue here is whether the government can meet  three and four of these of the just if occasions that it offers now this brings me to the other all of the favorite red herrings that the government likes to use this whole issue of the drug question right and that actually to do is to restrict the speech about them and we know from both of those cases that those cases get treated under conventional first amendment doctrine even though the law on the lawfulness of the sale could have been different and so the mere fact the day of the regulation what i mean we expect that the product will continue to be lawful we don't know what the outcome of the profit exactly there's other issue of id at the a p a and whether the whether the whether the pre market if you also will continue to sort of stand as the agency sees it you know council will deal with some of those issues but my point to you is that the notion that the government has either at the state or local level some unlimited power to make things on lawful doesn't include the lesser power to resign if we can are throwing appreciate your argument and i do think the government has clearly put itself in a very difficult position by asserting on the one hand though you know something that is even worse for the government here and that is how it's just if you do not directly advance what is trying to do and the lack of it even under central hudson i supplied by the modern court on the the stature that is a real first i'm a problem for the government and it is this i could get every federal judge in this country to agree that everything that i intend to say of the population as a whole now think about this in what world does the government get to deny each to a citizen that is absolutely truthful on the theory that it is not in the public interest another i believe the government's position  and this applies also to your pointing out that the f d a gets to say certain things and and why don't you get to say the same things their position really has to do with with context and we all know when you go into the supermarket and you know the lemonade says it's no fat and you know the butter says no sugar and i think you know certain consumers can think over them that's a dire product that i can consume and so what they're looking at is how the reasonable consumer would understand a modified risk product and and when they think that this is something that i can do no that's not that's actually not the case because you know the answer to the when we say it everybody will understand that it's not in on this leading but when you said how disclaimers are a preferable way to deal this issues than suppression so if you're if your objection is complex car companies can be provided with a disclaimer not with blanket preference of truthful speech as to the second point you know the whole question and with what your position take down the any of the pre clearance regime for tobacco products modified or not to say you can't have a truth of speech cannot be uttered if you will cause people for example to start using it to back a product because that isn't bad for the public health now i will concede that this is a big ape an appropriate concern for a public health authority is just not know beyond question that there are many things that the government can use here that will not involve the banning of protected truthful not misleading speech including uttering the very same thing the public health authorities in g seven countries themselves are which if the government thought may be misleading in the lives of others could be cautioned dealing with cautionary language as purest an indicator let me ask you mr estrada assuming that we were under the rule all that have taken the pre clearance for modified rest products regime had taken a fact and the question is how do we understand th here i will limit it to a let's say of a labeling or an advertising claim and the government is saying you know you can't make claims that are modified risk claims on this product you can't sell this product as a m that did not wash but the theory about that would occur is that what is on lawful is the sale of the compound with gene tended to be used for therapeutic purpose that is not just like it would appear right we have a intend to assassinate the president of the united states the underlying act can lawfully be made on lawful and the speech is merely evidentiary that's different now in this case my clients could come here and confess to you that they intend to sell their products within pen that they be used to diminish wrist and that would be lawful it would only be unlawful if they advertise that to the public i mean if they make a claim to the public they could secretly have the intent they could come first or in a secret letter to the kirtland that is discriminatory as against certain speakers and that keeps them from saying really important information that you know could be potentially important and life saving to many people because if you can read what public health save lives so there are other things in the balance here too and this will be important public policy information that the government is completely suppressing for no good reason under the first amendment and this is why this has to be set aside i think  thank you your honors my name is eric god whom i represent both make appear in a right to be smoke free coalition and i'll be addressing the two other issues on appeal both a free sample first and then an issue in the p m t a p a issue so with regard free samples are inherently expressive because of this message try need by me try my product you will learn about my product and its whether how it performs how compares to others and quotes the communication of free samples as a form of communication as a form of advertising and promotion because it isn't facing the could entice under in the contacts of vapor products manufacturers are one intending to convey this information about their products into the consumers are going to understand that because vapor vapors are looking to sample in nothing now to get that information is mr condit is the question not just whether the conduct might be understood to be expressive but whether the government in regulating is aiming at its expressive content or not and here the interest really seems to be in keeping i dicked of nicotine products out of the hands of any anybody really but they emphasize use i agree with you that is part of part of their interest but they have any interest that's directed at the expressive yes i think the content of where do you find it would be  says the regulations describing paragraph thirty which is referring to free samples those were the one thousand nine hundred six regulations imposed no more extensive restrictions on communication by tobacco manufacturers and sellers that are necessary to reduce the number of children are lost and so you cigarettes and the sit down to the such such regulations are narrowly tailored to restrict those advertising and promotional practices which are most likely to be seen or heard by youth and most likely to use them congress is talking about messaging here not just pricing or sales trends i'm not describing free samples as speech and satisfies the first prong of texas v johnson and also satisfy the second prong because there is this evidence that consumers of papers are in this case the vapors are looking for that information through menthol cigarette it is not enough for us to say that my device delivers nicotine better than your cigarette the only way that we can convey that information is through the sample and that is i think i don't feel sad as much even though that did involve it's sad when i was describing solicitation he said part of that process is it is trying products or services so you can come compare to product specific studies so in other words f d a would accept the application for scientific review if it included everything else in the t m t yet including a scientific review of publicly available literature the reason why this alternative is suggestive is that f d a found that most of these manufacturers were going to disappear before they ever filed the p m t a because it's so expensive and many of these manufacturers are small application so we don't accept the market before we have a far it seems like in the end this is really hard to evaluate in this posture and i understand it's important for you because you have to know what you're up against but that the f d a did say that if there were studies that you know were good he gave them reason to believe that without the kind of long term field studies that you're talking about that they could be confident that they would be they urge you to submit them and they would be happy to see them there also are these other avenues like the avenue the special rule for certain products where if you are making a narrow claim about you know tar or  product already on the market where they have you know they've gotten clearance that other products that are similar to piggyback on the clearance of the already approved product yes a couple things  product in a type goes ahead and then other products compete back under substantial problems yes but you always have to have that pretty brazen stuff yes and we don't have that with a little and i think it does if you did you say you always have to have the pretty two thousand and seven to if some brave and well financed liquid company does a p m t gets right you know goes through the regime and gets approved following by other products that are substantial scenario that they presented in the preamble first of all again according to them you're going to have this mass mass of market access even with that case by case approach the problem we have is we're not getting the signal to the marketplace that we will get a scientific review of the real reason is we are aware of only two applications that have ever made it to scientific review ever they all get kicked out of the pre kind of filing price process by f e m a so we can we're looking at what's actually happening and so what happens after a says we want to see everything it is that we want to see in the application they are telling us right now let me let me be just so you understand what we're not saying we're taking the bat that the study you're referring to not that it has to do with our product but those general studies out there and twenty two which is when we have to file our applications will be good enough will be good enough to convince f d a that it doesn't need a long term studies that enough has been done between now and then that they can approve  but we're taking that back we're not taking away and we're not asking the court to take away from after year the discretion to not approve our application because it doesn't have a long term study regarding our product we were reserving where you can file without long term studies in we will do scientific review the numbers that we're seeing right now we say to a f d a website is that only a fraction  before the question no thank you thank you it please the court lindsay howell for f d a cigarettes raise precisely the concerns that animate the tobacco control act they deliver highly addictive nicotine and they are now the backup product most widely used by middle and high school students scandal evidence more over that beginning to use the cigarettes can later lead to use of conventional so can't happen you claim that these are extraordinarily dangerous and given the government's postponing of the deadline for the controls to twenty twenty two are just that the argument that the bell cannot be on wrong you can imagine brings a little hollow against that paxil back drop a few things around or first the question about compliance deadlines of place only with respect to the review of new tobacco products it doesn't apply to market review of modified risk product i understand that but that's what mr strout have made his you know hung his first amendment argument on we can sell these as tobacco products we just can't sell them as modified products meaning we can sell them and we can say things about them whereas if the nicotine is so hazardous that none of these products should be on the market with explanation or not  you're argument would seem to have more weight to understand the problem i think you see the same thing in the drug context your honor and so with the example of sought him out of that's a product that could be on the market the question was whether it could be  make certain claims that turned into a driving you crazy thing here your products that can be on the market i see that as a formal matter it's just it's it's feels very far afield practically from what we have here in the sense that you know the record shows extraordinary uptake of cigarettes among for example middle schoolers there was no extraordinary uptake among men with prostate people of these products and your argument hangs on the notion well they can't be sold as less risky because that's going to make it even worse but you also taken the position that well let them be sold for a few more years health issues presented by these products so this summer after more than eleven hundred warning letters against you figure at retailers manufacturers that were marketing these products to you if violating that sounds and that starts to sound more like mr estrada's argument you shouldn't be establishing pre market review from out of progress party should be doing other less intrusive that congress does herman based on extensive record evidence that combat products of the type of public health not necessarily if it also contains other substances which is very much part of f t s ingrid me very well being more harmful substance and that's what the inquiry is my ticket to those smokeless or no smoke there are two things that that the reason why smokeless tobacco companies can say that is because it's part of the product definition it's always been called smokeless tobacco that's all people understand that that's not true of you cigarettes are not referred to as smokeless products and this  some of these products do a huge high enough that there is combustion and they are arguably produce smoke insofar as they are heated to create a vapor that is then inhaled and exhaled and in competitive enterprise institute this court upheld department of transportation regulations us on airplanes as smoking so to say there's no smoke they also want to say no tobacco but by definition these are tobacco products so to say that these claims are clearly truthful and i'm misleading is could not be farther from the truth and even if we accept that there are some such claims which there may be it doesn't mean that f d a is not entitled to assess and other time in the context of the particular products in which they want to be made to be sure they consumers will not be misled we know from history that when consumers are misled by products of the site it leads to a new generation of children addicted to these products many of them for their entire life and these products are and have not been shown to be safe and we know that self is very harmful when used by children at a loss and so there is a compelling government interest here and making sure that these don't harms don't happen again and is that interesting again i know this issue is not technically before us except it does seem bound up in the question of the government's interest in the prisoner's regime is that interest not undermined by the length of time that the government has decided to take before these regulations go into effect can't stop and the evidence for other shows that using the cigarettes can lead to the initiation of conventional cigarette use and we know how dangerous that is so there is clearly a substantial public health concern here and it is not undermined by f d a is more global comprehensive consideration of the tobacco issue as part of which it has determined to exercise important discretion and not enforce some of these specifically new product review for a period of time but that in no way undermines the strength of the government's interests here this is a crucial public health concern and we know what the stakes are here the congress recently gave the f d a these tools in order to prevent a very specific harm which is the continuing dissemination of information that will mislead consumers who believe these products are safe and that's in the will making record here that people already do believe they're safe that they have been misled and that's one of the things that's leading children to use than there are also other things prompting that used by children including the marketing of these products as juice boxes and lollipops and the ability to use them in classrooms because they're shaped like in conspicuous objects like because it's so onerous was your response to that it is not an effective ban and it is premature best for us to be making that argument when they haven't even attempted to meet show that it's not just that it's beneficial to the public but that it's more substantially more so than any other tobacco product basically the difference right there there are closely related inquiries on the modified by the company and so there is a growing public record both through those applications through the development of the scientific body of knowledge about these products that it will continue to  meet it easier for companies to put together the materials they need to make the showing required here and so it's not again starting on a clean slate every time it seems like a lot of the claims that they want to make about modified breast products are claims about specific attributes and there's i guess a slightly more truncated clearance for those but can you just give us a comparison of of what are the efficienc route as compared to a general claim that these are safer yes your honor so that's under subsection g two and the evidence for your burden is lifted somewhat so that the scientific evidence does not need to be quite as conclusive to review as your honor knows i do want to go back to the drug contacts for a moment just to get to know the well established appropriateness of this type of review even with respect to truth and even with respect to claims that are products that are clearly beneficial so if you had it you say greg that we all agreed could actually help people to quit smoking that's a huge benefit great product it would have to go through premarket drug revealed as a smoking cessation product never mind modified risk review it would be a drug subject to that long standing clearance regime and so the notion that potentially benefit the cigarette products would have to go through this paper pre market review for modified that's is not unfamiliar and it's completely consistent with the first amendment basically an o'brian question whether the government's interest is directed at the suppression of expression or whether it's directed at the conduct it has in o'brien the function of the selective service system and here the keeping of addictive nicotine products out of the hands of people who should not easily get them that is your brain scanner your honor and we would certainly withstand review under the way the supreme court has looked at you know truly economic regulations or price regulations that haven't even gotten to the you should be doing something more flexible than what the statute command i mean there are there are some opportunities for the f d a to to use some kind of flexibility yes your honor and f d a has said that it will use the flexibility that it is afforded by statute and so it's clear that long term clinical studies may not be required in every case but that will be a case by case inquiry to determine whether the evidence provided whether it's a long exercise its flexibility to the extent consistent with that framework and as i mentioned there may be opportunities for further efficiencies in that process certainly in manipal to applicants relying on earlier applications to the extent that the information i do not believe there are any patients that have yet been approved under either new market or new product or modified risk reveal any date for decision there are i do not believe any currently pending there's nothing that right now certainly piggybacking as one of the ways to gain efficiency of the growing body of scientific evidence is also one i mean people are studying this question very carefully because it is such a significant public health concern and as that body of evidence grows q thank your honor system points to going to a brian reasonable line doesn't apply here because a brian requires that the interest of the government has nothing to do with community of elements here as i a does the actual provision itself does it actually build in some flexibility it says that long term studies are only required when appropriate and other valid scientific evidence can be used to satisfy  the population of facts seen the alternative we were talking about doesn't even implicate dappy because we're not taking the discretion away from f d a to say look in twenty twenty two you submitted this without any  long term studies and we think you should have and they can disapprove what worse team is that f d a with the case by case basis approach they concluded that the vast majority of these people will not be around they will not file communities so again we're asking for more of a process oriented management of the applications to avoid that problem that they have concluded exists and i believe that f d a would have especially under the it is important to know that the government already puts a nicotine warning on these products and that any public health issue that have to do with how bad this is where you can be dealt with a disclaimer as you said in puritan but the later after the hope west and of youth it is a public health concern but of but of course no one here is urging there will be allowed to sell anything to youth which is of course illegal art our point here is that we are trying to make to  speech to adult consumers about a lawful product this you know recall something that was established in the law long time ago in one hundred fifty seven in an opinion by justice frank for when the state of michigan tried to ban you know the publication of risque magazines because they might be dangerous to the morals of the children and the kids went to the supreme court with just as frank per say said they in order to ban those  requirement that the f d a of pain from each manufactor of my brand and subway and a list of potentially harmful constituents of each brand and supper and and in there and the published on a government website as required by statute in a manner to be accessible to the public i am committing something that is contrary to the law but yet again saying the same thing is complying with the law and there is a plethora of similar statements espoused by the head of the agency in speech every other day anybody is it your understanding mr straw that if your clients want to add to it as a form of advertising simply post a you know claim which says my brand doesn't have this which the other brands have or my brain doesn't have what i'm asking you not that claim but printing out just a printing of the ingredients what one of the problems with schemes  years ago that commercials be sturdy but is a lot less dirty when this sanction is actually pure censorship without any procedure all avenues to actually get to a court which is why we're here one of the things that i should have mentioned earlier is that on the hill or in africa this not only are there far better ways of dealing with the issues that the government claims to be concerned about like the possibility of  telling you that we want to say the same things the public health authorities themselves say and to publicize the same thing the government published writer than its own website thank you so much