the claims there is no science record against them in this situation in re aren't j applies because the claims are supported by scientific evidence they are by definition not inherently misleading so they are wors potentially misleading and the supreme court has made clear that disclaimers are the resort for the government in such a circumstance not outright suppression see also this course sedition and piercing vs shit we have our focus on for  e errors in the system involving one the violation of the st amendment free speech and th amendment procedural due process rights to unlawful delegation of agency decision making our three false we have palm wonderful which is a more recent case and which is pretty directly on point so how do we assess earlier supreme court opinion which seems pretty strongly to help you but on at least at least one later d c circuit opinion that seems almost on all fours against you so palm is really distinguishable because it's the post publication context and the court there assessed actual market evidence of deception as the f t c found on the specific question of the standard of review when an appellate court considers whether speech is serious and misleading well in order to apply the central hudson standard and i don't believe there's any basis for exception to that in fact and ruin the course  between the standard her view for the factual findings about the scientific studies and then the standard by which we assess whether given those factual findings the standard of misleading us is met and i just want to make sure i understand which one you're talking about because wonderful speaks directly to the former question about the standard view for factual findings and and deems the to be substantial evidence there's also tillotson language in the opinion about the ultimate question of whether the speech is misleading but i want to make sure i understand where which one of those two aspects of the inquiry your directing your you meant to i think it's particularly appropriate and i hammer on this point that deals in the post publication context this case like pierce and deals in the prior restr pre publication context that's critically important to substantive basis because the court in palm has evidence of marketing they have actual evidence of the reception they speech and conclusions from an policing the market and and prosecuting post publication this is quite different this is in a pristine scientific environment there hasn't been any marketing so the court is looking at s  agency the speech in issue directly and the science supportive of it as opposed to anything that would relate d to deceptiveness from the market and in order to apply a central hudson as the court did in p necessity must look at the science so it's not only a matter that constitutional laws assess the for the court not to abdicate its essential responsibility to say what the law is under the constitution given the central between prior restraint and subsequent on issue manner advisory opinions matters on on this one question we still have and i was focused on the fact part of what the chief judge was talking about we still have this decision which seems to say that the factual assessment of whether or not a particular speech is misleading just get substantial evidence review and seems a lot like what we have here in this situation you end up with a horrible conundrum and that is that an agency that has a long history of censoring speech including of course directly on point by the supreme  court it would be in a conflict situation because of course it's prosecutorial interests is in defending itself and its judicial interests then merges with that and in this case not the facts create a crack in the government's because their term mix doesn't mean any evidence against the claim there is not for any x in protecting d n a from alcohol induced damage with one steady hand it represented fifty subjects showing a significant reduction in certain measures of d n a damage at some time points after administration meant yes so the point is this is not a situation where there is no evidence and the government even admits it in its own findings that leads us then to necessarily a a full some application of the central hudson standard i might i have six minutes i might with your indulgence take a bit of a deviation to cover of a matter of fact that i think is troubling in the government's brief and i want to i want to be sure that the court has a an adequate appreciation of the significance the government takes the position that the formula i here was not to find in fact there are only two bases for the government's calling into question science one the formula is undefined and secondarily that somehow the claim implies brain and liver treatment with regard to the argument about the in the denial letter at page thirty three j one thousand and eighty seven so that's to that point i can ask one question about this kind of the overall context of what we're dealing with here and i'm going to ask the government about this too but this relates in some measure in a prior restraint argument but it also relates to the central hudson point which is as i understand procedurally what happened here you you asked for a letter rolling under twenty seven dollars c f r seventy  and you get a response from the agency does that response from the agency have any legal consequences for you because you know like in a force it's not an enforcement action that is not an order that requires you to  desist from any conduct it's not the labeling regime whereby you can't go forward without pre approval because you didn't pursue that route so what we're talking about is in the nature of an advisory letter that tells you the agency views but it's know that the regulations require you to obtain pre approval for labeling and if you just proceed ahead and include something in your label without getting the pre approval well that in itself is a violation and the agency can take action against you because you didn't get the pre approval if we if we don't talk specifically about labeling the because this case isn't about the color process at least not directly this case is about this letter rolling process under the regs seventy point four seven one on that what's the legal consequence of the forty seven dollars page determination you got from the agency what is it actually the consequence if you read the t t piece actual order it ask the government about this but i don't read that to mean that if you went forward with the label let's say that the problem would be something about this particular ruling as opposed to just the general overarching mandate that the agencies impose that you can't issue a label without pre approval that's going to be a problem no matter what but with respect to advertisements for example what's the consequence of this because as i understand it you don't need pre approval to do an advertisement and you have a letter from the agency that tells you what they think about it but if you just went forward and did advertisements it's not apparent to me that this letter puts you in any worse a position than you would have been otherwise well the statute would prohibit us from engaging in and advertising that the agency prohibits for labeling and it's very clear from the enforcement history of this agency and from what they have told the store d equity that were we to proceed with the content that we're talking about here it would be deemed a violation of their regulations and also they couldn't vote the criminal provisions of the act and prosecute us is simply not the case that they either interpret this to be separate and to afford us an opportunity to advertise they view both together in their order and they prohibited both together in their order and we couldn't proceed in any event because of the decision because it makes clear that were we to do so we would evidence should be included which is that they don't have they have they have a superficial health claim process it that even suggests bias they don't have in place a mechanism for receipt of a petition to  review the health claims that makes any sense at all you know the cola system that you are required to use and we did and frankly in our age and use it in cross reference the petition likewise in the titian we cross reference the cola but to get the can i ask you about the disclaimer process so pearson clearly requires  agency to accommodate speech at least in some circumstances with disclaimers the disclaimer can make the speech non misleading they have to accommodate rather than suppress so how does that apply in the circumstance we have here where my understanding of what happens is the following your client  declaratory ruling about a set of statements some of them and some of them were what they wanted to say which was that this ingredient produces the n a damage and then they recommended a disclaimer which talked about health risks of consuming alcohol and then the agency's response is that's not good enough because the disclaimer d address two concerns that we have one is the degree of support for the studies and two is what they think is an implied claim about brain and liver damage so what happens at that point is it your continue to be made to bear a burden to propose a new disclaimer in light of the agency's concerns or is it their burden to anticipate every possible disclaimer that might work and compose it from scratch for you they have the burden of proof on the st amendment they also have the unique knowledge of what their interest is here the court violated central hudson by giving the agency an interest that didn't articulate and that was consumer fraud the agency's articulated interest was to reduce they can sumption of alcohol or another were words it was a health interests the question as to the disclaimer has arisen numerous times following pearson and has been dealt with in this ma they party that is the petitioner will d suggest a disclaimer and then as we did indicate we would accept any reasonable this clarity of the seed wish to insert because the agency has defined it defines its own interests necessarily as a practical matter is the agency's obligation consistent with the st amendment burden to define a qualification and then to ascertain whether or not it is d reasonable by determining the extent to which imperial evidence supports it so for example this agency has a history and course reveals that d forty four dollars liquor mart reveals it on the state level two from its sister state agencies  engaging in speculation and conjecture in lieu of imperial data so if the agency were to say oh as it has here without any proof whatsoever that this information on the label would cause consumers that's actually iranian and i want to point out something that supports why they reached that erroneous decision in their correspondences f t s correspondence with tb they make this remarkable admission and i quote we do not have a at the two hour interval thus adding support for a claim as opposed to being an all event or are certainly not being against the current thank you it thank you that would remain the standard they were not required for the advertising plans in particular to go through this process rights of the if they were required to go through in the st place and unless you tell me that if they issued an ad there some added consequence some added penalty that could ensue by virtue of the fact that the agency issued this letter then it's not clear to me why it is final agency action because i don't know what the legal consequence is of the ruling and just putting that aside the  effect if any on the cola because i understand that there's an argument that that's been wrapped into this i'm not sure about that but i understand the arguments there but if we just put that to one side for a nd and just isolate this question about the letter really because of the advertisement it's not apparent to me at all why it is final agency action into rightness and make it an ingredient of the rightness inquiry and and indicate that dispute can't be right if there's a final agency action problem if that's true then do you have a position on whether the dispute read then then can i ask you about the just the piece that we put to one side for the moment which is the cola piece so it's true that the request asked for pre approval for the labels and it's also true that the ruling at least in a couple of sentences kind of wraps that and both in the preview and the conclusion but i didn't read that to be a colon determination i just read it to be responding to what the letter asked the agency to do and the cola determination was sought by the the other entity i get that but that entity is not before us and so as i understand the procedural context of the cola question the cola action isn't directly in this case this is a letter ruling under the the regulation day that it's essentially an advisory sort of an opera or e advisory treatment but it doesn't carry a legal consequence it doesn't allow for an addition of a penalty if action is taken in contravention of it it's wonderful for now we just have to feel how would you distinguish that case for pill and vault a sort of forward looking general regulation not what we have here and it's consideration of inherent character of the statement places it beyond the protection of the st amendment is a question of law over which we the supreme court should exercise de novo review as a c pose and then there is an application of that principle to a question about whether the speech at issue was prescribe of will because it was misleading back to the pre peel decision which says that bo's is just about defamation and we do have we do have to post peel cases which tell you what neither of  and craft which does address the particular argument as to appeal that because people involved not this sort of consideration of particular claims on the basis of the agency record misleading advertising as you buy the f t c is wonderful and that line of cases or in this case a similar judgment made by the t v again that particular advertising particular claims are misleading on the basis  record and there's clearly substantial evidence for the t v s decision on the basis of the record and there has the two human clinical trials that were provided none of them provide credible evidence for the does the governing rule under the regs is adequately substantiated what does that mean and is adequately substantiated by scientific or medical evidence  conclusively proven proven by clear and convincing evidence proven by a preponderance as this is reflective requires at least credible evidence of the type that into the scientific or medical context that you would look for and we don't even have credible evidence here certainly as applied to the claims presented here it requires more than that it is a flexible standard that looks to is the sort of evidence required to substantiate the claims made not misleading this is again an area where as a scrap recognised judgments that a particular claim is misleading that is an impressionistic judgement the regulations provide additional clarity as to what sort of substantiation you need to make it not misleading and the agency appropriately sort of clarified the standard here sufficient  not be misleading does depend on the claim depends on the entire factual context of the studies seem to start to bump into pearson where we said on this specific problem of claims that have some degree of support but not a conclusive degree of support we said that that is a circumstance in which the agency pretty categorically that the agency has to accommodate on last and then there's a formulation at the end whatever the degree of support the degree of evidence contradicting the claim outweighs the evidence supporting the claim so i mean don't hold me to the exact formulation but the general idea is accommodated in most cases subject to just some outer brown women it says that i just said it says that in the context of nutritional supplements where it was there was no claim there was any health risk or health harm to health risk here is undisputed that alcohol does  interrupting you i apologize but perfectly fair distinction but why wouldn't we account for it by giving the agency more latitude with regard to the disclaimer rather than just watering down the legal standard we would say of course you can put in the disclaimer whatever information you want about the health risks of alcohol and make them say that their statement about agrees is harmful is relatively less harmful that there is a basis for being more skeptical of the value of spammers there and then i guess this is not a case where the agency refused to consider slammers at all the problem is the claims just cannot be substantiated based on the studies and it is no reasonable swimmer has been proposed to get around that problem that the disclaimer essentially would have to contradict the health claim to adequately captures centralized and is you know not the least restrictive alternative and not more than just when the agency does consider the disclaimer there's no other reasonable disclaimer that they refuse to consider anyone   but the sequence the sequence that happened was they proposed a disclaimer you said it wasn't good enough because it neither addressed the degree of support for the express claim nor what you thought was the implied claim then would seem like that shouldn't be the end of the process of accommodation if that's as far as the analysis goes there's pretty obvious open question of well what about nine a more robust disclaimer that says number one the degree of support for this claim is less than conclusive and number two we're not saying anything about facts st i would i'm just sort of who bears who bears the burden of taking the next step when the parties are at this intermediate position where they you've set their disclaimer by the evidence presented the agency can reasonably conclude there is no reasonable disclaimer that would just hypothetically th problem here about lack of about degree of support were curable through a robust enough disclaimer whose whose burden would it be on these facts to drag out and position on this particular point just rises or falls on what i just ask you to put aside which is the fact question about whether the support here is there some but it's inconclusive as opposed to just there's no support or the evidence against is stronger than the evidence of prayer i think in this case it is yes just i just meant that there is not sort of a less restrict use the word credible at some point alicia say that there's not credible evidence that what you read the agency to to be saying in terms of a disclaimer in that context is there's no disclaimer that can address that because even if you try to have a disclaimer that says oh you know this there may not be credible evidence but just you the consuming public we want you to know that the evidence may not be credible but here's what we're saying about it anyway your point is well that's just not a disclaimer that really doesn't a constructive work and so there's no there's never an onus under the st amendment to allow an entity to use that kind of disclaimer as a means for engaging in the speech that's right and i would say that's particularly true with the sort of now products which is distinct from your considered god and you can ask you just one quick question about pr restraint so on the prior restraint part of the case you've made the point in your briefs that there could be a prior restraint problem under the cola ok there could be a prior restraint claim made under the cola procedures but those procedures weren't  pursued by belly on as opposed to the other entity but by bellowing on and so that's a an impediment to making a prior restraint argument but i didn't seen your brief that you necessarily tethered it to some legal doctrine and i'm just wondering is that does that ultimately become a standing argument or is there something what what doctrinal footing comes from the intuitive point that in order to make a virus don't claim you have to pursue the process that could get  restraint i don't understand them to be challenging the whole process that's in their prior restraint argument so it is just looking at what the arguments they are raising they are not challenging the whole process as a prior restraint and that makes sense because they did not in fact go through the whole process the extent they are raising additional challenges on a procedure that does not govern a situation which pre approval is required you know the pri think false fundamentally both on the facts and the law that we're not challenging the prior restraint in cola process franklin is the agent only and let's understand the relationships here  franklin is the bottler beilin is the brand owner and sugar content technologies is the owner of the n t x ingredient all of them are inextricably health claim that titian in the cola that we have to resort to the petition process but their order addresses both and it is this entire action of the agency which we addressing in our meeting it adversely affects us it is it is present there are criminal provisions that the agency has available for example that t t p regulations if they were violated as to the cola that t v regulations both s that labeling and advertising defines any advertisement not in compliance with t t p regulations as criminal subject to finds another sanctions under twenty pleadings they did argue that the supplements would be harmful to people in particular on the phone with gas and supplement they said that it would mask a vitamin b twelve  deficiency it was the case that they argued that the use of the claims there in issue did pose a public health threat and furthermore as a pointed out before core is does not give an exemption on alcohol from the rigors of the central test in addition or action of the anti competitive regime here which if the court were to decide it on a procedural basis creates a capable of repetition a bit of a thing review problem  substantial because it creates a defacto anti competitive regime it prevents in perpetuity parties like this one from introducing into the marketplace an innovation that reduces the level of harm associated with alcohol and so it locks this system into an archaic byzantine ancient alcohol formulation that is always going to be harmful the irony here is that this is agency that says it interest is public health is acting in a way to ensure that the public health is harmed by not allowing the evidence one less than your honor there are one hundred and twelve dollars study submitted in support of the claims the experts that we hired and they found them all to be consistently supportive of the claims but the expert reports were also excluded by yet the so they have a truncated universe of evidence that they looked at and that is a quarter not mates or so there seems to have been a a time line throughout the deadline that was reset only when you submitted additional information seems perfectly reasonable i'm sure and then they missed we've agreed that these two trains are moving along the tracks and yes and that's a consequence of the regular classes not just as to what amount of time the agency will require pretty clean to titian's could have extended which could hardly have been surprising when again limited itself to ninety one mind but the point i think that we're making and it's in it's intertwined with the adequate substantiation argument too is that there is no definition that they have given the regulated class as to the time period it would take for the assessment of a health plan petition and as a result there is no reliability there's no if i may speaking to the adequately substantiated lack of definition but well to me just i think we we have your submission on that is want to make sure that my colleagues are not further questions for you and you're in a rebuttal time