[00:00:00] Speaker 03:
May it please the court?

[00:00:01] Speaker 03:
I'm Justin Pearson for the appellants and I would like to reserve four minutes if I may.

[00:00:06] Speaker 03:
Your honors, the district court expressly found that we had plausibly pleaded that the phrase low FODMAP is banned from food labels, that the district court still dismissed at the pleading stage both of our listener-based and speaker-based free speech claims.

[00:00:22] Speaker 03:
In doing so, the district court made three

[00:00:26] Speaker 03:
separate, reversible errors.

[00:00:28] Speaker 03:
First, based on Virginia State Board of Pharmacy and the Fifth Circuit's persuasive precedent in association of American physicians, this Court should reverse the dismissal of the listener claim for failure to identify a willing speaker.

[00:00:41] Speaker 03:
Second, based on this Court's decisions in Rhodes v. Robinson and Ellis v. Stroh, this Court should reverse the dismissal

[00:00:48] Speaker 03:
of the speaker's FDA claim.

[00:00:50] Speaker 03:
Third, based on this court's decision to McBride, this court should reverse the dismissal of the speaker's USDA claim for failure to exhaust.

[00:00:57] Speaker 03:
I would like to begin with the listener claim, if I may.

[00:01:00] Speaker 03:
And the sole basis for that dismissal, Your Honors, was the district court's finding that we had failed to specifically identify a willing speaker.

[00:01:07] Speaker 03:
But that is not a requirement at the pleading stage.

[00:01:10] Speaker 03:
And even if it were, our listener plaintiff, Michelle Presbaki, met it anyway.

[00:01:15] Speaker 03:
And so first, Your Honors, as to the first point,

[00:01:18] Speaker 03:
only court to examine the pleading standard for listener claims is the Fifth Circuit in the Association of Americans Physicians case.

[00:01:25] Speaker 03:
And what it explains is that because of the bedrock principle that every reasonable inference must be given to the plaintiffs at the pleading stage, the requirement to specifically identify willing speakers does not arise until the merit stage.

[00:01:38] Speaker 03:
And what the court said there, what the Fifth Circuit said, Your Honor, was that as long as there are sufficient pleadings to give rise to that reasonable inference, that those willing speakers are out there,

[00:01:45] Speaker 03:
That is sufficient at the pleading state.

[00:01:47] Speaker 04:
And I just want to be clear that although there was a motion, a 12-B-1 motion, it was a 12-B-1 motion challenging the failure to plead standing as opposed to raising a factual challenge to standing.

[00:02:03] Speaker 04:
Is that correct?

[00:02:04] Speaker 04:
Yes, Your Honor.

[00:02:04] Speaker 02:
OK.

[00:02:05] Speaker 02:
And so, for example, the idea that there are lots of people who need to have this kind of diet so there would be a market for this wasn't challenged.

[00:02:13] Speaker 03:
No, Your Honor.

[00:02:14] Speaker 02:
Yeah.

[00:02:14] Speaker 03:
And as Your Honor is obviously aware, we explain this at length in the complaint where we expressly allege that 33 to 50 million Americans suffer from these conditions, that it is mainstream medical advice for doctors to advise these tens of millions of Americans to seek out low-fibonacci foods.

[00:02:31] Speaker 04:
Let me ask, so part of the issue here, right, is that, am I right that Ms.

[00:02:37] Speaker 04:
Prisbaki, she has claims against both the FDA and the USDA, is that correct?

[00:02:41] Speaker 04:
That is correct, yes.

[00:02:42] Speaker 04:
As to the USDA, is there any real dispute about the existence of a willing speaker, given that Gourmand Products wants to sell a labeled beef broth, but has been told it can't do so?

[00:02:57] Speaker 03:
Well, so we don't think there should be, Your Honor, but just to be honest about this, the District Court found that because Ms.

[00:03:05] Speaker 03:
Presbaki

[00:03:06] Speaker 03:
can find out that information online that that meant that the appellate speakers did not qualify as willing speakers.

[00:03:12] Speaker 04:
But assuming that there's a question, that may be mistaking the kind of informational injury that would be relevant in a mislabeling case, for example, with the kind of speech injury that you're talking about here.

[00:03:25] Speaker 04:
So assuming that that's a separate issue, but there's

[00:03:30] Speaker 04:
The question of whether there is a willing speaker as to the claims against the USDA, at least there is a party out there who wants to speak to her, correct?

[00:03:39] Speaker 03:
Yes, and there are parties to this lawsuit, Your Honor.

[00:03:41] Speaker 02:
It's just a district court disqualification.

[00:03:43] Speaker 02:
So I think I might have a different view of how this is, so I'd like to probe this for a second.

[00:03:48] Speaker 02:
So you started with the willing speakers.

[00:03:51] Speaker 02:
There are so many people that there must be a market for this.

[00:03:53] Speaker 02:
So if this was allowed, there would be other willing speakers.

[00:03:57] Speaker 02:
I find that pretty persuasive, but I do think, am I right that you need that argument for the USDA for the individual listener plaintiff?

[00:04:06] Speaker 02:
Because I don't see how she can say she at this point doesn't know about the beef broth.

[00:04:11] Speaker 02:
She knows the beef broth is low FODMAP.

[00:04:13] Speaker 02:
And so there's really, I understand that in general for other speakers, she wants it to be on the label instead of the website so she can go to the store and see it.

[00:04:19] Speaker 02:
But as to the particular speaker who already exists at the beef broth, do you have an argument that she's having an injury about the knowledge of the beef broth?

[00:04:27] Speaker 03:
Well, she does know about the beef broth, your honor.

[00:04:30] Speaker 03:
And what I will point out is that as the Supreme Court pointed out at length in footnote 15 in Virginia State Board of Pharmacy, it's up to the listeners and the speakers to decide the best method.

[00:04:40] Speaker 02:
I totally understand that.

[00:04:42] Speaker 02:
So for the new willing speakers, the first thing you started with, you're like, it really should be on the label.

[00:04:47] Speaker 02:
They shouldn't be have to resort to their website.

[00:04:49] Speaker 02:
That goes to the Virginia Board footnote.

[00:04:51] Speaker 02:
But at this point, is there an argument that your single plaintiff who already is a plaintiff with these people doesn't know about the beef broth, so it matters if it's on the label?

[00:05:00] Speaker 03:
So no, your honor, if this court were not to follow the Fifth Circuit's precedent and to only restrict the willing speaker allegations to the speaker appellants in this case, then she clearly knows about the beef broth.

[00:05:13] Speaker 03:
You're right, your honor.

[00:05:14] Speaker 03:
However, what I would point out is that there are many, many other willing speakers out there.

[00:05:18] Speaker 03:
She doesn't know all about them.

[00:05:19] Speaker 03:
And many of them, your honors, sell both low-FODMAP and non-low-FODMAP foods.

[00:05:23] Speaker 03:
And so she would not know.

[00:05:25] Speaker 03:
But you're right, if this court were

[00:05:27] Speaker 02:
Split from the Fifth Circuit, then I would agree with what you're saying Yeah, so it seems like for the USDA for you need for the listener theory You need this additional thing the Fifth Circuit has said is basically your point.

[00:05:38] Speaker 03:
I think or the listeners claim against USDA I believe that's correct.

[00:05:43] Speaker 03:
I will point out that we have specifically alleged in paragraphs 162 and 163 self-censorship by the speaker appellants and

[00:05:51] Speaker 02:
Right.

[00:05:51] Speaker 02:
They could have other products, but not the beef broth.

[00:05:53] Speaker 02:
So they might have it.

[00:05:54] Speaker 02:
So they, right.

[00:05:55] Speaker 02:
That's a fair point.

[00:05:56] Speaker 02:
So as to them, they might have other products that would be regulated by the USDA.

[00:06:00] Speaker 02:
Although I actually wondered if you alleged that, like you sort of lumped the products.

[00:06:05] Speaker 02:
I don't know what products they want to launch, whether they would be regulated by the USDA.

[00:06:09] Speaker 03:
Well, to be fair, I mean, as we explained earlier in the complaint, your honor, all but one of my client's products are governed by FDA.

[00:06:17] Speaker 03:
The USDA beef broth is kind of the exception.

[00:06:19] Speaker 03:
So I think it's clear from paragraphs 162 and 163, we allege that there would be more FDA governed products.

[00:06:26] Speaker 03:
I think it's fair to say that we don't expressly allege that one of them would also meet that USDA governing session.

[00:06:33] Speaker 04:
Is it the case that a listener's harm from a restriction on speech is solely tied to the receipt of the information that is being provided or can the

[00:06:43] Speaker 04:
harm or injury result from the restriction on one speaker?

[00:06:48] Speaker 04:
Can it be denial of receiving the speech at issue, even if there's some way to get the informational content through another?

[00:06:55] Speaker 04:
Would we make that analogy in the political context to say, as long as I could read the Times to find out about ex-person's political critiques of the existing regime, that it's fine to, I have no interest in receiving it directly from that person?

[00:07:09] Speaker 03:
No, Your Honor, as I think Your Honor is indicating, that's not how the First Amendment analysis works.

[00:07:15] Speaker 03:
The listeners get to decide what way is most useful for them.

[00:07:19] Speaker 03:
And it should be pointed out that this argument was made by the government, Virginia State Board of Pharmacy, as well as elsewhere, and expressly rejected by the Supreme Court.

[00:07:30] Speaker 03:
Where the consumer successfully challenged the ban on price advertising, the government argued that there were other ways to obtain that information, and that many of the consumers already knew aspects of that information.

[00:07:39] Speaker 03:
And the court says, that does not matter.

[00:07:41] Speaker 03:
When analyzing listener claims, you have to use the same logic as speaker claims.

[00:07:46] Speaker 03:
And then, of course, the Supreme Court gave a list of famous Supreme Court speaker decisions where

[00:07:51] Speaker 03:
the speaker could speak in other ways, it was still able to win because they weren't allowed to speak in their preferred manner.

[00:07:57] Speaker 04:
So as to the FDA claims, do you agree going to the listener issue?

[00:08:03] Speaker 04:
I think we understand your arguments as to the pleading requirements as to other things.

[00:08:08] Speaker 04:
Do you agree that Ms.

[00:08:10] Speaker 04:
Prisbaki can't rely on any

[00:08:16] Speaker 04:
on Gourmand's own speech or the existing products as a basis for any allegation of harm because, in fact, she is receiving that speech as it stands because Gourmand is already selling those products with the low food map labeling.

[00:08:31] Speaker 03:
I agree that it's a much closer call, Your Honor, because I do want to point out that people don't have perfect memories.

[00:08:37] Speaker 03:
And so here, we're only talking about one company.

[00:08:41] Speaker 03:
But I bet she I mean she as to that company she is getting their speech right now as on the FDA products correct Your honor is correct that as to the current products not governed by the self censorship then yes Mr. Spock he knows that those are low FOMA products, but as more and more companies You know if we were to win this case Start speaking you know no normal human being is gonna be able to keep all that all what is I'm sorry so

[00:09:08] Speaker 02:
If you persuade us about the self-censorship of the other willing speakers, like if we agree with the Fifth Circuit, then you would have, I still don't know how to say her name, but the individual plaintiffs claim for standing based on the listening, based on the self-censorship of both your client and other people who would enter the market as to both agencies.

[00:09:31] Speaker 02:
If we were to agree with you about that,

[00:09:33] Speaker 02:
Do we need to reach the standing of the company?

[00:09:36] Speaker 02:
Because aren't they all making the same claims?

[00:09:38] Speaker 02:
Do you need them all to have standing, or you really just need one of these plaintiffs to have standing?

[00:09:41] Speaker 03:
So you're right.

[00:09:42] Speaker 03:
We only really need one, Your Honor.

[00:09:43] Speaker 03:
And if we were up here on appeal from a marriage decision, I would agree that if you ruled in favor of Mr. Spocky, you wouldn't need to reach other issues.

[00:09:50] Speaker 03:
But because we're up here on a dismissal at the pleading stage, I think we probably do need a ruling on all of the claims.

[00:09:54] Speaker 02:
And why?

[00:09:55] Speaker 02:
Just so can you explain why?

[00:09:56] Speaker 03:
Well, because once we go back down, Your Honor, if we're fortunate enough to do that,

[00:10:03] Speaker 03:
we're allowed to plead in the alternative.

[00:10:04] Speaker 03:
We're allowed to bring different claims.

[00:10:05] Speaker 03:
And there's no guarantee that the district court will agree with us on the merits for any one of them.

[00:10:09] Speaker 03:
Although I do recognize, Your Honor, that the legal arguments are very similar.

[00:10:13] Speaker 03:
So I get where Your Honor is coming from.

[00:10:15] Speaker 03:
If Your Honor, I understand Your Honor's point.

[00:10:20] Speaker 03:
I think it's a fair point.

[00:10:22] Speaker 03:
We would ask that the dismissal be reversed on all of the claims.

[00:10:26] Speaker 03:
But I do understand what Your Honor is saying.

[00:10:28] Speaker 04:
I mean, I guess there's a pragmatic issue, which is like why what's, I mean, I think legally,

[00:10:34] Speaker 04:
these are parties who've had their claims dismissed, so they have a right to a ruling on the propriety of that having appealed, but the question on whether its overall impact on the case may be minimal.

[00:10:44] Speaker 04:
I think that why is it the case, you know, if it's okay if I ask about Gourmand,

[00:10:51] Speaker 04:
This is an odd case that most of the authorities that you're relying on to establish the standing to pursue a challenge to the enforcement of this law, usually they involve either new laws, that there has been a statement that the government intends to enforce them, or a concrete evidence of an intent to enforce.

[00:11:15] Speaker 04:
Here we have the fact that as to the FDA, setting aside the USDA issue, but as to the FDA, they have been successfully

[00:11:21] Speaker 04:
Marketing these products with a low food map labeling for some period of time So why doesn't that?

[00:11:28] Speaker 04:
Sort of why isn't that sufficient to say there's they're really not a realistic threat of enforcement Just that mere fact that they they've been doing this and there's been no enforcement for a period of time your honor I seem into my rebuttal time go ahead as long as we're asking you should answer.

[00:11:42] Speaker 03:
Thank you well I think I think it's important to recognize your honor that

[00:11:45] Speaker 03:
The FDA has expressly enforced against specific FODMAP sugars for using undefined nutrient content claims.

[00:11:53] Speaker 03:
And so both in our opening brief and in our reply, we point to the example of a cease and desist warning letter that was sent over the nutrient content claim, low lactose content.

[00:12:03] Speaker 03:
Well, Your Honor, lactose is a sugar, and not only that, it's a FODMAP sugar.

[00:12:06] Speaker 03:
It is a disaccharide, which is the D in FODMAP.

[00:12:10] Speaker 03:
And so, Your Honor, FDA is enforcing against

[00:12:13] Speaker 03:
very similar claims, they just have not yet enforced against FODMAP, and they could tomorrow.

[00:12:18] Speaker 03:
There's nothing stopping FDA from arresting my speaker clients tomorrow, but for our possible First Amendment process.

[00:12:24] Speaker 01:
Has there been any official disavowal of enforcement against low FODMAP?

[00:12:30] Speaker 03:
No, Your Honor, and of course, this touches on the holding from this court in Ellis over Stroh, where that was a substantial basis of this court's decision, where there, there wasn't self-centership like there is here.

[00:12:42] Speaker 03:
But even there, the court found that because it is a free speech claim, and because the government knew about the issue and did not disavow enforcement, that those were two important factors towards finding that there was standing, even though there had not yet been any self-censorship at all.

[00:12:59] Speaker 04:
I understand the arguments about the exhaustion obligation, and particularly as to the theory on why you wouldn't have to exhaust your facial challenges, but couldn't

[00:13:11] Speaker 04:
exhausting you know going through the process that is required under the statute to challenge the USDA's decision as to the beef broth be relevant even to your facial claim to the extent that the USDA could determine that it's not it doesn't have a problem with the low food map label in which case there's just no standing to pursue either a facial or an as applied claim here because you're there's no harm to your your client but no your honor because the regulations expressly mandate

[00:13:40] Speaker 03:
that the people involved in that agency review process have to follow the agency's own interpretation of the regulations?

[00:13:47] Speaker 04:
Well, and that's sort of what gets into the as applied issue and the question on whether in fact, you know, there's a dispute about whether the outcome of the process is preordained.

[00:13:55] Speaker 04:
Let's assume that we conclude there's some possibility that it's not preordained, that we're not certain that the outcome is preordained.

[00:14:04] Speaker 04:
So if that's what we conclude, wouldn't

[00:14:07] Speaker 04:
exhaustion be useful to the extent that it would be make clear whether you, in fact, have standing to pursue this claim, whether Gorman has standing to pursue its claims?

[00:14:18] Speaker 03:
So, if I may, 7 CFR 11.10B is the one that says that they have to follow the agency's interpretation of their own regulations.

[00:14:28] Speaker 03:
And so, but if that regulation didn't exist, Your Honor.

[00:14:31] Speaker 04:
Well, but I guess there's some dispute about whether low food map is a nutrient claim.

[00:14:36] Speaker 04:
I mean, that's the core issue here.

[00:14:39] Speaker 04:
Obviously, internally they've said they think it was, but that's the issue.

[00:14:43] Speaker 03:
Your Honor, I'm obviously happy to answer hypotheticals, but just so the record is clear, the agency's own interpretation of their own rules as stated in their guidance expressly and unequivocally say that when you characterize

[00:14:56] Speaker 03:
the level, using terms like low or high, of a nutrient, that is a nutrient content claim that is big.

[00:15:02] Speaker 04:
Right, but they don't say food.

[00:15:03] Speaker 04:
They don't specifically, in regulations, say a low food map, FODMAP claim is a nutrient claim.

[00:15:10] Speaker 04:
That much hasn't been taken into position, but it hasn't been.

[00:15:13] Speaker 03:
I apologize.

[00:15:14] Speaker 03:
I obviously don't mean to speak over your honor.

[00:15:17] Speaker 03:
The regulations, and especially the guidance, which is clear and unequivocal, say that all nutrient content claims are banned unless expressly defined.

[00:15:26] Speaker 03:
in the regulations.

[00:15:28] Speaker 03:
And so, Your Honor, that unequivocal guidance would have to be followed if my client had pursued an administrative appeal.

[00:15:35] Speaker 02:
Oh, sorry.

[00:15:36] Speaker 02:
Go for it.

[00:15:37] Speaker 02:
I'd like to ask this exhausting question maybe a little differently, or maybe a different exhausting question.

[00:15:41] Speaker 02:
So I understand there's cases that say a facial challenge doesn't really need to be exhausted before the agency when the facial challenge is to a statute.

[00:15:50] Speaker 02:
And I think the logic of that is, why go to an agency that can't change the statute?

[00:15:55] Speaker 02:
But do you have a case that says,

[00:15:56] Speaker 02:
You can't have a facial challenge to the agency about the facial constitutionality of a regulation, where maybe the facial challenge to the regulation would cause the agency to do something different with its regulations, which it does have control over.

[00:16:12] Speaker 03:
Well, so the direct answer to your question, Your Honor, is no, I don't have that case.

[00:16:17] Speaker 03:
But second of all, I do want to point out

[00:16:19] Speaker 03:
In terms of the agency changing their regulations, they'd have to go through notice and comment.

[00:16:23] Speaker 03:
They couldn't do that as part of an administrative appeal.

[00:16:26] Speaker 03:
The regulations are clear about that.

[00:16:30] Speaker 02:
So maybe this exhaustion obligation that the USDA has, does it clearly not contemplate that notice and comment and changing regulations is part of what could be a result of the exhaustion effort?

[00:16:44] Speaker 03:
Well, so, and I thought my friends did a great job explaining this on pages 32 and 33 of their brief.

[00:16:52] Speaker 03:
They go through the regulations where they point out that you officially apply, as the speaker appellants did.

[00:16:58] Speaker 03:
But then if you get denied, you appeal through one level of agency review, which the speaker appellants did not do.

[00:17:03] Speaker 03:
And then if you lose that appeal, there's one more level.

[00:17:06] Speaker 03:
Then after that, you can go to court.

[00:17:07] Speaker 03:
You go to the DC Circuit, usually.

[00:17:10] Speaker 03:
So there's not a requirement to seek out rulemaking.

[00:17:14] Speaker 03:
And, Your Honors, I'm reminded of the Supreme Court's decision in McLaughlin just last term, where the Court explained that because rulemaking is so lengthy and uncertain, it cannot be a requirement to bring a case.

[00:17:30] Speaker 02:
So, I mean, your argument is essentially that

[00:17:34] Speaker 02:
Maybe there's like a First Amendment exception to this exhaustion or something.

[00:17:37] Speaker 02:
Like if it's too long, your rights are violated too long in the meantime or something.

[00:17:41] Speaker 02:
I'm trying to understand.

[00:17:42] Speaker 03:
Perhaps that wasn't clear.

[00:17:44] Speaker 03:
So we think that under McBride, we meet all three factors.

[00:17:48] Speaker 03:
And there's only two that are in dispute, the collateral question factor and the futility question.

[00:17:54] Speaker 03:
And so just taking them in turn.

[00:17:55] Speaker 02:
Let's just for a second assume we don't agree with you about collateral.

[00:17:58] Speaker 02:
So I think we're mostly talking about futility or some other reason that it shouldn't be, I guess, futility.

[00:18:04] Speaker 03:
Right, so for futility, like I pointed out, you know, the unequivocal guidance says that this is a nutrient content claim that is banned by law.

[00:18:16] Speaker 03:
The regulations say that that has to be followed.

[00:18:18] Speaker 03:
Like, that's, in my view, you know, as futile as something can get, Your Honor.

[00:18:22] Speaker 02:
Unless somehow the idea that you bring, you say to the agency,

[00:18:27] Speaker 02:
I think this is violating my First Amendment rights and I think it doesn't make sense and all these people want to know this information and maybe they say oh well good point we should write another regulation like we do for gluten or whatever.

[00:18:37] Speaker 03:
Well I mean your honor I think does touch on an important point which is that you know every day of delay because we're talking about the First Amendment here is causing per se irreparable harm and so I do think there is some logic in what your honor is saying but I don't know of any support for it.

[00:18:55] Speaker 02:
Okay.

[00:18:56] Speaker 02:
Sorry.

[00:18:57] Speaker 02:
We've taken you over your time.

[00:18:57] Speaker 02:
I'll still give you three minutes for rebuttal, but let's hear from the government.

[00:19:09] Speaker 00:
Good morning.

[00:19:10] Speaker 00:
May it please the court, Laura Myron for the government.

[00:19:12] Speaker 00:
The district court correctly concluded that the complaint here should be dismissed on threshold grounds of sanding and exhaustion effectively because the constitutional question is not right for judicial review.

[00:19:25] Speaker 00:
The plaintiffs had the opportunity to amend their complaint.

[00:19:28] Speaker 00:
They chose not to do so, and this court should affirm based on the allegations in the complaint.

[00:19:33] Speaker 00:
I'd like to start with the exhaustion and the company's claims, if I may.

[00:19:40] Speaker 00:
I think important to this court's review is the position that we have made very clear in our brief and that I am standing as a representative of the agencies today to tell you that

[00:19:50] Speaker 00:
There has not been a determination by either agency that the term low FODMAP is an undefined nutrient content claim and therefore could not go forward on the label.

[00:20:00] Speaker 00:
As a- So why did the USDA reject the label?

[00:20:04] Speaker 00:
So this is on page 130 of the excerpts of record and it says specifically that the label application has been returned because they needed to remove all references to

[00:20:17] Speaker 00:
digestible, gut-loving, and FODMAP because, quote, FSIS regulations do not provide for structure function claims or medical claims.

[00:20:26] Speaker 00:
A similar note was provided on the second return of the label that the products that imply they're meant to treat a medical disease are considered medical foods and are not under FSIS jurisdiction.

[00:20:39] Speaker 00:
So I'm not suggesting that the agency has decided it is not a low FODMAP claim, simply that a final determination has not

[00:20:47] Speaker 00:
been made and that there is significant value in continuing to exhaust the administrative process in order- I'm confused about this though, because basically they are saying, we want to say low FODMAP.

[00:20:57] Speaker 02:
Low FODMAP is what they tried to say, and the agency said, you can't do this.

[00:21:01] Speaker 02:
So maybe the agency wrote the wrong thing.

[00:21:02] Speaker 02:
Is that what you're saying?

[00:21:03] Speaker 02:
It's not responsive or something, but they rejected the label.

[00:21:07] Speaker 02:
So how does that- Sure.

[00:21:09] Speaker 00:
We'll look around.

[00:21:10] Speaker 00:
So they haven't concluded the decision making about whether or not this particular term could

[00:21:15] Speaker 00:
could be allowed or not allowed on the label.

[00:21:17] Speaker 00:
And I think the point is that they initially flagged some other parts of the regulations that aren't the regulatory scheme challenged by plaintiffs here.

[00:21:26] Speaker 00:
The plaintiffs have an email from a mid-level official at the agency suggesting that it is an undefined nutrient content claim from USDA.

[00:21:34] Speaker 00:
And they changed their label and went forward with it without exhausting the administrative appeal process.

[00:21:42] Speaker 00:
This court is now being asked to excuse the failure to conclude the administrative process, which would, I think, inform a lot of the questions that you're asking.

[00:21:52] Speaker 00:
And specifically with respect to the futility question, there are reasons to think that this

[00:21:59] Speaker 00:
term low FODMAP might be allowed under the regulations, or might be disallowed for a reason other than that that plaintiffs have.

[00:22:06] Speaker 02:
It seems more likely that it would be disallowed for the reason that they're trying to say it would be disallowed, right?

[00:22:10] Speaker 02:
I mean, is there any reason to think it wouldn't be?

[00:22:13] Speaker 00:
Yes, and I'll give you a couple.

[00:22:14] Speaker 00:
Again, I'm not saying that it's not.

[00:22:17] Speaker 00:
I am simply saying that a decision has not been made.

[00:22:19] Speaker 00:
First, it doesn't expressly say on the face of the regulation that this is a nutrient content claim of the type that would not be allowed.

[00:22:30] Speaker 00:
I will point you to the gluten example.

[00:22:32] Speaker 00:
This is in our brief.

[00:22:33] Speaker 00:
But they say they have this allergy statute, and that's really why that one's different.

[00:22:39] Speaker 00:
No, it is true that the gluten-free term comes from a directive of Congress that says, please define the label term gluten-free and allow people to put it on the thing.

[00:22:50] Speaker 00:
But that's all the statute says.

[00:22:52] Speaker 00:
What the regulation says, and I think this is what we're relying on, is

[00:22:56] Speaker 00:
We are not defining the terms low gluten or very low gluten and we will consider those on a case by case basis to determine whether they are truthful and not misleading.

[00:23:06] Speaker 00:
That approach would be inconsistent with the way plaintiffs have understood the undefined nutrient content claim.

[00:23:12] Speaker 00:
If they're right, that all you need is something that would fall within, you know, it's a nutrient and therefore, you know, you can't put the term low on the label.

[00:23:22] Speaker 00:
like to address the lactose claim, although that goes to the FDA.

[00:23:27] Speaker 00:
And as products under FDA's jurisdiction rather than USDA's jurisdiction, they have pointed to a single warning letter in the 30 plus years that these regulations have been in effect, flagging the term low lactose as potentially an undefined nutrient content claim.

[00:23:44] Speaker 00:
That warning letter, as far as I understand, did not lead to an enforcement action by the agency.

[00:23:48] Speaker 00:
They have no other

[00:23:50] Speaker 00:
evidence that either FDA or USDA has considered the term low FODMAP, specifically either denied any other label applications or issued any other warning letters or taken any enforcement actions that would suggest that this particular term is prohibited under the regulations.

[00:24:08] Speaker 01:
Is the agency disavowing that it would enforce against low FODMAP?

[00:24:13] Speaker 00:
I'm not saying that.

[00:24:14] Speaker 00:
I'm saying it hasn't made a decision that the district court correctly concluded this.

[00:24:18] Speaker 01:
But there has been no official disavowal?

[00:24:20] Speaker 00:
No, Your Honor, the district court concluded that this suit was effectively premature.

[00:24:25] Speaker 00:
And all I'm saying is that the agency has not taken a position one way or the other.

[00:24:29] Speaker 04:
And just to be clear, you're not in a position today before us to disavow any intent to enforce as to this claim by the FDA, correct?

[00:24:38] Speaker 00:
Your Honor, this court acknowledged in Peace Ranch that an agency's refusal to disavow something is not itself sufficient to give rise

[00:24:47] Speaker 00:
to standing absent a otherwise credible threat of enforcement?

[00:24:52] Speaker 00:
And I think that speaks to some of the questions.

[00:24:54] Speaker 01:
Well, as alleged here, we do have the agency denying preapproval and then saying in consultation, the USC saying in consultation with the FDA, we're not going to approve, which would at least add some heft to the idea that this is not going to be approved and would be subject to an enforcement action coupled with the absence of a disavow.

[00:25:16] Speaker 00:
So that speaks to the USDA claim only, and we haven't challenged... There's an allegation that the USDA consulted with the FDA.

[00:25:26] Speaker 00:
I think it would be somewhat extraordinary for this court to conclude that a single sentence in a letter from a different agency that says, without reference to any officials of the agency or any decision-making, that that would give rise to a credible... Was it true?

[00:25:41] Speaker 00:
No, I'm not saying it isn't true, Your Honor.

[00:25:42] Speaker 00:
I'm just saying it's

[00:25:44] Speaker 00:
doesn't give rise to a substantial threat of enforcement, which is what this court has recognized and the Supreme Court has recognized is necessary in order to bring a pre-enforcement challenge.

[00:25:54] Speaker 02:
So the thing about that, though, is we have dry house, which in the First Amendment context says that if something is arguably prescribed and you're self-censoring,

[00:26:05] Speaker 02:
You have standing I mean I'm not sure if the pre-enforcement challenges that aren't about speech and self-censoring Help you unless are you pointing to one that is about self-censoring and and?

[00:26:18] Speaker 00:
First amendment so I just to be very clear.

[00:26:21] Speaker 00:
We're not challenging standing with respect to the USDA Claims we are only challenging the exhaustion failure to exhaust and the statutory requirement that you exhaust USDA claims we are challenging and

[00:26:32] Speaker 00:
And the district court resolved it in this way.

[00:26:33] Speaker 02:
But as to the individual, Ms.

[00:26:37] Speaker 02:
Prisbaki, you are challenging her standing, I think.

[00:26:40] Speaker 00:
With respect to the USDA.

[00:26:44] Speaker 00:
Sorry, with respect to the USDA.

[00:26:48] Speaker 00:
But the willing speaker standard is different.

[00:26:51] Speaker 00:
And this is this court's case in Johnson, in which the court said specifically that to allege an actual injury

[00:26:58] Speaker 00:
you must have a willing speaker to give that information.

[00:27:01] Speaker 00:
And I think I understood

[00:27:03] Speaker 00:
my friend on the other side, to agree that she does not have an injury with respect to the beef broth because she has the information.

[00:27:10] Speaker 02:
But if we think we agree with the Fifth Circuit that it's just logical that with this many people with low FODMAP dietary issues, there would be a market if you would allow it, then I think we could get past this willing speaker thing and say that there are self-censoring willing speakers all over the place who want to have this label.

[00:27:29] Speaker 00:
So Your Honor, I guess I would point you to the specifics of the complaint here.

[00:27:33] Speaker 00:
And what the complaint says, and this is the total of the allegations made by the plaintiff, is many food businesses would make more low FODMAP foods if they were allowed to tell customers on their food labels that they were indeed low FODMAP.

[00:27:47] Speaker 00:
And that is effectively an argument that the market would behave differently if the market were regulated differently.

[00:27:52] Speaker 00:
They haven't pointed to any other markets in other countries that would

[00:27:57] Speaker 00:
you know, demonstrate evidence that in fact there are willing speakers out there.

[00:28:00] Speaker 00:
I thought they actually had.

[00:28:01] Speaker 00:
Don't they say Australia has this?

[00:28:03] Speaker 00:
They say in their brief that there are markets in other countries.

[00:28:06] Speaker 00:
But in the complaint, which is what, you know, this comes to this court on a standing, you must take the complaint as it comes to the court.

[00:28:14] Speaker 00:
And again, as I mentioned at the outset, they were offered the opportunity to amend their complaint and declined to do so.

[00:28:20] Speaker 00:
They say there is a university that certifies products as low FODMAP.

[00:28:25] Speaker 00:
They have made no allegations about

[00:28:27] Speaker 00:
products in other markets, about consumers in other markets, about anything that would suggest that if the regulation were different that the market would behave differently other than to say.

[00:28:38] Speaker 00:
Of course, the market would behave differently if it were regulated differently.

[00:28:43] Speaker 02:
So it would be a stronger allegation if they pointed to Australia.

[00:28:46] Speaker 02:
But I'm still struggling with why the allegation they make.

[00:28:49] Speaker 02:
I mean, if it was like there were three people with this thing and it's a rare condition, that would be one thing.

[00:28:53] Speaker 02:
But they're alleging that there's a lot of customers who care about this.

[00:28:56] Speaker 02:
And to me, that actually does suggest that if it was regulated differently, there would be a different market.

[00:29:03] Speaker 00:
Your Honor, this Court has understood in the standing

[00:29:07] Speaker 00:
context that an actual injury is necessary to demonstrate a listener standing and that there must be identified a willing speaker.

[00:29:20] Speaker 00:
standing inquiry stage.

[00:29:22] Speaker 00:
It is not a question just for trial, as the Fifth Circuit has understood.

[00:29:25] Speaker 04:
Well, sorry, where did they say that when evaluating a claim on its face, there's a sort of specialized, you know, we go beyond the plausible.

[00:29:36] Speaker 04:
Do you agree that we generally apply the plausibility standard to evaluate the allegations that support standing if you're raising a facial challenge to the allegations of standing?

[00:29:46] Speaker 00:
Yes, but I think you're also looking for specific facts.

[00:29:51] Speaker 00:
This is a rule eight question.

[00:29:52] Speaker 00:
You must plead specific facts that would support your conclusion that there is an actual injury.

[00:29:58] Speaker 00:
And that injury in this context is that there are willing speakers who are being chilled by the regulation.

[00:30:05] Speaker 00:
I also would note that, as I said, there have been, as far as we know, no other submissions to USDA for products that would include the label low FODMAPs that have been rejected.

[00:30:16] Speaker 00:
The FDA has never flagged the use of the term as problematic, and neither has USDA.

[00:30:23] Speaker 04:
Well, presumably it's not being used on USDA-governed products because they would have had to.

[00:30:30] Speaker 04:
Is there any evidence of the USDA's approval of that?

[00:30:34] Speaker 00:
No, as far as I know, no evidence of any request to use the term.

[00:30:38] Speaker 00:
That would be subject to USDA's consideration.

[00:30:41] Speaker 02:
Sorry, just to make sure I didn't miss something.

[00:30:43] Speaker 02:
Were you saying that we have a case that already says that the complaint has to identify the specific willing speaker?

[00:30:50] Speaker 00:
I am saying that both Johnson and in Tingley, and in Kirchmeyer, which is a more recent iteration of the willing speaker, that the court has said

[00:31:01] Speaker 00:
There must be a speaker who is willing to convey the information.

[00:31:04] Speaker 00:
It has not said that we assume that there would be speakers.

[00:31:09] Speaker 00:
It says to establish actual injury, you must identify a willing speaker.

[00:31:14] Speaker 04:
Does it say there must be a willing speaker?

[00:31:20] Speaker 04:
Does it say you must identify?

[00:31:22] Speaker 00:
Sorry, I'm just finding the pin site for you.

[00:31:25] Speaker 00:
195.

[00:31:27] Speaker 00:
To establish actual injury from a restriction of the right to receive information, there must be a speaker who is willing to convey the information.

[00:31:34] Speaker 04:
And they've alleged that, correct?

[00:31:36] Speaker 04:
I mean, they've alleged that they haven't said this is the speaker.

[00:31:40] Speaker 04:
They've alleged, though, that there are multiple speakers who are willing to provide the information.

[00:31:45] Speaker 04:
And we're here on a facial challenge to the sufficiency of their allegations of standing.

[00:31:51] Speaker 00:
Look, Your Honor, this is a standing question, and it is at the motion to dismiss stage.

[00:31:57] Speaker 00:
But the basics of rule eight require that you must plead facts that give rise to your claim.

[00:32:05] Speaker 00:
And the most they have is a suggestion in their complaint, and this is at ER 197, that businesses would change their behavior if the market were regulated differently and

[00:32:18] Speaker 02:
evidence that other markets operate differently

[00:32:33] Speaker 02:
that someone would start labeling to respond to that?

[00:32:37] Speaker 02:
Is your argument, like, actually, FODMAPs aren't a thing?

[00:32:42] Speaker 02:
Why wouldn't it?

[00:32:43] Speaker 02:
Explain why the inference isn't reasonable.

[00:32:45] Speaker 00:
Well, Your Honor, I think it also goes back to what we were discussing earlier, which is that there hasn't been a determination by the agency that it is, in fact, prohibited.

[00:32:54] Speaker 00:
There hasn't, you know, the products in this case... It required preapproval and denied it.

[00:32:59] Speaker 00:
But the products in this case that the company is selling have been on the market for a number of years.

[00:33:04] Speaker 00:
They haven't identified any warning that they have received from the agency.

[00:33:10] Speaker 00:
They haven't identified any other products that have been subject to the same warning letter.

[00:33:14] Speaker 00:
And so I don't think it is fair to draw the inference that, of course, if this were different, that the market would behave differently, partly because that is insufficient in terms of the factual development.

[00:33:27] Speaker 00:
But also because I think as where we started, there hasn't been a determination that this is prohibited by the regulation.

[00:33:34] Speaker 00:
And in fact, plaintiff, the company have been selling their products on the market for a number of years.

[00:33:39] Speaker 00:
And so I don't think you can sort of simply assume that it is the regulation that is standing in the way of a dramatic change in the market's behavior.

[00:33:50] Speaker 00:
And certainly, they haven't alleged any facts that would allow a court to further develop that conclusion.

[00:34:00] Speaker 01:
Isn't Gorman itself alleging that it would develop more products but has been chilled from doing so because it can't label them FODMAP?

[00:34:09] Speaker 00:
It has said that.

[00:34:10] Speaker 00:
I mean, it's somewhat in tension with the decision not to change the label on any of the products it's continuing to sell.

[00:34:16] Speaker 00:
And, you know, I don't think rises to the level of a concrete plan to violate the statute that this court has required in other standing cases.

[00:34:24] Speaker 00:
Oh, censorship.

[00:34:27] Speaker 00:
But even in those cases, the court has required a concrete plan to violate the statute that you've chosen not to engage in, and has also required this similar substantial risk of enforcement.

[00:34:40] Speaker 00:
And I'm happy to address why we don't think that that's been demonstrated here.

[00:34:44] Speaker 00:
But I see I'm over time, and I know we've discussed that.

[00:34:48] Speaker 02:
I guess, could I ask whether it's your position that the exhaustion include, I mean, okay, I guess you're saying we don't even know if it's, but let's just assume for a second that we do think that this regulation prohibits low FODMAP labels.

[00:35:04] Speaker 02:
Would it still need to be exhausted because you think exhaustion includes trying to ask for different regulation or change of regulation or what is the limit of what the exhaustion obligation is?

[00:35:14] Speaker 00:
No, I think if that were the case, if you assumed that, that you would still need to exhaust because it is, as we've discussed, not collateral and that it isn't, and I believe it's understood to be futility, but the actual term is that resolution would not serve the purposes of exhaustion.

[00:35:33] Speaker 00:
I think under those circumstances, resolution of the claim by the agency would still serve the purposes of exhaustion because it would allow the agency to develop

[00:35:41] Speaker 00:
further explanation of why this particular term should be considered an undefined nutrient content claim.

[00:35:48] Speaker 00:
I understand that these kinds of claims are often subject to intermediate scrutiny, so it may speak to the agency's reasons for the regulation and what purposes it's serving.

[00:36:00] Speaker 01:
You're saying in the administrative exhaustion process, the agency would be able to explain essentially its First Amendment defense?

[00:36:09] Speaker 01:
Because I thought the question was a little different about whether in the administrative exhaustion process contemplated by the agency is someone who seeks pre-approval is denied under regulation.

[00:36:25] Speaker 01:
Are they supposed to say as part of that administrative exhaustion process, we want you to change the rule because it's unconstitutional?

[00:36:34] Speaker 01:
Is that something that can actually be exhausted through the process you're saying should have been used here?

[00:36:39] Speaker 00:
Maybe I misunderstood the question.

[00:36:41] Speaker 00:
I apologize.

[00:36:42] Speaker 00:
I'm not saying that they are required to go through the process that would require them to petition the agency to add low FODMAP as a defined nutrient content claim.

[00:36:53] Speaker 01:
You're not saying they have to engage in a petition for rulemaking.

[00:36:56] Speaker 00:
No.

[00:36:56] Speaker 00:
I am saying they have not exhausted their administrative appeals.

[00:36:59] Speaker 00:
The statute requires them to do so.

[00:37:01] Speaker 00:
And this court's standard for when exhaustion should be excused has not been met.

[00:37:06] Speaker 04:
And could they pursue that at this time?

[00:37:09] Speaker 00:
I don't see why not.

[00:37:10] Speaker 00:
I mean, they presumably need to submit a new label for approval, but I don't see why they wouldn't be able to receive a determination from the agency and appeal.

[00:37:22] Speaker 04:
There's nothing, there's no bar that would say stop them.

[00:37:25] Speaker 00:
As far as I know, there's not?

[00:37:28] Speaker 01:
So I understand you're not taking the position that they would have to engage in a petition for rulemaking.

[00:37:36] Speaker 01:
In the administrative exhaustion process,

[00:37:41] Speaker 01:
Would they have to say, would they just have to process their claim to get this one specific label approved or not approved?

[00:37:52] Speaker 01:
Or would they actually have to say, if the reason why you're denying me approval is because your rule is unconstitutional, we want you to change?

[00:37:59] Speaker 01:
I mean, do they have to raise what they would raise in the rulemaking process in the

[00:38:05] Speaker 01:
as such a more adjudicatory pre-approval process?

[00:38:09] Speaker 00:
I'm not sure, Your Honor.

[00:38:10] Speaker 00:
I mean, I don't think that question is presented by this case, but I think it gets to... Are they bringing a facial challenge to the rule?

[00:38:16] Speaker 01:
So I guess I'm saying, to the extent that... I mean, is a facial challenge to the rule even something that the agency would entertain in the administrative exhaustion?

[00:38:24] Speaker 01:
Right.

[00:38:24] Speaker 00:
So I guess what I would say is that administrative exhaustion here is relevant and should not be excused because there is a

[00:38:31] Speaker 00:
reasonable possibility that at the conclusion of the process, their claim will not be denied or would be denied on a different basis that would inform their constitutional claim and that it was correct for the district court to not excuse the undisputed requirement that Congress put in place that you exhaust administrative appeals before you bring a claim because the administrative

[00:38:57] Speaker 00:
appeals process would inform the court's resolution of the constitutional question.

[00:39:01] Speaker 02:
Can I ask about this?

[00:39:02] Speaker 02:
So you're saying something that I also think the district court said, which is sort of the exhaustion steps could help us with further litigation by informing what is going to happen in further litigation.

[00:39:13] Speaker 02:
I had understood before that futility for exhaustion was more about is there any chance you can actually get relief from the agency, not that it helps further litigation in court.

[00:39:21] Speaker 02:
Do you have a case that says

[00:39:23] Speaker 02:
When we think about exhaustion, we should think about whether it would help litigation in court later.

[00:39:27] Speaker 00:
Well, I guess I would say, I think there are lots of cases that say that even if the agency cannot resolve your constitutional question, you still have to present it to the agency before you come to court.

[00:39:40] Speaker 02:
That is not a... And because it will inform the later litigation or something.

[00:39:46] Speaker 00:
Yeah, I think that's basically thunder basin in all the cases that follow in that vein.

[00:39:52] Speaker 00:
But I think the argument that I'm making is more narrow, which is this court said in Murillo v. Matthews that if exhaustion would mean that the court doesn't need to decide the constitutional question because the administrative appeals process might be resolved in such a way that the constitutional question is addressed, that that undermines an argument that exhaustion should be excused.

[00:40:16] Speaker 00:
And that's what we're saying, that there is reason to think that the administrative appeal process here

[00:40:21] Speaker 00:
would allow for a different resolution of the claim that plaintiffs are making and would change the contours of the constitutional question that the court is being asked to decide.

[00:40:30] Speaker 00:
And that's why exhaustion should not be excused.

[00:40:35] Speaker 02:
OK.

[00:40:35] Speaker 02:
Thank you very much for the arguments.

[00:40:38] Speaker 02:
I can't remember.

[00:40:39] Speaker 02:
Let's put four minutes on the clock, please, to be fair.

[00:40:45] Speaker 03:
Thank you, Your Honors.

[00:40:47] Speaker 03:
Unless the court has more questions about the listener claim, which I think the court understands, I'll just focus on four quick points about the speaker claims.

[00:40:53] Speaker 03:
First, to answer Judge Sung's question, the regulation I mentioned earlier that directs that they have to follow the agency's interpretation of the regulations does not have an exception for constitutional claims.

[00:41:04] Speaker 03:
So there's really no way they could do that, Your Honor, based on the express language of the regulation.

[00:41:09] Speaker 03:
Second, Your Honor, my client talked about how there's that one low lactose letter.

[00:41:15] Speaker 03:
there are hundreds and possibly thousands of letters that directly contradict my friend's argument.

[00:41:20] Speaker 03:
And remember, their argument is that even though on these certain categories of nutrients are clearly nutrient content claims when used low or high, that a subset isn't necessarily a nutrient content claim.

[00:41:31] Speaker 03:
And FDA has literally sent out hundreds of letters in that precise scenario for hundreds of different subset nutrients.

[00:41:38] Speaker 03:
And so unless all of those are wrong, Your Honor, then my friend is also wrong.

[00:41:43] Speaker 03:
Additionally, your honors, I'd just like to point out, going back to my point about the express language used by USDA in its own guidance, I quote, and this is on page 73 of the USDA labeling guide that we mentioned in the briefing, a food label may not bear an express or implied claim that characterizes the level of a nutrient in a food, then in parentheses it says nutrient content claim, unless the term has been defined by regulations.

[00:42:08] Speaker 03:
I think when you take that express plain language and you add

[00:42:11] Speaker 03:
the regulation that says they have to follow it.

[00:42:13] Speaker 03:
I don't see how it's not futile, Your Honor.

[00:42:16] Speaker 03:
And then, Your Honor, I'd also like to point out one last thing, which, and I know the court might not be sympathetic to the collateral argument, but what I would like to quickly point out is that in McBride, in the collateral section, it cites to Johnson v. Shalala, which in turn talks about Bowen v. City of New York, a Supreme Court case.

[00:42:36] Speaker 03:
And both this court and Johnson v. Shalala

[00:42:38] Speaker 03:
And the Supreme Court in Bowen v. City of New York dealt with situations that I think directly defeats my friend's collateral argument.

[00:42:46] Speaker 03:
Both of those had to do with claims, one social security, one disability.

[00:42:49] Speaker 03:
Both dealt with situations where if the plaintiff won the case, they would get that claim.

[00:42:53] Speaker 03:
And in both situations, this court and the Supreme Court said that doesn't mean it's not collateral.

[00:42:57] Speaker 03:
What matters is that they were challenging something that the agency was doing.

[00:43:01] Speaker 03:
And if that ends up leading to the relief, that doesn't make it collateral.

[00:43:04] Speaker 03:
It's only collateral if, for example, we were here saying,

[00:43:06] Speaker 03:
We'd like your honors to instruct us to grant us, you know, label pre-approval, but that's not what we're doing.

[00:43:11] Speaker 03:
We're saying they just can't say that honest language is banned when it's not on this pre-approved list.

[00:43:16] Speaker 03:
And so we think under Johnson v. Shalala and Bowen v. City of New York that we have met the collateral prong of the problem.

[00:43:22] Speaker 02:
And how do you respond to this Thunder Basin idea?

[00:43:25] Speaker 03:
I don't think it defeats it, Your Honor.

[00:43:29] Speaker 03:
I think both the New York

[00:43:31] Speaker 03:
The Supreme Court's precedent in Bowen and this court's precedent in Johnson v. Shalala are directly on point.

[00:43:38] Speaker 03:
And so I would just direct the court to those cases.

[00:43:42] Speaker 02:
Thank you.

[00:43:43] Speaker 02:
Thank you very much, both sides, for the arguments.

[00:43:46] Speaker 02:
This case is submitted.

[00:43:48] Speaker 02:
And we are going to, we're adjourned for now.

[00:43:51] Speaker 02:
We're going to conference.

[00:43:52] Speaker 02:
I think some of our law clerks may talk to the students and then we'll come back up.

[00:43:56] Speaker 02:
Thank you, everyone.