[00:00:18] Speaker 02:
for Appellants Nico Pure and Elle, and Ms.

[00:00:21] Speaker 02:
Powell for the Appellees.

[00:00:26] Speaker 02:
Good afternoon.

[00:00:28] Speaker 00:
Good afternoon, Your Honor.

[00:00:30] Speaker 00:
Miguel Estrada for the Appellants.

[00:00:32] Speaker 00:
I will address the modified risk issue.

[00:00:35] Speaker 00:
Co-Council will address the remaining two issues on behalf of the Appellants.

[00:00:39] Speaker 00:
Now, under current law, it is perfectly legal to sell e-cigarettes and vaping products

[00:00:45] Speaker 00:
for any recreational purpose that appeals to the user.

[00:00:51] Speaker 00:
But it is now unlawful for manufacturers of these products and for nobody else to say truthfully that their products do not contain certain substances, such as tar or ash, or that they are smokeless, say, unlike cigarettes, or indeed to repeat the very statements that the FDA and Commissioner Gottlieb, the head of the agency,

[00:01:14] Speaker 00:
have repeatedly made themselves.

[00:01:17] Speaker 00:
In fact, in this very rulemaking, in this very rulemaking, the deeming rule, the FDA says, quote, that it believes that the inhalation of nicotine, nicotine without the products of combustion, is less of a risk to the user than the inhalation of nicotine delivered by smoke from combusted products.

[00:01:35] Speaker 00:
In this rulemaking, the FDA said, and I quote, the FDA agrees that the use of e-cigarettes actually ends is likely less hazardous for an individual user than the continued smoking of traditional cigarettes.

[00:01:50] Speaker 00:
And in this very rulemaking,

[00:01:52] Speaker 00:
The FDA says that it expressly recognized, and I'm quoting recognized, that switching completely from combusted cigarettes to e-cigarettes may reduce the risk of tobacco-related disease for individuals.

[00:02:06] Speaker 00:
Those are quotes from this very rulemaking.

[00:02:08] Speaker 00:
Similarly, the head of the agency, just one more, said in a speech just a couple of months ago, we, the agency, believe that fully transitioning to ends can reduce the morbidity and mortality associated with tobacco use.

[00:02:21] Speaker 00:
The public health authorities in England and Canada have said the same things to the public repeatedly, but we are precluded from saying the same truthful information to the public, although we are not precluded from selling the product to the public.

[00:02:36] Speaker 00:
Under conventional First Amendment doctrine, that ought to be subject to strict scrutiny, but in our view, it fails even intermediate scrutiny under Sen.

[00:02:44] Speaker 00:
Paul Hudson, both as to prompts three and four.

[00:02:48] Speaker 00:
I'm sorry, Judge Pillar, I think I interrupted a question you wanted to pose.

[00:02:52] Speaker 04:
Mr. Estrada, because this is a pre-enforcement challenge, it's a little bit unclear what conduct exactly your clients are seeking to engage in and therefore what exactly we need to review.

[00:03:11] Speaker 04:
Is it your position that if someone associated with one of your client companies wanted to speak on a panel about the relative risks of e-cigarettes or write an op-ed, that they would be restricted in doing so?

[00:03:28] Speaker 04:
Or what exactly, which conduct should we consider?

[00:03:32] Speaker 00:
Which speech should we consider?

[00:03:33] Speaker 00:
Yeah, I understand your question, and I think this actually sort of springs from an argument that the government tried to make in page 37 of its brief.

[00:03:40] Speaker 00:
which frankly I consider a bad merits argument wrapped in a frivolous rightness objection.

[00:03:46] Speaker 00:
Here is the issue.

[00:03:47] Speaker 00:
We filed two different complaints in district court and brief summary judgment.

[00:03:52] Speaker 00:
And we made very clear in the briefing of the summary judgment papers that Nikar Por had identified in declarations specific statements that he had made and would continue to would like to make

[00:04:05] Speaker 00:
Including A, that is products are smokeless.

[00:04:08] Speaker 00:
B, that is products do not contain tar ash or many of the products found in combusted cigarettes.

[00:04:17] Speaker 00:
C, that the products do not contain diacetyl, acetyl,

[00:04:21] Speaker 00:
or other allergens, and four, you know, the stuff that I actually just opened with, the very things about comparative risks that the FDA repeatedly have said itself.

[00:04:33] Speaker 00:
Now, we put the Stamler, you know, declaration, and we have said that the essence of our challenge, and this is why this pre-enforcement argument is somewhat of a red herring, is that having to ask permission is a First Amendment injury itself.

[00:04:47] Speaker 04:
I understand that that's your sort of leading position.

[00:04:51] Speaker 04:
And I think the difficulty is, you know, you start with the premise that these are lawfully sold and used and that the only restriction is a restriction on what can be said.

[00:05:03] Speaker 04:
But under the Tobacco Control Act, I mean, isn't that just a product of the time delay for the modified risk product clearance and or the tobacco product?

[00:05:15] Speaker 04:
market review.

[00:05:17] Speaker 04:
So if you look at the baseline as you can't sell a tobacco product, be it a modified risk product or a conventional tobacco product under this

[00:05:29] Speaker 04:
act unless and until there's been pre-market review, then that's a different baseline from the one that you started from.

[00:05:36] Speaker 00:
Okay.

[00:05:37] Speaker 00:
Judge Pillard, I understand again, you know, the question, and this is, you know, to the extent you want to view it in that light, to put it harshly, it's a problem of violating, you know,

[00:05:47] Speaker 00:
First Amendment that the agency itself made.

[00:05:50] Speaker 00:
If the agency has said, we considered these products inherently unsafe, we will make them illegal to sell to the public.

[00:05:59] Speaker 00:
Then the claim of any speech issue would fail under the first step of Central Hudson because the product would not be legal to sell.

[00:06:08] Speaker 00:
Having said, we will give you several years to continue selling the product under the pre-market aspect of this, then the product is legal to sell under Central Hudson.

[00:06:17] Speaker 00:
And the only question under the speech issue here is whether the government can meet

[00:06:25] Speaker 00:
prongs three and four of the justifications that it offers.

[00:06:30] Speaker 00:
Now, this brings me to the other of the favorite red herrings that the government likes to use, this whole issue of the drug question, right?

[00:06:39] Speaker 00:
And that actually has two components.

[00:06:42] Speaker 00:
If you posit a drug-making company

[00:06:45] Speaker 00:
that is on the verge of coming out with a new compound that has never been on the market, and that it wants to offer for a therapeutic intended use.

[00:06:54] Speaker 00:
Say it's going to cure cancer, and it's saying virus names, or what have you, but the compound has never been on the market.

[00:07:00] Speaker 00:
The FDA would be entitled to say that a speech about that product intended for use for the cure for cancer fails at Central Hudson's step one, because the product is not on the market, it's not legal to sell.

[00:07:13] Speaker 00:
Now, that's case one.

[00:07:15] Speaker 00:
Case two is Pearson versus Shalala and Thomason versus Western States in the Supreme Court, where products are lawful to sell, and what the FDA wants to do is to restrict the speech about them.

[00:07:27] Speaker 00:
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.

[00:07:38] Speaker 00:
And so the near fact that government could have changed the law or could have arranged the law to restrict the sale doesn't really avail the government once the sale is lawful and what the government has chose is a pure naked speech restriction.

[00:07:53] Speaker 04:
But this is a little bit different because it's only during this grace period or this transition period that the sale is lawful.

[00:08:01] Speaker 00:
Yeah, but you cannot suspend the First Amendment for two years.

[00:08:04] Speaker 04:
So is that the only time that your clients are concerned about is up until the effective date of the regulation?

[00:08:13] Speaker 00:
Well, I mean, we expect that the products will continue to be lawful.

[00:08:17] Speaker 00:
We don't know what the outcome of the process will be.

[00:08:19] Speaker 00:
Exactly.

[00:08:20] Speaker 00:
There's this other issue about the APA and whether the pre-market issue also will continue to sort of stand as the agency sees it.

[00:08:30] Speaker 00:
Council will deal with some of those issues.

[00:08:33] Speaker 00:
But my point to you is that the notion that the government has at the state or local level

[00:08:40] Speaker 00:
Some unlimited power to make things unlawful doesn't include the lesser power to restrict speech.

[00:08:47] Speaker 04:
I fully appreciate your argument.

[00:08:49] Speaker 04:
And I do think the government has clearly put itself in a very difficult position by asserting on the one hand the, you know,

[00:08:56] Speaker 04:
you can't unring this bell, and how addictive these products are, and how they really can't be safely marketed, and on the other hand saying, and let's give all this extra time for them to be sold without restriction.

[00:09:10] Speaker 00:
Well, if I could say something that is even worse for the government here, and that is how its justifications do not directly advance what it's trying to do, and the lack of fit even under central Hudson as applied by the modern court.

[00:09:24] Speaker 00:
On the question of directly advance, keep in mind that if you view this as trying to prevent deception, this is vastly overbroad because it's trying to sort of prevent speech even that is demonstrably true.

[00:09:42] Speaker 00:
Sutter and the Supreme Court said that you could not prevent, say, these graphics just in the expectations that some of them could prove to be misleading after the fact.

[00:09:52] Speaker 00:
But more fundamentally, there's an aspect of the statute that is a real first amendment problem for the government.

[00:10:01] Speaker 00:
And it is this.

[00:10:02] Speaker 00:
I could get every federal judge in this country to agree that everything that I intend to say in every John and Tittle is absolutely the gospel truth.

[00:10:13] Speaker 00:
And the government would be required to deny my application of a modified risk product if, in the words of the statute, the FDA concludes that the speech will not benefit the health of the population as a whole.

[00:10:27] Speaker 00:
Now, think about this.

[00:10:29] Speaker 00:
In what world does the government get to deny speech to a citizen that is absolutely truthful on the theory that it is not in the public interest?

[00:10:37] Speaker 04:
I believe the government's position is, and this applies also to your pointing out that the FDA gets to say certain things and why don't you get to say those same things, their position really has to do with context.

[00:10:51] Speaker 04:
And we all know, I mean, you go into the supermarket and the lemonade says it's nonfat.

[00:10:56] Speaker 04:
And the butter says, no sugar.

[00:10:58] Speaker 04:
And I think certain consumers can think, oh, then that's a diet product that I can consume.

[00:11:04] Speaker 04:
And so what they're looking at is how the reasonable consumer would understand a modified risk product.

[00:11:11] Speaker 04:
And would they think that this is something that I can do that's not safe?

[00:11:15] Speaker 00:
No.

[00:11:16] Speaker 00:
That's actually not the case.

[00:11:17] Speaker 00:
Because the answer to the, when we say it, everybody will understand that it's not misleading.

[00:11:24] Speaker 00:
But when you say it, you're a liar.

[00:11:26] Speaker 04:
But they say it with a lot of context.

[00:11:28] Speaker 04:
If you go through the record and look at where they say the things that you say you want to say, they say them hedged right there with the qualifications.

[00:11:37] Speaker 00:
Judge Pillar, sorry to interrupt, but the answer to the point is both Thompson versus Western states and Pearson versus Shalala.

[00:11:45] Speaker 00:
Thompson actually dealt with this question at page 376, where it says, even if the government did argue that it has an interest in preventing misleading statements, you could deal with that by requiring each compounded drug to be labeled with a warning that the FDA has not approved this and that there are risks and yada, yada, yada.

[00:12:04] Speaker 00:
And in Pearson versus Shalala, the court expressly dealt with the question how disclaimers are a preferable way to deal with these issues then.

[00:12:14] Speaker 00:
So if your objection is context, context can be provided with a disclaimer, not with blanket suppression of truthful speech.

[00:12:23] Speaker 04:
As to the second point, you know, the whole question... And would your position take down any of the pre-clearance regime for tobacco products modified or not?

[00:12:37] Speaker 04:
I'd just say you can't have a pre-clearance regime.

[00:12:40] Speaker 00:
Well, I think that any, I mean, you know, the point I was gonna get to on the second point is that any pro-clearance, you know, regime that says that truthful speech can be banned if the government thinks it's not in the public interest ought to trouble any judge in this country, right?

[00:12:55] Speaker 00:
And, you know, that aspect of the statute, which is, as I said to you, 387KG1AB,

[00:13:05] Speaker 00:
It does say that the government basically gets to conclude that truthful speech cannot be uttered if it will cause people, for example, to start using a tobacco product because that is bad for the public health.

[00:13:18] Speaker 00:
Now, I will concede that this is an appropriate concern for a public health authority.

[00:13:24] Speaker 00:
It's just not one that can be furthered by blanket prohibition on speech.

[00:13:28] Speaker 00:
And, you know, just to translate what this does in the words of the Supreme Court is the banning of truthful speech because of our concern that people, when they hear the information, will make bad decisions with it.

[00:13:40] Speaker 00:
And both in Thompson and in Sorrell, the Supreme Court says the governments don't get to do that.

[00:13:46] Speaker 00:
If I could just say one word on the fourth prong.

[00:13:51] Speaker 00:
of central Hudson is that although the government likes to go back to the halcyon days of 1980, when we're all lived in the, you know, happy days of the current administration and central Hudson was thought to be a very diluted test.

[00:14:08] Speaker 00:
In the modern age, what the Supreme Court has said, as it did in Thompson, an FDA case, is that if the government can achieve its interests in a manner that does not restrict speech or restricts less speech, the government must do so.

[00:14:24] Speaker 03:
Now, the government did that in an FDA case.

[00:14:27] Speaker 00:
This is Thompson v. Western States, 535 U.S.

[00:14:30] Speaker 00:
at page 371, and it was an FDA.

[00:14:34] Speaker 00:
It has many of the same considerations that the government urges here, and it is absolutely beyond question that there are many things that the government can use here that will not involve the banning of protected, truthful, non-disleading speech, including uttering the very same things that public health authorities

[00:14:51] Speaker 00:
in G7 countries themselves utter, which if the government thought might be misleading in the lips of others, could be cautioned dealing with cautionary language as Pearson indicated.

[00:15:03] Speaker 04:
Let me ask you, Mr. Estrada.

[00:15:07] Speaker 04:
assuming that we were under the rule that had taken the pre-clearance for modified risk products regime had taken effect.

[00:15:18] Speaker 04:
And the question is how do we understand the, and here I would limit it to let's say a labeling or an advertising claim.

[00:15:29] Speaker 04:
And the government is saying, you know, you can't make

[00:15:33] Speaker 04:
claims that are modified risk claims on this product.

[00:15:36] Speaker 04:
You can't sell this product as a modified risk product unless you've been through this pre-market review.

[00:15:43] Speaker 04:
And we're trying to decide, does this just go under the traditional tobacco product pre-market review or does it go under the modified risk product pre-market review?

[00:15:53] Speaker 04:
How would you distinguish that situation from our opinion and what occur?

[00:16:01] Speaker 04:
And say that this is there we said that the speech was being looked at for evidentiary purposes to determine which category of review.

[00:16:10] Speaker 04:
And I'm sure you have an argument for why that.

[00:16:13] Speaker 04:
No, but here it's not.

[00:16:15] Speaker 04:
It is a speech restriction, not that Whitaker applies, and I'd like to hear that.

[00:16:19] Speaker 00:
No, but here's the question.

[00:16:20] Speaker 00:
I mean, you know, the district court in this case, in footnote 37 of its opinion, looked at the government's Whittaker case and said it doesn't wash.

[00:16:28] Speaker 00:
Even discount tobacco, which held the TSA in sort of a punitive, you know, rationale against R.J.

[00:16:34] Speaker 00:
Reynolds

[00:16:35] Speaker 00:
on the theory that they had it coming, which doesn't really apply to an entirely new industry here.

[00:16:42] Speaker 04:
Right, but I'm interested in your argument.

[00:16:43] Speaker 00:
No, no, but even they say that this whole thing of the FDA gets to approve this because you get to analyze new drugs.

[00:16:52] Speaker 00:
Even they say that that did not wash.

[00:16:54] Speaker 00:
But the theory about Whitaker is that what is unlawful is the sale of the compound with the intent that it be used for a therapeutic purpose.

[00:17:05] Speaker 00:
That is not the statute we have here, right?

[00:17:07] Speaker 00:
We have a statute that says that the sale is lawful irrespective of intent.

[00:17:13] Speaker 00:
What is unlawful is the speech.

[00:17:15] Speaker 04:
No, no.

[00:17:16] Speaker 04:
I think what's unlawful is the sale of a product as a modified risk product.

[00:17:20] Speaker 00:
No, it is.

[00:17:20] Speaker 04:
And so too saw palmetto extract.

[00:17:24] Speaker 04:
What was unlawful was the sale of saw palmetto extract as a drug for prostate disease.

[00:17:31] Speaker 00:
But if you look at that single two paragraph discussion in Judge Williams' opinion, first he says that a version of what you are actually espousing, which is what the FDA was arguing, was, as he said, circular.

[00:17:47] Speaker 00:
And then he said, but the statute looks at intent.

[00:17:51] Speaker 00:
And looking at the speech for the evidentiary purpose of ascertaining intent.

[00:17:55] Speaker 00:
So if I said today that I intend to assassinate the President of the United States, the underlying act can lawfully be made unlawful, and the speech is merely evidentiary.

[00:18:05] Speaker 00:
That's different.

[00:18:06] Speaker 00:
Now, in this case,

[00:18:08] Speaker 00:
My clients could come here and confess to you that they intend to sell their products with the intent that they be used to diminish risk.

[00:18:15] Speaker 00:
And that would be lawful.

[00:18:17] Speaker 00:
It would only be unlawful if they advertise that to the public.

[00:18:21] Speaker 00:
I mean, if they make a claim to the public.

[00:18:23] Speaker 00:
They could secretly have the intent.

[00:18:25] Speaker 00:
They could confess it in a secret letter to the government.

[00:18:28] Speaker 00:
But the intent is not made unlawful.

[00:18:29] Speaker 00:
is very different from the drug regime.

[00:18:33] Speaker 00:
Like it or not, and foolishly or not, the government has chosen a path in which it has made the sale of the product lawful for any recreational purpose, irrespective of the intent of the manufacturer.

[00:18:45] Speaker 00:
And the only thing that is unlawful is the speech.

[00:18:47] Speaker 00:
And that, as the district court recommends in this case, has to be analyzed under central Hudson.

[00:18:52] Speaker 00:
And under the most recent cases from the Supreme Court, it is a really severe speech restriction that is discriminatory as against certain speakers, and that keeps them from saying really important information that could be potentially important and lifesaving to many people.

[00:19:08] Speaker 00:
Because if you credit what public health authorities

[00:19:11] Speaker 00:
in G7 countries, not backward, you know, third world countries ruled by child dictators, but G7 countries, you know, say changing completely from combusted cigarettes to some of this stuff could save lives.

[00:19:27] Speaker 00:
And so there are other things on the balance here, too.

[00:19:30] Speaker 00:
And this could be important public policy information that the government is completely suppressing for no good reason under the First Amendment.

[00:19:38] Speaker 00:
And this is why this has to be set aside.

[00:19:40] Speaker 00:
Thank you, Judge.

[00:19:41] Speaker 00:
Thank you, Your Honor.

[00:19:57] Speaker 01:
Thank you, Your Honors.

[00:19:59] Speaker 01:
My name is Eric Gotting.

[00:20:00] Speaker 01:
I represent both Nick Appier.

[00:20:02] Speaker 01:
and the right to be smoke-free coalition, and I'll be addressing the two other issues on appeal, both the free sample First Amendment issue and the PMTA APA issue.

[00:20:12] Speaker 01:
So with regard to free samples, free samples are expressive conduct, and we know that because Congress told us that.

[00:20:22] Speaker 03:
expressive conduct can be deserting of First Amendment free speech protection.

[00:20:28] Speaker 03:
That does not automatically mean that an action becomes protected speech just because it also has expressive content, does it?

[00:20:37] Speaker 01:
I agree with you.

[00:20:37] Speaker 01:
I think there's some conduct that is not inherently expressive.

[00:20:41] Speaker 03:
What would you draw a line that would put sampling

[00:20:45] Speaker 03:
tobacco products on the speech side and not, but all conduct on the speech side.

[00:20:53] Speaker 01:
I think there are two answers to that.

[00:20:54] Speaker 01:
First, we look at Texas v. Johnson in the two-factor test, and here in the record there was evidence that manufacturers are intending to send a message with their conduct, particularly with regard to... Okay, that can't be enough.

[00:21:11] Speaker 03:
That can't be enough.

[00:21:14] Speaker 03:
I would intend to send a message with my conduct if I hit you in the nose.

[00:21:18] Speaker 03:
That wouldn't mean that I had First Amendment rights to hit you in the nose, would it?

[00:21:22] Speaker 01:
Well, we know that there are cases out there, just counting back on Bailey, how that free samples are inherently expressive because of this message, try me, buy me.

[00:21:33] Speaker 01:
Try my product.

[00:21:36] Speaker 01:
You will learn about my product and how it performs, how it compares to others.

[00:21:41] Speaker 03:
And that is... Suppose it were heroin instead of tobacco that I were offering them for free.

[00:21:47] Speaker 03:
Try it and you'll like it.

[00:21:49] Speaker 03:
Would that make the fashion of heroin?

[00:21:51] Speaker 03:
First Amendment protected?

[00:21:53] Speaker 01:
I guess technically under Texas v. Johnson it could.

[00:21:58] Speaker 03:
Okay, you're going to rely on me?

[00:21:59] Speaker 01:
No, but it's not a... I'll leave it right there.

[00:22:03] Speaker 01:
It's a good hypo, but it's not a commercial transaction between people who are in the commercial marketplace buying products that are legal, for example.

[00:22:13] Speaker 01:
You can restrict First Amendment free speech if it is illegal and selling cocaine or heroin is illegal.

[00:22:25] Speaker 03:
But isn't Mr. Go very far toward making the act of passing free samples, protectable speech.

[00:22:32] Speaker 03:
It may have expressive conduct, but the fact that conduct has expressive content cannot possibly render it.

[00:22:39] Speaker 03:
Protectable speech, all that stuff that would take way too much ground with it.

[00:22:44] Speaker 01:
I don't think so.

[00:22:45] Speaker 01:
I think that that there's you can look at also what Congress told us.

[00:22:52] Speaker 01:
Congress said in the Tobacco Control Act, it is regulating and it quotes the communication of free samples as a form of communication, as a form of advertising and promotion.

[00:23:07] Speaker 01:
because it is enticing, it could entice underage kids to use these products.

[00:23:15] Speaker 01:
So this was, Congress told us they were targeting the communication aspect of free samples.

[00:23:21] Speaker 03:
Well, that will not make conduct in the speech.

[00:23:25] Speaker 03:
Conduct is not inherently speech.

[00:23:26] Speaker 03:
Conduct can be speech.

[00:23:28] Speaker 03:
Right.

[00:23:28] Speaker 03:
Conduct is not inherently speech.

[00:23:30] Speaker 03:
In fact, the conduct that Congress regulates it can't change it in the speech, can it?

[00:23:35] Speaker 01:
But as applied here,

[00:23:38] Speaker 01:
We know that we have record evidence that in the context of vapor products, manufacturers are one, intending to convey this information about their products, and two,

[00:23:53] Speaker 01:
the consumers are going to understand that because vapors are looking to sampling and nothing else to get that information.

[00:24:03] Speaker 04:
But Mr. Cutting, isn't the question not just whether the conduct might be understood to be expressive, but whether the government in regulating is aiming at its expressive

[00:24:17] Speaker 04:
content or not, and here the interest really seems to be in keeping addictive nicotine products out of the hands of anybody, really, but they emphasize youth.

[00:24:30] Speaker 01:
I agree with you.

[00:24:31] Speaker 01:
That is part of their interest, but Congress did... Do they have any interest that's directed at the expressive?

[00:24:37] Speaker 04:
Yes, I think the... Content, where do you find that?

[00:24:40] Speaker 01:
It would be the findings, the legislative findings, Section 232, which is ADD 035.

[00:24:49] Speaker 01:
And it says, if I hit the right tab,

[00:25:00] Speaker 01:
And it says, the regulations described in paragraph 30, which is referring to free samples, those were the 1996 regulations, impose no more extensive restrictions on communication by tobacco manufacturers and sellers that are necessary to reduce the number of children and adolescents who use cigarettes.

[00:25:19] Speaker 01:
So I'm going to skip down to the such.

[00:25:24] Speaker 01:
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 entice them.

[00:25:35] Speaker 01:
Congress is talking about messaging here, not just pricing or sales transaction.

[00:25:39] Speaker 04:
They're not describing free samples as speech.

[00:25:44] Speaker 01:
I think they are.

[00:25:45] Speaker 01:
I think they're saying that there's a communication aspect to freeze in this.

[00:25:48] Speaker 04:
Advertising and promotional practices is, first of all, it describes it as practices, not as messages or speech.

[00:25:57] Speaker 04:
So where were you just reading?

[00:26:00] Speaker 04:
I didn't follow.

[00:26:01] Speaker 01:
Oh, I'm sorry.

[00:26:02] Speaker 01:
It's at finding.

[00:26:03] Speaker 01:
Yeah, ADD.

[00:26:05] Speaker 04:
Can you give me an appendix page or something?

[00:26:08] Speaker 01:
Yeah, so that's the addendum to our brief.

[00:26:12] Speaker 01:
So that would be the...

[00:26:15] Speaker 01:
And I'm sorry, I said 35, it's five.

[00:26:19] Speaker 01:
And it is the legislative finding two.

[00:26:21] Speaker 04:
I'm sorry, just which page are you on?

[00:26:22] Speaker 04:
ADD.

[00:26:24] Speaker 01:
ADD 005.

[00:26:26] Speaker 04:
Thanks.

[00:26:28] Speaker 01:
Yep.

[00:26:34] Speaker 04:
You can go ahead.

[00:26:35] Speaker 04:
You can continue.

[00:26:36] Speaker 01:
Go ahead.

[00:26:43] Speaker 01:
So again, we know

[00:26:44] Speaker 01:
that there is in this, this is an as-applied, as-applied claim.

[00:26:53] Speaker 01:
So we do have evidence that this is expressive conduct and satisfies the first

[00:27:00] Speaker 01:
prong of Texas v. Johnson and it also satisfies the second prong because there is this evidence that consumers and vapers are in this case, vapers are looking for that information through state or through the actual sampling.

[00:27:19] Speaker 01:
It is not enough for us because this is such a personalized experience for us to say that my e-liquid tastes better than your menthol cigarette.

[00:27:29] Speaker 01:
It is not enough for us to say that my device delivers nicotine better than your cigarette.

[00:27:35] Speaker 01:
The only way that we can convey that information is through the sampling.

[00:27:41] Speaker 01:
And that is why it's expressive conduct.

[00:27:49] Speaker 01:
And I think Adamfield said as much.

[00:27:52] Speaker 01:
Even though that didn't involve conduct, it said when it was describing solicitation, it said part of that process

[00:27:59] Speaker 01:
is trying products or services so you can compare to others.

[00:28:04] Speaker 01:
And so the merchant can convey information through that sampling to the customer.

[00:28:11] Speaker 01:
That is solicitation and that is protected by the First Amendment.

[00:28:23] Speaker 04:
Do you want to address the PMTA?

[00:28:27] Speaker 04:
Yeah, sure.

[00:28:32] Speaker 01:
So with regard to the PMTA, commoners suggested that FDA streamline this process.

[00:28:38] Speaker 01:
so that an application would actually be accepted for scientific review, even if it didn't have long-term studies, long-term product-specific studies.

[00:28:49] Speaker 01:
So, in other words, FDA would accept the application for scientific review if it included everything else in the PMTA, including a scientific review of publicly available literature.

[00:29:01] Speaker 01:
The reason why this alternative was suggested

[00:29:04] Speaker 01:
is that FDA found that most of these manufacturers were going to disappear before they ever filed a PMTA because it's so expensive and many of these manufacturers are small.

[00:29:17] Speaker 01:
And so FDA responded to this by saying, well, we don't have enough information to make this decision.

[00:29:21] Speaker 01:
We weren't asking FDA

[00:29:24] Speaker 01:
to make a decision then and there that they would never need long-term studies.

[00:29:29] Speaker 01:
All we're saying is, please accept our application so we don't exit the market before we ever find.

[00:29:35] Speaker 04:
It seems like 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.

[00:29:44] Speaker 04:
But the FDA did say that if there were studies that were

[00:29:52] Speaker 04:
gave you 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 for the special rule for certain products where

[00:30:10] Speaker 04:
if you are making a narrow claim about, you know, no tar or no ash.

[00:30:15] Speaker 01:
I think you're thinking of MRTP.

[00:30:17] Speaker 04:
I am thinking of MRTP.

[00:30:18] Speaker 04:
You're right.

[00:30:20] Speaker 04:
But for the general preclearance, isn't there also the substantial equivalence shortcut if there is a product already on the market where they have

[00:30:33] Speaker 04:
you know, they've gotten clearance that other products that are similar can piggyback on the clearance of the already approved product.

[00:30:43] Speaker 01:
Yeah, so a couple things.

[00:30:46] Speaker 01:
First, substantial equivalence.

[00:30:47] Speaker 01:
FDA found in the crack that no e-liquids were on the market as of 2007, so we can't do that.

[00:30:53] Speaker 04:
Got it.

[00:30:54] Speaker 04:
They also found... Now, doesn't that happen, though, iteratively over time?

[00:30:58] Speaker 01:
No.

[00:30:59] Speaker 04:
If somebody who, you know, the first out of the gate

[00:31:02] Speaker 04:
is somebody that's an e-cigarette or e-liquid that other e-liquids could show that they were, so that's not just for products that were already on the market before the act, it's also for products going forward, one product in a type goes ahead and then other products can piggyback under substantial equivalence?

[00:31:21] Speaker 01:
Yes, but you always have to have that pre-2007, yes.

[00:31:24] Speaker 01:
And we don't have that with e-liquid.

[00:31:26] Speaker 04:
Did you say you always have to have the pre-2007 to skip any kind of pre-clearance?

[00:31:32] Speaker 04:
But if somebody gets market clearance under the new regulation, then you still have the substantial equivalence pathway.

[00:31:41] Speaker 01:
So if someone is on the market as of 2007, they don't need to do PMT.

[00:31:47] Speaker 04:
I understand that.

[00:31:48] Speaker 01:
And so anyone who is

[00:31:51] Speaker 01:
substantially equivalent to that.

[00:31:53] Speaker 04:
I understand that as well.

[00:31:55] Speaker 01:
No e-liquids existed in 2007.

[00:31:57] Speaker 04:
I understand that as well.

[00:31:58] Speaker 04:
So my question was, if some brave and well-financed e-liquid company does a PMT, it goes through the regime, it gets approved

[00:32:11] Speaker 04:
following that, other products that are substantially equivalent get to use that path, do they not?

[00:32:18] Speaker 01:
I think the answer is no.

[00:32:20] Speaker 04:
Maybe that's a better question for the FDA.

[00:32:23] Speaker 01:
The answer is no.

[00:32:25] Speaker 01:
So going back to your, you kind of presented the case-by-case scenario that they presented in their preamble.

[00:32:32] Speaker 01:
First of all, again, according to them, you're going to have this massive market exit even with that case-by-case.

[00:32:42] Speaker 01:
The problem we have is we're not getting the signal to the marketplace that we will get to scientific review.

[00:32:49] Speaker 01:
And the reason is we are aware of only two applications that have ever made it to scientific review, ever.

[00:32:57] Speaker 01:
They all get kicked out at a pre-filing process by FDA.

[00:33:03] Speaker 01:
So we're looking at what's actually happening.

[00:33:06] Speaker 01:
And so what happens is FDA says, we want to see everything that we want to see in the application.

[00:33:12] Speaker 01:
They are telling us right now that because there are no long-term product-specific studies that we're going to have to do long-term studies.

[00:33:23] Speaker 01:
So if we submit a study that doesn't have those long-term studies, we are running the risk of getting kicked out after having spent all that money.

[00:33:29] Speaker 01:
getting kicked out before we ever get to scientific review.

[00:33:33] Speaker 07:
Perhaps you can explain to me then if G7 and England, for example, have these studies out there.

[00:33:43] Speaker 07:
Have those been submitted to FDA by anyone?

[00:33:47] Speaker 01:
That's a great question.

[00:33:48] Speaker 01:
We can submit them and actually we have to submit them as part of our PMTA.

[00:33:53] Speaker 01:
But there's a difference between just long-term studies that either FDA has done or academics have done and product-specific long-term studies, which we have to do and pay for.

[00:34:05] Speaker 01:
So we would have to do like a clinical study or an epidemiological study on our product.

[00:34:10] Speaker 07:
How do you know that?

[00:34:11] Speaker 01:
That's what it says in the, not only do we know it because FDA is telling us that in guidance, but if you look at the actual provision.

[00:34:21] Speaker 07:
If the British regulatory agency had done a study and looked at A, B, C, and D, and you say your product is A, B, C, and D,

[00:34:31] Speaker 07:
You wouldn't have to do anything other than submit.

[00:34:33] Speaker 01:
We wouldn't.

[00:34:34] Speaker 07:
The British regulatory study, isn't that correct?

[00:34:36] Speaker 01:
That is correct.

[00:34:38] Speaker 01:
But the chances of that happening are so small.

[00:34:40] Speaker 07:
Well, that's a different issue, isn't it?

[00:34:41] Speaker 01:
Yes.

[00:34:42] Speaker 07:
I mean, that's what's interesting about this case.

[00:34:45] Speaker 07:
No one wants to submit because it's burdensome, and yet they say it's perfectly clear that the things you want to say are true.

[00:34:55] Speaker 01:
Let me be, just so you understand what we're not saying.

[00:35:01] Speaker 01:
We are taking the bat that the study you're referring to, not that it has anything to do with our product, but those general studies out there in 2022, which is when we have to file our applications, will be good enough to convince FDA that it doesn't need the long-term studies, that enough has been done between now and then that they can approve

[00:35:25] Speaker 01:
But we're taking that back.

[00:35:27] Speaker 01:
We're not taking away and we're not asking the court to take away from FDA the discretion to not approve our application because it doesn't have a long-term study regarding our product.

[00:35:39] Speaker 01:
We're reserving that for FDA.

[00:35:43] Speaker 01:
But we need to know now what we're asking is in the deeming rule to have a statement that simply said, look, you can file without long-term studies, you're taking the risk,

[00:35:55] Speaker 01:
But you can file without long-term studies, and we will do scientific review.

[00:36:00] Speaker 01:
The numbers that we're seeing right now, and we cited to a FDA website, is that only a fraction get through this pre-filing process, because those applications aren't including what FDA wants to see, and FDA is telling us they want to see long-term studies in the application.

[00:36:23] Speaker 01:
So it's really a process-oriented solution to the market, kind of the mass exit that they're predicting.

[00:36:30] Speaker 01:
It has nothing to do with the actual merits of the study.

[00:36:37] Speaker 01:
Or, excuse me, of the application.

[00:36:43] Speaker 01:
Any further questions?

[00:36:45] Speaker 07:
No, thank you.

[00:36:46] Speaker 01:
Thank you.

[00:36:49] Speaker 07:
We have a council for our police.

[00:36:58] Speaker 05:
May it please the court, Lindsay Powell for FDA.

[00:37:02] Speaker 05:
E-cigarettes raise precisely the concerns that animate the Tobacco Control Act.

[00:37:07] Speaker 05:
They deliver highly addictive nicotine, and they are now the tobacco product most widely used by middle and high school students.

[00:37:13] Speaker 05:
There's substantial evidence, moreover, that beginning to use e-cigarettes can later lead to use of conventional cigarettes.

[00:37:20] Speaker 04:
How can you claim that these are extraordinarily dangerous given the government's postponing of the deadline for the controls to 2022?

[00:37:29] Speaker 04:
The argument that the bell cannot be unrung, you can imagine, rings a little hollow against that factual backdrop.

[00:37:38] Speaker 05:
A few things, Your Honor.

[00:37:39] Speaker 05:
First, the question about compliance deadlines applies only with respect to the review of new tobacco products.

[00:37:44] Speaker 05:
It doesn't apply to pre-market review of modified risk products.

[00:37:48] Speaker 04:
I understand that, but that's what Mr. Estrada made his, you know, hung his First Amendment argument on.

[00:37:54] Speaker 04:
We can sell these.

[00:37:55] Speaker 04:
as tobacco products.

[00:37:57] Speaker 04:
We just can't sell them as modified risk products, meaning we can sell them and we can't say things about them.

[00:38:03] Speaker 04:
Whereas if the nicotine is so hazardous that none of these products should be on the market with explanation or not, your argument would seem to have more weight.

[00:38:16] Speaker 04:
Do you understand the problem?

[00:38:18] Speaker 05:
I think you see the same thing in the drug context, Your Honor.

[00:38:21] Speaker 05:
And so with the example of Saw Palmetto, that's a product that could be on the market.

[00:38:26] Speaker 05:
The question was whether it could be on the market.

[00:38:27] Speaker 05:
The example of, I'm sorry, I didn't catch that.

[00:38:28] Speaker 05:
Sorry, the Saw Palmetto was the product at issue in Whitaker versus Thompson.

[00:38:32] Speaker 05:
And there, under the analysis required by the pre-market review of drug scheme, the product could be on the market.

[00:38:40] Speaker 05:
The question was whether it could be on the market and also make certain claims that turned it into a drug.

[00:38:45] Speaker 05:
And you had the same thing

[00:38:46] Speaker 05:
Here, you have products that can be on the market.

[00:38:49] Speaker 04:
I see that as a formal matter.

[00:38:51] Speaker 04:
It feels very far afield practically from what we have here in the sense that the record shows an extraordinary uptake

[00:39:04] Speaker 04:
of e-cigarettes among, for example, middle schoolers.

[00:39:08] Speaker 04:
There was no extraordinary uptake among aging men with prostate problem of salt palmetto oil in the absence of the control on its sale for that purpose.

[00:39:19] Speaker 04:
So here you have what you describe in your materials as a rampant

[00:39:25] Speaker 04:
rampant misuse by young people of these products.

[00:39:29] Speaker 04:
And your argument hangs on the notion that, well, they can't be sold as less risky, because that's going to make it even worse.

[00:39:38] Speaker 04:
But you've also taken the position that, well, let them be sold for a few more years.

[00:39:42] Speaker 04:
What's the harm?

[00:39:43] Speaker 04:
And I find that hard to understand and to square with your claims of interest.

[00:39:48] Speaker 05:
So these are the two pre-market review provisions are also not by any means the only tools that FDA is using to address the public health issues presented by these products.

[00:39:58] Speaker 05:
So this summer FDA issued more than 1,100 warning letters against

[00:40:03] Speaker 05:
e-cigarette retailers, manufacturers that were marketing these products to youth, violating the restrictions on... That starts to sound more like Mr. Estrada's argument.

[00:40:13] Speaker 04:
You shouldn't be establishing pre-market review for modified gross products.

[00:40:18] Speaker 04:
You should be doing other, less intrusive things.

[00:40:21] Speaker 05:
determined based on extensive record evidence that to combat products of this type, the public health problems presented by tobacco products, FDA needs all these tools.

[00:40:30] Speaker 05:
So certainly being able to issue warning letters, go after companies that are unlawfully selling these products to young people is not enough.

[00:40:38] Speaker 03:
You're getting unlawful sales.

[00:40:40] Speaker 03:
The issues that Mr. Estrada was raising concern true statements by the practitioners, right?

[00:40:48] Speaker 03:
no your honor we what what what what statements were they wanting to make that are not true uh several your honor and again the way this um this would be pretty easy if i'm wrong when you say no you should be able to tell me why i i what is the untrue statement that they're wanting to make

[00:41:04] Speaker 05:
At the outset, I would like to note that the review is case by case, so not every e-cigarette is created the same by any stretch.

[00:41:11] Speaker 03:
You'd rather do that than answer my question.

[00:41:13] Speaker 05:
To take a few examples, Your Honor, they would like to say no diacetyl.

[00:41:17] Speaker 05:
I'd like to say what?

[00:41:18] Speaker 05:
No diacetyl.

[00:41:19] Speaker 05:
It's a dangerous substance that is found in some e-cigarettes.

[00:41:21] Speaker 03:
Is there diacetyl in the e-cigarettes that are willing to say that?

[00:41:24] Speaker 05:
There is diacetyl in some e-cigarettes.

[00:41:26] Speaker 03:
Apparently, even if they... Is there diacetyl in cigarettes that are willing to say there is no diacetyl?

[00:41:30] Speaker 05:
Well, that's something that we haven't yet been able to determine, Your Honor.

[00:41:33] Speaker 05:
This is precisely what the... No, Your Honor, I don't concede that.

[00:41:39] Speaker 05:
So FDA would need to determine whether it's true as far as... How long have they had that question?

[00:41:45] Speaker 05:
FDA has not had that question at all, because no application has been submitted to FDA.

[00:41:49] Speaker 05:
So every product is different.

[00:41:51] Speaker 05:
Some may contain diacetyl, some do contain diacetyl, and some may not.

[00:41:55] Speaker 03:
So there's no problem with the no diacetyl.

[00:41:57] Speaker 03:
No, your Honor, let me further.

[00:41:58] Speaker 03:
As far as the statement, it simply looks like the one that you have on smoke is tobacco.

[00:42:03] Speaker 03:
There's no either.

[00:42:04] Speaker 03:
It may not be exact, but there's no ash.

[00:42:07] Speaker 03:
There's no combustible tobacco.

[00:42:09] Speaker 05:
I would be very happy to take each statement in turn, but it does require a little bit of explanation.

[00:42:13] Speaker 05:
So with respect to no diacetyl, even if a product actually contains no diacetyl, which FDA would need to determine, it may contain higher quantities of other harmful substances and therefore present a greater risk to both individual... That still would not change the statement about no diacetyl into a false statement would it?

[00:42:29] Speaker 03:
It would be misleading insofar as it... How is it misleading to say it has no diacetyl when it has no diacetyl?

[00:42:35] Speaker 05:
This is precisely the problem that was raised by light and low tar in some of the statements made about smokeless tobacco.

[00:42:40] Speaker 03:
No, it isn't exactly the same problem.

[00:42:42] Speaker 03:
As you know, the light and low tar cigarettes, there was very good documentation that they increase the consumption.

[00:42:50] Speaker 03:
So that despite the fact that per unit they might have less tar,

[00:42:54] Speaker 03:
The actual incidence of tar was not any less.

[00:42:58] Speaker 03:
Is that not fairly accurate?

[00:43:00] Speaker 03:
Or were we deceived by the council in the tobacco case?

[00:43:03] Speaker 05:
That certainly is part of that history, Your Honor.

[00:43:04] Speaker 05:
With a claim like no diacetyl, it will convey, may very well convey to consumers that the product is relatively safe or even safe in absolute terms.

[00:43:13] Speaker 03:
Well, wouldn't it be safer than any product that did contain diacetyl?

[00:43:16] Speaker 05:
Not necessarily, if it also contains other substances, which is very much part of FDA's inquiry.

[00:43:20] Speaker 05:
It may very well be a more harmful substance.

[00:43:23] Speaker 05:
And that's what the inquiry is meant to get to.

[00:43:25] Speaker 05:
No smokeless or no smoke, there are two things with that.

[00:43:29] Speaker 05:
The reason why smokeless tobacco companies can say that is because it's part of the product definition.

[00:43:33] Speaker 05:
It's always been called smokeless tobacco.

[00:43:35] Speaker 05:
That's how people understand that.

[00:43:36] Speaker 05:
That's not true of e-cigarettes.

[00:43:38] Speaker 05:
They're not referred to as smokeless products.

[00:43:40] Speaker 03:
Nonetheless, if they have no smoke, no combustible, and they have no

[00:43:47] Speaker 05:
Some of these products do heat high enough that there is combustion, and they are arguably produced smoke insofar as they are heated to create a vapor that is then inhaled and exhaled.

[00:44:02] Speaker 05:
And in Competitive Enterprise Institute, this court upheld Department of Transportation regulations that prohibited e-cigarettes on airplanes as smoking.

[00:44:11] Speaker 05:
So to say that there's no smoke, they also want to say no tobacco.

[00:44:13] Speaker 05:
But by definition, these are tobacco products.

[00:44:16] Speaker 05:
So to say that these claims are clearly truthful and non misleading could not be farther from the truth.

[00:44:22] Speaker 05:
And even if we accept that there are some such claims, which there may be, it doesn't mean that FDA is not entitled to assess them ahead of time in the context of the particular products in which they want to be made to be sure that consumers will not be misled

[00:44:37] Speaker 05:
We know from history that when consumers are misled by products of this type, it leads to new generations of children addicted to these products, many of them for their entire life.

[00:44:46] Speaker 05:
And these products have not been shown to be safe.

[00:44:49] Speaker 05:
And we know nicotine itself is very harmful when used by children and adolescents.

[00:44:53] Speaker 05:
So there's a compelling government interest here in making sure that these harms don't happen again.

[00:44:59] Speaker 04:
And is that interest again?

[00:45:01] Speaker 04:
I know this issue is not technically before us, except it does seem bound up in the question of the government's

[00:45:09] Speaker 04:
interest in the pre-clearance regime.

[00:45:12] Speaker 04:
Is that interest not undermined by the length of time that the government has decided to take before these regulations go into effect?

[00:45:21] Speaker 05:
know, Your Honor.

[00:45:22] Speaker 05:
I mean, there's no dispute that the government has a compelling interest in protecting children and adolescents from nicotine addiction.

[00:45:32] Speaker 04:
What about adults?

[00:45:33] Speaker 05:
Not adults as well, right?

[00:45:35] Speaker 05:
Nicotine addiction?

[00:45:36] Speaker 05:
Yes, and adults as well, certainly.

[00:45:37] Speaker 03:
But to say that you have the governmental interest in protecting people against addiction is not to say that you have the governmental interest in protecting people against truthful information.

[00:45:47] Speaker 05:
But we're not only talking about truthful information, we're talking about people being... We are.

[00:45:51] Speaker 03:
We're talking about truthful information.

[00:45:53] Speaker 03:
We are not going to enter an order that says you have to accept false information.

[00:45:58] Speaker 03:
Anything we're doing is going to be due to truthful information.

[00:46:01] Speaker 03:
It isn't.

[00:46:02] Speaker 05:
The examples that we're talking about that plaintiffs want to make are not clearly truthful.

[00:46:08] Speaker 05:
And what Congress and what FDA were talking about is the potential of statements of this type to continue to mislead the public, and that does lead to addiction.

[00:46:17] Speaker 05:
People believe products are safe when they're not, and they begin using them, and then they can't stop.

[00:46:22] Speaker 05:
And the evidence further shows that using e-cigarettes can lead

[00:46:25] Speaker 05:
to the initiation of conventional cigarette use and we know how dangerous that is.

[00:46:30] Speaker 05:
So there is clearly a substantial public health concern here and it is not undermined by FDA's more global comprehensive consideration of the tobacco issue as part of which

[00:46:43] Speaker 05:
It has determined to exercise enforcement discretion and not enforce some of these provisions, specifically new product review, for a period of time.

[00:46:54] Speaker 05:
But that in no way undermines the strength of the government's interest here.

[00:46:58] Speaker 05:
This is a crucial public health concern.

[00:47:00] Speaker 05:
And we know what the stakes are here.

[00:47:03] Speaker 05:
So Congress reasonably gave FDA 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.

[00:47:14] Speaker 05:
And that's in the rulemaking 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 them.

[00:47:23] Speaker 05:
There are also other things prompting that use 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 inconspicuous objects like flash drives.

[00:47:37] Speaker 05:
So it's a very, very serious concern and FDA is taking it seriously.

[00:47:44] Speaker 04:
Appellants here argue that the pre-clearance regime for modified risk products effectively bans their products because it's so onerous.

[00:47:54] Speaker 04:
What's your response to that?

[00:47:57] Speaker 05:
It is not an effective ban, and it seems premature at best for plaintiffs to be making that argument when they haven't even attempted to meet the requirements set forth.

[00:48:08] Speaker 05:
They haven't tested the rigor of that process.

[00:48:12] Speaker 05:
Going to a conversation related to this earlier, there are also potential efficiencies in this process, and this relates both to new product review and modified risk review.

[00:48:22] Speaker 05:
So that a company putting together an application to market its new product under those PMTA provisions will assemble much of the same information that would subsequently be required if it wanted to also market its product as a modified risk product.

[00:48:38] Speaker 05:
And so you're not talking about starting on a clean slate every time.

[00:48:41] Speaker 04:
In fact, aren't they virtually identical, the two pre-market review processes, except that the modified risk product has to 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.

[00:49:01] Speaker 04:
That's basically the difference, right?

[00:49:02] Speaker 05:
they're closely related inquiries.

[00:49:05] Speaker 05:
I mean, the modified risk review will focus on the particular representation that's being made.

[00:49:10] Speaker 05:
And so the scientific inquiry will look at that representation.

[00:49:14] Speaker 04:
But as you point out, all the rest of it also that would have to be shown for a new tobacco product generally is sort of the foundation for that.

[00:49:22] Speaker 04:
It's the foundation.

[00:49:23] Speaker 05:
Yes, Your Honor.

[00:49:24] Speaker 05:
And then going to another question raised earlier, although the substantial equivalent

[00:49:29] Speaker 05:
equivalent pathway is only available for products on the market before the February 2017.

[00:49:33] Speaker 04:
I saw that after my questioning of counsel on the other side, that yes, it's only for the pre-2007 products.

[00:49:39] Speaker 05:
But there may nevertheless be substantial efficiencies to be gained after these

[00:49:44] Speaker 05:
applications are made public with the exception of any confidential proprietary information provided 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 will continue to make

[00:50:07] Speaker 05:
it easier for companies to put together the materials they need to make the showing required here.

[00:50:12] Speaker 05:
And so it's not again starting on a clean slate every time.

[00:50:17] Speaker 04:
It seems like a lot of the claims that they want to make about modified risk products are claims about specific attributes.

[00:50:27] Speaker 04:
And there's, I guess, a slightly more truncated clearance for those.

[00:50:32] Speaker 04:
But can you just give us a comparison of what are the efficiencies of that route as compared to a general claim that these are safer?

[00:50:41] Speaker 05:
Yes, Your Honor.

[00:50:41] Speaker 05:
So that's under subsection G2 and the evidentiary burden is lifted somewhat so that the scientific evidence does not need to be quite as conclusive.

[00:50:51] Speaker 05:
There's more of a likelihood standard in the way that it's phrased.

[00:50:55] Speaker 05:
Both of these provisions are long enough that it

[00:50:59] Speaker 05:
is more helpful just to look at the statute itself.

[00:51:02] Speaker 05:
This is on pages 40 and 41 of the addendum to the plaintiff's opening brief.

[00:51:10] Speaker 05:
So there is still a substantial showing required of

[00:51:16] Speaker 05:
products going through that G2 pathway, and that's appropriate for the reasons I was explaining earlier.

[00:51:20] Speaker 05:
A statement that a product doesn't contain diacetyl raises the concerns I mentioned.

[00:51:24] Speaker 05:
Formaldehyde is another helpful example.

[00:51:26] Speaker 05:
If a product may be put on the market in its packaging, it may not actually contain formaldehyde in that form, but when it's heated and inhaled, it may deliver a great deal of formaldehyde to the user.

[00:51:41] Speaker 05:
statements that a product contains a reduced level or is free of a substance still raise real concerns and are subject to a rigorous review, but it is a more lenient standard than the G1 review, as your honor notes.

[00:51:54] Speaker 05:
I do want to go back to the drug context for a moment just to note the well-established appropriateness of this type of review, even with respect to truthful claims and even with respect to claims that are products that are clearly beneficial.

[00:52:07] Speaker 05:
So if you had an e-cigarette that we all agreed could actually help people to quit smoking, that's a huge benefit, great product, it would have to go through pre-market drug review as a smoking cessation product.

[00:52:19] Speaker 05:
Never mind modified risk review, it would be a drug subject to that long-standing clearance regime.

[00:52:25] Speaker 05:
And so the notion that potentially benefit e-cigarette products would have to go through this type of pre-market review for modified risk products is not unfamiliar, and it's completely consistent with the First Amendment.

[00:52:43] Speaker 05:
with respect to free samples.

[00:52:48] Speaker 05:
that conduct at issue there is emphatically conduct.

[00:52:52] Speaker 05:
The regulation applies to a commercial transaction.

[00:52:55] Speaker 04:
And am I right, I don't think you say it O'Brien in your brief, but am I right that it's basically an O'Brien question, whether the government's interest is directed at the suppression of expression or whether it's directed at the conduct, as in O'Brien, the functioning 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.

[00:53:16] Speaker 05:
That is the O'Brien standard, Your Honor, and we would certainly withstand review under it the way the Supreme Court has looked at truly economic regulations, so price regulations.

[00:53:26] Speaker 05:
It hasn't even gotten to the O'Brien inquiry.

[00:53:29] Speaker 05:
It has said, if you're talking about just a requirement,

[00:53:32] Speaker 05:
that a product has to be at its price.

[00:53:35] Speaker 05:
This came up in Expressions Hair Design.

[00:53:37] Speaker 05:
It hasn't applied O'Brien in cases where it has found the regulation to be merely a price regulation.

[00:53:46] Speaker 03:
But if we got to O'Brien, you'd win that issue anyway.

[00:53:49] Speaker 05:
We would win that issue anyway.

[00:53:50] Speaker 05:
We win under central Hudson, as we explain in our brief.

[00:53:52] Speaker 05:
Yes.

[00:53:53] Speaker 05:
But we don't think you need to get there.

[00:54:00] Speaker 05:
I'm also happy to address New Market Review if the court is interested.

[00:54:06] Speaker 04:
What is the, I guess the position that you should be doing something more flexible than what the statute commands?

[00:54:17] Speaker 04:
I mean, there are some opportunities for the FDA to use some kind of flexibility.

[00:54:25] Speaker 05:
Yes, Your Honor.

[00:54:25] Speaker 05:
An FDA has said that it will use the flexibility that it is afforded by statute.

[00:54:30] Speaker 05:
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-term study or something in the alternative, is sufficient to demonstrate compliance with the statutory standards.

[00:54:47] Speaker 05:
So the standards themselves are clearly set forth by statute.

[00:54:50] Speaker 05:
And in each case, the applicant will have to show compliance with the standard.

[00:54:54] Speaker 05:
And FDA has said that it will exercise its flexibility to the extent consistent with that framework.

[00:55:01] Speaker 05:
And as I mentioned, there may be opportunities for further efficiencies in that process.

[00:55:06] Speaker 05:
So FDA is certainly amenable.

[00:55:07] Speaker 05:
to applicants relying on earlier applications to the extent that the information provided is relevant and helps make the showing required by statute.

[00:55:17] Speaker 05:
But FDA was required to follow the statute and was certainly not arbitrary and capricious in describing the way it would provide flexibility here.

[00:55:27] Speaker 07:
So there's a reference in the brief that

[00:55:31] Speaker 07:
Not many applications have been filed of those applications.

[00:55:34] Speaker 07:
Few have been approved, but some have.

[00:55:38] Speaker 05:
Is that correct?

[00:55:42] Speaker 05:
I do not believe there are any e-cigarette applications that have yet been approved under either new product or modified risk review.

[00:55:50] Speaker 07:
Any date for a decision?

[00:55:54] Speaker 05:
I do not believe any currently pending applications.

[00:55:58] Speaker 05:
There are very few within that product category that have been submitted.

[00:56:01] Speaker 07:
In other words, what I hear you saying is the flexibility, et cetera.

[00:56:07] Speaker 07:
Basically, it's a piggybacking flexibility.

[00:56:11] Speaker 07:
And there's nothing to piggyback right now.

[00:56:14] Speaker 05:
Certainly piggybacking is one of the ways to gain efficiency.

[00:56:18] Speaker 05:
The growing body of scientific evidence is also one.

[00:56:20] Speaker 05:
I mean, people are studying this question very carefully because it is such a significant public health concern.

[00:56:25] Speaker 05:
And as that body of evidence grows, that evidence is available to these companies as they submit their applications.

[00:56:31] Speaker 05:
But yes, I think it does appear that people are reluctant to be the first movers here when they won't benefit from those efficiencies.

[00:56:39] Speaker 05:
For these reasons, we ask that the court affirm.

[00:56:41] Speaker 05:
Thank you.

[00:56:53] Speaker 01:
Thank you, Your Honors.

[00:56:54] Speaker 01:
Just two points.

[00:56:55] Speaker 01:
Going to O'Brien, the reason O'Brien doesn't apply here is because O'Brien requires that the interest of the government

[00:57:03] Speaker 01:
has nothing to do with commutative elements.

[00:57:07] Speaker 01:
Here, as I pointed out, we do have an interest by Congress in the commutative element of free samples as expressed in the THCA and the provision that we talked about.

[00:57:20] Speaker 01:
Secondly, I will note, the PMTA does, the actual provision itself does actually build in some flexibility.

[00:57:29] Speaker 01:
It says that long-term studies are only required when appropriate.

[00:57:35] Speaker 01:
and that other valid scientific evidence can be used to satisfy the population effect standards.

[00:57:40] Speaker 01:
The alternative we were talking about doesn't even implicate that because we're not taking the discretion away from FDA to say, look, in 2022 you submitted this without any long-term studies and we think you should have and they can disapprove.

[00:57:57] Speaker 01:
What we're saying is that FDA with the case-by-case basis approach

[00:58:03] Speaker 01:
they concluded that the vast majority of these people will not be around.

[00:58:07] Speaker 01:
They will not file PMTAs.

[00:58:10] Speaker 01:
So again, we're asking for more of a process-oriented management of the applications to avoid that problem that they have concluded exists.

[00:58:20] Speaker 01:
And I believe that FDA would have, especially under the flexibility that PMTA has in its own language, would have the flexibility and discretion to do that.

[00:58:29] Speaker 01:
And they should have, and it was arbitrary and capricious not to.

[00:58:33] Speaker 01:
Thank you.

[00:58:42] Speaker 00:
Thank you, Your Honor.

[00:58:43] Speaker 00:
Now, counsel for the government started by saying two things.

[00:58:47] Speaker 00:
Number one, that nicotine is bad for you.

[00:58:51] Speaker 00:
And number two, that there is a problem with the use of these products by youth.

[00:58:56] Speaker 00:
It is important to know that the government already puts a nicotine warning on these products.

[00:59:01] Speaker 00:
and that any public health issue that has to do with how bad this is for you can be dealt with a disclaimer, as you said, in Pearson versus Shalala.

[00:59:11] Speaker 00:
As to the whole question of youth, it is a public health concern, but of course, no one here is urging that we be allowed to sell anything to youth, which is of course illegal.

[00:59:22] Speaker 00:
Our point here is that we are trying to make truthful speech to adult consumers about a lawful product.

[00:59:29] Speaker 00:
This recalls something that was established in the law a long time ago in 1957 in an opinion by Justice Frankfurter when the state of Michigan tried to ban the publication of risque magazines because they might be dangerous to the morals of the children.

[00:59:47] Speaker 00:
And the case went to the Supreme Court

[00:59:49] Speaker 00:
with Justice Frankfurter said that in order to ban those magazines, you will be burning down the house to roast the pig, and that the government could not reduce the entire population of the state of Michigan to reading only what was fit for children.

[01:00:05] Speaker 00:
And yes, of course, the government has a concern about youth.

[01:00:09] Speaker 00:
It should use means calculated to deal with a problem having to do with youth.

[01:00:14] Speaker 04:
Isn't there, Mr. Estrada, also a problem of addiction among adults?

[01:00:18] Speaker 00:
Well, again, if that is a public health issue, it can be dealt with tools that are appropriate to public health, Judge Pillard.

[01:00:26] Speaker 04:
My point here is not that the government... As I understand it, that wasn't Congress's position.

[01:00:31] Speaker 04:
I mean, you may disagree with it, but that wasn't Congress's position in enacting the Tobacco Control Act.

[01:00:36] Speaker 00:
But, Judge Pillard, again,

[01:00:38] Speaker 00:
The Supreme Court said both in Thompson versus Western states and more recently in Sorrell that if the speech is true, the government cannot ban it on the theory that adults would be better.

[01:00:49] Speaker 04:
Well, under commercial speech doctrine, if the speech is

[01:00:53] Speaker 04:
true it may be subject to regulation because if it's misleading or potentially misleading there are even true speech.

[01:01:02] Speaker 00:
I will remind you that Thompson and Zorro were all commercial speech cases and that Thompson was an FDA case involving compounded drugs where the FDA wanted to restrict the speech

[01:01:13] Speaker 00:
because it was not good for the public and where the Supreme Court said expressly that if the speech is truthful it cannot be banned on the theory that will cause people to make bad decisions.

[01:01:27] Speaker 00:
Now if addiction is a public policy problem the government has other tools to deal with it but the banning of truthful speech especially on a blanket basis as here is never an appropriate tool for the government.

[01:01:40] Speaker 00:
Now just to judge

[01:01:41] Speaker 00:
Centelle asked another question about compounds and their presence.

[01:01:45] Speaker 00:
And I think I should point out, and this is dealt with at page 27 of the blue brief, that this statute has a requirement that the FDA obtain from each manufacturer by brand and sub-brand a list of potentially harmful constituents of each brand and sub-brand, and that it then publish them in a manner accessible to the public.

[01:02:11] Speaker 00:
All the citations are on page 27 of the blue brief.

[01:02:15] Speaker 00:
And so what the government is saying is that when we assert that my product does not have diacetyl, which is something that is 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 the FDA in saying the same thing is complying with the law.

[01:02:35] Speaker 00:
And there is a plethora of similar statements that are espoused by the head of the agency in speeches every other day and by the agency itself.

[01:02:43] Speaker 04:
Is it your understanding, Mr. Estrada, if your clients wanted to, as a form of advertising, simply post a sign in the metro or put on their packaging the list of ingredients that FDA would deal with that as a misbranded or adulterated product?

[01:03:02] Speaker 00:
I think a fair reading of the statute is that any implied health claim, which says my brand doesn't have this, which the other brands have, or my brand doesn't have this.

[01:03:14] Speaker 04:
Well, I'm asking you not that claim, but just a printing of the ingredients.

[01:03:19] Speaker 00:
Well, one of the problems with schemes that are sensorial, Judge Pillard, is that my clients are subject to the chilling effect.

[01:03:27] Speaker 00:
And I don't know that I would readily advise a client to take a chance to be sanctioned by a government agency or to go close to the line.

[01:03:34] Speaker 00:
Because the Supreme Court may say 40 years ago that commercial speech is sturdy, but it's a lot less sturdy when the sanction is actually pure censorship

[01:03:45] Speaker 00:
without any procedural avenues to actually get to a court, which is why we're here.

[01:03:53] Speaker 00:
One of the things that I should have mentioned earlier is that on the tailoring aspect of 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 deception and problems with youth,

[01:04:10] Speaker 00:
But the government has gone to the most extreme form of First Amendment offense.

[01:04:16] Speaker 00:
It has gone to the pure censorship prior restraint, the type of thing that in a legal system is almost never available except with the strictest substantive and procedural safeguards.

[01:04:28] Speaker 00:
And it would be hard to say in most cases that that is something that could possibly meet

[01:04:33] Speaker 00:
of central Hudson when we are here telling you that we want to say the same things the public health authorities themselves say and to publicize the same thing that the government publicizes in its own websites.

[01:04:46] Speaker 00:
Thank you so much.

[01:04:47] Speaker 07:
Thank you.

[01:04:47] Speaker 07:
We'll take the case under advisement.