[00:00:48] Speaker 00:
Okay, the next case is number 16, 1125, Sigma Tau Health Sciences, Incorporated, against the United States.

[00:00:57] Speaker 00:
Mr. Monica.

[00:01:00] Speaker 02:
Thank you, Your Honor.

[00:01:01] Speaker 02:
John Monica from Porter Wright on behalf of Sigma Tau Health Sciences.

[00:01:06] Speaker 02:
We believe the primary issues raised in our appellate brief are clear.

[00:01:10] Speaker 02:
There's been clear error committed below.

[00:01:12] Speaker 02:
The court below failed to apply Chapter No.

[00:01:16] Speaker 02:
3 to Chapter 29.

[00:01:18] Speaker 02:
This is a case where we're dealing with two competing classifications in a single chapter.

[00:01:23] Speaker 03:
It boils down to the question of whether this is a vitamin or not.

[00:01:26] Speaker 03:
And you're not even disagreeing about the definition of a vitamin.

[00:01:30] Speaker 03:
I'm sorry, we're not?

[00:01:31] Speaker 03:
Disagreeing about the definition of what's a vitamin.

[00:01:35] Speaker 03:
Well, there was disagreement below, Your Honor.

[00:01:37] Speaker 03:
Well, we don't care whether there was disagreement below.

[00:01:40] Speaker 03:
In this court, there's no disagreement.

[00:01:43] Speaker 03:
You and the government agree on the definition?

[00:01:46] Speaker 03:
No?

[00:01:47] Speaker 02:
We agree and we agree we made a prima facie case below that it was a vitamin.

[00:01:53] Speaker 02:
And that's all we had to do to get the chapter note to apply.

[00:01:56] Speaker 02:
We apply the chapter note, our argument prevails.

[00:02:00] Speaker 02:
That's the whole of the case.

[00:02:02] Speaker 02:
I can take you through the prima facie evidence that we presented below that the court relied upon.

[00:02:07] Speaker 02:
The court relied upon Webster's Dictionary, relied upon an admission by customs themselves that it was a vitamin when it was discovered,

[00:02:18] Speaker 03:
Let me tell you what I think this boils down to.

[00:02:22] Speaker 03:
There is proof in the record that for infants and neonates that this is a vitamin because that class of individuals can't produce this substance on their own.

[00:02:42] Speaker 03:
The question then becomes does that make this a vitamin or not if

[00:02:48] Speaker 03:
the adult population doesn't require exogenous sources of this.

[00:02:55] Speaker 03:
That seems to me to be the issue here.

[00:02:58] Speaker 03:
Am I wrong?

[00:03:00] Speaker 02:
I think that's a very narrow reading of the definition of vitamin.

[00:03:04] Speaker 02:
I don't think there's anything in anybody's definition of vitamin, and there have been several submitted to the court that says it can only be a vitamin for an adult, or it can only be a vitamin for an adult, healthy adult human,

[00:03:15] Speaker 03:
I understand that, but what you're saying is that for the neonate and infant population, you need exogenous sources for this.

[00:03:25] Speaker 03:
And that makes it a vitamin.

[00:03:27] Speaker 03:
Even though for adults, you don't need it.

[00:03:30] Speaker 02:
There are certain classes of adults who need supplementation as well.

[00:03:35] Speaker 02:
Also, I will say that at least one of the documents that the government attached to in the Joint Appendix indicated that only about 25 percent

[00:03:46] Speaker 02:
of quarantine is produced in the body and the rest has to be produced exogenously.

[00:03:52] Speaker 02:
So I don't think it's very limited just to infants or hemophiliacs or people with heart conditions or the unhealthy.

[00:04:02] Speaker 02:
I think it's broader than that.

[00:04:04] Speaker 02:
But I agree that there is a large body of literature pertaining to neonates.

[00:04:10] Speaker 02:
I would not exclude others.

[00:04:13] Speaker 03:
Where's the document that says that

[00:04:15] Speaker 03:
healthy adults only produced twenty-three percent.

[00:04:18] Speaker 03:
Twenty-five percent.

[00:04:19] Speaker 02:
Give me one moment.

[00:04:35] Speaker 02:
It's cited in the government's aptly brief at page nine.

[00:04:39] Speaker 02:
It's a biocent carnitine group, sigma tau, the next generation of carnitine.

[00:04:45] Speaker 02:
It's at page 488 of the joint appendix.

[00:04:49] Speaker 02:
It says, L-carnitine is a naturally occurring compound found primarily in meat and dairy products.

[00:04:55] Speaker 02:
The body can also make a certain amount of carnitine approximately 25% through endogenous synthesis in the liver and kidneys.

[00:05:03] Speaker 02:
We've also cited another study at page 1125 of the joint appendix by a Dr. Chazot,

[00:05:13] Speaker 02:
carnitine supplementation and hemodialysis patients.

[00:05:18] Speaker 02:
And that document says, quote, carnitine sources are mainly meat and dairy products and represent 75% of carnitine supply.

[00:05:26] Speaker 02:
So those are at least two documents, in this case, upon which the parties rely to show that there is a significant requirement of supplementation in the diet.

[00:05:43] Speaker 02:
So we think there's clear error in the court failing to apply Chapter No.

[00:05:47] Speaker 02:
3.

[00:05:48] Speaker 02:
We think we established a prima facie case below.

[00:05:51] Speaker 02:
The court cited at least four pieces of evidence establishing our prima facie case.

[00:05:55] Speaker 02:
The only expert in the case, Dr. Bass, was our expert.

[00:06:00] Speaker 02:
He submitted at least six other pieces of evidence to support a prima facie case.

[00:06:06] Speaker 02:
If you take all that prima facie evidence,

[00:06:08] Speaker 02:
Apply Chapter 03.

[00:06:09] Speaker 02:
We think it's very clear that there's reversible error and that the case should be reversed.

[00:06:15] Speaker 02:
And if you have any questions, I'd be glad to answer them or I'll reserve my time.

[00:06:19] Speaker 00:
Okay.

[00:06:19] Speaker 00:
Thank you, Mr. Monica.

[00:06:27] Speaker 00:
Mr. VanderWyde?

[00:06:28] Speaker 01:
Your Honor, you may have pleased the court.

[00:06:31] Speaker 01:
Your Honor, you're correct.

[00:06:33] Speaker 01:
The only issue is whether or not, with these specific neonates, whether or not rises to the level of vitamin.

[00:06:38] Speaker 01:
And infants.

[00:06:40] Speaker 01:
And infants.

[00:06:40] Speaker 01:
But it's only certain infants.

[00:06:43] Speaker 01:
It's up to four months old.

[00:06:44] Speaker 01:
And those infants, at least the articles that were cited in Plano's reply brief, only those infants that are having trouble because of IV feeding.

[00:06:54] Speaker 01:
They're not producing enough carnitine on their own.

[00:06:57] Speaker 01:
But that article itself is the use of carnitine in pediatric nutrition.

[00:07:03] Speaker 01:
It's called carnitine, a non-essential nutrient in adults.

[00:07:06] Speaker 01:
but it could be a conditionally essential nutrient in certain pediatric populations.

[00:07:11] Speaker 03:
Okay, but so why doesn't it make it a vitamin if it's an essential nutrient for certain neonates or for neonates generally?

[00:07:23] Speaker 03:
Why doesn't that satisfy the definition of a vitamin?

[00:07:27] Speaker 01:
It's vitamin-like, but it's conditionally essential.

[00:07:30] Speaker 01:
And this is the turn of the medical community, the scientific community.

[00:07:34] Speaker 03:
But you don't dispute that it would be a vitamin if the adult population had the same need as the neonates, right?

[00:07:40] Speaker 01:
If the majority of the adult population required supplementation of carnitine for their health, then that would be a vitamin.

[00:07:49] Speaker 04:
You say the majority.

[00:07:51] Speaker 04:
So are we to apply some sort of level here, a percentage?

[00:07:55] Speaker 04:
What would be in a 50%, 25%?

[00:07:58] Speaker 04:
Why not 2% of the population?

[00:08:00] Speaker 01:
I'm deferring to what the medical literature and the scientific establishment describes carnitine as a conditionally essential nutrient.

[00:08:08] Speaker 01:
That's how it's defined by the Linus Pauling Institute.

[00:08:11] Speaker 04:
Is it a series of vitamins to any percentage of the population?

[00:08:15] Speaker 01:
I don't know what the percentage of the population is that requires... Well, we do know it does for certain infants, correct?

[00:08:20] Speaker 04:
For certain infants... Well, why is that not enough?

[00:08:22] Speaker 01:
Because it's only conditional up to four months old for only a certain subset of those infants.

[00:08:29] Speaker 04:
Why is that not enough?

[00:08:30] Speaker 04:
I mean, for that subset, it is a vitamin.

[00:08:35] Speaker 01:
Because it has vitamin-like properties for a limited period of time for just those specific individual infants.

[00:08:44] Speaker 01:
Why is that not enough?

[00:08:45] Speaker 04:
Why is that not enough?

[00:08:48] Speaker 01:
Because the definition of a vitamin

[00:08:51] Speaker 01:
requires that there be an exogenous supplementation or production.

[00:08:57] Speaker 01:
There's no recognition in the medical and scientific community that carnitine is a vitamin.

[00:09:04] Speaker 03:
Well, I think your statement in answer to that question is not correct.

[00:09:08] Speaker 03:
This is not limited to infants who have IV feeding.

[00:09:12] Speaker 03:
It says neonates rely on exogenous supply of L-carnitine because their capacity for

[00:09:19] Speaker 03:
endogenous synthesis is still poorly developed.

[00:09:22] Speaker 03:
It's not limited to a subclass.

[00:09:23] Speaker 03:
It's all neonates, right?

[00:09:25] Speaker 01:
I was looking at the use of carnitine in pediatric nutrition.

[00:09:28] Speaker 01:
Which article are you looking at?

[00:09:33] Speaker 01:
Is that the physiological role of L-carnitine?

[00:09:36] Speaker 01:
It's 1089.

[00:09:39] Speaker 01:
Both of these articles recognize that the endogenous synthesis abilities of all neonates are poorly developed.

[00:09:46] Speaker 01:
Okay, so why isn't that enough?

[00:09:48] Speaker 01:
because it is only limited and conditionally essential just for that segment of the population.

[00:09:56] Speaker 00:
Even on your theory, which seems to be extreme, you can argue that the vitamin classification is less specific than the quaternary ammonium salt classification, which the record says, and I think anyone can take note,

[00:10:16] Speaker 00:
includes millions or possibly billions of compounds.

[00:10:21] Speaker 01:
Yes, Your Honor, but we only get to a relative specificity if it's presumed that... But that's the issue, is it not?

[00:10:30] Speaker 01:
No, well, the issue in this case is just whether or not carnitine, or the products at issue, not just carnitine, the products at issue, which are el toro and glycocarb, it's not just one component of carnitine.

[00:10:43] Speaker 00:
But the alternative is classification as a quaternary ammonium compound, is it not?

[00:10:48] Speaker 00:
So those are our choices.

[00:10:50] Speaker 01:
Exactly.

[00:10:51] Speaker 01:
There's no dispute whether or not these products are quaternary ammonium.

[00:10:55] Speaker 00:
Or one with a billion other compounds.

[00:10:58] Speaker 00:
And we also have the rule of specificity and the listing on the table and all the rest of it, to which I've seen no response by the government.

[00:11:08] Speaker 01:
Because we don't get to relative specificity, Your Honor, because there's a chapter note at play.

[00:11:12] Speaker 01:
And that chapter note comes in before we get to GRI 3A.

[00:11:16] Speaker 01:
And that chapter note says that all things being equal, if these goods are prima facie classifiable as quaternary ammonium salts and as vitamins, then the tie goes to sigma tau, because it's the heading later in order.

[00:11:30] Speaker 01:
Our argument is that these goods are not prima facie classifiable in two or more headings, because these goods are not a vitamin.

[00:11:37] Speaker 01:
We're not just looking at L-carnitine.

[00:11:39] Speaker 04:
What about use?

[00:11:40] Speaker 04:
Are these goods used as a vitamin?

[00:11:42] Speaker 01:
They are not used as a vitamin.

[00:11:44] Speaker 01:
The record that was developed to afford the trial court was that these goods are performance enhancing ingredients in workout supplements.

[00:11:52] Speaker 01:
You take these goods, they increase the nitric oxide in your blood.

[00:11:55] Speaker 04:
In a commercial sense, or in the sense of the marketplace, are they marketed as vitamins?

[00:12:02] Speaker 04:
No.

[00:12:03] Speaker 01:
They're marketed as just ingredients in workout supplements.

[00:12:06] Speaker 01:
So whether or not they're single use, whether it's taken a pill with just these ingredients in them, or whether they're mixed in with sort of a multi ingredient package that someone would take to go increase their production when they're working out, whether how much they could bench press or exercise

[00:12:22] Speaker 01:
or to benefit the recovery.

[00:12:24] Speaker 04:
So is there any evidence in the record that these products are known as vitamins in the marketplace?

[00:12:33] Speaker 01:
They are not known as vitamins in the marketplace.

[00:12:35] Speaker 01:
The only link to whether these things are known as a vitamin in the marketplace is you go buy the stuff at the vitamin shop, but the vitamin shop also sells many different products, dietary supplements, not all dietary supplements are vitamins.

[00:12:52] Speaker 01:
That's the channel of trade in which these things are sold.

[00:12:55] Speaker 01:
You can buy them on Amazon and the internet as well.

[00:12:57] Speaker 01:
But the people that are using these items are using them for workout.

[00:13:02] Speaker 03:
That's what they're doing.

[00:13:03] Speaker 03:
Is that pertinent to determining whether they're a vitamin or not?

[00:13:08] Speaker 01:
It's not necessarily germane because this is not a use provision.

[00:13:12] Speaker 01:
It's whether or not this good meets the standard, meets the definition of a vitamin.

[00:13:17] Speaker 04:
So when we look at 29

[00:13:19] Speaker 04:
32, 79, 50.

[00:13:20] Speaker 04:
That's not a use provision?

[00:13:23] Speaker 01:
It's a hybrid, isn't it?

[00:13:25] Speaker 01:
It's a hybrid.

[00:13:26] Speaker 01:
There's an aonominate, whether it's a provitamin or a vitamin, or whether a substance is used as a derivative of a vitamin.

[00:13:34] Speaker 01:
There's no claim here that these things are being used as a derivative of a vitamin.

[00:13:38] Speaker 01:
But they fail to satisfy the definition of a vitamin, because a vitamin must be produced from an exogenous source to either supplement something that the body can't produce itself.

[00:13:49] Speaker 01:
We can produce carbotene.

[00:13:52] Speaker 03:
But most animals can't produce it.

[00:13:54] Speaker 03:
Infants can't.

[00:13:55] Speaker 01:
That's the problem.

[00:13:56] Speaker 01:
That's why the medical establishment deems with a certain populations, whether it be people with primary deficiencies, you have a genetic abnormality, which means that you can't produce enough, very small subject to the population, a secondary deficiency, you have kidney failure because of that.

[00:14:12] Speaker 03:
We're not talking about that population.

[00:14:13] Speaker 03:
We're talking about normal humans and normal neonates and infants

[00:14:19] Speaker 03:
need this from exogenous sources?

[00:14:22] Speaker 01:
I would still even defer to the articles themselves, which say any article that these are considered, when looking at the use of carnitine in pediatric nutrition, recognizing the certain infants and newborns require supplementation of carnitine.

[00:14:40] Speaker 01:
Still, those articles are not calling, these sources are not calling carnitine a vitamin.

[00:14:46] Speaker 01:
They're calling them conditionally essential.

[00:14:49] Speaker 01:
The articles themselves.

[00:14:50] Speaker 01:
None of the articles.

[00:14:50] Speaker 04:
But it meets the scientific characteristics of a vitamin.

[00:14:54] Speaker 04:
On the one hand, you're arguing the scientific characteristic of a vitamin.

[00:14:58] Speaker 04:
And it seems that this meets those characteristics because it's needed by a certain percentage of the population, albeit a small one.

[00:15:08] Speaker 01:
Well, I think it meets that definition of a vitamin for that limited population.

[00:15:15] Speaker 01:
OK.

[00:15:15] Speaker 04:
So if I start there, why shouldn't that be enough?

[00:15:18] Speaker 01:
I do not feel comfortable claiming that this is a vitamin when the National Research Council on the Academy of Sciences, the FDA, all of these articles are not calling this substance vitamin.

[00:15:32] Speaker 01:
They draw that distinction, and we are drawing that distinction as well, that for those segments of the population, it's just conditionally essential.

[00:15:40] Speaker 01:
It's conditionally essential until it's no longer essential.

[00:15:43] Speaker 01:
And even then, even with a conditionally essential group,

[00:15:47] Speaker 01:
say the neonates or primary, secondary deficiencies, carnitine is now being taken as a drug.

[00:15:55] Speaker 01:
It's being prescribed by a doctor.

[00:15:57] Speaker 01:
They're not taking El Toro.

[00:15:59] Speaker 01:
They're not taking glycocarn.

[00:16:01] Speaker 01:
Well, that's irrelevant, right?

[00:16:03] Speaker 01:
But that's what's at issue is the full chemical composition of these products.

[00:16:10] Speaker 01:
These products are not just carnitine.

[00:16:12] Speaker 04:
See, now you're arguing the use.

[00:16:14] Speaker 04:
And on one hand, you don't want to go there and argue the use part of a hybrid classification.

[00:16:21] Speaker 04:
And now you seem to want to take us to that particular point.

[00:16:26] Speaker 01:
I don't think I'm going to use your honor.

[00:16:28] Speaker 01:
I think I'm just looking at what was actually imported.

[00:16:32] Speaker 01:
What is the imported merchandise?

[00:16:35] Speaker 01:
It's a carnitine base, yes.

[00:16:39] Speaker 01:
But it's rendered chemically stable by the other ingredients in there.

[00:16:44] Speaker 03:
I don't recall any argument before that the other ingredients made this not a vitamin.

[00:16:50] Speaker 01:
We brought that argument to the trial court, and we put it in our brief as well, that the court must analyze the goods in their imported condition.

[00:17:00] Speaker 03:
Where does your brief argue that because of these other ingredients, it doesn't constitute a vitamin?

[00:17:05] Speaker 01:
That's in our brief, Your Honor, at Page

[00:17:21] Speaker 01:
Page 28, page 28 to 30.

[00:17:27] Speaker 01:
We made that argument that the court has a duty to classify the merchandise in a condition that is imported.

[00:17:39] Speaker 01:
And the condition that is imported are these bulk drums of white powder of acetyl-l-carnitine-toronate hydrochloride

[00:17:48] Speaker 01:
and glycine propionol, L-carnitine, hydrochloride.

[00:17:53] Speaker 01:
These two separate 25 kilogram drums is what they're bringing in.

[00:17:57] Speaker 01:
Later on, they're reformulated with single-use capsules or in workout products.

[00:18:03] Speaker 01:
That's what they're being reformulated.

[00:18:04] Speaker 01:
But they're not just bringing in L-carnitine.

[00:18:07] Speaker 03:
You say that L-carnitine is the sole biologically active component.

[00:18:11] Speaker 01:
It is the sole biologically active.

[00:18:13] Speaker 01:
But in order for these products to be taken in,

[00:18:16] Speaker 01:
and ingested, they have to be rendered chemically stable.

[00:18:19] Speaker 01:
And so that's what the other, it's not that the other ingredients in these products have no function.

[00:18:25] Speaker 01:
They do have a function.

[00:18:26] Speaker 03:
They're rendering them a chemically stable and... Wouldn't that be true of all importations of L-carnitine that they have to be rendered stable?

[00:18:35] Speaker 01:
It depends.

[00:18:37] Speaker 01:
I can imagine a scenario where L-carnitine is imported just on its own to be used as a medicament with a certain subset of the population

[00:18:46] Speaker 01:
that needs carnitine for that limited purpose as prescribed by the care of a doctor.

[00:18:51] Speaker 01:
Doctors aren't prescribing these items.

[00:18:54] Speaker 01:
That's not happening at all.

[00:18:59] Speaker 01:
I think the important distinction here is that line between a vitamin and a conditionally essential nutrient.

[00:19:08] Speaker 01:
And that's what the Lyme's Polling Institute

[00:19:11] Speaker 01:
The FDA, the National Research Council of the National Academy of Sciences, the vast majority of authoritative scientific and medical establishment has drawn that line.

[00:19:21] Speaker 01:
And that's the distinction.

[00:19:22] Speaker 04:
So let's say this is a close case.

[00:19:26] Speaker 04:
Can we really say that Judge Karman committed clear error in his decision?

[00:19:35] Speaker 01:
I think it's an error as a matter of law, because it's about whether or not this

[00:19:40] Speaker 01:
This product meets the legal definition of a vitamin.

[00:19:44] Speaker 01:
And these products do not meet the legal definition of a vitamin.

[00:19:48] Speaker 01:
So it's a legal finding that the court errors.

[00:19:51] Speaker 04:
If it meets that definition just to a certain extent.

[00:19:57] Speaker 01:
But it, again, not recognized, doesn't meet that definition.

[00:20:02] Speaker 01:
That's why the true definition of carnitine as a conditional essential nutrient, not as a vitamin.

[00:20:11] Speaker 01:
If there are no further questions, Your Honor, and no further questions around, then thank you for your time.

[00:20:18] Speaker 00:
Thank you, Mr. Van Der Waal.

[00:20:25] Speaker 00:
Mr. Van Der Waal again?

[00:20:26] Speaker 02:
Yes, just a few statements in rebuttal.

[00:20:29] Speaker 02:
As Your Honors are probably aware through our briefing,

[00:20:33] Speaker 02:
We've been shooting a moving target as to what the government says is a vitamin from day one.

[00:20:40] Speaker 02:
This part about neonates being insufficient, that was not in the original protest denial.

[00:20:45] Speaker 02:
That was not in any of the discovery denial.

[00:20:47] Speaker 02:
That's something they're making up in briefing.

[00:20:50] Speaker 02:
There are established definitions for vitamins.

[00:20:52] Speaker 02:
Our expert says these products meet them.

[00:20:57] Speaker 02:
When our expert says that, what do they do?

[00:20:59] Speaker 02:
They add different terms that are necessary in their mind

[00:21:03] Speaker 04:
in order to create... They cite information sources that are, I would call, prestigious sources.

[00:21:12] Speaker 04:
Sure.

[00:21:12] Speaker 04:
NIT and NIH, Harvard, and others that don't look at carnitine as a vitamin or don't list it as a vitamin.

[00:21:24] Speaker 02:
And we cite many to do.

[00:21:26] Speaker 02:
And all we have to show is a prima facie case that it is a vitamin.

[00:21:31] Speaker 02:
We don't have to conclusively establish

[00:21:33] Speaker 02:
on a duel to the death under chapter note three, that there are no authorities out there that say it's not a vitamin.

[00:21:40] Speaker 02:
We presented a premedication case.

[00:21:42] Speaker 02:
We had an expert.

[00:21:43] Speaker 02:
He had several pieces of evidence, several equally valid scientific studies.

[00:21:49] Speaker 02:
He's the only one who offered two academic definitions of vitamins and said, hey, these substances meet that.

[00:21:57] Speaker 02:
He also presented other evidence from the Merck index.

[00:22:01] Speaker 02:
from the Sigma Aldrich sales catalogs of common usage of this term, of these products, that vitamin Bt is carnitine and vice versa.

[00:22:11] Speaker 02:
We deposed customs, 36 witnesses, they admitted that these were prestigious.

[00:22:16] Speaker 02:
I wanted to buy some of this product and walk into one of these retail shops.

[00:22:19] Speaker 02:
What would I say?

[00:22:21] Speaker 02:
Let me have some vitamin Bt.

[00:22:23] Speaker 02:
L-Carnitine.

[00:22:24] Speaker 02:
You'd probably say let me have L-Carnitine.

[00:22:27] Speaker 02:
But not vitamin Bt?

[00:22:28] Speaker 02:
You could ask for vitamin Bt and they would know what it is because it has the same definition, but auto-carotene is the more common name to the average late person.

[00:22:40] Speaker 02:
But we don't think that precludes it from being a vitamin to any extent.

[00:22:44] Speaker 02:
So do you agree that the name vitamin Bt is a misnomer?

[00:22:49] Speaker 02:
No, do not.

[00:22:52] Speaker 02:
Our experts testified that that was what it was first called and that it's called that up to the present time

[00:22:57] Speaker 02:
He listed several sources as recent as 2010, 2013 that still call L-carnitine vitamin Bt.

[00:23:05] Speaker 04:
But you just said that I would go in and I would order carnitine, not vitamin Bt.

[00:23:09] Speaker 04:
No.

[00:23:10] Speaker 02:
You could ask for either.

[00:23:12] Speaker 02:
I'm saying the more probably widely known name would be L-carnitine.

[00:23:15] Speaker 02:
It was imported.

[00:23:16] Speaker 04:
Was it imported as vitamin Bt?

[00:23:18] Speaker 02:
When it came in.

[00:23:19] Speaker 04:
On the declarations and all?

[00:23:24] Speaker 02:
No.

[00:23:25] Speaker 02:
On the MSDS sheet that came in with it.

[00:23:28] Speaker 02:
it sends vitamin on the MSDS sheet, and then on the MSDS sheet that's distributed with it from our client to the final processors, it's called the vitamin as well.

[00:23:42] Speaker 02:
For advertising purposes, they may go by other names in the shop, but it doesn't mean it's not a vitamin.

[00:23:52] Speaker 02:
And it goes beyond, another point I'd like to bring up is that

[00:23:57] Speaker 02:
It applies to more than just neonates.

[00:23:59] Speaker 02:
I think that's the major application, but we've cited in our brief scientific studies that point to hemophiliacs needing it, the government itself.

[00:24:14] Speaker 03:
So it doesn't have to be part of a normal human population rather than people with particular needs?

[00:24:23] Speaker 02:
No, we all need and use carnitine, and whether we have to have it supplemented is a different issue.

[00:24:28] Speaker 02:
Well, that's what I'm talking about.

[00:24:30] Speaker 02:
It doesn't have to be supplemented to the entire population.

[00:24:33] Speaker 02:
I can tell you that one of the government's own sources cited on page 15 of their appellate brief, they cite one page, and they attach it, as it is at six, to their cross-merchant for summary judgment.

[00:24:45] Speaker 02:
If they had attached the whole article, which they should have, they would say this.

[00:24:49] Speaker 02:
The doctor in the study they cited from Vitamin Connection, March 2006, that doctor, who's a board certified cardiologist and a fellow of the American College of Cardiology, he said in their article, I think everybody on the planet should take some form of carnitine.

[00:25:06] Speaker 02:
People really should take 500 milligrams, 250 milligrams twice a day because they're really not going to get enough in the diet to provide what the body really needs.

[00:25:15] Speaker 02:
That's from one of their own documents.

[00:25:17] Speaker 02:
It didn't limit to neonates.

[00:25:20] Speaker 02:
Thank you, thank you both.