thank you judge joe flat may please the court my name is john i'm and i'm here representing high tech this is a case about the rules that the that the f d a is required to follow under the through drug and cosmetic act when it wants to take certain dietary supplements off the market today i'd like to convince the court of three points which i can summarize really quickly all of which focus on the first argument we've made on our brief in our brief first at the district court misinterpreted the words constituent and botanical in the amendments to the f t c a known as the dietary supplement health and education act a second under the proper interpretation of those words my clients are entitled to prevail not simply reversal for a trial but reversal with directions to enter summary judgment in my client's favor of the third is that from a health perspective there should be nothing troubling about the first two conclusions that we are asking the court to draw when i think underline a lot of what the agency is arguing here and it switches in theories in the district course interpretation of the statute is a concern that the words constituent and botanical need to be interpreted in a way more narrowly than their text suggests because otherwise you'll have the situation in which products that are not safe or are on the market bad is not the role that the dietary and creed eant definition  was designed to play under the shade when the government wants to take certain supplements off the market because the government believes that they are unsafe the government has a statutory mechanism for doing so that's found in section three forty two f one of the statute w reproduced at the end of our brief it's not supposed to use the statutory mechanism that it use to hear the entire point of the shia was to put the burden of proof on the government to establish that dietary supplements are unsafe when it wishes to take them off the market at the agency was able to effectively flip the burden of proof here by trying to categorize d n a as a non dietary in creating a greeting as an as a food additive thus require my clients approve not only that idea may say but that it's generally regarded as safe which is at fairly substantial burden i think my client satisfied that burden at least to the extent that a trial would have been necessary on that but the court doesn't need to go there in that district court shouldn't have gone there either but they only reason why the district court even considered that question was because it can be construed the words constituent in an amber tanach will in a way th no i think it needs be naturally occurring in the botanical adjudged jordan but yes as long as long as the word constituent means a part of something else something that's a part of something else the word botanical means plant something that i naturally occur in a in a plant the words history of extraction and and commercially usable quantities do not appear in the statute the statu just gave just short really is if i understand your position is that the term dietary ingredient means any substance contained in florida and any identical caviar i would add is that it needs to be naturally occurring in the flora but yes that's exactly right enough and and again to the extent that there is concern that that that definition is broad i think that's quite consistent with w congress was trying to achieve and the shia you know we need to look at the the in creating this listed right before constituents of the tangibles in section three twenty one ethel one five there is an incredibly broad definition of things that can be dietary ingredients congress wanted to allow dietary supplement manufacturers to include a wealth of items within dietary supplements did not want unsafe products in the market but the way that those products were supposed to be taken off the market was by the government established in those products are unsafe that's not something that could have been done here but when you look in the dictionary under botanical and it says things like something extracted plant in this context if there's a if there's a choice between two definitions that the court consistent with congress's purpose is understood the shia should choose the broader of the definitions again that should raise any concerns because the safety provisions are always there to ensure that unsafe unsafe materials aren't put on the market i mean to give an example of how the district court's interpretation doesn't make sense here if the court were to ask me well let me back up a second that the government's definition proffered in its brief of constituent includes it says that the work constituent is synonymous with the word ingredient so if the court were to ask me to go fetch as quickly as possible cake i would try within the three minutes and forty five seconds i had left to go sprint to the lawyers lanch and bring back the back of sugar from the coffee table over there and i think i would have complied with the court's request to bring an ingredient  cake with me even though that sugar had never actually been extracted from the cake itself as long as it is that everybody acknowledges that sugar is a part of cakes and the fact that there is no history of people  extracting sugar from cakes or that the sugar i brought you had never actually been in a cake would not change the reality that sugar was part of a cake so when i look in the dictionary under constituent and it says things like an essential part the essential just read that out of it is just constituent means any part of well i think you need anything found in is a constituent i understand the word essential is used in the government's definition which is only one of one of several definitions that are have been proposed but i understand the word essential to basically mean inherent and so when i when i say to you the constituency a naturally occurring part of the plan i think that's the role essential means but it can't be the case that merely because the amaze an essential part of of those geraniums the fact that well the fact that some humans have hair and some don't like me doesn't mean that for the humans who have hair on top of their head that hair is not essential likewise for d n a here is worried about essential but couldn't find anything in the dictionary that made it quite as broad as you suggest meaning anything included in i think the word constituent means a natural part of something else and i think congress had a very broad view of things in mind under the proper interpretation of those of those words something that is part of something else and that's naturally found in geraniums the evidence here establish that d n a was naturally  or at least that the government had not satisfied its burden of showing that d n a is not naturally found and geraniums it in considering that question and considering what the right remedy it should be here i think the right place for the court to start is by looking at the evidence the high tech put forward in terms of studies that have found the m a in geraniums the government brought this litigation on the premise that it was going to disprove those studies the living study the least id the ping study and it was going to do so through the studies from the university of mississippi but discovery in this case revealed that in fact the studies from the university mississippi had revealed d n a and d n a geraniums that they had studied i did want to ask you one other thing you started off by saying that if we agree with you we should reverse and render don't they get to prove it's unsafe not in this context my client's products they have not going to do you think they do not get an opportunity to prove that it's actually unsafe that if they lose on the dietary ingredient question they just lose in this case that's correct i mean they they brought this were they seized they seize these materials let me can i ask one more question and the reason you say that about the government not being able to go to trial on that second issue if you prevail on the first that you tory question is because whether or not something is generally accepted as safe is an exception to the bar that the government was travelling on in the first place essentially right that that's correct your honor so the government's theory o where your client's products because of its ingredients fall in the table if the government is wrong about that then you don't have to show an exception to the government's theory in the first place that's correct i mean if the court disagrees with me on the first point then at the very least my clients would like an opportunity to prove that the general general garner the safety of this product at a trial but i don't think you need to get there because i think the government had satisfied its burden of perspective dietary treatment on that second point if you lose on the first point you agree that you don't necessarily win as a matter of law on the second point on that second point the remedy you're seeking is a trial well we're seeing that at the very least i do think there are some substantial problems with dr keith's testimony in terms of its reliance on case studies of her case reports as opposed to genuine studies here but yes at the very least i think that there's a battle of the experts here in terms of whether they view this product is general regarded as say thank you mom sorry your honor of first whether d m a is a dietary ingredient because it's a constituent of tentacle or whether it's a food additive and then second if it's a food additive whether it's generally recognized to say by qualified scientific  regular before you finish your fifteen minutes i'd like you to address one issue and you can do it whenever you'd like my concern in this case is that the district court rejected your initial theory of fo no i wouldn't agree on that but i can continue with russert question and explain he said your theory reason was founded as presented factually right no i wouldn't agree with that if i could explain just on that issue this was cross motions for summary judgment was it would be inclined to find that the united states had not met its burden for its own summary judgment motion but if the united states if it was inclined to find that the united states was an entitled to summary judgment that doesn't necessarily entitle heigh judgment you could think that you find yours reasonable finders of fact might disagree and at that point the resolution would be a jury trial rather than a summary judgment order for high tack ok but you're not defending your initial theory of forfeiture on appeal brief with the evidence that we presented there on contamination methodological flaws and the lack of biologically possible mechanisms for producing d m e ok so might my question is and you can address it whenever you'd like during your fifteen your remaining time is this however you view it the district court adopted an interpretation that you had not proposed am i right so far that's correct ok and that interpretation was not purely legal it was based on facts in the record as well in terms of whether to grant summary judgment or not right because the district court said there had to be a history of extraction in usable quantities right yes you have not proposed that standard corrects that our standard was that it didn't exist at all correct so you have not proposed that standard that is evidentially in order to show a history of anything you need to do discovery you have to show whether something happened in the past or didn't happen in the past if the district court came up with this interpretation of the statutory framework without your assistance and without you proposing it why wasn't high tech entitled to at least some limited discovery to determine or make an argument as best as it could that there had been a history of commercial extraction in other words if that issue had never been teed up by either side during the entire case and its summary judgment why wasn't high tech entitled to an opportunity to prove its case under the district court's theory sure i'm having to address this right now so we address this argument pages twenty nine of thirty one of our answering prefer me to still what argument is here and i think it's correct is that court doesn't provide notice on a particular ground that is going to render summary judgment the appellant still has to show that that is prejudicial it's subject to harmful error analysis that's the fifth circuit's decision in the spring street partners case so what high tech has claimed in both its opening and reply brief is it was prejudiced because there were two particular pieces of evidence that it did not develop but that it would have to developed if it had known about that those due to lack of discovery without giving them discovery but they had discovery on this your honor no they did not you did not the issue the government the government has the burden in a forfeiture proceeding and you have to assert a legal theory on which the government can force fit goods is accurate yes and if you t up a certain theory if you say these goods are for for double for reason x that's the only reason that the claimant has to fight it doesn't have to fight other things in the in the either that it doesn't know about but here's the thing your honor of the district let me flip this question for you make it a little more difficult for you if the district court had come up with a legal theory statutory interpretation that high tech had not advanced and had said i'm coming up with theory number three and granted summary judgment against you would you  you would have been you would have been incensed that a district court in an adversary system would have come up with a legal theory that neither side had advocated and not giving you a chance to develop it respond to it or do anything else you would have been up here in a heartbeat you don't have to respond your honor the particular evidence that we were talking about here the two patent applications high tech knew about them it presented them at depositions it them would not have developed more evidence once it knew that that was one of the critical issues because if they could have if they could have asked anything about this plan application if they could have verified it at all i don't know of any evidence that we could have produced in response to say that the m a a is an injury means they would have been there at three percent three thirty million parts per billion that would have been essentially conclusive in this case about whether it existed in dreams at all they had every incentive to develop that evidence and they claim that this was the only evidence that they now knew that they had to rely on after never relying on it in any of their summary judgment papers i don't want to derail your from the rest of your arguments of thank you very much for answering the question on this first question the this report's can interpretation here is correct it's correct because if you look at what congress was concerned about at the time and enact in these amendments the food drug and cosmetic act there were a series of cases in the early ninety's when the united states was taking in foresman actions against products such as oil from black current berries that's the seventh circuit case or evening primrose oil  oil from flour and in the senate report to these amendments the congress stated that what it was concerned about was products like ginger garlic pine bark extract caffeine which has produced implants and it was concerned that these products that are obtained from plants and physically derived from them should be treated as a new category of dietary and reading for use in dietary supplements and the list of words that congress used in this statute concentrate metabolite extract combination and constituent are methods of physically driving something from a plan and preparing it for that use in a dietary supplement so this statutory words here in the applicable canon is the associated words can and also to also cease where you take the words potentially extremely broad meaning and you narrow that to the meaning that it shares with the words in the same list and so the late justice scalia and brennan garner explained this in their book reading one on the side it's a particular case called state versus taylor that discussed a case that could literally be any type of container but in the particular statute to talk about if you have a gun in a car that's illegal unless it's in a gun box a case or securely tied package so there you take that word case with the relatively broad meaning and you narrow it's meaning based on the words that it's surrounded by so here you don't always use that cannon you but you use the can and when the words appear in a lists where every other word shares a common meaning and so here i'd like to but sometimes all the words in the list don't share a common meaning right and so constituent isn't necessarily the same as the others you've mentioned and so this is what the canon is used for when you have a particular contested word in the party system agree about its meaning you look to every other word in the list and you say ok we'll admit that that one we're not sure about let's look to all of the other ones in here concentrate orange juice concentrate concentrating on one tab light something that's been metabolized within the plant an extract metabolite has to be extract commercially extracted well metabolite is usually something in a plant that's been brought about by the plant's metabolic processes so what kathleen is an example of plant will produce caffeine is part of it's not a taboo but again my question is commercially extracted that's usually how it's done yes so but it has to be done yes because if i can explain on this point all these other words and all of the history of these dietary supplements are things that have been physically extracted from plants and obtained by them that's what that's where the concern is what's new and what's the edge case it's not even the edge case it's kind of just a different category of cases is something that's merely been detected in a plant in the process of effort detection if you read the plumbing and we studies as it take a solution of dreams  they vaporize it into a gas and then they look at the gas to determine what chemicals are in there you can't use that gas for any product you can't put that in a pill it's never been obtained from the plant and so all of these words go to show that it's never been obtained there is no evidence to that the only evidence that the claim on this point was a patent applications which as we explained we think that every incentive to develop earlier understand what you're saying and they got a certain intuitive appeal to say something that's in such a small amount that it's not practical to do it and then i understand all that is i want to ask you about this notion that it has to have been done that the history of it is somehow the controlling factor  it's fifty percent a b c magic dust but nobody has ever harvested the magic dust and made a dietary ingredient out of it and somebody comes along in the laboratory and makes a supplement with  c magic dust but it's never been taken out of the draft you a tree why isn't that a dietary ingredient well i think what the such you contemplate previously in it is before we get to the other words and  subsection off is previously it says you can just use the plant itself the herb or other botanical so if something was present in such those high quantities i would think that there would be a way that you could just use the plant itself or could the could never hav is is how did the disk you know the district judge says what has to have been done and i can't find that in the statute and i don't know why in my hypothetical that would be the test so i would think that it's the way that section three twenty one both the the term works defining food additive in essex on what's not a food additive and f f one go to this f one says you are a dietary and greedy and if you're used or intended to be used in a dietary supplements and for food additives it says food additives are not an ingredient that's in your intended for use in a dietary supplement so i think there it's talking about a process where you're actually going to put this in something to sell and so then reading all of the other words the concentrate the metabolite the constituents those are all processes where you are obtaining it from the plant and so i think we're not reading anything into the statute we're reading it as a whole to understand how these terms apply here issue of whether or not this is generally recognized as safe i point the courts of the fact that high techs own two experts agreed that there isn't sufficient information on the magnitude of association between consuming dma and adverse medical this question about reversing and rendering if we disagreed with you on the legal question about what this means i had come in thinking you would be entitled to a re man to prove that it was actually unsafe mr namin tells me that's not wanted to get your position on that i think at a minimum if you disagreed with us on the threshold legal issue we would be entitled to remain to at a minimum litigate the issue of whether or not  a is even present injuring him because as we noted the district court never made an explicit holding on there and then i guess the subsidiary question would be then is it unsafe i believe that's provided for in section three forty two  f two i think is the one where it says some dietary greens can still be adulterated or they can pose a serious risk to health and in that case there's still a seizure option available in his response wasn't that the statute wouldn't allow it but that you hadn't pleaded it i know that's correct we didn't plead that in our amended complaint because we argued that it was an unsafe food additive why isn't that the end of the issue then well i think because the you're the party going it's present in dreams at all and i think we need to think about this little bit more maybe there's an issue about whether or not we would be entitled to an amended complaint but i'm haven't studied this early so i don't wan to commit to a particular answer because i'm just i'm sure of it at this time thank you please the court first in response to the questions that judge jordan was asking mr aguilar my client certainly was prejudiced by a lot of things in this case and one of them was the district court's imposition of the interpretation the statute that even the government had not proffered here the government says it was in consequential because we there was this evidence of patents in the record but by the time we got to the point where the parties could have followed up on that there was no need to do so by that point discovery he revealed that the various studies from the university mississippi and the university of texas that the government had premised this entire forfeiture on had in fact revealed d n a in the geraniums there was simply no need for my client to follow up on the patents at that point in time but didn't you have every incentive i mean you didn't you didn't know you were going to win at that point didn't you have every incentive to find and present all of the evidence you could on whether this product had ever actually been derived from a plant and in what quantity you found the patents and if in fact they had manufactured the product based on the patents wouldn't you have been the very first court found below they had in fact done so all of the the studies that the government had relied on turned out to be flawed and had revealed d n a in the in the plants but if we sent the case but if we in on the through the judge jordan's questions asked we send the case back and have some discovery to prove that this has ever been done the don't you think a year from now we're going exactly the same place we are now and if there was evidence of this ever been done you have already found it would you  well i can't speculate on the answer that question i feel quite certain that my client would at the very least one an opportunity to pursue that theory and to defend itself against this interpretation of the statute that the district court adopted that said i don't think the court needs to go that  that direction and that's why i've asked the court to to remain and with instructions to grant my client's summary judgment motion all of the evidence below show that d n a is in fact in geraniums the government had not satisfied its burden of establishing that d m me a is not naturally produced in geraniums so i don't even think an re man is necessary but at a minimum that would be required judge pinkel you had asked some questions about the definition of a constituent but if you look at the government's own definition of constituent it is very broad it says a constituent is a is a is a is a part of a complex whole and it refers to the constituents of a chemical compounds so in other words hydrogen oxygen would be constituents of water under the government's theory under that theory d n a is well within the constituents of the botanical in light of the evidence that was in front of the district court i understand my colleague mr apple are to have conceded that caffeine is a constituent of a botanical and rightly so but it occupies the same place within a certain plants that that d n a occupies within a drain according to the the only evidence that was in front of a district court in this case mr aguilar said even if we agree with you on the definition that the government's entitled to a trial on entitled to a trial when they know i disagree with that assessment the evidence and here is why that evidence is based soley on the declaration of dr paula brown from the university to university of british columbia in her testimony she does not say that it's impossible for uranium to make d n a and she says that there is no known biological pathway by which plants could make d n a but the evidence is and there is evidence that this isn't fertilizer and that that could be the source end of the day the government has the governor has the burden of proof here it's always had the burden of proof and it needed to establish if it's theory is that bird allies or it's causing the d n a to be in the geraniums it needed to establish that in this forfeiture proceeding where it sees two million dollars of my we're going back to judge ingles question isn't the government experts declaration or deposition viewed in the light most favorable to them enough to create an issue of fact you're a summary judgment you're not a trial you know that's certainly the case judge or in that weird summary judgment and they're entitled to have every inference drawn in their favor here in the context of our summary judgment correct but i don't think that drawing every inference in in favor of the government here gets them to the point where they can get past  judgment again they have the burden of proof that this is a forfeiture proceeding they're seizing my client's property we understand the government has a burden of proof the point of the matter is both sides told the court that this case is ready for summary judgment on both sides proof the first place well i think it does to the extent the government has the burden of proof because they brought the case that's correct and now we're talking about that about what does this statute mean one of these words may correct but i think in assessing