education act does not preempt mr durham for its claim here that by advertising the arnold schwarzenegger iron mass protein product to have twice the amount of protein that it actually has milk muscle far misleads consumers in violation of california law his lawsuit does not proport to impose a requirement different from federal regulations even assuming congress intended to preempt such a claim in the first instance nor is it rational reasonable to require him to perform a rigorous regulatory style twelve sample testing protocol to satisfy that protocol in order to survive a motion to which he eventually need to muscle farm so it would not be a situation where we would have to do an f d a regulatory style investigation we would know how the product was produced is that because you just jump to a different form of your claim so i understand that part of your theory is that this protein isn't really coming from beef and lactoferrin it must be something else that's different than what you started with which is that they're listening twice as many grams as they should be listing that's a different thing one thing is i different type of protein and then there's the question of how much protein so when i asked you the question about what kind of testing you would need you jumped from quantity to type as i understood it i thought maybe i'm not can you correct me if i'm wrong well i would guess the two are the two are related right because if we're talking about what is actually digestible protein so so if the composition is these these nitrogen and hansing filler products then that would affect the total protein content overall and so you think you can have a claim for getting whether it's beef and lot different just how many grams of protein are in this product you think you can win on a claim about how many grams of protein are in this product without using the f d a is testing method yes your honor even though you started with even assuming i think you said even assuming it's not create what was your are you challenging that testing method as valid in order to say that you don't ever have to show what i am i am challenging it as valid for preempt for preemption analysis and the reason that we challenge it as valid for preemption analysis is that no consumer could ever satisfy it right now at least that has to do with the pleading stage so i asked you about whether to succeed on the claim ultimately i think ultimately taken to succeed on the claim we have to show that the protein  in that protein in the muscle farm product is not what's represented now the fact that the f d a independently does this test as a as a regulatory compliance mechanism does not determine whether or not the protein representation of the thrust of your argument to the twelve step process was you you as a consumer have no ability to be able to use that process in advance of filing a complaint and because of their twelve separate units that have to be extracted and your suggestion was we need to go through discovery which would permit us the opportunity to go through this particular testing i thought that was your main thrust at least in your pleadings now you're suggesting that even if you got past the motion to dismiss you wouldn't even necessarily try to adopt these particular protocols correct your honor there's sort of two questions plus it in that and the first is yes we say that if the requirement is to do the twelve sample testing we would never be able to do it without without some form discovery that is we would never be able to do it unless we knew  it's a required it is only used by the f d a in those occasions where the f d a seeks to do a compliance analysis it is not required and sorry ok but yes so it's not required as it's not some sort of pre approval test if makes if that analysis makes sense but if your argument is that they that the company has not complied with f d a regulations you would think you would use the protocols that they've set out to establish that position we could if we and i'm  foreclosing the the i'm not foreclosing are doing that test what makes it difficult however is what the tests actually requires that that's true at the pleading stage that let's give you that you might have to do it at the pleading stage i'm very confused why you don't think you ever have to do it can you explain that because it is not it is not a test that a manufacturer has to do to produce to produce the product so it's a regulatory it's a regulatory analysis if you will a regulatory check but it is not it is not in and of itself it is the way that you show the product is in compliance with the regulations and your position of course is the product is not in compliance with the regulations so it seems to me self evident that you'd have to go through this twelve twelve step protocol well i think that's let's let's concede that for us for the sake of your standing is that you're not really i thought that you were focusing on number three now number two forty grams of opponent blend of hydrology ice beef protein and back to firm protein and saying that in fact there isn't forty grams of those two things together there's actually only twenty grams of those two things together which has nothing to do particularly with doesn't have direct me to it implicates the protein spiking but it's not directly the protein spiking and therefore a kind of not testing testing whether or not they complied with regard to the protein spiking one kind of anything anyway well that's correct that's sort of the second part of the second prong of that of that analysis is that when muscle form chooses to make a separate representation outside of the nutrition box that is regulated by the f d a and that representation comes there's actually a misrepresentation on on a different part of the label and then there's another misrepresentation in the nutrition box that they added then we've come we've come completely outside of what we're talking about in terms of the twelve sample testing because we have a completely different misrepresentation that is not required by  its role but you know challenging that well in fact we are challenging that we were challenging that from the perspective of and it's actually in our first amended complaint right in the introduction where we have statements from the f d a that they never intended for a manufacturer to be able to use the six point two five percent nitrogen measurement as a basis to misrepresent the total digestible protein content of the product that was not for that purpose and i guess you would need to be able to demonstrate claim i do i do think that what's going to happen is once we once we establish the claim is not preempted we're going to be able to obtain discovery about how the product is manufactured so for example the product formula and whether or not we in fact have what our single test verified which is that there is a half half of the actual product protein scuse me in the product is real protein and if that is true of that though what will you do in what you're going to get the samples or what will you think are those out i think this is so we would have to get if we're talking about complying with the twelve sample testing i just want to know what you think you're going to do to prove this claim you're going to get discovery and what are you going to ask for and how are you going to prove that this is false we are going to get discovery i would say document discovery on how the product is produced what the formula is we would get discovery a sense of the testimony from from persons most knowledgeable relative to the how the product was developed we could get tests and i would assume all that would be but like all intimately you're going to have to translate that into grams of protein and you're going to do that some way other than the way the f d a says to do it i don't understand quite how you're going to get to show that it's false i don't know that we would have to do it in some in some other than the f d a i think the problem with imposing the f d a requirement is that we have to know we have to know specifics about where how the product was shipped so that we can get twelve samples from different shipping cases we i'm saying well i won't i won't foreclose that here we could we could do that if we can get samples that somehow satisfy the specifics of that requirement but i don't think i don't know that that's going to be possible because i mean it certainly wouldn't be possible without information from muscle pharm perhaps they've done this testing independently and we sit here right now not knowing any of this so when the district court judge is the approach of protein content basically suggesting that six point two five is the standard laid  out the f d a that in fact nitrogen is very much a part of that test suggesting that your claims would impeach were would discredit that particular approach and therefore it's preempted but then in the protein composition said that there was no preemption and yet you in your briefs have basically suggested that the judge should never have made that distinction between protein content and composition why is that well because they're in essence they're the same they're the same claim from a consumer perspective there the claim that what is represented on the label is not an accurate representation of the actual protein in the proud whether that is because filler and the measurement or you know whether we call that a composition claim relative to the to the measurement using nitrogen or whether we call it a protein content claim relative to the representation separately on the label that this forty say that that the protein composition which is the six point two five thousand i was ok ok so so that measurement we would we be able to continue on the claim if if that were only if that were the only claim we were making i think that we could because we still have separate misrepresentations the focus of the separate must be that that there's forty grams of two proteins but now you jump to a different climb right that's you added the of two proteins which gets to the other form of your claim which is what the type of protein it is or where it's from what you can measure i mean you measure the forty grams of protein in some way it's you're standing also what i mean they're they're saying forty point but i but you're also as i understand challenging the the official label correct and that you can only succeed if they're not complying with the f d a well not the way they've designed the label because remember at the end though they've also added something to the label itself they've added this muscle plasma proclaim i understand to be not the official label the official label is above the line were ok so what if we're eliminating the muscle plasma diet right now that we have then the state there's the simple protein statement and at that point the reason that that does not itself become preemptive is because i go back again to the fact that in particular to this case at this have independent misrepresentations oh i didn't know that's that's different but if you really want to go forward on that on the official label and the protein spiking then that piece of it it seems to me we have w any case law at all and whether the f d a this is in fact what the what the f d a regulation means i am i'm out of time here but but but there is the only case law of the of the analogy that analyzing what the f d a means in regard to these regulations that i'm aware of are the many district courts cases that we've that we've cited in the brief so there's a debate about what the f d a means a lot of those are coming in that is in the in the motion to dismiss context i thought it was generally understood that in fact allow for the measurement of the protein for f d a i have some plans to be to be based upon the six point two five percent they do not allow a separate misrepresentations in this and can i ask one question about the separate misrepresentation so your test that you did you did some kind of protein test clears it are we supposed to read your complaint to suggest that if the protein had all been from beef and lactoferrin the test results would have had to be higher and test correct it would be it would be it would show up as i believe it's digestible protein and that in that test it would show up higher so did you allege that beef and lactoferrin is all digestible protein and did you allege this this the logical connection that i just asked you about believe so i believe that's paragraph thirty of the first amended complaint i think where we allege that that the testing we did show that that this product only had a certain amount of digestible protein relative to relative to the non digestible filler product and but i'm asking you whether you have ever said that beef and lactoferrin are all digestible and thus any protein gram from beef would show up as a full gram on the test that you conducted i don't think we were that specific in the first amended complaint no your honor ok thank you very much s good morning your honor may please the court my name is michael suffern i'm with a law firm of all men burn in cincinnati ohio and i represent muscle pharm corporation i must admit that hearing councils argument presented a case that i didn't really see in in the first amended complaint or in the briefs in this case and indeed it presents a case that goes well beyond the holding of any court that has addressed the issue manufacturer is specifically permitted to use in measuring protein first of all it assumes there are non digestible it assumes they have no value it assumes contrary to the naproxen i'm sorry i well your honor i think that what this brings us back to the statute as opposed to the regulations and i think that this is a very important point that maybe we even missed a little bit in the briefing twenty one u s c section one hundred one point nine c seven clearly permits mussel farm to declare the amount of protein based on including the six point two five times but the stats show regulation at the center right the statute requires manufacturers to state the total amount of protein if a manufacturer has protein in its product and if a manufacturer manufacturer calculates total protein in a way that one zero one zero point nine c seven permits it to a manufacturer must under twenty one u s c section three forty three q one the state the total amount of protein and they have to call it protein your honour's under twenty one u s c section  have to have and you don't have to even go to know what i was saying your honor is that if a manufacturer did use that method that that it specifically permitted to use and if the test result came back and showed that using the method that you did that specifically permitted by regulations for you to use you get a number that you have to put that number on the label otherwise we'd be in here on a false labeling claim where where stating where we're differentiating between the sources of protein on the label and the teaching of the case law is that f d a does not permit you to do to be does not require manufacturers to differentiate between the sources of protein i as i said before i was not aware that there are actually challenging kiran the notion that the f d a regulations  uses it is one way i guess to read the regulation an odd way has the f d a i gather the f d a is and has suggested some just comfort with that but has never actually written the regulation that is correct your honor and i actually i'm not aware that they have expressed discomfort with it it is what it is it's a regulation that permits manufacturers to include the nitrogen content in declaring the amount of protein and you don't have to say though that the amount of protein comes from beef and lactoferrin we do not have to differentiate on our label the sources of the protein but nor did we have done in this case and that when you don't think the label tells us that the protein comes from beef and lactoferrin we think that the differentiations on the label are our classic structure function claims that they address the the role that the different them by saying that it's both it's both in the panel in the supplement facts panel and elsewhere on the label and what i'm saying is that the only differentiation regarding the sources of protein were intended to serve a structure function claims these kind of think of reasonable consumer would read forty grams of a potent blend of hydrolyzed beef protein and lactoferrin protein as meaning there are forty grams of protein from beef  false and we want to proceed what is wrong with that well as every court that has addressed this issue has held whether they've held it as a pleading requirement or as a proof requirement when an f regulation requires that the question of compliance must be determined using the method specified i'm not sure i would let's say you're going to win on whether the f d a label is accurate because you think we've done a test that shows this isn't really beef and lactoferrin well they might be able to bring a claim like that if they plausibly allege that the test upon which they are basing that claim could  form a basis for liability if and so there they say they've done a test they say they we've done this protein test it shows that there's no way that all this protein they're claiming is really from beef and lactoferrin so we think this label is false  what is your problem that the test isn't good enough and if not why can't that be fixed with amendment or later discovery i'm not sure what you're saying they're not there are two problems with it one is that the entire theory of the case including the theory of the testing is that we're going to prove this by and therefore seek to impose liability on muscle farm for doing something that you are explicitly permitted to do by the regulations  lactoferrin thing that you didn't say the beef in like affair and things so why can't they challenge that is false well if i could get back to your original question which was and give you an answer the second part of it why the testing is non compliant this test if you look at the test in the first amended complaint it doesn't even identify what the product is it doesn't identify what methods were you don't we so ok so we could i mean maybe the answer should have been that there's not enough specificity about the top why do you have to start honing in on more details and simply making their their pleading just pleading more onerous and then there's throughout this calendar you will see a great reluctance to anybody ever getting to testing protocol requires that the company prove if challenge they're trying to prove something different they're trying to prove that these two particular products are not making up the protein that one even be a question under  the protocols because that's not what they care about so it's not this it's apples and oranges in terms of what they're trying to prove and that's why we think it gets to the heart of the  every court to have considered the issue has at least issue i e if you say we have protein made up of a protein and b protein and we have forty grams of it that that is can't be to test it however one would ordinarily test that and i about you didn't answer my question suppose you had a label that said forty grams a real protein not just nitrogen tested protein that would be a threadbare allegation of a violation of the consumer protection statutes with nothing more anything more if they do testing i mean what if they do the twelve the twelve sample test before they file their pleading and they say we've done this test that we can show it then we would have an entirely different case your honor and we would not be arguing real preemption but here could i ask you a different question so if they if we think the states a claim about whether there really is it's all beef and lactoferrin and they get discovery and they can get your formula and there's no beef in there at all do you think that claim is preempted i don't think that claim is preempted but i don't think that they are permitted at this point to go on that fishing expedition and this the jury this case was dismissed without prejudice your honors and this content which is suggest this preemptive because of the six point two five required use and then using nitrogen as a result that's preempted because it puts at risk the very test that's being used and but then the composition argument suggesting that are there in fact is not preemption because there is no definitive requirement by the f d a that you actually list where the source is of the particular product so as a result at least as to that fundamental approach that was made by the district court you agree basically what you want to say is that the protocol is required and that of course was not done here but that becomes an issue of pleading versus  know application of the protocol some time later but at least as to the way the district court approached this i think you would agree well you know i don't beat just because conceptually there is no fair way to read the first amended complaint in this case without reading it as an indictment of one hundred one point nine c seven and the very test upon which they purport to a lie they appear to admit although we can't tell because there's all there is is a table of results but it appears except thing is true their theory it also appears to comply with one a one point ninety seven so so i don't conceptually agree with what the district court did but i do think there is a path to plead a misrepresentation claim they just haven't come close to noncompliance but the compliant testing is not to test this i think it's not to test the composition question i understand that they had he said clearly today that he is also going at the other issue but as to this part does it have beef and whatever else that isn't what the testing was here and the regulation says that this is to test whether there is compliance with the f d a requirement he is not claiming as to that noncompliance with the f d a regulations he's claiming something else so it's just as i said before apples and oranges but but but it's not in the sense that if the california state law claims were permitted to proceed in the face to face of a federal statute that said noncompliance can only be but as a different noncompliance they're not saying one can they are partly saying noncompliance with the regulations but they're also saying forget the regulations this says forty grams of a and b and there isn't forty grams of a and b and the regulations don't talk to that but therefore when i try to test compliance with the regulation they would still have to prove that claim right but why do we have to work in is about that but it isn't the total i think another way of phrasing the same question i think is following the f d a testing it is never going to tell you whether it's beef or not right following  each of a different law a shipping container that is representative of a lot for the composition of the protein as well and if you and if you were going to prove a mislabeling claim under california law based on that theory you would follows yes sure it's not claiming noncompliance with this section so he does what does he have to do it this way because if he if he's allowed to hold muscle pharm liable under california state law for something less than what federal law requires now something something different to watch is what exactly excuse me what exactly is in the product is there actually forty grams of beef protein and some other kind of protein and again twenty one u s c section three forty three point three prohibits states from establishing any requirement for nutrition labeling of food that is not identical to the federal law does the federal law have an approved method for testing whether something is beef no your honor not that i'm aware of how about whether it has a way of testing whether it's lactoferrin not that i'm aware of ok so we don't have a federal test for either of the claims that is putting aside the grahams this says our protein comes from beef and lactoferrin if we read it that way th he can't do a federal test as there is no federal test so don't we have to i don't know either way oh no he can he can he said he would still have whatever test he chose to to do in an attempt to prove that would still have to comply with the requirement basically said the protocol was required and frankly they couldn't do the twelve protocols so if they actually were to amend they couldn't amend it in a way which would have been acceptable to the court because they couldn't do the twelve step protocol so as a result they appealed i think to actually criticize them for not for not trying to amend to resolve some of the issues that you're talking about is not accurate because they couldn't amend that to satisfy the district court frankly your are two things on that one is they they certainly could have alleged that testing done pursuant to one hundred one point nine g forget reliance they for their they gave up they abandoned the opportunity to allege to to plead reliance which in and of itself it is a reason to affirm the district court this court's jurisprudence that permits plaintiffs to appeal motions to dismiss when you leave to a man was granted is founded on the notion that if you do it you must stand on the sir if i may say first of all the reliance the alliance will be the first thing i address very quickly the district court addressed reliance only in regards to a separate claim what they called the night with the district were called the nitrogen spiking claim otherwise there was sufficient reliance to get protein composition and protein content forward the second point i will make is one question that has never been answered in any of the briefing to date is how on earth a plaintiff is ever going to satisfy one  one point nine g two at the motion to dismiss stage they don't have access to production facilities they don't have access to shipping containers there is no way to do it do you need to allege though that whatever test you did do is equivalent to  to what the federal test is that once you do get twelve samples the result will be the same no your honor because that would be i may have at best that would be a speculative statement in and of itself but by the federal test i mean as written in the r allege that a that that there is less protein in this product than advertised and that forty grams of two proteins we did a test it showed half but i mean your test was let's look at the blue or red that's not going to cut it right so you have to say something about how  your test is getting at least close to the test you don't really have to do to win don't you i don't believe so i think we have to show a test that answers the question of does it consider this really this consumer have a reasonable belief that there's been a plausible claim that there is less protein th represented and there's no there's no way to you know conducting this one test if we're going to talk about the merits of the test that again takes us beyond motion to dismiss in any event we question them we question the methodology and we question whether it goes whether it satisfies the