a dietary supplement under state law differs from the suit drug in cosmetic act the answer is clearly no it's the same standard under both whether advertising is true or false is causes of action and in fact all state advertised causes of action are preempted as a matter of law the standard used by the district court is that is is that a structure a structure function claim a dietary supplement structure function is established as true if there is any evidence at all if they said it has any or the company has any evidence at all that the product is effective as advertised was evidence was not even in the record because the stage of the proceeding so the court do you think a court was really saying that any proof is sufficient that they're doing it in a way to court i do yes i do because it wasn't that she thought they were approved it's that she thought there was a different standard of proof for ultimately determining whether the claims are true or fa they're supposed to have already reviewed all that to the evidence and have evidence based upon the way the evidence are true and have certain disclaimers the f d a only will come back in and unless there is a difference unless state law imposes additional or different requirements state laws not preempted so it's not a it's not a safe harbor provision as defend i don't have to produce studies defendant has to come forward and prove the claim is true and that's not its case even on the pleadings you can see it we have a lot of evidence showing that the structure function claims are false me it's not entirely clear whether this is a disease claim or a structure function claim i believe what the judge did you look at her order it's really the last two pages st she says these are not disease claims these are structure function claims and that's our nd issue up there but she st separates out these are not disease claims so she's looking only at structures she says after the structure function claims aren't those preemptive she said factual determination look to any factors and then they look at how consumers actually read the advertising and we and for instance t v s post on their website testimonials consumers saying they used this product for describe the role of a nutrient or dietary greedy and intended to affect the structure of function in humans or characterizing the documented mechanism by which a nutrient or dietary ingredient acts to maintain a structure function what that means is that a manufacturer can advertise on its labeling and that includes the bottle the box signage other kinds of consumer facing advertising i may venture may advertise that its product provides such general supportive properties for ready a structure function of the body and so the f d a interpret in the statutory language has said that terms like strengthen reduce improve modify inhibit protect and defend are all permissible structure function terms so long as the terms not suggest disease treatment or prevention  bottle it's in a box with the label and the box are fair game lets say that that box is on an end cap of your c v s store at that end cap has signage what's on that signage is fair game let's say c b s runs an advertisement in a publication and it says something different on that occasion then what is on the label self advertising is fair game and to point to one thing that plaintive is actually in vote here the picture of the two elderly people smiling walking happily on the beach images are also fair game if they're on the labeling so get any kind of consumer facing advertising but what the f d a would special requires and the f d a does is they look at sum total of that consumer facing labeling and then determines whether or not withstanding precise words used the labeling somehow implies disease treatment and what does the f d a look at that and make a determination as any labeling could be because it not only uses what it uses the safest of the terms that the f d a in the federal register has told us that we can you use the terms supply so if the f d a doesn't  in there for michigan it was denied well i guess if i could if i could respond to both parts of that question st of all even though the f d a doesn't pre approved the label claims manufacturers example what kinds of claims are structure function claims what kinds of claims are disease or imply disease claims and those are the guy posts on top of that once the notification goes into the f d a the f d a can respond and in fact this court has before in the absence of record i believe it's and age of sixty eight to seventy eight there are some warning letters couriers letters from the f d a back to manufacturers regarding certain claims once the f d a responds and says court with science in hand and that would include at the pleading stage the plaintive has to plead that he or she has science that refutes the precise claims made on the labels so this is why the outside said that it's important to properly categorize these claims as either structure function claims or implied izzy's claims because if they are true structure function claims and again they are they are as clean as f d a comply if you see a compliant as any claims could be if they are proper failed in and it's not because they just report found as much he tried and failed because his science was a mismatch to the actual claims made and this goes back to the he alleges in his complaint that his studies actually focus doesn't stop pain but also does doesn't support general joint health he has to explain how those studies support is challenge to the label claims and i guess one way to look at it is that plaintiff has effectively pleaded himself into preemption because even beyond the titles of the studies his own descriptions of the studies make clear that they are not appropriate studies are challenging the general health maintenance and support claims on c b s s labels so to give you an example an appropriate study that would be a mismatch in this context would be a long term study with a lot of individuals a control group and a test group and that study would measure the overall health and level of activity over time of the test group versus the control group and even if you look at plaint is only descriptions of his studies and then on top of that look at the titles it's clear that he is that those studies are not being exclusively healthy individuals and conducting a proper agrees the one study that seemingly comes the closest is far as having the right kind of population study study the effects of m s m which is a chemical that's not even in the product and should be here so the force that it can you make these decisions on emotion under twelve is six i don't understand that given what you just said because if the plate has the burden to allege what you're saying is that the legal what they have to if you just elevated that study to a legal requirement you know they don't have that kind of study that you just articulated they don't have a client that's correct and where does that come where where where look at me if the act our says that in order to go to trial you have to have studies that match the label claims it logically flows from that at the pleading stage you have to plead that you have studies that actually challenge the label claims if with science that actually attached the label claims and he has to do so because if he doesn't it turns this case into an impermissible lack of a lack of substantiation case that would put too much of a burden on the manufacturer and result in alleged i have studies that challenge the label claims actually made here they are and if clampett actually cited even just once thirty that was sufficient and that's the label claims then we would be moving on but all four studies is a safe harbor regime that we are operating under meaning if the manufacturer complies with the federal standard then a plaintiff's suit seeking to use evidence that goes beyond what the federal busy requirement implicitly imposes an additional requirement is printed and it's that implicit part that if the plaintiffs is essentially using evidence that the f d a would not consider then their claims are preempted or that respect with the players trying to do each woman was absolutely proper here part of it is that plate of studies are mismatch and that plaintive has never proffered despite or opportunities to do so that he can come forward with the kind of appropriate study that i mentioned or you are briefing is being consistent in this case we laid out in our motion to dismiss exactly the argument that i'm making here today we said you need you know a study that matches your studies don't match plaintiff opposed but he never came back and said oh registration but not determinative of the challenge though is that it is because basically you know in order for plaintiffs to again not be implicitly trying to impose a requirement that's different from the federal standards he's he basically has to stand in the shoes of the a and so if the f d a says we're still look at the label labeling that the plate the plaintiffs isn't entitled to look at things that go beyond a label label that would be inconsistent with the federal requirements and therefore preempted so k thank you i'm going to start with my opponent left off which is we should knock it lead to event to allege facts supporting the disease claim because whether a claim is structure function claim or disease claim you determine that only by looking at the labeling well that's not true it can almost inherently not be true in claim because it's implied  apparently did not agree that you had alleged deficient scientific evidence to or about the structure function claims are on the label and that the that you referenced the district court did not match the claims argued we shouldn't have to present evidence in a false advertising case a law should be should that burden shifted to dissent well the court said no the law is plaintiff has the burden of production and the burden of proof we agree