doctrine exception to the general principle that a court is obligated to decide cases within its jurisdiction the doctrine should only be invoked in a very limited set of circumstances none of which exist here the issue of whether defendants are fancy advertising products containing australian is not an issue of first impression and not a particularly complicated issue that is committed to the f d a standpoint of claims rest on determination ok so the complaint alleges i am mag's products are misbranded and then walk away marketed as dietary supplements and that the products of prescription drugs or new drugs and or the  is issues within the f d a is regulatory authority and expertise and if not why not all the clear claims do not rely on those specific allegations some context here but i don't think our claims or the allegations concerning me at dca are not critical to the claims so for example we've offered to amend the rico claim i think we have alleged here that their sales have been diverted that remained so i guess are you saying you can't say anything more sal either it you rise or fall on what you've already said on the rico claim one more point i'd like to make if i ok if i still so the united states supreme court has made clear here that private lawsuits under the lanham act like the one issue here are critical to protecting against unfair competition and deception in the market the prototypical false advertising case between competitors what it is is a case involving violations of the food drug and cosmetic act as well as a case that requires determinations under the food drug and cosmetic act as to whether austria is a new drug a per script drug or have been mis branded as a dietary supplement the district court correctly applied the primary jurisdiction doctrine in this case and ask you this though and in its supplemental briefs ira mag argues that the recent warning letter from the f d a is not significant because it's not final agency determination why is agency action significant for purposes of the primary jurisdiction jocker and only if it constitutes a final determination can you point us to any cases supporting your views well this boils down to as a practical matter what that means is while it may communicate the agency's position on a matter it's not final that it may change there's no one for spain action that needs to be taken and so as a result of the lack of enforcement action there's no legal consequence that flows from the letter there is no rights rob legations that have been pre determined and you can see that outside of the ninth circuit in the d c circuit case of holistic candle layers where the f d a actually filed an amicus brief before or excuse me in response to the petition for cert before the supreme court on this very issue the second reason is that as a practical matter when you're dealing with violations of the f t c a issue such as a misbranding or misclassification of an ingredient in whether something is a new drug a purse christian drug those are issues that are firmly committed to the f d a suppose we take  r allegations of the a misleading conduct well take for example your honor that the allegation that something is safe and effective the way plaintiffs would prove that and the support for to this is it's important to look at what's actually alleged in the complaint and an allegation that they would not necessarily deleting so if you look at the supplement supplemental excerpt of record i believe it's page two forty four paragraph twenty nine this is what the allegation says it says the f d a previously concluded that products like auster in our perception drugs and therefore present significant potential safety risk to consumers who take them without supervision what plaintiffs are essentially argu y record it's footnote two and their opposition brief and they what they actually say and that is to the extent that the primary jurisdiction doctrine applies the dismissal should be without prejudice appellants did not phone no your honor again similar reason it's because appellant's never raise that argument down but that's what the primary that's what the doctrine says either dismissed without prejudice or you stay at right and foremost is under the syntax decision the court observed that when the remedy contemplated is a referral to the agency to get an agency determination just as what it is in this case  missal without prejudice is the proper remedy the second reason is you have to look at the arguments before the district court on this issue there was no allegation of unfair disadvantage or prejudice that would support an entry of the stay in austin yana the reason why the district court was reversed is because the district court failed to consider those arguments not that those arguments were not made it would not be an abuse of discretion for the district court to not dismissed them because of the failure to provide proximate cause ation but the rico claim as as a matter of law it's deficient no amount of amendments no amount of ploys is what insufficient to allege that your actions diverted sales to nutrition and cause economic injury as a result of the why isn't the us vision and legation well your honor it doesn't meet the strict standards for proximate cause ation under section one thousand nine hundred sixty two c under the holmes decision the supreme court imposed a strict proximate cause ation requirement and since that decision the general tendency get not go beyond the first step and you see this in the hemi decision as well and what that means here there's there's actually two separate defects what that that the appellants could not cure the first is that plaintiffs cannot allege that that they that it was directly injured courses that ensued when we were our sails were diverted to you meg right now if i'm a salesman and my seals are diverted to someone else that's nonsense that i've been injured well your honor under the supreme court's decision in homes that is not enough near where i live to say the sales were diverted on monday tuesday enterprise is here the target of the enterprise are consumers consumers are the ones that have been misled not a competing supplement company because the nutrition distribution is not the target of the enterprise or the brocade decision as well as the home's decision which the supreme court discussed this very issue it's plainly insufficient holmes said when a plaintiff complains of harm merely flowing from misfortunes to a third party in this case the consumers hurt correct that's correct your honor however this then goes to the second requirement of proximate cause ation which is a measurement of the directness between the injury alleged less a matter for expert witness who come up and so yes they have the only sales before you of the injury between the lost sales and the misrepresentations are clear in the onset decision it's on first ideal steel supply corporation that the supreme court decided in two thousand and six it's highly instructive on that point in that case what you had was a defendant that was filing false tax returns with the state of new york that then allowed it to lower its prices and capture market share what the supreme court said was that was too many cars a link so that's where at ten you waited then the facts here that it's not it's not directly on point correct your honor they're there and when you're asking us to do it on the pleadings and not give a person at least chance leave to amend that pretty you know it we would have to be able to say as a matter of law it would be futile and your honor respectfully it is well that's your point ok that's your we've gone over time unless an you a lifeline and you jumped out at and now you've heard why they're they cited a case that said you're really it's too speculative what you would allege when you address you should be given leave to amend on the rico cop