of jurisdiction not necessarily compel us to have the same so i wouldn't appreciate if you could argue years absolutely right that i will start with jurisdiction ok isn't the statutory language of thirteen thirty seven c crystal clear determination the commission under subsection d f or g of the section may appeal such determination within sixty days after the termination becomes final two united states court of appeals for the federal circuit for review in accordance with chapter seven of title five and then you have to any and your honor what you might be referring to is not in c but in the where it says indeed if the commission determines as a result of an investigation of the section that there is a violation of this action it shell excluded from entry so that the do you want is exclusion of articles from entry and then f is seasoned desist orders and our point your honor is if you take a look both at the engine decision and just generally the idea is that commission negative determinations are also  are positive determinations and the practical effect of this decision here are going to determinations for example if they get through an investigation and they decide not to articles from them that we are clearly at step one but you're on to what i would say to that in this gets to my other points of why you have jurisdiction is that the commissioner is why you left your firm for your pure honor because for exactly the reason i'm going to explain here which is that this is a requirement that the commission has one issues if the what we did put in every visit the commission has a mandatory obligation to initiate an investigation the commission can't digest this for the first extent by avoiding that mandatory obligation and then going on ahead and saying well because we avoided that mandatory obligation now the court has no authority to review congress contemplated both that this court would have authority to review final decisions and second that except in limited circumstances specified in the regulations to define what it calls a represent complaint in a case and they have the right to make that determination not foreclosed by the language of the statute and what they did is say the complaint here  could so yes there are what i would say is those gap filling regulations relate to the foreman and the content of the petition like a procedural requirements they don't rely on those regulations to say that this complaint can't go for what they rely on and you see th the regulation set forth in which case they will dismiss without prejudice and then the party has the ability to plead in order to remedy the defect the problem here is not that they so when they use the word properly filed it's not properly filed in the sense of that somebody files  investigate based on a legal error and you are allowed you're saying they have that authority that you question is that they have the authority to not decide not to investigate and to make  the claim for its efficiency you're just saying they're wrong and therefore we have to prove that you're out of it if i may be a little more specific about that we think there are four situations where the commission can decide not to investigate in this is not one of them one example we're talking about is a properly fall complaint meaning complying with the procedural requirements that's a dismissal without prejudice the other ones are specified in the statute three three seven itself when it involves an anti dumping issue or whether in alleged copyright infringement that's three three seven b and then under this court's decision and john there are the bell the hood reasons which is if it's wholly insubstantial or frivolous or if it seems like it's irrelevant it's just there to get jurisdiction those are the only situations where the commission can decide not to proceed here the commission decided not to proceed based on a legal conclusion which we are submitting to the court is legally wrong because it's going into the system with the way that palm wonderful looks at the statute and as a result it circumvents the obligation of the agency under the statute to initiate an investigation so your honor let me just if i may just finish the thought is that even if you didn't think you had jurisdiction under those two provisions under my reading which is th violate the statute in order to avoid judicial review you would have judicial review under seven zero six one of the a p a which makes the point that if an agency fails to fulfill a mandatory obligation this way for the  if so your honor in a situation where the and the d c circuit handles this all the time with agency actions that are on lawfully withheld or delayed and it's the same thing that you apply in your main damus contacts which is if the court has potential jurisdiction meaning that congress assigned to this court the authority to review the final decision if an agency fails to take a mandatory act on the way to that decision this court also has jurisdiction to protect that jurisdiction by requiring them to take that mandatory act  that that's an e p a claim under three three seven that's correct your honor and so under this statute you could say just like the that and the supreme court has talked about this recently there are you mention the s a s case but if there's a mandatory act that the commission must do that is a step on the to a decision that this court would have authority an explicit authority to review like in this case you can say that the agency you improperly failed to investigate and we are requiring you to open the investigation do what congress told you and the reason you have that is because you have is in the three three seven itself under main damus jurisdiction this court's decisions we cited in a trying decision says that you have jurisdiction not only if you have actual jurisdiction but if you have potential jurisdiction and the reason for that is that you will not allow an an agency or other court to avoid your jurisdiction that you would have we all agree will the quote that's kind of circular to me because what we were talking about human on the threshold issue there is a threshold issue about whether or not we have  diction over this question so why am i wrong that this is kind of a circular answer to my place because your honor the reason it's kind of circular is because the same reason that the supreme court in s a s talks about having jurisdiction when an agency gauges  shenanigans but when they mean shenanigans i don't mean misconduct they need not doing something that the statute requires it would be odd to send this to the district court because you congress is best to do it with authority to oversee final determinations of the commission we all agree there's no dispute that if the commission had gone through the investigation process and either denied or rejected our complaint on the merits that you would have authority this is what the engine decision talks about all the middle east that was after investigation and my only point is  this court has been vested with authority to decide the final determination if we are correct that they have a mandatory obligation to initiate the investigation their decision not to initiate the investigation doesn't shield them from judicial review it's a legal issue and it would be a proper procedural step they don't initiate the investigation they would do it as the statute requires on a hearing after briefing then they would say we can't because the f t c a precludes us from doing that and then we would have the legal issue on the merits and we would say just like we here to your honor the dietary supplements are not pre approved by the f d a they are decided by manufacturers on their own there are anytime you want to go ahead and put a dietary supplement on the market there is no f d a approval at all and in fact when f issues under the tariff facts to be extended or not is let's just hear about whether or not whatever it is comes under column for dolly's dietary supplements or for drugs that that's that that is the first part of the issue in your honor you will remember regulations and any f d a guidance and making a determination as to whether those products in that case were cosmetics or drugs our point here is that it's not a predictive judgment by the commission as to what the agency might do or how it might change the policy it's just a question on the merits as to whether we are right they can look at the statute the regulations and decide for themselves has has has this been clearly said one where the other they're not asking the f d a whether or not he just you know they can look at the regulations cac says all such proceedings for the enforcement or to restrain violations of this shelby why in the name of the united states what's the phrase enforcement or restrain to restrain violations mean you're in the way we interpret that which i think is consistent with palm wonderful and allegan which means bringing a cause of action under the f t c f d a does not have litigating authority so that statute says that the united states will bring to enforce the plan to address today ok can i let me start off with just one kind of off topic question because i didn't understand that it goes to the f d a so maybe it's just as the train answers i don't quite understand what position commission declining to institute an investigation was reviewed by mandamus if you're wrong about you like leaders and then you would have had to go with an investigation right if we are drugs or an hour and then come to you and say you're being informed currently labeled as something else why would you concede mandamus jurisdiction and if you think that there's a route that they can do it properly and then invoke your investigation every complaint where you on if it just if the statute just said south then then that would be much harder for us but there's a key word which is upon its initiative the same word shall modifies both on across i think it's quite helpful in that because the relevant work were to shall and they contradict they they compare it to a statute where it may have stead said the director who quote start proceedings on his initiative and that's a slip of six so the  supreme court definitely understands that you read the entire statute that statute did not have the word upon its initiative so what congress did when they replaced the word authorize with shout they made clear it was a non substantive decision nine seventy four senate report not so not just somebody talking on the floor the key senate report section three through seventy one of the act would continue as it was originally and acted to authorize our supporters the same way you go back to one hundred eighty four w have regulations from the i t c saying that they have discretion so the idea that it's a shout in the sense you're on the start or if i know you it may at first read like that but when you look at opponents initiative that shell has to modify that and of course i it's a necessary element of the cause of action and so that is not something that the i t c should be looking at our position but i think there is some daylight basically if it's an f d a violation if they may have some enforcement authority but that's not that's not what we've been saying and not what the united states has been saying if there's a cause of action that depends on the f d a is a part you well know that there is a strong presumption of judicial deal and to overcome that congress has to speak very explicitly and i don't think we see anything in the statute that suggests judicial review of this question is bar what we have here is the n a c not doing anything which which really is you know i get all that but is it an a p a action that is it the agency is is it is failing to properly exercise of its authority  vehicle as you're referring your honor the a p a of course plays an important role and in guiding agency action and so if they had an argument that they could they could run it so i don't want to becoming a process suggesting otherwise i did have one final point about the itc's actions and consequence is entitled to monitor that if there's something extreme your honor which i think is what you're implying that then down the road maybe there will be an eye a p action but the thing that strikes me about this case is that there is no disagreement the fundamental core question and that's why you have a six page letter in it detailing why then there's the legal question the interpretation of the f t c is something they want to do is remember the problem problems with the executive branch if one agency is doing something and the other  did different point in time but but still to the same end which is the courts are we don't have any authority to be here yes but the stat relevant statutory words if you're honest and emphasizing it as a result of an investigation when you have a real day with a hundred eighty eight page report good morning in may it please the court a job you saw on behalf united states as and because we have participated only on the question of the merits of the preclusion question and so i thought it might be most fruitful to start with chief judge post your question about whether the intervene about whether these articles are unapproved drugs or rather dietary supplements and there is no guidance forthcoming on that specific question i think what you might be remembering is references to draft guidance that f d a has been developing for some hears about what does and doesn't constitute a new dietary ingredient that is still in draft form i don't believe it will i don't think it is imminently entering final status of i'm not sure about that but what's crucial is that is general guidance about what counts as a new dietary and greedy and that kinds has not been issued it wouldn't specifically resolve the question present about these articles and whether they are or are not dietary supplements within the meaning of the f t c i don't want the guidance this over there was a suggestion that not that this is imminent but this is more or less likely to happen closer i do believe that the guidance about what constitutes a new dietary not be a they will not be able to hear that further case and the and that's because it's it takes difficult scientific and technical judgments as well as deep knowledge of the f t c and its regulations to apply even that helpful guidance about new dietary ingredients to any given article and determine whether that article constitutes a dietary supplement or an unapproved new drug that determination is something after d n a takes very seriously and it's not possible for  a non specialist tribunals to make those kinds of difficult terminations indeed that's why congress assigned to f d a and the f d a on the ability to enforce the f t c i say that section twenty one u s c three thirty seven your honor which you asked my person counsel about and i think the best construction of what it means to bring the proceedings for the enforcement of the f t c a it's pretty clear right here if you read their complaint from back to front interest your honor the united states as amicus has not taken a position on the judicial review ability finality or mandamus issues presented and that's because of the unique situation arising here where you have the commission with independent litigating authority but you also have deep equities by a coordinate agency inside the federal government we intervene to protect those broader united states interests and so we have not taken a position on the jurisdiction review ability issues we've simply argued that should you reach the merits of the preclusion issue here you should conclude along with the unanimous determination of the other courts of appeals on this subject that invoking the cause of action under some other statute john and that's an import so it's not just to clarify i don't think they would have to go to the district court i believe there's administrative proceeding in front of the f d a to determine whether and in which the importers participates and they can determine look are these articles  that your honor but i do understand that my understanding is that there is a p a review of those exclusion or determinations just in a very similar way to if f d a were to seek to enforce and junction or criminal liability or civil forfeiture the f d a would work with d o j to institute those proceedings by on behalf united states and the district court and that court be able to review those determinations what's and congress has created a specific highly ridiculous reserving exclusive inforced now forty two the f d a to allow private parties like cameron to come to the commission or to district courts around the country circumvent f d a is procedure and try to obtain enforcement  that case exclusion of those items from entry into the country working with your  that's exactly the crucial point here are they can come to f d a and they can tell f d a we think that our competitors items are violating the f t c they're unapproved new drugs we want you to exclude them if the f d a agrees one th there are many things the f d a could be pursuing around the country is this the most important that is a decision that congress assigned to the f d a the expert decision makers in this issue amber and what have you opened that exclusivity up with the necessary consequence that there would be cases all around the country in district courts on lanham act claims that would force not an expert decision makers to make these very difficult judgments and divide the agencies attention and the agency and congress made  your honors i'd like to make three points that i think could be helpful to the court judge here is your question the commission's counsel outlines jurisdictional analysis and i'd like to cite your case that echoes i think your question this is the d c circuit at seven fifty  then seventy six to seventy nine to judge edwards decision that case the question was will the a p a doesn't confer you an independent and name that it's telecoms research an action center versus f c c and what the court says there is that a p a itself does not confer an independent basis of jurisdiction but a court says that when the court of appeals ability review on the merits may defeated by an agency that fails to resolve disputes a circuit court may resolve claims of unreasonable de lay in order to protect  future jurisdiction and explains what it means by that which is that the jurisdiction comes to this court to reduce require the agency actually relates to the potential jurisdiction down the road second judge across your question about the shell means shell all i would suggest to the court is in addition to looking at that initial language you read on in section b because it's specifically not only says that the agency shell institute an investigation of one complaint and then gives two exceptions in the context of the antidumping laws and copyright infringement the agency may not when it's wholly dependent on that and it may in the context of one it's in parts of congress specifically carved out exceptions where the agency would have discretion this is not one of those finally your honor honor the government of the attorney from the estes office tries to create the conflict but he is just wrong about the scheme f d a does not pretty approve these things these decisions are made by manufacturers every day f d a does not get to decide where they come in or on they go to a court and the court has to look at what the law is at the time to decide whether f d a is right or wrong there is nothing that prevents congress from doing what it did here which is recalling the commission to take a look at whether or not these things are or are not in fact dietary supplements that's not a difficult decision but in any event it's a merits decision if we cannot prove that we're right about this that the law is clear then the commission rules against us on the merits and you have a full record to review the problem with this case your honor is that three three seven eight says that the commission and under the i p c supposed to be quote in addition to any other provision of law the f t c a is another provision of law this remedy is in addition it provides us a private right of action we have been thrown out of the commission legislative plans here trumps the executive branch it directed the commission to initiate investigation we would be very grateful if the court would direct the commission to do that and address our claims on the merits thank you for your time and very critical thank you thank god