would proceed with your argument thank you your honor and may have please the court i'm david salmond's on behalf of met him to tear up this appeal from the the mile over plumeria junction concerns f t a's recent dramatic change of policy governing the importation and marketing of homeopathic drugs before turning specifically to the court's question about ok's i like to focus for a short moment on the nature of this policy change which i think answer the court's question for decades c p g four thousand four hundred dollars made clear that homeopathic drugs that reflect the recognized or customary homeopathic practices and complied with manufacturing and labeling requirements fight in the guidance may be marketed in the us without st going through a new drug application process remember that applications are only required for new drugs which are defined by statute as ones not generally recognized as and by qualified experts sometimes referred to as the grassy standard remember also the f d a has position for decades was that its existing grassi protocols were developed for pharmaceutical drugs and were poorly suited for the uniqueness of homeopathic medicine so f d a indicated it would eventually develop a homeopathic specific protocol for determining new drug status in the meantime four thousand four hundred dollars effectively treated homeopathic drugs there complied with the standards as if they were not new drugs were instead at least potentially generally accepted a safe and effective now through its withdrawal of forty thousand four hundred and it's import seeks not only to impose the existing grassi process on traditional homeopathic drugs for the st time but to suddenly declare unsafe and block from importation any homeopathic drug to cannot show it has already gone through the approval process that f d a until recently declared was neither required nor appropriate for these products not so i understand your point about requiring tests that take time to perform but i want to be clear you're not saying are you that f d a couldn't change the standards and require a new new drug understand it you have or the main concern is that the alert was finally agency action well that is certainly one of the grounds on which we're we're seeking review  other is that the withdrawal of four thousand four hundred dollars the district court below concluded it was finally agency action as well and that gave that prior policy had given rise to legitimate reliance interest under the current court's were reliance interest whether they were substantial and properly weighed them against the reliance interested issue and we think the court there was fundamentally wrong that was by that reasoning of the district court its prior policy in an in an inappropriate and inaccurate way and therefore it never determined that there was a substantial reliance interest and it didn't meaningfully weigh them against the agency's stated reasons this to make clear what what the concern is that i think that i have which is that there's a final wait and see action here now that says that it is sound these injectable homeopathic drip products to be not generally recognized as safe in effect under the food truck in cuts nick back now that that finding has been made  doesn't cook say same for the proposition that the agency is now owned by that regardless of whether we that the issuance of the import of learned itself that declares that it appears our products are unapproved drugs was finally agency action the government's argument against that all along has  been it's merely an advisory statement and that the the local field office staff can decide whether or not to follow it and i think all the authorities we cited for that proposition already defeated that you cook destroys it makes clear that once the agency has made a determination that it appears that there is an unapproved drugs or some other drug that's not admissible  mandatory to block it so it just underscores our view that from the very beginning the important work was finally agency action with regard to article three i don't think cook is relevant your honor it's of course in itself is not an article three case it included certain enforcement discretion that was claimed by the agency in that case was not in fact within the ages committed to agency discretion by law but in fact was mandated by the statute but that case the agency was attempting to write on a blank slate in the terms of reagent spec case was about is required by the statute in this case you we have we're not running on a blank slate there's longstanding policy that treated our products as if they were argument i know the court below concluded this but i think it's just clearly wrong that the agency would continue to be able to detain medicare as products or exclude method that your products and you don't have to take my word for the reconcile what however you may be reading cook with what the supreme court said in regions where example the supreme court in regents was very clear it was beside the point for purposes of reliance interest and remedy whether or not the prior policy was lawful you know the primary reason it was withdrawn the state reason by the act you could turn the general was that it was an unlawful policy the dissents in  determination but nothing about that determination foreclosed or even addressed the options of retaining for parents or accommodating particular reliance interest the acting director should have considered those matters but  establishment and you all are registered and the language from judge ginsburg about or otherwise is plain late dicta well i think that is correct your honor i think also obligated to do so because they were manufactured in an unregistered facility all of our products were manufactured in a registered for stilly this is are in the framework of four hundred dollars portland all of our products were registered to be were manufactured in registered facilities and the f d a routinely inspected those facilities to ensure compliance with those guidelines fundamentally what we have here is a policy change on the part of the agency that had previously because of their unique nature and because we have not yet developed a grassy a formal grassi determination process that is suited to homeopathic drugs we have adopted this policy guidance that makes clear that if it's part of the you may market in the united states and it's the in per import of learn itself not even the actions that follow this for the st time and finally impose the obligation on homeopathic drugs to satisfy the agency's current rassi standards in order to import their drugs it's it's the withdrawal of forty thousand four hundred and it's the imposition of the import of learned that has that effect and even if you put good morning and they please the court courtney dixon or the government a start with this question about cook judge henderson we agree with you that cook is not relevant here because as your honor noted cook dealt with the agency's obligation have and we don't think the court needs to certainly weigh in on any of those questions here cook is doubly irrelevant here and say as well because cook dealt with in the unregistered facility context the agencies obligation at the end after i had made a final determination that the drug was unlawful whether it needed to refuse admission or whether it might have discretion here after the agency finished its process and made the final determination that miniaturize drugs are not really recognized a safe and effective respect to the guidance and with respect to the importance or you know to the extent the police are claiming that there are reparable harm because they can't presently market and sell their drugs and implement merely directed to or sorry an appropriate injunction determination of which drugs to be detained pending administrate of review you can see it's not a recent final decision so adding and removing plaintiffs drugs to the import of lawyer you know that could have an effect maybe that would explain to drugs on the import but again that's so maybe that article three standing could be satisfied but in terms of the legal status of place of drugs an f d a determination the import of alert removing its products from the importer isn't going to change that but will it change the fact that f d a has now made final detain it's not a final determination about the legal status of plaintiff drugs because again the import is preliminary even to a decision whether to detain the drug and the detention is the start of the administration process and not the end old guidance which no longer elected the agency's current important priority is in light of recent significant see he concerns and the tremendous growth of the homeopathic drug industry in the last several decades the agency explicitly acknowledge reliance interest this person's drugs were safe some are as so far as anyone knew they were part of a class but there was no evidence swept up so you're i guess there's there's a few ways of answering that question in the st being you know the important issue here there's there's a lot of different important lyrics this specific important issue experts qualified to recognize the safety and efficacy of drugs so it's not likely that was there evidence here that the plane has drugs we're not safe i just want to be clear  and just a risky particularly risky category yes your honor because plain just drugs are injectable which means there are in injected directly into the bloodstream and potentially bypass some of the body's natural defenses and because of the ingredients that they are label to contain here potentially toxic ingredients so clearly when you have that combination generally toxic ingredients injected directly into the bloodstream it does present a heightened a heightened risk and of course you know the notice in the federal register doesn't even mention it and it's it's a pretty weighty consideration after the amount of time that the guidance has been in effect what is your best authority for answering the reliance interests coming from the citizens because the titian from a different from a different document sure so petition from the americans for homeopathic choice that said hey don't resend your guidance in fact you should makes them they had suggested as they call it modifications but the agency said they were quite drastic changes but the american for homeopathic choice wanted t to make these modifications and then codified its guidance as a regulation and the agency again in the course of making this decision about its guidance it responded to this it is with tish and said no we're not going to maintain our guidance we in fact are going to withdraw the guidance at this time and the agency acknowledged that this institution had explicitly in boat the longstanding nature of the guidance and reliance interests and the agency said you know you've been you've asserted these reliance interests oath on behalf of industry professionals and consumers but the fact that the agency has determined that this guidance no longer reflect is correct priorities because the homeopathic drug industry has grown  significantly to a one billion dollars industry which has led to increased consumer exposures to these drugs and that has come with a corresponding increase in safety concerns some of which are quite significant including infant deaths and seizures and in the case of one homeopathic interest in withdrawing again this outdated guidance document that didn't reflect current facts before the agency didn't sorry those the f d a the interest in doing so in the interest of public health outweighed the assorted reliance interests and your with respect to the federal register notice the agency essentially said all the same reasons in the federal register notice the next day it didn't explicitly say the words reliance interest in the federal register notice but again the same underlying points were based approach answers the reliance interests i would say that the agency answer to reliance interest at the time it made its decision and that set forth in the citizen the titian the federal register know it the next it's interest more specifically improves in the federal register notice is you know them similar to a post hoc rationalization of government counsel but the concern there is that when the agency hasn't had any discussion about something you don't want to you know take my word for it and speculate about what the agency might have been thinking means here that's certainly not the case we know what the agency was thinking at the time it said it explicitly in its system petition response which was the day before it published the federal register notice and again these are the words of the agency articulate at the time so you don't have to take the words of government counsel particularly speculate about what the agency was thinking we know what the agency was thinking and it set forth its reasonings clearly why is clear on this record that the agency itself said we cannot pursue our new important priorities while forty thousand four hundred is in place which is the very reason he gave for why it has withdraw we had to comply with the grassy determination for for pharmaceutical drugs which of course four thousand four hundred dollars says we don't have to do and you can't have it both ways your honor if the two things are unconnected then they had not considered reliance answers with regard to the important work they need to do to be connected because the only discussion of reliance interest is in the system that they claim is connected to sufficiently through the withdrawal of four is exactly on point here what the agency said they did what what the it what the what the screen court required is that they assess whether there were reliance interest urban whether they were significant and way any such interest eating policy you look at the language that the government points to and throughout this litigation it's taken the position that there are no legitimate reliance and so therefore there is no way the property balancing that was required and they never considered alternatives the supreme court makes clear that even if the underlying policy is illegal which you would think would give strong interest in favor of withdrawing it they say that doesn't preclude them from considering forbearance which was required here or the alternative of actually providing  pacific grassi standard that they've promised all along it's just as it doesn't how is barred by the statute now for doing that even though for decades they said they had the authority and they promised to do it by changing another policy that can solve the reliance interests that the supreme court sought to protect in regents all right thank you counsel that clerk if you would call 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