[00:00:00] Speaker 04: Case number 21-5170, Mark McCaffey and Farm to Consumer Legal Defense Fund, the balance, versus United States Food and Drug Administration. [00:00:10] Speaker 04: Mr. Subraman for the balance, Ms. [00:00:12] Speaker 04: Farmore for the appellate. [00:00:15] Speaker 01: Good morning, counsel. [00:00:16] Speaker 01: Mr. Subraman, please continue to be ready. [00:00:19] Speaker 02: Good morning. [00:00:20] Speaker 02: May it please the court. [00:00:22] Speaker 02: My name is Mahesha Subraman. [00:00:24] Speaker 02: It is my privilege to represent plaintiff appellants in this matter. [00:00:27] Speaker 02: Together with me at council's table is Appellant Mark McAfee, and also with me is Alexia Kulwick, Executive Director of Appellant Armed Consumer Legal Defense. [00:00:37] Speaker 02: This case is about whether Congress has given FDA the power to say that butter can only be made from pasteurized milk or cream, thus banning interstate commerce in butter made from raw milk or cream the way that butter has been made for millennia. [00:00:54] Speaker 02: The answer is no. [00:00:56] Speaker 02: Butter holds a special place under federal law. [00:00:59] Speaker 02: Since the late 1800s, Congress has reserved to itself sole jurisdiction to determine the content of butter. [00:01:07] Speaker 02: Congress has thereby affirmed that butter regulation is a matter of vast economic and political significance. [00:01:15] Speaker 02: The Food, Drug, and Cosmetic Act expressly states that FDA may not pronounce a standard of identity for butter [00:01:23] Speaker 02: Butter Standards Act, in turn, expressly authorizes trade in butter made from milk or cream or both without any pasteurization mandate. [00:01:34] Speaker 02: Against this reality, FDA argues that the Public Health Service Act gives FDA virtually unlimited authority to prevent foodborne illness. [00:01:44] Speaker 02: FDA skips past 42 USC 262 G, part of the Public Health Service Act, which says that nothing in the act shall be construed in any way to affect or supersede the food, drug, and cosmetic. [00:01:59] Speaker 02: Now, the court should reject FDA's over-broad reading of the Public Health Service Act for three basic reasons. [00:02:06] Speaker 02: First, FDA does not dispute that under its position, FDA could abrogate the Butter Standards Act wholesale. [00:02:14] Speaker 02: For example, the Butter Standards Act allows butter to be made with or without common salt. [00:02:21] Speaker 02: Under FDA's view, however, it could ban all unsalted butter nationwide tomorrow if FDA reached the conclusion that salted butter reduced the risk of foodborne illness because of salt's antibacterial properties. [00:02:38] Speaker 02: FDA does not dispute that its position cannot be squared with the legislative history of the Public Health Services Act, which makes plain that Congress understood milk sanitation to be an issue requiring a separate law or an amendment of the PHS Act. [00:02:56] Speaker 02: Third and finally, FDA does not dispute that its position would afford FDA virtually unlimited power to permanently ban any fresh, unprocessed food to reduce the risk of foodborne illness. [00:03:09] Speaker 02: In one fell stroke, FDA could ban fresh lettuce, raw oysters, cantaloupes. [00:03:14] Speaker 02: The list goes on and on. [00:03:16] Speaker 02: That kind of power requires a clear statement from Congress. [00:03:19] Speaker 03: But don't we want the FDA to have the authority to ban where there's evidence of adulteration? [00:03:25] Speaker 03: For example, I take your brief to argue that the FDA could, under its authority to prevent the marketing of adulterated food, prevent the sale of butter made with adulterated milk. [00:03:40] Speaker 02: That's correct, Your Honor. [00:03:41] Speaker 02: And it's important to recognize that the adulteration authority under 21 USC 342 has its stance and it has its limits. [00:03:53] Speaker 02: One of the limits is that FDA has to prove adulteration on a case-by-case basis. [00:03:58] Speaker 02: It has to show that the butter is made from adulterated ingredients or that it's unfit for food. [00:04:04] Speaker 02: And that's the way FDA has enforced its authority [00:04:07] Speaker 02: for decades in federal courts. [00:04:09] Speaker 03: There is a requirement of grounds under the Public Health Service Act as well. [00:04:14] Speaker 03: I guess I'm just trying to get at why if regulation of the Public Health Service Act alters the standard of identity, wouldn't the same logic mean that [00:04:26] Speaker 03: prohibiting adulterated butter made with adulterated milk also be in conflict with butter standard of identity because it's not incorporated into that standard of identity, which I take it to be the nub of your argument. [00:04:37] Speaker 02: So it's important to recognize that food can be adulterated without violating a standard of identity. [00:04:43] Speaker 02: The standard of identity in principle part dictates the ingredients of food. [00:04:47] Speaker 02: It says, for example, for butter, it has to be made from milk or cream. [00:04:51] Speaker 02: Now, if FDA investigates a particular butter making facility and it finds that the milk or cream that is being used in that facility has some form of tainted food product in it or bacteria or whatever, [00:05:03] Speaker 02: then FDA can commence food seizure proceedings and injunction proceedings to address that particular threat. [00:05:10] Speaker 02: It's not changing the standard of identity in terms of saying this has to be made from something different. [00:05:15] Speaker 02: It's saying that what you have made violates this separate provision. [00:05:19] Speaker 03: So under your hypothetical about the banning of salted butter, you're not disputing that the FDA could ban the sale of salted butter if it had reason to believe that the relevant supply of salt was itself something other than salt or is somewhat dangerous. [00:05:36] Speaker 02: If you could prove in particular instances that that was the case and prove that through evidence in accordance with its authority, because it's important to recognize adulteration. [00:05:45] Speaker 03: In a court, it couldn't prophylactically say, well, we have information that [00:05:50] Speaker 03: This salt is not salt, it's some other powdered substance that's really hazardous. [00:05:56] Speaker 02: So you're honored to answer that question. [00:05:58] Speaker 02: The way adulteration findings work under the Food, Drug, and Cosmetic Act is FDA does an investigation and makes a finding. [00:06:06] Speaker 02: Then the FDCA provides means for FDA to enforce that finding. [00:06:10] Speaker 02: One way is through bringing injunction proceedings in federal court. [00:06:13] Speaker 02: Another way is by seizing food and going to a court and asking for issuance of a libel. [00:06:18] Speaker 02: This is under sections 331 to 334 of the Food, Drug, and Cosmetic Act. [00:06:24] Speaker 02: Merely because FDA believes that something is adulterated doesn't mean that they can just jump to banning something. [00:06:30] Speaker 02: They have to use the authorities that Congress has provided, the scalpels, as we call them, to address the issue that they have identified. [00:06:40] Speaker 00: You, both at the beginning of your argument today and in your brief, you invoked a major question, Dr. [00:06:48] Speaker 02: I'm sorry, your honor. [00:06:49] Speaker 02: Could you repeat that question? [00:06:50] Speaker 00: Yeah, you invoke the major question doctrine. [00:06:53] Speaker 02: That's correct. [00:06:53] Speaker 00: Yeah, but you know, we that's applicable only when there's a statutory ambiguity. [00:07:01] Speaker 00: And I'm curious to know what it is that the district court said. [00:07:04] Speaker 00: The district court said that that that the statute, the statute here called Grant CFT authority. [00:07:15] Speaker 00: to combat infectious diseases apart from the authority to set standards of identity." [00:07:22] Speaker 00: Those authorities do not conflict. [00:07:26] Speaker 00: What's the ambiguity we're trying to resolve? [00:07:28] Speaker 02: Well, Your Honor, if I may gently push back on the assumption that the major questions doctrine only applies when there's statutory ambiguity, I think [00:07:35] Speaker 02: that if you look at FBA versus Brown and Williamson, or if you look at the court's more recent decisions in the Alabama Realtors case or in the OSHA case, what the court makes clear is that if FDA or any agency wants to exert authority that touches upon a question of national importance economically or politically, [00:07:55] Speaker 02: and you need a clear statement from Congress authorizing the agency to do that. [00:07:59] Speaker 00: That's exactly why I asked the question. [00:08:01] Speaker 00: What's not clear here? [00:08:03] Speaker 02: Well, what's not clear, Your Honor, is again, we're not arguing ambiguity. [00:08:07] Speaker 02: What we're saying is that the Butter Standards Act is clear. [00:08:11] Speaker 02: It says that butter can be made from milk or cream or both. [00:08:15] Speaker 02: It doesn't require a pasteurization mandate, and FDA cannot deviate from Congress's standard of identity [00:08:22] Speaker 02: any more than food producers can deviate from the standards of identity that FDA has promulgated using the FDCA. [00:08:30] Speaker 01: And what's major about the treatment of butter? [00:08:32] Speaker 01: I will say that when you think about the kinds of things for which that phraseology has been invoked, they seem broader in sweep than the treatment of butter. [00:08:41] Speaker 02: Well, Your Honor, I think that there are two ways the court can approach that question. [00:08:44] Speaker 02: One way is to ask, how has Congress historically treated butter? [00:08:48] Speaker 02: And there's no dispute that on this record, from 1886 to 19... I'm sorry, from 1886 to 1902 to 1923, Congress passed a series of laws that have remained unamended in the intervening years, all addressed to regulating and protecting the sale of butter. [00:09:06] Speaker 02: So Congress itself, in a way, has said this is a major question of importance [00:09:10] Speaker 02: And because it's so important, we are assuming the authority to regulate in this area when we could otherwise just delegate the question to the agency. [00:09:19] Speaker 02: So that, I think, by itself distinguishes butter. [00:09:22] Speaker 02: But then on top of that, if you look at the history of butter in America, it is a... [00:09:28] Speaker 02: a standard food staple, as many of the congressmen that we quote in our brief say, at points in time in this history, butter sales and butter purchases by consumers were second only to meat purchases in terms of their importance in the American family, the American household, and on the American farm. [00:09:46] Speaker 02: So that's what makes it a question of nationwide importance. [00:09:50] Speaker 02: The fact that if, just to put it bluntly, if FDA tomorrow were to just ban the sale of butter completely, [00:09:56] Speaker 02: I don't think that there's any question that the dairy industry would be suing the next day and say, you've ended a billion-dollar industry in the United States. [00:10:04] Speaker 03: Mr. Subraman, I assume in that case you'd bring an arbitrary and capricious challenge, which reminds me that I have a question about your arbitrary and capricious challenge here. [00:10:16] Speaker 03: You have a separate question focused on that. [00:10:18] Speaker 03: But I take it that maybe it's not really a traditional arbitrary and comprehensive challenge, because I take your position principally to be that arbitrary and comprehensive review is [00:10:30] Speaker 03: inadequate as a safeguard. [00:10:32] Speaker 03: That's really too toothless to prevent abuse of the FDA's powers. [00:10:39] Speaker 03: And so in a way, it's sort of a supporting argument for your statutory claim. [00:10:43] Speaker 02: Is that right? [00:10:44] Speaker 02: That is a correct interpretation of our argument. [00:10:46] Speaker 02: And we're basing that on this court's analysis in the genus case, where it made the same observation that FDA's attempt to defend an overreaching law by saying, well, don't worry. [00:10:56] Speaker 02: arbitrary and capricious review will be sufficient to address this issue, the court said no, we're not going to rely on that standard alone when we have clear limitations being imposed by Congress. [00:11:06] Speaker 02: Your honor, I see my time has expired, but I'm happy to answer any questions that the court may have, and I hope the court will afford me a little time for rebuttal. [00:11:12] Speaker 01: We will give you a little time for rebuttal, Mr. Subraman. [00:11:14] Speaker 01: Thank you. [00:11:15] Speaker 01: Thank you. [00:11:15] Speaker 01: Ms. [00:11:17] Speaker 01: Farmer, we'll hear from the government now. [00:11:42] Speaker 05: I'm Cynthia Barmore, here for the federal government. [00:11:48] Speaker 05: FDA's decision here rested on its independent authority under the Public Health Service Act to prevent the spread of the disease. [00:11:56] Speaker 05: That power is not limited by restrictions on FDA's separate statutory authority to create standards which address the different problem of ensuring the consumer [00:12:07] Speaker 05: McAfee did not present any compelling cause to FDA who would require to change its regulations that for decades have prohibited the interstate sale of rock green butter. [00:12:17] Speaker 05: I'm happy to answer any questions this court has, but we are also. [00:12:24] Speaker 03: So how do we distinguish pasteurization from a production method that would, in fact, have a bearing on the identity [00:12:35] Speaker 03: of food that's statutorily described. [00:12:40] Speaker 05: So typically, the types of production methods that may bear in the standard of identity would be, in the cheese context, the way that a particular cheese is manufactured gives it its characteristics that consumers expect with something labeled, for example, cottage cheese. [00:12:55] Speaker 05: But I would like to note that standards of identity are fundamentally valid. [00:12:59] Speaker 05: So if you want to sell a product, all the same thing, you have to conform to the standard of identity for that. [00:13:07] Speaker 05: But you can quite easily just change the name of the product and then avoid the standard of identity. [00:13:12] Speaker 05: And so that is why fundamentally we don't think the standards of identity pose any limitation on FDA. [00:13:21] Speaker 03: I mean, I think that's where you and appellant are kind of ships passing in the night in the sense that they very much argue that unpasteurized butter or raw butter is a distinct product with a distinct market and distinct features, just like ricotta cheese might be different from cottage cheese, that there are different textures, smell, flavor that consumers care about. [00:13:47] Speaker 05: FDA did address similar arguments in 1987 when it undertook its rulemaking. [00:13:53] Speaker 05: So there was an argument made there that raw milk is a different product nutritionally, immunologically. [00:14:01] Speaker 05: And FDA evaluated those arguments and found no scientific basis for that. [00:14:06] Speaker 05: And now he hasn't challenged those types of arguments here. [00:14:09] Speaker 05: He made no argument to FDA below that butter's characteristics are different fundamentally when it's raw versus fat. [00:14:17] Speaker 05: So because he never made those arguments, and they were specifically rejected by the agency in 1987, they really provide no basis here to consider this a different ingredient. [00:14:27] Speaker 03: You said the FDA found no scientific basis. [00:14:32] Speaker 03: Is that what's necessary? [00:14:34] Speaker 03: Because I think their argument is it's an appreciable, it's important to people who consume it. [00:14:42] Speaker 05: It may be important to some people to consume it. [00:14:44] Speaker 05: There is just no basis in science to say that there's a different nutritional property there. [00:14:50] Speaker 05: But again, I'd like to go back to what a standard vitamin does. [00:14:54] Speaker 05: It really just requires that a product have a certain name if it's going to be sold as that product. [00:15:00] Speaker 05: It doesn't report to constrain FDA's ability to ensure food safety, which is ultimately what most of the FDA is aiming at, and that the Public Health Service [00:15:10] Speaker 05: There's no indication that Congress wanted to curtail FDA's ability to ensure food safety, even though it might want to change FDA's ability to protect limited products like butter to match consumer access. [00:15:26] Speaker 01: Can I ask you just to address the argument, and I don't know that it was featured in the briefing until the reply brief, but your argument about the adulteration statute? [00:15:38] Speaker 01: And if you can, can I just, I think there's something on the mic. [00:15:41] Speaker 01: Can you just slide over a little bit and it may, maybe I'll be able to hear you a little more clearly. [00:15:48] Speaker 05: Can you hear me a little better now? [00:15:49] Speaker 05: Yeah. [00:15:50] Speaker 05: So FDA has a number of overlap. [00:15:57] Speaker 05: Adulteration is one. [00:15:59] Speaker 05: Obviously here, FDA only relied on its Public Health Service Act authority, didn't rely on its adulteration authority. [00:16:05] Speaker 05: But there are various ways that FDA could ensure food safety through standard of quality. [00:16:12] Speaker 01: I thought it did invoke the adulteration authority as an alternative, no? [00:16:14] Speaker 05: So no, so this particular regulation is currently only supported by the Public Health Service Act. [00:16:21] Speaker 05: It's quite possible that, you know, if that weren't adequate to support it, FDA could find support in the adulterations provisions for it, but currently it's only supported. [00:16:31] Speaker 03: And are the processes there more onerous for the FDA? [00:16:35] Speaker 05: I think that, you know, FDA identified, so there's nothing in the record to say exactly why they [00:16:39] Speaker 05: I think probably it's just seen as a more straightforward way to regulate under the Public Health Service Act in this type of situation where you so clearly have a necessity to address it. [00:16:52] Speaker 05: I would note under the adulterations provisions, you don't always need to have a finding that a specific product is adulterated. [00:16:59] Speaker 05: So under 342A4, that refers to products that have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated or rendered intervastable. [00:17:11] Speaker 05: You also have 371A, which generally gives the FDA ability to enact regulations that are necessary for the efficient enforcement of the FDA. [00:17:20] Speaker 05: And so you might have a prophylactic type of regulation there where this type of regulation where it's quite difficult in some times to test dairy products to determine that a specific product is contaminated. [00:17:33] Speaker 05: And so to efficiently enforce even the A1 provision, you may have a necessity of this type of prophylactic [00:17:42] Speaker 03: Could you just restate for us in simple terms the distinction between the permissibility of cheeses made with raw milk and the impermissibility of butter with raw milk? [00:17:54] Speaker 05: Sure. [00:17:54] Speaker 05: So in 1950 when FDA addressed [00:17:57] Speaker 05: It looked at the data, and it found that trees that had been held under a 60-day aging period had no incidence of foodborne illness. [00:18:06] Speaker 05: And so it determined, based on the evidence for trees specifically, that an aging process provided an alternative for pasteurization that just as effectively protected human health. [00:18:17] Speaker 05: It did not find any similar alternative for butter. [00:18:19] Speaker 05: I would also know that McAfee didn't present an alternative that would similarly provide an alternative that would safely [00:18:30] Speaker 05: There are no further questions. [00:18:31] Speaker 05: We would urge this court to affirm that extra. [00:18:34] Speaker 01: Thank you, Mr. Farmer. [00:18:36] Speaker 01: Mr. Subraman will give you two minutes for rebuttal. [00:18:43] Speaker 02: Thank you, Your Honor. [00:18:45] Speaker 02: I want to devote my time here principally to addressing, I think, the main argument that FDA has presented to you, which is that the standard of identity is just about labeling. [00:18:54] Speaker 02: It has nothing to do with food safety whatsoever. [00:18:56] Speaker 02: That argument is simply false. [00:18:59] Speaker 02: Now, counsel just mentioned FDA's regulations, the 60-day aging period for raw milk cheeses. [00:19:06] Speaker 02: That is promulgated as a standard of identity. [00:19:10] Speaker 02: for cheese. [00:19:11] Speaker 02: Now, if FDA is correct that standards of identity have nothing to do with food safety and products can be sold that don't conform to the standard of identity just under a different label, then that food safety standard that has stood for 60, 70 years can now be abrogated by any food producer who can say, well, I'm going to sell cheese that's been only aged for 15 days or not aged at all. [00:19:33] Speaker 02: because I'm selling it under a different label. [00:19:35] Speaker 02: That's their argument. [00:19:38] Speaker 02: If standards of identity are just about labeling, and if you change the labeling, you can buy your way out of what a standard of identity says. [00:19:46] Speaker 02: then standard of identity becomes meaningless, at least as a means of protecting food safety, which is how FDA used it for raw milk cheeses and which is how they are trying to use it for butter, except for the fact that Congress has said you can't use it that way for butter. [00:20:01] Speaker 02: The other point I want to make on this is I encourage the court. [00:20:05] Speaker 02: Look at Baker Oats case. [00:20:07] Speaker 02: Look at 62 jars of jam. [00:20:09] Speaker 02: They may be funnily named cases, but those cases are the Supreme Court's authoritative interpretation of the Food, Drug, and Cosmetic Act and standards of identity. [00:20:19] Speaker 02: And what the Supreme Court says in those cases is that when FDA dictates an ingredient requirement, when it says a food cannot be sold unless it's made of X, Y, and Z, then that is conclusive. [00:20:30] Speaker 02: And it doesn't matter what the purpose of the standard is. [00:20:33] Speaker 02: It doesn't matter that it's about a manufacturing process versus ingredient. [00:20:37] Speaker 02: If they're saying, [00:20:38] Speaker 02: this is what the food has to contain, then that's a standard of identity. [00:20:42] Speaker 02: And that's exactly what the regulation FDA has promulgated here says. [00:20:46] Speaker 02: It says that butter has to be made from pasteurized dairy ingredients. [00:20:51] Speaker 02: And that's as far as this court's decision has to go in addressing this issue. [00:20:54] Speaker 01: Unless the court has any questions. [00:20:57] Speaker 01: Thank you, counsel. [00:20:57] Speaker 01: Thank you to both counsel. [00:20:59] Speaker 01: We'll take this case under submission.