This episode was recorded at the 2025 Petfood Forum in Kansas City, Missouri. Austin begins with an overview of the Association of American Feed Control Officials (AAFCO). Their membership consists of all government officials in the US and other countries who are charged by law to regulate animal feed, including pet food, in their jurisdictions. Canada, Costa Rica, and the US all participate in AAFCO. In the US, animal feed regulation is an integrated food safety system with a partnership between state and federal regulators as well as FDA. AAFCO’s ultimate goal is to harmonize animal feed regulation across all states and provide a level playing field for the industry. (8:14)
This episode was recorded at the 2025 Petfood Forum in Kansas City, Missouri.
Austin begins with an overview of the Association of American Feed Control Officials (AAFCO). Their membership consists of all government officials in the US and other countries who are charged by law to regulate animal feed, including pet food, in their jurisdictions. Canada, Costa Rica, and the US all participate in AAFCO. In the US, animal feed regulation is an integrated food safety system with a partnership between state and federal regulators as well as FDA. AAFCO’s ultimate goal is to harmonize animal feed regulation across all states and provide a level playing field for the industry. (8:14)
He goes on to explain that AAFCO and FDA’s Center for Veterinary Medicine had a long-standing MOU in place that outlined an ingredient approval pathway that ended on October 1, 2024. FDA chose not to renew that MOU to focus on improving their other regulatory pathways, the Food Additive Petition Process and the Generally Regarded as Safe (GRAS) Notice Program. The FDA also has a new Animal Food Ingredient Consultation Process for ingredient approval. AAFCO has partnered with Kansas State University’s Olathe Innovation Campus to scientifically review new ingredients, then bring them back through the AAFCO process to get formal approval. Ingredient companies can choose one of these four pathways for new ingredient approval. (10:05)
Dr. Starkey notes that the process a company chooses will depend on the ingredient. If it’s similar to ingredients proven safe on the market already, the KSU-AAFCO system would be a good route. If it’s something a little more sophisticated or a new chemical, that may be more appropriate for a food additive petition, where toxicology studies would be conducted. (12:49)
The panel discusses how scrutiny of GRAS rules might impact the pet food industry. Dr. Larson explains the scientific rigor involved in evaluating new ingredients. Dr. Starkey notes that there are different levels of GRAS, one of which is self-affirmed, which might be the one under the most scrutiny at this point. The panel agrees that transparency is critical for consumer confidence and ensuring health and safety of pets. (15:47)
Austin talks about some of the ripple effects of the federal reduction in force in the regulatory arena. He and Dr. Larson talk about how the AAFCO-K-State partnership came to be, how K-State is ramping up to manage this project, and future plans for the partnership. (19:52)
Dr. Starkey underlines the importance of timely ingredient approvals and how the new AAFCO-K-State partnership allows for companies to be more competitive due to the speed of approvals. Austin notes that an ideal submission with no follow-up questions or back-and-forth would have taken about 18 months to get approval under the old MOU between AAFCO and FDA, and a very small percentage of applications would be considered ideal. With the new AAFCO-K-State process, an expert panel reviews the submission in 60-90 days and the entire approval process is cut roughly in half, to about nine months. (25:55)
Scott and the panel discuss how approval pathways differ for ingredient approval based on the claim being made. For example, is it a nutrient or is there some sort of pharmaceutical claim? (28:36)
Panelists share their take-home thoughts. (37:19)
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Scott (00:07):
Good evening everyone, and welcome to the Real Science Exchange, the pubcast where leading scientists and industry professionals meet over a few drinks to discuss the latest ideas and trends in animal nutrition. We've got an interesting one teed up. Today we're gonna be talking about the role of AAFCO in the pet food nutrition industry. We're here at the Pet Food Forum in Kansas City, and we're gonna be talking with Austin Therrell. Austin, you're with AAFCO. If you wouldn't mind, just start us off by telling us about yourself and tell us a little bit about your favorite pet.
Robert Mason (00:49):
Welcome to the PetShure Video series. I'm Robert Mason, senior Application Scientist with Balchem. Today we'll discuss the new sensory systems line of inclusions. As a pet parent myself, I love sharing those special times with Pam, our rescue lab. There is no better feeling than offering her favorite snack and sharing her excitement. As we try new treats, now we can help bring that excitement and create those special moments for families everywhere. The Chem Pet team has created a unique line of lipid-based inclusions that will make your treats look and smell good enough to place in your own cookie jar. Currently, we are offering a variety of flavors, including cranberry, blueberry, pumpkin, cinnamon, cheese, peanut butter, and bacon. Include them in your baked treats individually or in combination to offer specialty and seasonal treats with minimal product development time, reformulation, or major production changes. They're stable during handling and mixing.
Robert Mason (01:48):
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Moderator (02:37):
This is just one in a series of videos highlighting product usage examples and new ideas. Visit the pet Sure. Webpage to see more ways to turn your imagination into reality.
Austin Therrell (02:58):
Yeah, absolutely. Appreciate you having us today. My name's Austin Thell. I'm the Executive Director for the Association of American Feed Control Officials, and I've been at AAFCO in that role for about two and a half years now. And prior to that worked for the South Carolina Department of Agriculture and have been involved in around AAFCO for about 10 years now.
Scott (03:18):
Okay, good.
Austin Therrell (03:19):
Favorite pet? I've got several. I've got coonhounds my competition, Hunt, and I,
Scott (03:25):
You know how to lie then.
Scott (03:27):
I've done some hunting
Austin Therrell (03:29):
I do, I do, unfortunately, I, we call, we call tell a little fip, but if I had to pick a favorite, I've, I've got a blue tick female named Roxy that's she's, she's half hunting dog, half family pet, and I've got small, small kids and they, she's just a joy to have around the house. So we've she, she has to be one of my favorites.
Scott (03:47):
Well, I grew up around blue tick Hounds,
Dr. Haley Larson (04:09):
I do not. So my name is Dr. Haley Larson. I am a faculty member at Kansas State University, and I work in our regulatory affairs program for animal health. So it's a very unique program that has been established at Kansas State, at our Olathe campus that's here in the KC Metro region. That was built in partnership with industry because they saw a need that we needed to better inform the next generation of students on regulations as they pertain to animal nutrition and animal health.
Scott (04:41):
Okay. Now, you mentioned earlier that you're not native to K-State. So what's your, what's your education background? I'm
Dr. Haley Larson (04:47):
Not, I have my PhD from the University of Minnesota, actually. Okay. So I'm a native Minnesotan. I have tried very hard to lose my accent over the years.
Scott (04:57):
Yeah,
Dr. Haley Larson (04:57):
Sure. Whether or not that was successful or not ultimate done my os I suppose. But as I get back to your original question about pets, I am a ruminant nutritionist by training. Okay. So my husband, dairy
Scott (05:10):
Beef,
Dr. Haley Larson (05:11):
I am a beef nutritionist. Okay. Predominantly work in the feedlot was my training, and then diversified out as I went to industry when I finished up with my PhD and started working as a senior scientist and decided that I, I loved research and wanted to continue to work in that space. And industry has a way of diversifying you outside of that original silo of what you're trained in, and, and got exposed to the whole breadth of animal nutrition. And was very fortunate that as I transitioned over to K State, was able to keep that industry tie and marry that back into an academic position where I can work closely with industry and other trade associations like AAFCO as we work to, to move animal nutrition forward. But when it comes back to cattle, my favorite pet actually ties back into cattle as well. My husband and I have a cattle herd here in Kansas. We'd also had an Aussie and who just passed away this past summer. He was a terrible herding dog, but obviously very close. And near and dear to our heart. He, he tried his best
Scott (06:34):
No, I hear you. I love working dogs. I've had working dogs my entire life. Started out my, my very first dog was a border collie, and along the way I've had mostly border collies, but I've had an Australian shepherd, an Australian cattle dog, and, and now I've got two border collies. But the one border Collie looks more Australian shepherd than he does border Collie. He looks like an Aussie shepherd with a tail, but he, he, he's a good, good dog. But anyway, thank you for joining us, Charles. This is not your first time at the pub, but welcome back. Why don't you tell us a little bit about yourself? Yeah, thank
Dr. Charles Starkey (07:06):
You. My name's Charles Starkey background in nutrition. Went straight into the industry outta school, and then had an opportunity to join the faculty at Auburn for, for several years. Work in mainly monogastric poultry and swine, but also did learn some about beef cattle, so of cross species. Then I had a, a great opportunity to go back in the industry with the North American Render Association. And so trained at K State in feed manufacturing. So learn some about feed regulations and feed, feed milling and, and ingredient, the importance of ingredient quality there. And so I've been able to sit on committees and stuff as an industry advisor with AAFCO off and on for about the last 15 years or so. So work, work closely with the bringing the ties together between the regulators and the industry.
Scott (08:00):
Alright, good. Charles, nice to have you back here. Austin why don't we start off, I'm sure that most of our audiences heard of AAFCO, but maybe they don't know exactly what it is. Can you maybe just start us off with that? What is AAFCO and what do you do? Yeah,
Austin Therrell (08:14):
Yeah, for sure. So, the Association of American Feed Control Officials our membership consists of all the government officials in the United States and in other countries that are charged by law to regulate animal food, including pet food in, in their particular jurisdictions. And so we have representation from Canada through the Canadian the, the Canadian Food Inspection Agency, as well as Costa Rica participates in AAFCO as well. So in the us animal food regulation is what we like to refer to as an integrated food safety system. So it's a partnership between state and federal regulators with the FDA FDA also serves as they're a member of AAFCO and all of us together collaboratively. We develop a model bill, model regulations, guidance standards, definitions and really ultimate goal in doing that is to harmonize animal food regulation across all the states and then provide a level playing field for the industry that's participating in the US as well.
Austin Therrell (09:14):
So we do a, a lot of different work, whether it's in in the ingredient space, whether it's in labeling requirements in laboratory and proficiency testing. We, we, we wear about 20 different hats at all the times. We have 14 different committees. And really what's neat is, like Charles mentioned, we have the opportunity. So we, we, we put on two main meetings a year, a midyear and an annual meeting. And they're collaborative, they're open meetings where industry representatives as as well as consumers, everyone can kind of come together in those spots and we can have these open discussions and to discuss, you know, issues or trends or labeling requirements all together and kind of come up with some solutions. So it's it's a very collaborative and open process. It's, it's pretty unique to the animal food industry.
Scott (09:59):
Yeah. You mentioned issues and trends, but so what are some of the key issues that you guys are dealing with right now?
Austin Therrell (10:05):
Yeah. you know, there's interesting times in in animal food right now for sure. I think probably what comes to mind and, and when most people think about current trends, they're gonna think about the ingredient space. And specifically, you know, within the last year we have AAFCO as an association, we've had a longstanding memorandum of understanding in place with the FDA Center for Veterinary Medicine. And that kind of outlined an ingredient approval pathway that we had in place. And that, that MOU was, was intact for about 17 years formally, and, and really went back further than that informally, where FDA participated in that process. And that ended last year on October 1st. The, the agency chose not to renew that MOU and to kind of focus their efforts on improving their other regulatory pathways, like the Food Additive Petition Process or FDA's Grass Notice program.
Austin Therrell (10:57):
And, and so that really has created some change in the ingredient space and how companies would bring get formal approvals to bring new ingredients to the market. So because of that, that change we have FDA's new animal food ingredient consultation process. And, and, and what we're most excited about is that we, it all also has opened up the door for us to partner with Kansas State University o Olathe Innovation Campus where we now have this really collaborative partnership between us and the university to kind of to review new ingredients scientifically and to bring those back through the AAFCO process and to get formal approval for the state regulators.
Scott (11:37):
Okay. Said a lot there. I do have a question though, just to get my, my head wrapped around it. So the way companies bring ingredients to market, right? That's important for a company like ours. So what is, what does that process look like, like now, and how's that different? Who wants to address that?
Austin Therrell (11:56):
Well, don't I, they probably don't wanna just listen to me talk the whole time, so I want these other two to jump in. Yeah. But so now there are essentially four main processes. Two of those lie with FDA food additive petition process FDA's grass notice program, grass being generally recognized as safe FDA's new animal food ingredient consultation process, that's aic. And I'm gonna keep with the acronyms here. Yeah. And, and then af o's new partnership with Kansas State, Olathe is the SRIS process, the scientific review of ingredient submissions. So, so those are the four main pathways. And those all look, you know, there's some nuance to, to each of them and, and some pros and cons. But either of those processes would, would be acceptable for an ingredient to get it approved in the us. So
Scott (12:45):
How do you determine which path you take ache?
Dr. Charles Starkey (12:49):
It, it would depend some on the ingredient. So if, if it's an ingredient that's similar to things that are been proven safe and are out there already, the, the, the new system through KSU and, and AAFCO would be a good route because that's part of what we do at the AAFCO meetings is industry works with the FDA or CVM and, and AAFCO and, and review the safety and, and give true definitions to the ingredients. So it's clear what they are. It's clear to the consumer, it's clear to a feed company that's purchasing an ingredient and, and all of that. So it, if, if it's something a little more sophisticated or maybe a new chemical that would be introduced as a new ingredient, that's gonna take probably more of food additive petition, potentially more toxicology studies, different things like that. So the, the, the thing about now is FDA's in process of renewing some of their systems for approval as well, but that's gonna take some time.
Dr. Charles Starkey (13:51):
That's why this AIX system was put into place. But again, if you've got a traditional ingredient or, or a derivation of like one of your current products that maybe you've concentrated more or something, it's different enough. You can't just maybe go straight to market without doing a scientific review. That's where the grass and, and the program that they're talking about comes in. You get an expert panel of, of nutritionists, toxicologists, veterinarians to review the data behind it, ensure the safety. The whole goal with all this, and, and, and it benefits the industry, is to ensure ingredients are safe. You don't want to be making pet food with an ingredient that's gonna cause a recall or a big issue. The, the whole goal of the industry, and that's why we collaborate with AAFCO and CVM, is to produce safe food across the board, at least as safe as we can to our scientific understanding today.
Dr. Charles Starkey (14:50):
So that's, that's where the partnerships are really important. And so, you know, pet Food Institute, who, who supports pet food, American Feed Industry Association, my association, the North American Renderers and, and many, many others, do, do a lot of collaboration to make sure we want every ingredient and every food that's manufactured safe. It, it doesn't help anybody when there's a recall or, or an issue that makes an animal I or anything like that. So, so that's kind of the goal of working together. And, and the pathways would be slightly different just depending on what the ingredient is.
Scott (15:29):
Yeah, makes sense. Thanks Pat. Charles. you guys have mentioned grass multiple times, and, and I think I've heard recently that RFJK is going to take a different look at grass and, and, and, and what is that and what impact, if any, is that gonna have on, on the feed industry?
Austin Therrell (15:47):
Yeah, that's it's a hot topic right now. I've heard, you know, a lot of conversation around reforming grass. You know, there's a lot to be decided, right? Still with those conversations. We don't know if that's grass in general as a whole, or because there's grass for human food, there's grass for animal food. And so it gets pretty complicated. And so you know, it, it right now you know, it certainly depending on what is decided or if ultimately they decide to reform grass at all it, it could end up, you know, kind of changing some of the things that we're doing within the, the new process with K State. But, but I don't think ultimately that part, we feel so confident in that partnership that even if grass changes a little bit we still have the ability and the freedom to, to tweak that program and to, to make sure it's still a, a, a viable pathway for, for the industry.
Dr. Haley Larson (16:39):
And I think it's important to note that the, the safety standards and the research that's required, I mean, that's not what's being questioned here either, right? So when we look at how we're going to review the, the scientific aspect of these ingredient submissions, that science has had longstanding tradition of how we have, how we put safe food out into the marketplace today. And we're just adding in a new elements of how we come together as an industry under the organization of Kansas State. But we really wanna leverage the entire industry and all of these key thought leaders that we have throughout the United States, and how they all play a role in how we understand these new and novel ingredients and leverage that expertise in how we evaluate them moving forward under the same types of rigorous safety standards and research requirements that we've had in place for such a long time. As Austin alluded to,
Austin Therrell (17:32):
One, one of the things I was gonna say, too, and one of the, I I think the really neat features of being able to partner with an institution like Kansas State Olathe, is that for us, and, and like Haley mentioned, you know, we're, we're kind of, we are building this, you know, kind of program where we can rely on the broad knowledge and expertise of the university. But really we're open to being able to, to pull expertise from Kansas State Olathe, but from other universities or private consultants out there in the industry. So for us, it really gives us a, a, a really big reach to bring in people that are qualified subject matter experts to help us do those scientific reviews, make sure we're meeting those rigorous scientific standards.
Dr. Charles Starkey (18:13):
It's not, not to belabor this point, but there are different kinds of grass even. So there's, there's one type where self affirmed, where your company does your own evaluation, but you hold that information internally.
Scott (18:26):
And isn't that the one that's being called into question
Dr. Charles Starkey (18:28):
More? That, that's, I, we, just, from what I've read, I think that's the one that concerns more people because it's not quite as out in the open. The other types of grass are out in the open, they're reported to FDA. So this system, all, all that information and, and that the safety assessment's been done, and that that ingredient is available, has been determined to be safe, will be in, in the hands of the state regulators and the federal regulators and the industry. So it's not, you know, not saying anybody was doing anything wrong, but if you can't see some of the information behind the scenes, it gives concerns. And so, I think, so there are two different tiers of grass, and so we aren't, we aren't real clear exactly how that's gonna be reconstructed, but I, I, there definitely ain't gonna be changes that's, that's been announced, but I, our feeling is more, it's probably more to that self affirm. We need more openness. The consumers demand it. I agree.
Scott (19:29):
Agree. Let's go for transparency that what's going on. Yeah, for sure. Boy, I had a question. I, I lost it, but one of the things I wanted to, to ask is, you know, the new administration and Doge, and we're losing some, some government people, has that, is that impacting AAFCO at all people you work with?
Austin Therrell (19:52):
You know not, not immediately, but I, I do think we're starting to feel a little bit of the ripple effects of that. So certainly the reductions in force that have impacted FDA, like I said, we, we work closely with FDA and specifically the Center for Veterinary Medicine, but also a lot of the other, you know, offices within FDA. And we we're certainly a lot of the liaisons or the folks that we work with our states reach out to, we're starting to see some impacts from some of those reductions in force. On the funding side being that we in the us our state members conduct roughly 60%, if not more, of the animal food inspections across the us. You know, they rely on contracts with FDA and, you know, funding through cooperative agreements with FDA to do that work on behalf of the agency.
Austin Therrell (20:40):
So delays in some of that funding are, are starting to, to trickle their way down and, and impact some of our state members where they have to consider, you know, from a staffing perspective if, if they're able to keep, you know, full-time employees. So that's, that's all still, you know, it's, it's moving slowly, but we're hoping things are gonna slow down and, and some of those things will, will quiet back down. 'cause Certainly at the end of the day, you know, animal food safety and ensuring that for consumers and animals across the us that's our main goal. We just wanna be able to get out there and do the work.
Scott (21:09):
Yeah, makes sense. I've been asking too many questions, need to turn it over to the experts, but I do have one more. So you have, you, you talked about the partnership with K State, you had a lot of choices, right? And so I'm kind of curious, how'd you pick K State
Austin Therrell (21:22):
Yeah, you know what we, when we started to kind of go down this pathway to, when was that? So we, last year, now I can back up to, to 2024 our membership after the MOU expired we, our membership put forward, our, our process is through a resolution. And, and basically a resolution for us was all of our AAFCO members, our state regulators came together and said, Hey, we're, we want the association to pursue you know, continuing to have a new an ingredient approval pathway through the association that's state led and state driven. And so as the executive director, I get those, those marching orders from our folks and I say, okay, let's go to work. And so we started having conversations with different potential partners in the industry. And it was immediately clear to me when I started talking to to Haley specifically and you know, in case state Olathe that they were super interested and really I think a lot of the work that they, that y'all do at that campus specifically really fit the mold for what we were looking for in a partner.
Austin Therrell (22:28):
So it, it, it's been a great partnership. We're just now starting it, but, but we're excited to see where that goes and just kind of working with them as partners throughout the year.
Scott (22:37):
Yeah. So from a partnership perspective Haley is what have you guys had to do from a staffing perspective, from an organizational perspective, those kinds of things. Can you talk to that?
Dr. Haley Larson (22:48):
Yeah, so it's a very pertinent question 'cause I think we are in the, in enthralls of that at the moment. We are waist deep making our way through that. But we have a phenomenal team. The case, a Olathe innovation campus was designed with the mission of animal health, food safety, and food security. So that is why we came into play in 2011. And from there we have transpired to create other programs like the regulatory affairs program I mentioned earlier. And with that, we have a very nimble and agile team. 'cause We are a smaller campus that's based here in the Casey Metro, but in our name you also hear innovation campus. We're designed to, to move a little differently in the way that we can work directly with industry and help meet those needs as they're coming down the pipeline in a faster fashion that we can try to respond as an academic institution.
Dr. Haley Larson (23:43):
So there's some grace that needs to happen there, because at the end of the day, we still are in a university, but at our core mission that that is really what we're here to do. And so as we've taken things off, we have our own marketing team who has done a phenomenal job of trying to get things up and running. We just launched our website here recently. And then we've also kind of backfilled and we're looking to fill some positions as a program manager to help oversee this partnership and then myself as the scientific lead. And we'll continue to recruit subject matter experts from all over the country, from all the different universities, as well as independent consultants that can help with the review of these ingredient submissions.
Scott (24:28):
Excellent. Do you guys see this as a long term partnership? And, and, and what does long term mean, I guess? What, what, what's the horizons look like?
Austin Therrell (24:37):
We certainly do from a's perspective and, and honestly, a lot of that I think is gonna be driven by industry support. 'cause This is a new, new process. And certainly the, the success of it is going to rely on, you know, the ingredient suppliers within the industry really trusting it and, and utilizing the process to, to make it successful. So we, we feel like that's the case and we're confident that, that it'll, it'll remain for, for many years to come.
Dr. Haley Larson (25:04):
And that's such a critical aspect of this partnership. And, and we have a steering committee that oversees that, that's made up of representatives from all throughout the industry, representing all the facets that are involved in animal nutrition and, and feed and pet food manufacturing. And so having their insight as we continue to shape this pathway and move forward and keep that scientific rigor there and those safety standards, but also make sure that we are responding to the needs of industry and what they need and how we can better help serve them to create a, a safe and relatively agile food food industry as we continue to move forward with new innovations to support both consumers and, and pets.
Scott (25:47):
Yeah. Sounds exciting. You know, like I said, I talked too much. Let me turn it over to, to the rest of the folks over here. You guys got some good questions.
Dr. Charles Starkey (25:55):
You know, one of, I, I think one thing to add on this could, from the industry perspective, we have to have these approvals. It, it ensures safety, it ensures trust for the consumer and the customer that you're selling the ingredient to. You can't make feed unless you know, you're getting trusted ingredients. And by going these pathways with industry support, that's also the speed of that as well. We can't be innovative in the US or North America without getting these ingredient approvals. We get, you know, new nutrients. You know, we really aren't talking about pharmaceuticals per se, but things that we do know have benefits, maybe probiotics, biotics those need a pathway to get approved in a, in a, in a quick fashion. So we can be innovative in, in, in the industry because things are changing. You know, we, we, this whole show is about pet and pet health and longevity. There's been multiple talks on aging canine nutrition and, and they have different needs. And so getting something that maybe we didn't have before as a tool to use in taking care of these animals, being able to get that insured, it's reviewed by scientific experts that it's safe and, and have it be, be able to use it legally as an ingredient is really important for the industry and the speed of, of which we can do that.
Scott (27:23):
Yeah, no, as an industry, a person, myself, Charles, I think that that's very important. I'm glad you brought that up, and I'm glad you said agile before as well, so that, that's all working together. So, yeah, go ahead.
Austin Therrell (27:34):
If I can just add onto that too. 'cause We had really haven't touched on the speed of the process at all. But that's, that's one of the big factors in this. And, and like Haley mentioned, and Charles, like the, the speed and the agility. So historically under the old AAFCO IDC process with FDA, that old MOU and an ideal submission that was, you know, the data was great. There was no questions, no back and forth. An ideal submission through that process would've taken about 18 months to get approval. And, and a very small percentage of those were ideal. And, and so with this new process and a partnership with K State, we can, we have the ability to shoot for doing those reviews with an expert panel in 60 to 90 days. And the entire process being able to cut that in half. So an ideal submission that we're shooting for a target approval in about nine months which is real exciting, I think for the industry. And like Charles mentioned, it, it, it really gives the opportunity to bring some of those new novel ingredients to market that are safe. And, and about half the time is what they previously would've taken.
Scott (28:36):
Yeah, I'm gonna sound a little bit naive here, but I'm just thinking you know, we've got a, we've got a, a product that, that Balchem owns, it's K two and it's not approved for use in in pet food feeds or even animal feeds. And yet it is a nutrient, it could have some profound impacts on, on the health and wellbeing of animals. And yet, you know, we're told, at least internally, we talk through the fact that, oh, it's gonna have to get a drug claim, it's gonna take years and millions of dollars. And, and I don't know if that's fair or not, but for something like that, it is the, is the process gonna be pretty quick? Or may, may, maybe that's too theoretical. I don't know it
Dr. Charles Starkey (29:20):
Well on that. It's kinda like what I was talking about. There's some different pathways for different reasons. Certain ingredients and nutrients are pretty easy because they're very similar to things that are already approved, have been used longstanding. Some of the novel ingredients we just don't know enough about yet. And if there's true physiological changes, that's when we start to question is it a nutrient or a pharmaceutical type activity that gets into a very gray area. It's a completely different pathway through FDA at that point. And a lot more just supportive data just to ensure the safety. Some of that depends on dosage, recommended dosage things, things can be pharmacological at a high dose, but at at low doses, they're, you know, beneficial every day. So it, some of that's, and that's part of where this review panel, taking this step back, having good scientists look at the information, they can help the industry or that company make those decisions. And based on the package you put in, if it looks like it might need a little more work, that's part of that back and forth. And, and, you know, even, even both AAFCO and through this process and CVM, you know, we will start to have that conversation with you about what, what you need additional information wise to get that for.
Dr. Haley Larson (30:47):
I think the first thing that catches my ear when you said that was the word claim. Yep. So when you say the word claim, it makes me think, okay, what is the intended use? Because that intended use and the claim that you want associated with that, that's really gonna drive that decision for what pathway you should pursue and how you wanna market that. Is this an ingredient to be included, or does this have a specific health related claim that you want associated with that
Scott (31:13):
Product? Product? Don't most nutrients have health related claims? And then let's talk about, I don't know what claim means, right? But if, if, if nutrients are doing what nutrients do, you're gonna be healthier. We're getting into a gray area. I know.
Dr. Charles Starkey (31:26):
Yes, you're correct, those guys,
Scott (31:28):
Right? I mean, I, I, I'll take choline as an example, right? We, we've shown through research, it has an impact on fetal programming and how that animal will, will perform throughout its life, and perhaps even its grandchildren. And so is that a drug claim? Is that, or is that nutrients doing what nutrients do?
Dr. Charles Starkey (31:47):
I think it depends on the intent. And, and I'll let them speak there, you know, what's your intent in marketing it? We know choline is needed. We know it's a, a vitamin like substance that is needed in daily nutrition. Now, if you've received those benefits as well, that's just part of the natural metabolic process of that. So there's a difference in just saying, look, we know it's a nutrient. We know you need it. Every nutrient to your point, has, has some kind of claim or benefit, or we wouldn't need them. If you start marketing it for solely that benefit, then you're making a claim that I think you have to back, and that's when we start, you know, what's the dosage, what's the rate? Can, can we make that claim every time? Does it work? Not everything works a hundred percent, but is it, you know, the 95th percentile type thing that, that's how I view that difference is what's your intent on marketing? What's your intended end use? If, if you're getting that benefit by just adding it to a daily diet, like pet food has to be formulated to provide every nutrient and that benefit comes along because it's an essential nutrient, and that's what it does metabolically or physiologically. That's very different than making a specific claim and marketing toward that claim.
Scott (33:07):
Yeah. So if I'm hearing what you're saying, it's, it's not so much what the compound or the molecule does. It's what you wanna say It does. Yeah.
Scott (33:15):
I, wow. I
Austin Therrell (33:16):
Can give us I'll kind of give us the regulatory answer here. And we're talking about claims they should always, at least in this point in time, should be related to nutrition, taste, aroma, or technical effect. Anything outside of those bounds that's gonna put you in a, in a area where you may get questioned by a state, state regulator. And there's some interesting, there's a, there's a bill called the Innovative Feed Act that's out in in Congress now. That's, that bill may change a little bit of that and allow some additional claims, claims like you know, affecting the gut microbiome or you know working on pathogens that may be of human food safety concern. There's some different things like that. But, but right now, really the safest bet is if you're making a nutritional claim or a claim around flavor or aroma or a technical effect like a pH balancer then, then those are, those are all within the realm of, of safe claims to make.
Scott (34:08):
I know if it's any clear to me, or it still, still still a frustrating, quite honestly,
Dr. Charles Starkey (34:14):
That's why we all have to work together.
Scott (34:20):
Out. Yeah.
Dr. Haley Larson (34:20):
And at the end of the day, we work in a complicated business, right? Innate variation in animals today is pretty great. So, you know, there's breed differences, there's species differences. How each of those respond to nutrients is slightly different. So making sure that we can communicate what these nutrients are doing effectively to the consumer who's purchasing that, and so that they are going to see the results that they're expecting to see. That's really why we wanna make sure those
Scott (34:51):
Claims are. No, that makes sense. That makes perfect sense. Yeah. Yeah. Thanks for that. Yeah. Austin, any big things that you'd like to discuss that we haven't kind of uncovered yet today? We've kind of gone all, all over the place. It's been fun. Yeah,
Austin Therrell (35:03):
I, I, I really have enjoyed the conversation. Honestly, it's just, it's it's, we really appreciate being able to talk about AAFCO and the work that the association does and the different roles that we have within, you know, our partners like KSU and through NARA and a lot of other trade associations. A lot of times I tell people, you know, when you look at similar you know, similar associations on the human food side, they don't really exist. So it's a really, it's a unique platform that we have and a process where we can get everyone together to talk about the complexities of some of these issues and to come up with some solutions that hopefully benefit everybody. So we, it's, we're, we're excited about that and always appreciate having everyone come and participate in the AAFCO process.
Scott (35:47):
Yeah. So I gotta tell you personally, I'd much rather have us kind of self-policing ourselves and not having some government agency making sure we're doing it. So I appreciate what you guys do and, and the fact we, we can do this listen, as we kind of wrap up here if you guys wouldn't mind, just kind of give us a couple key takeaways you'd like the audience to remember from our conversation. And Charles, if you don't mind being the, the extra special co-host down there. Why don't you give us a couple
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Dr. Charles Starkey (37:19):
You know, I, I kind of mentioned, I started working with AAFCO sitting on committees and attending their meetings about 15 years ago. That was about the time the Food Safety Modernization Act on the federal level was coming out. And we were trying to learn and engage. And, and one thing I've noticed over time, and I think part of this, this relationship that, and, and program that Austin and and Hailey have talked about today, back then, we didn't have conversations with regulators. It, it was more you know, up against each other and, and who had the bigger pile of data and, and who had the better argument. Today, what's great is all of the industry associations, pet food, feed rendering grains distillers sit at the table. They work hand in hand with the regulators and CVM and the state to ensure this feeds safe.
Dr. Charles Starkey (38:19):
And then on top of that, getting this new program introduced, getting it off the ground, the speed at, at which we can get something deemed safe, very safe reviewed, but be able to be competitive in the market. 'cause Everything, there's, there's talks here at this meeting. This is a global market now. There's pet food manufacturers in Europe that's imported. We import a lot of pet food to other countries, especially ones that don't have a big pet many food manufacturing industry yet. So the speed of, of being able to keep up and, and keep innovative and feed at that higher plane in nutrition and health that these animals need is imperative.
Scott (39:00):
Awesome remark, Charles. Thanks for that. Haley, any final comments from you?
Dr. Haley Larson (39:05):
Yeah, I'm gonna piggyback right off of that and, and play on that speed piece. But if we were to have one takeaway from today, it's the regulatory landscape is changing. There is, and there can be some uncertainty that exists there. But at the end of the day, it's exciting to see where we're going and to see these partnerships form and for us to circle the wagons and come together as an industry to really make an impact on how we can continue to create safe feed and pet food for our, our nation. And then moving forward how we can incorporate the science that we do here into that as well. Because there is a lot of cool stuff that's going on in the research world these days and how we can make sure that our consumers and our, and our pet pets as well as other animals, are able to reap the benefits of that science in an effective timeline, that, that's really big. So I think that's exciting to see where we're going.
Scott (40:05):
Absolutely. Yeah. Austin, final words.
Austin Therrell (40:08):
I, I can't say it much better than those two already,
Scott (40:11):
Already summarized.
Austin Therrell (40:14):
But no, honestly, I, I just you know, it's real. Like Haley said, it's exciting that we have the opportunity for all of us to work together on these things. We have the platform to do it. And, and, and as regulators, you know, we see this as, as our job to, to provide some standardization, some, some, you know, a a a rules-based system for the industry so that everyone's on the same level playing field. But at the same time, we want to support the industry and to make sure that, you know, the industry can still innovate and be agile and compete on that global marketplace. And so we, we have a very small role within that. But, but it's a role that we take very seriously. Our members take very seriously. And we really value being able to work one-on-one with the industry to do those things. And so so
Scott (40:58):
Austin, you've been a great guest and you've, you've brought a couple good ones to be a on the cast with you. It's been a great conversation. I've really enjoyed it. Been a little bit over my skis here a little bit. It's not my expertise, but but I did enjoy it. So thank you for coming along and, and sharing your expertise and your time to our loyal audience, as always, thanks for joining us once again. We hope you learned something. We hope you had some fun, and I hope to see you next time here at Real Science Exchange, where it's always happy hour and you're always among friends.
Moderator (41:27):
We'd love to hear your comments or ideas for topics and guests. So please reach out via email to anh.marketing at Balchem.com with any suggestions, and we'll work hard to add them to the schedule. Don't forget to leave a five star rating on your way out. You can request your Real Science Exchange t-shirt in just a few easy steps, just like or subscribe to the Real Science Exchange. And send us a screenshot along with your address and t-shirt size to a h.marketing at balchem.com. Balchems Real science lecture series of webinars continues with ruminant focused topics on the first Tuesday of every month. Monogastric focused topics on the second Tuesday of each month, and quarterly topics for the companion animal segment. Visit balchem.com/realscience to see the latest schedule and to register for upcoming webinars.