Are AAFCO and FDA Ever Getting Back Together? How Their Split Will Reshape Pet Nutrition

Episode 31 • 2nd October 2024 • Barking Mad • BSM Partners

Jordan Tyler: New and novel ingredients are the lifeblood of pet food product innovation. Ensuring nutritional advancements are properly substantiated and vetted, so they can one day grace a pet's bowl. The pet food industry is innovating all the time, through ingredients that stand to improve gut health, support cognitive function, fuel growth and development, and generally keep our pets happy, healthy, and thriving.

However, recent regulatory developments increase the current process for getting new pet food ingredients approved in the United States. And this isn't just a procedural update. It's a watershed moment poised to ripple across the entire pet nutrition industry, affecting pet owners’ experiences, and potentially even implicating American companies’ competitive edge on a global scale.

Stephanie Clark: In early August, the Association of American Feed Control Officials, or as we better know them AAFCO and the US FDA shared some unfortunate news. They would not be renewing a longstanding Memorandum of Understanding—or what we'll refer to as MOU—that allowed the two entities to collaborate on how new pet food and animal feed ingredients are vetted and approved at the regulatory level. This shakeup is expected to impact everything from the safety of the food we feed our pets to the cost and availability of innovative products on the market.

Jordan Tyler: For today's episode, we've spoken with three experts, Dr. Bradley Quest, Dr. Renee Streeter, and August Konie, who have been following this development closely to understand what this MOU stood for and what its termination means for the industry at large. We'll also discuss how this latest development highlights a trend toward mixing state involvement in favor of centralized federal regulatory control and what consequences this trend may have for industry professionals and pet owners.

Stephanie Clark: Welcome to Barking Mad, a podcast by BSM partners. We're your hosts, Dr. Stephanie Clark

Jordan Tyler: And I'm Jordan Tyler.

Man, talk about a shakeup. You know, you certainly said it. This episode is going to be packed with a lot of juicy insights, but I do want to make sure that we set the stage before going too deep into this because it's a little complicated as it stands. So, the FDA is the gatekeeper for food safety in the United States, including food for people as well as pets and other animals.

Now, when it comes to what goes in your pet's food bowl, the FDA has partnered really closely with AAFCO over the last 17 years through this MOU to ensure that every ingredient used in pet food is not only safe but also effective. We're talking about a longstanding process here, relatively streamlined, in which both state and federal regulatory officials have worked side by side to ensure new ingredients meet stringent safety standards before they hit store shelves. But now, with the ending of this MOU, we're entering uncharted territory.

Stephanie Clark: Dun, dun, dun! Yeah, the regulatory landscape is poised for change. Pet food companies may face longer approval times, higher costs, and increased uncertainty. All of these factors could trickle down to the consumer in the form of higher prices or even fewer choices.

On the flip side, though, this shift could also be an opportunity for the FDA to refine and perhaps even improve the approval process, aligning it more closely with modern public health needs and industry demands.

Jordan Tyler: Absolutely, yeah. This doesn't have to be all doom and gloom. Maybe something really fantastic will come out of this. Time will tell. In the meantime, though, it can be helpful to lean on experts with a ton of industry experience to navigate in the interim. Speaking of such experts, Dr. Quest, could you provide a little bit of background on AAFCO and the FDA and their respective and, in the past, collaborative roles in regulating pet food and pet food ingredients?

Bradley Quest: Yeah, sure, Jordan. That's a really good question. AAFCO and FDA have done a pretty decent job in collaborating and helping us regulate pet food and pet treats for a long time. So AAFCO, which stands for the American Association of Feed Control Officials, is a voluntary group and it's made up of experts.

From industry to academia, at the state regulatory level, and also at the federal regulatory level, meaning there are members of the FDA that serve on AAFCO committees. AAFCO for decades, has outlined how ingredient definitions should be, they have outlined what nutrient requirements should be for pets, and they're constantly updating those recommendations. The FDA, on the other hand, is an actual federal agency. The FDA has the ultimate regulatory control of pet food and pharmaceuticals, both for humans and animals, but they have historically taken a lot of the guidance from nutrient requirements and things on the enforcement side from recommendations from AAFCO.

Stephanie Clark: Thank you for that, Dr. Quest. And pivoting to August, as our food safety quality assurance and regulatory expert on the call, what was the purpose of the MOU between the FDA and AAFCO? How did it facilitate collaboration between these two and what was it like when it was first put into place 17 years ago?

August Konie: Well, when it was first put into place, it was pretty exciting for sure. Back in the day, this was not much of a different initiative than what Pet Food Institute was doing today in that they were part of the key players and actually trying to help support them receiving this Memorandum of Understanding through AAFCO.

were happening, even back in: 2007

The Memorandum of Understanding is a partnership between the federal government to individual organizations. It's not unique to AAFCO. There are hundreds of Memorandums of Understanding. It's where they kind of recognize they may not have the resources to fully enforce certain policies. So, they look to larger groups, whether it be an airline type group, or even in this case, for the pet group with the FDA regulators, is that if there seems to be a consensus and agreement amongst the group to sit there and defer to the better judgment of the group because they have more resources and can add some quicker turnaround time to the actual, things that that Memorandum of Understanding covers. In this case with the AAFCO group, it was on ingredient definitions, trying to provide an additional pathway to move new ingredients to market quicker, and then to be able to have the backing of the FDA when it comes to the overarching or final yes or no.

Stephanie Clark: Yeah, it's not very often that when government is involved, things move quicker. That's refreshing! So, Dr. Streeter, I kind of want to pivot to you. How does the MOU help ensure the safety and availability of pet food products? Especially with the additional pathways of ingredient approval.

Renee Streeter: Well, I think the process in general is helpful to really get those ingredients assessed and approved. So, it creates a pathway between, and the FDA, to help make that happen, ideally efficiently. So, for years, the FDA provided kind of that expert review panel, right? And now that won't happen. So, we would need a new expert panel, or the FDA would have its own process. It really helped that there was a process by which to get this done so, that new ingredients could come out and innovation could happen.

Stephanie Clark: Do you speculate with the ending of this that, you know, safety of novel ingredients or new ingredients entering pet could be an issue?

Renee Streeter: I don't speculate that's the case. Truthfully, I expect that regardless, we will find good subject matter experts to review the ingredients. So, the overall safety, I really don't anticipate that being an issue. Good scientists are still going to be there, but I do worry that the process will become much hairier, especially in the short term, and I'm uncertain about the long term.

Jordan Tyler: Absolutely. I totally understand that. So essentially, AAFCO and the FDA both announced that they were not going to renew this MOU in early August of this year and that the MOU was officially discontinued on the 1st of October.

Jordan Tyler: Neither AAFCO nor the FDA really gave a robust explanation of the reasons behind ending this MOU. And then there's also this piece of the PURR Act that comes in. So, the PURR Act was a proposed piece of legislation that came, and I'll let Dr. Quest explain more about it, but it came about earlier this year, and it kind of feels like these two regulatory developments are linked in a way. So, Dr. Quest, I was hoping you could tell us a little bit more about the PURR Act, and what does it have to do with this recent MOU news?

form Regulatory Reform Act of: 2024

And, we said earlier how AAFCO and FDA do work together and, for the most part, it's a pretty good, balanced, and a pretty good relationship. But what the PURR Act does is it takes away regulatory oversight that the states have. At BSM, that concerns us for a lot of reasons. One, as everybody can appreciate, is we have a process.

We have a regulatory process in pet food that's been that way for a long time. Is it perfect? No, it's not perfect. But honestly, there's no regulatory process probably in any industry that is. However, it's known, and we know how to navigate it, and it works pretty well. And I would venture to say that we probably have the safest pet food regulatory landscape in the world.

Now, people will argue that it is confusing for people to be not only navigating state regulatory landscape and federal regulatory landscape at the same time. However, I would say that we've been doing it for decades, and it actually works really well. I would also say, and this may be a more personal opinion, um, but I struggle to come up with an example where we have taken away local regulatory control and given it to a federal entity that has turned into a better, more streamlined process.

That usually doesn't happen. Usually, when we take away local control and we give it away to federal control, it usually Enacts longer, more bureaucratic timelines. Does that mean the PER Act helps spur the cessation of the MOU? I don't know. You could definitely speculate that it does, and I don't think that anybody, um, at least as we sit now with what we know, with what's been shared to us from the FDA, that you could dispute that that could be connected.

Stephanie Clark: And Dr. Quest, this really, ultimately at the end of the day, it affects the timeline for brands to get product on the shelf, which always seems like it's a race with this potentially added lengthy process or unknown process.

Bradley Quest: Yeah. No, absolutely. And we like to try to help advise our clients on what we think is the best path forward for them. Now, sometimes it doesn't necessarily mean one pathway is shorter than another one, because honestly, they all require pretty much the same level of demonstration of intended use, safety, and regulatory oversight, and the FDA's role in really all the processes is to evaluate safety.

I think from the cessation of the MOU, what we actually lose, and Dr. Streeter touched on this, is AAFCO has a lot of experience and expertise. When you put together decades of experience of both industry folks, and, in some cases, academic experts, as well as state and federal regulatory officials, making up AAFCO, you take away a lot of expertise, and I don't know why we would want to take that away from the ingredient approval process, or at least as an option, I would also say that really when you look at this, this isn't necessarily a joint decision, when you look at what Austin Terrell said, and I know we're going to get to that, AAFCO actually didn't want this to happen. So, this was actually a decision by the FDA.

Jordan Tyler: On August 2nd, AAFCO Executive Director Austin Terrell stated, “AAFCO believes that its ingredient definition process has been a shining example of successful collaboration and partnership between states and the federal government. Although we are disappointed that the MOU is not being renewed, we are committed to being a conduit between the FDA and state regulatory programs, and to our work to provide standardization in the animal food industry.”

Renee Streeter: I mean, the intention of both of these, as it was stated, was to actually improve the timeline overall going forward. Both the FDA say that and AAFCO says that. So, I know that that's the intention, and I hear your concerns, Dr. Quest. It's going to take actually longer, and I totally think that's true, at least initially while we get the kinks out. I mean, taking 50 states right now and trying to align them all is difficult. And so how is this potentially going to improve or not ] on that, you know, 50 states versus one federal thing? I think that's a lot of the discussion right now.

August Konie: Most states have, in part, codified into their state laws, some of the model regulation as presented by AAFCO.

Jordan Tyler: To codify means to arrange existing laws, rules, or regulations systematically. In simpler terms, codifying pieces of legislation isn't about creating new laws, but organizing and restating existing laws in a code. Sometimes called a codex. It's almost like making a rulebook for a game, so everybody can play the same way and understand the rules throughout.

August Konie: So, any changes at the federal level will require state legislators to go back to their own houses in Congress to sit there and change laws that are already on the books. So that in itself, I'd like to throw out one other point because we're talking about timing and the implementation of things.

Let's not forget. But passing a bill through Congress is not necessarily a quick thing. So most bills from inception to actually passing and hitting the floors and getting through the whole process can take as long as five to eight years.

So where I have a concern is what do we do between October 1st and five years from now before this bill actually gets passed? And to Dr. Quest point is we've taken a channel away from approval, but they have nothing to backfill this, and they don't have the bill passed. So that's going to lead to some additional challenges in that interim.

So back to Dr. Renee's point that she believes it's going to be longer. I can say pretty much without a doubt it's going to be longer because they don't have anything ready to go. One thing that is encouraging is since the announcement of the memorandum to me was for the call for opinion, meaning that there's a channel that's currently open where they're taking people, industry, business, consumers, and opinion right now on what that new process needs to look like. So, there is a chance because currently they said, well, we got these two processes that we can currently have had for years and years, but we're open to new suggestions. We're open to new ideas. That's encouraging to me because I think that's the first step to potentially streamlining. Otherwise, a very long process.

Stephanie Clark: That's a good point, August. Because I was wondering, I haven't seen any proposed tentative plans, and this is happening. So, what do we have to look for? Are there any plans that you've seen in the meetings that you've attended?

August Konie: You've got the three channels that are currently available. You got self-affirmed GRAS, you've got GRAS, and you've got a Feed Additive Petition.

Jordan Tyler: Now, when August says GRAS, he's not talking about the stuff that your dad or your grandpa obsess over in the summer. GRAS, in this instance, is an acronym. G-R-A-S for Generally Recognized as Safe is a way to classify some foods, ingredients, and substances that are commonly consumed by a significant part of the population and therefore deemed safe. Once a food or ingredient has achieved GRAS status, it is no longer necessary to go through pre-market review and approval by the FDA.

August Konie: And it's in the same hierarchy and the process that's in law right now. So, until something changes with the PURR Act to give them more authority to make changes to that, or until they decide to make changes to that through normal codification anyhow, that's what we got to fall back on. So we're just removing a channel with nothing to backfill.

Stephanie Clark: We're narrowing the highway.

August Konie: Yeah, we're even making it narrower, which, overall, just to speak on that one thing. America is slow when it comes to new ingredient approval, which puts American companies at a slight disadvantage over foreign companies because they can work through their regulatory process much more quickly.

Jordan Tyler: Now, aside from these three pathways, the FDA has also proposed an interim process that they're calling The Animal Feed Ingredient Consultation, or AFIC, it's also part of the FDA's Draft Guidance for Industry, number 294. Now, when this draft guidance is examined closely, thanks to our experts on the call today, it reads much like the current Food Additive Petition route for new ingredient approvals, with one exception, that all information provided to the FDA Including intended use, safety, manufacturing, quality, and food safety information, et cetera, will automatically be public record.

So, this is unlike the food additive petition, where the FDA reviews all such data without giving the public transparency into the content. Now there's another difference in that the new AFIC has no mention of any involvement with AAFCO or local regulatory entities. And all review and oversight are through the FDA solely. In a nutshell, the AFIC now looks kind of like a hybrid between the grass notice process and the food additive petition process, neither of which are super clear nor expeditious. as they currently stand today.

Bradley Quest: Before the MOU was ended, and the reason I want to talk about that is because we do this a lot for our clients, we help companies that have new novel pet food ingredients that they want to get approvals on. And with the MOU, it gives companies another option.

So part of what we do as consultants to these companies is identified. What we think is the right path for them, whether that's based on their ingredient, based on research that they already have, or research that they still need to do, we try to identify what we think is the best regulatory path, whether that's going through the GRAS notice pathway, going through food additive petition, and in this case, with the memorandum understanding.

Going through the AAFCO ingredient definition process. Now we don't have that. So it does take away a lot of the flexibility that companies had before and that we had as experts in the industry to help advise our clients.

Jordan Tyler: Oh. And one could argue that. Speed to market wasn't necessarily a hallmark of the previous new ingredient approval processes, right? I mean, according to AAFCO, based on our experience at BSM Partners, it can take an average of three to five years and $600,000 per ingredient before gaining regulatory approval. So, I mean, this is already a pretty lengthy, pretty expensive process. And now we're entering this realm of uncertainty with the ending of this MOU.

Stephanie Clark: It'll be really interesting to see how a lot of startups survive this.

Jordan Tyler: Oh, absolutely. Just already have a limited number of resources and have different priorities than an established company. Man, I could see how that would really set them behind, especially when you consider the rigorous research that must be done before new ingredients can even start going down one of these approval pathways.

Renee Streeter: In part, that's because the study has to be done on an ingredient. In the intended species. So, we have to feed it to an animal that it's intended to be fed to and monitor the outcome via various different diagnostics and exams. And so that takes a lot of time and it's very expensive. And when that's all done, then you have to review the data, and that data has to be determined. Yes, it's safe, or no, it's not safe. We're not going to prove it. And that's why it takes so long and why it's so expensive.

But I will say that it doesn't have to take so long. And it doesn't have to be so expensive. There are other processes in place that we could model ourselves after that take less time and less money. And so that's what the goal is, right? That's what we want to get to and unfortunately, not quite where we are yet, but where we hope to be heading.

August Konie: So, I think we're a lot of ingredient companies make a mistake is that they don't elicit help to look at their actual safety protocol before actually initiating their safety tests. This is where a lot of brands get kind of caught up or new ingredient companies get caught up is they do a safety test. They take their data; they take their analysis in front of the FDA, or even AAFCO in some cases. And then AAFCO says, but you forgot this, this, and this, they didn't get that kind of pre-proofed before they actually started their research, and then they have to go back and redo it.

And this is where the legs of the test can get really, really long. So, let's say that you mandatorily need to do a six-month feeding study. And then it takes three months for the analysis, so you're already in nine months, and then you find out that you should have looked at three more factors, and that's what's going to make or break your approval as a new ingredient to FDA or to even AAFCO, as part of their committees.

And now you have to do another nine-month study. Okay, so now we're in 18 months, and we haven't even started the actual approval process yet. So, it's very important. I think that somebody with experience should review your protocol. We have experts here at BSM who can help with that for new ingredient approval, but it's very, very important.

Bradley Quest: I think August is absolutely right. We do work with the FDA on a lot of things, including, new ingredient approval processes. And it's a dialogue. And I think August hit the nail on the head, the key, it doesn't matter what approval process you go through is doing your pre-work.

What you don't want to do is jump into the process without having the right pre-work and the right consultation beforehand. That's something that we like to help clients with. Where we see a lot of the timing where it really can get long is kind of at the end of this. So, there's a lot of back and forth, as Dr. Streeter said, and August said. So, really what we're looking at there in this situation is probably at least a three-year process. In some cases, we may recommend one pathway over the other based on that individual client's ingredient.

You know, one concern I have, whether it's, we're talking about, you know, stopping the memorandum or the per act is, you know, we work with the FDA a lot. We actually like working with the FDA on a lot of things that we do, whether it's doing functional claim substantiations or in some of these ingredient approval processes that we advise clients to go down. But one of the things that concerns us is when we're asking about, whether are there ways to expedite things.

Are there ways for us to help streamline things, what we run into a lot of times is the FDA, and this actually comes from them. They talk about how they're very resource-constrained. They don't have the resources to do something faster, or they don't have the resources to maybe do certain research that actually needs to be done.

So what concerns us is if we take an agency that already tells us their resource constraint and we give them more to do more regulatory authority and more responsibility, is that then going to extend and make timelines even longer because nowhere have I seen in any of this legislation language that talks about how we're going to expand and we're going to add to and we're going to increase resources. And so that's a huge concern for me. And I think for us as an organization, that's what we communicate to our clients.

August Konie: Well, I think that is another issue as I understand what they did when they tried to enact the Generally Recognized As Safe stipulations. So, they were basically saying foods that are in use, foods that have been known, that have been consumed years and years and years, we understand that that's generally safe.

And we're just going to kind of grandfather them in. What they failed to do in that is they failed to take in a global supply chain kind of landscape. So, there are literally common-use ingredients. in other countries that are not native to the USA but are banned from falling under GRAS rules because of the way they codified the law and they said it had to be common to the United States, and you can point to this and you can point to other codex.

There are tons of research around the safety of those ingredients, but they still, once again, have to go through this long process to be approved in the United States when they're commonly used throughout the world and are generally recognized as safe in other parts of the world. This is one of the shortcomings of the GRAS or even Self-Affirmed GRAS in that regard, which still puts it into that long process.

That would be nice if they could streamline some of that and kind of codify the indexes. On a global scale, since now we have access to most of the world's ingredients, the world's definitely has shrunk as supply chains have improved and it'd be kind of nice to get more unified with the streamlining.

Jordan Tyler: That's a really interesting point. And I think a perfect segue into how all of this is going to impact innovation and new product development in the pet food space. Dr. Streeter, do you think innovation will suffer? If we don't quickly figure out what we're going to do in place of this MOU.

Renee Streeter: Well, it's going to slow down, first of all, right? Because nothing's going to be being reviewed. Nothing's going to be going through and getting its way into a definition into the AAFCO guide as it is now. So, it's definitely going to be slowed down again in the short term. And again, I'm optimistic that eventually, we will get this to where it needs to be.

But you know how it works. It'll be years and the trouble with that really is in addition to being slow. I think that there's a possibility and I don't like being the pessimist, but I do think that there's a possibility that for those companies that are caught up in the middle, meaning they're about to try to go through the process or in the middle of the process and have invested a lot of money into the studies that are now being slowed down.

Will they run out of money and be unable to get that product approved and into pet food? I think that that's maybe a possibility for some companies. First of all, that's really unfortunate for them, but it's really unfortunate for pets that may have benefited from those functional ingredients or ingredients in general

Bradley Quest: That's absolutely right. We do work with companies that are looking for new ingredient approval processes and since this kind of happened rather suddenly it does put a lot of companies in a bad situation from a financial standpoint because when you think about it, where does innovation usually come from? Innovation usually doesn't come from large established companies that make a lot of money.

Most innovation actually comes from small entrepreneurial companies with a new novel idea. The problem with companies that are small and have these new novel ideas usually don't have a lot of funding and the funding that they get usually comes from other sources. Well, these other sources want to see a return on their investment at some point in time or they get unhappy.

And so, Dr. Streeter described it. We actually see it. We see it in the industry. We see examples of this, and how it has absolutely negatively affected some companies. And what I would say, hindsight is 20 20, what we should have done is we should have given some kind of an extended timeline instead of announcing something.

And then, you know, two months later, it's gone that way. At least some companies would have had some time to prepare. That was a. huge miss in our opinion with this whole process that we should consider the next time something like this comes.

Stephanie Clark: So, Dr. Quest, are you recommending that people in the middle of the process continue or are you recommending that they just stop? Maybe it's not worth it. We don't know if it's actually going to be worth the money to go through.

Bradley Quest: Well, a lot of that depends on their financial situation. Our recommendation is we try to help them pivot to what we feel is the next best option for them. The wild card is, whether can they financially do it, which puts stress on them.

I know not everything's fair, and we need to improve on our processes, but we should have done here, though, is we should have given a lot longer heads up that, Hey, this is coming down the pike. We're going to give you some time to either decide whether you can continue here and try to get your ingredient through this process because to Dr. Streeter's point, even if AAFCO comes up with a new pathway, it's still going to have to go through and it's going to have to have the buy-in of FDA, and that's going to take a long time.

Renee Streeter: And I think the other set of advice that I would consider is like Dr. Quest said, we do work with the FDA and we like working with the FDA on some projects and they can be very approachable. So, continuing to work closely with them, and get their guidance on when to go and when to not, and what to do to move through it is also advisable.

August Konie: I think there's a potential for another miss to a lot of these new ingredients, novel ingredients. Are stemming from the standpoint of better nutrition, better availability, and more sustainability, all those things that are important in an ever-growing pet population, that this process being slow or being stifled also takes away from some of those advantages, too.

Jordan Tyler: Now this, and maybe I'm getting ahead of myself, maybe this is the elephant in the room, but What other options do we have other than, you know, just relying on having to rescind regulatory control to the federal level? What would self-regulation of the pet food industry look like?

August Konie: I think that the SROs are something that we do need to look into. We get a much better response from the industry when the industry is actually part of that decision-making process.

portation. But as recently as: 2019

It lends doubt as to do they have the capacity to do the job that they're doing. Are they actually putting in the measures to make sure what they're doing is effective? And I think that when you have industry already on board, it's almost self-monitoring or self-governing at that point. They don't need additional oversight because everybody's playing by the same kind of rule book.

Jordan Tyler: You mentioned a government seize of power. Are you talking about a regulatory capture? And what exactly does that mean?

August Konie: Well, regulatory capture is when they perceive that there's a problem, and then they would sit there and enact a law to, you know, fundamentally take care of the problem. You know, one that's kind of also in the recent news right now is a challenge against, uh, social media and holding them accountable for content, you know, so there's a lot of people that say, okay, well, there's a lot of misinformation on social media platforms yet because they're protected under law right now, there is no way for them to be held accountable.

The government is actually considering, and there have been many congressmen who put forth bills to stifle that. That's kind of like an idea or the concept behind a regulatory capture that would sit there and create a controlling environment. The problem is, is like, who is going to determine what is truth? It's very difficult to understand if it's actually going to improve or make things worse.

Bradley Quest: We had talked about the PURR Act earlier and how we're basically going to take all regulatory oversight and give all of that, not just monitoring and enforcement as they do now, but everything that's also being done at a lot at the state level.

Some of the questions that we have about that are what is that going to look like from a resource standpoint, because right now, we work a lot with the FDA and, on the individual level, they do a great job, but for the most part, overall, they're resource constrained. And we know that because when we work with them on different official project capacities, our lead times for interactions are very long and that's, that's kind of the standard.

So, it makes us wonder, how is this going to change? Because even if the PURR Act passes, legislation does not always equal funding. You can pass a law, but it doesn't mean that anything's really going to happen until it gets money, if it takes money for that legislation to be active. And there's been really little to no talk about how that's going to be like, how many more FDA associate officers are going to be hired.

Even if it is, where are you going to get that pool of individuals that are going to be, have the level of expertise that we already have, I think there's something to be said. We know PDF operates as an SRO. Whether or not that would work well here, I think we need to investigate.

Jordan Tyler: Okay, so I promise this is the last time I'll, but in for this episode at least, so as we have AAFCO in the United States, the European Union has FEDIAF, which stands for the European Pet Food Industry Federation. That's F-E-D-I-A-F, if you'd like to look it up.

Now, FDF is a self-regulated organization comprised of experts from 15 trade associations, which represent approximately 375 pet food companies from various countries across the European Union, according to the FDF website. And there are even a handful of pet food manufacturers that participate in FDF as well.

Now, similarly to AAFCO, FEDIAF collaborates not only with industry experts, but also with regulators and academia to develop its guidelines for pet food safety and quality, nutrition, and labeling. Then, it's up to each country to adopt, codify, and enforce those regulations. But, unlike in the United States, recommendations set forth by FEDIAF are, for the most part, readily adopted across the European Union, and even in other parts of the world, like Asia, because they are unburdened by a centralized regulatory authority and come directly from experts across the industry.

This is just one example of how an SRO has successfully and efficiently guided and recommended regulations for an industry. And there are several other examples for other industries outside of pet, as well.

Bradley Quest: Going back to the resources and the FDA, you know, we were all, uh, most of us in the industry and at BSM we were deeply involved with researching, you know, the grain free dog food, DCM, alternative protein theory, and that caused a huge change in the industry in a relatively short period of time. And what we actually found was, and we know this because we met with the FDA several times prior to COVID, and we actually met with them during COVID, you know, virtually too.

We were able to view all of the records. medical records and the case studies that were submitted to the FDA. And what we actually found was it was a pretty limited sample and it was pretty inconsistent. And when we talked to the FDA about it, the FDA was resource constrained. They couldn't do their own research.

They rely on either industry, academia, Other research organizations to actually feed information to them. And we found that was a pretty narrow data set that really had a huge impact. So those kinds of things are a little worrisome too. I mean, the bottom line is if, if the FDA is going to take this on themselves, they are going to have to have a lot more resources than what they currently have.

ernization Act that passed in: 2015

But judging by the length of time between audits for different facilities. It's pretty evident that they don't have enough resources, nor can they even hire enough third party contractors to assist them in this.

Jordan Tyler: Yeah. And then the other part of that is when COVID happened, you know, not only was this DCM thing still going on and resources were diverted away from that, but resources were also diverted away from, you know, facility inspections, you know, correct me if I'm wrong, but I'm pretty sure non essential inspections were basically put on hold during COVID. So it just kind of makes you think, you know, if those resources weren't there during this crazy time, like what about the other crazy times that will happen in the future? What about when the government shuts down?

Bradley Quest: Which is inevitable.

August Konie: When COVID sent everybody home, essential workers, food workers were still on duty and still working hard to provide Americans with what they needed. However, all the agencies, they were gone. Threw it into a chaos and it would take over nine months to get things even moving in the directions of moving forward. So it like totally stifled the food industry when it comes to those necessary regulatory pieces.

I think the one thing that an SRO would do would be to allow industry to actually having a voting voice. Currently with AAFCO, the membership is only state regulators or the FDA. You can be in an advisory role to a committee, but when it comes to the actual vote, you can't, from industry, actually vote. So that's, what would be different in an SRO. An SRO would allow industry to actually have a direct voice and a direct vote in the guidance that would be put out.

Jordan Tyler: So it's clear, you know, I'm hearing there are a ton of benefits to having an SRO regulate the industry. A lot of those benefits are realized, you know, in the industry and the regulatory environment. But what benefits? What would this have to the consumer?

August Konie: I think there's actually a lot of value to the consumer by those people closest to it understanding it. As I said, not only do they have the research with the direct marketing with the consumer to understand what is important to them, but they also invest a lot in the research and science of their products.

Bradley Quest: It directly impacts the consumer when we have things like shutdowns, disaster-type situations, pandemics, and being resource-constrained at the forefront. And again, we're talking about the FDA and giving them full and 100% unencumbered oversight, because if they can't do that, then that's going to directly impact the consumer. Meaning, are we going to ensure that all of the processes, that all of our regulations are being followed, and that we are providing the consumer with a safe, wholesome product if we don't have the resources to ensure that from a regulatory standpoint?

I mean, to me, that's the biggest impact on the consumer. If we can't unequivocally say yes to that, then the whole thing needs to be worked over.

August Konie: When you utilize the input of SROs, I think that it's actually regulatorily tighter than [it would be] from the FDA. The laws themselves are written very vaguely and open to a lot of interpretation. When you utilize an SRO, they get very prescriptive and very detailed. This benefits the consumer because then it's, it's very prescriptive on how you're going to do something.

Jordan Tyler: And I think what happened with Boeing is another example of if you take on too much responsibility as a government organization and you don't have the resources or the time to really make sure that things are safe, you get doors flying off of airplanes midair. And, I mean, I wouldn't want to be that traveler that day, that sounds traumatizing. But ultimately, that's what's on the table if we don't have experts in the room making sure that our I’s are dotted on our T’s are crossed. Do you think that's fair to say?

August Konie: I definitely think that's fair to say. Like I said, the people who know where the pinch points or the trouble spots are, are the industry experts. You know, they're the ones that are living in our closest to it every day. So they definitely can lend better insight as to the actual prescriptive nature of how something's done. Or how it needs to be done so that it's not only agreed upon through the industry, so it's kind of fair across the playing field, but also to have the best efficacy to actually do what the intended purpose is supposed to do.

Bradley Quest: Anything that happens, you've got two ways. You've either got to have the FDA full buy or you're going to have to have new legislation because it all goes back to the Food, Drug, and Cosmetic Act, which does give FDA full purview and oversight. The difference is we've been able to have other folks have input, including industry, which means we definitely should look at the SROs. It has worked in places. We just need to investigate it and come up with a plan to try to see if we can make it work here.

Jordan Tyler: Yeah, that's really interesting. And I think goes to show that leveraging the expertise of the industry is the right path. to go down in this situation. And it sounds like it's just a matter of how can we make this work from a legislative standpoint, and making sure that we can educate all industry stakeholders about the benefits of collaborative standard setting between industry experts and official regulators, as well as the potential risks of allowing this to become a completely federalized process. As the situation unfolds, BSM Partners will be keeping this issue at the forefront to best advise and advocate for our clients, industry partners, and consumers. And you, the listener. As we wrap up today's discussion, it's clear that the cessation of the MOU between AAFCO and the FDA marks a new chapter of pet food regulation, one filled with both challenges and opportunities. As it stands today, this change is likely to bring about uncertainty and complexity for the industry and pet owners alike. affecting everything from pet food pricing to market entry timelines, and potentially impacting the public's confidence in pet food safety. However, it also opens the door for potentially streamlined processes and innovations that could better align with contemporary needs and standards.

Stephanie Clark: In the meantime, the FDA has opened the floor for comments from the public. This is a call to action for everyone within the pet care community, whether you're a brand, a manufacturer, an ingredient supplier, a pet owner, a veterinarian, or just an animal lover at heart, help shape the future framework that will govern our pet foods. And we encourage our listeners to get engaged in these industry dialogues. Your insights and advocacy are crucial as we collectively navigate these changes and press for a regulatory framework that continues to ensure the safety and availability of safe, high-quality pet food products.

Thank you for tuning in to another episode of Barking Mad. If you want to learn more about BSM Partners, please visit us at bsmpartners.net. Don't forget to subscribe on your favorite leading podcast platform or share it with a friend to stay current on the latest pet industry trends and conversations. We'd also like to thank our dedicated team, Ada-Miette Thomas, Neeley Bowden, Paige Lanier, Kait Wright, and Dr. Katy Miller. A special shout-out to Dr. Bradley Quest, Dr. Renee Streeter, and August Konie for sharing their insights today. And an extra thank you to Lee Ann Hagerty and Michael Johnson in support of this episode.

Jordan Tyler: See you next time.

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