AI Can't Replace This in Food Regulation

Do you remember when food safety was it was always a thing, but it wasn't part of a leadership team until there were all these high profile outbreaks. And now the chief food safety officer should report right to the CEO. And people have come over time to accept that. And I think it's a similar trajectory. Regulatory doesn't have to be the chief safety officer, the most important person on the team, but being part of that leadership team I think is huge and makes a big difference. And I think the way to cascade that and make it stick is how the top leaders act and perceive us as a function. You're listening to Food Tech Talk Supply Chain Insights from Farm to Fork, a podcast discussing the latest trends in technologies in the food and supplements industries. Brought to you by TrustWell, featuring conversations with regulatory experts, quality and safety champions, and thought leaders across the industry. I'm your host, Katie Jones, CEO at TrustWell. If you're loving the conversation, don't forget to subscribe. And stay tuned to the end of the episode where you'll hear our guests tell us their key food industry predictions for the next 12 months. All right, let's jump right in on today's episode of Food Tech Talk, Supply Chain Insights From Farm to Fork. We're joined by Susan Bond, founder of Bond Advisory Group and chief regulatory strategist at the B2B Builder, LLC. With more than two decades of experience spanning the US food and drug Administration and senior roles across the global food and ingredient industry, Susan brings a unique perspective of how regulatory strategy can drive, not delay, innovation. She has worked at the intersection of science, policy and commercialization, helping organizations turn regulatory complexity into a source of competitive advantage. Welcome to the podcast, Susan. Thank you, Katie. Thanks for having me. So we're going to talk today about how companies can embed regulatory thinking. Earlier, we're going to talk about how they can build true regulatory readiness, which especially in this day and age, is a bit hard to do and to also stay ahead of emerging trends that are shaping the future of food and ingredient innovation. But first, we're going to start. We love asking this question on the podcast about kind of what brings people to the industry. And so, Susan, what initially drew you to regulatory science? And obviously you've devoted your entire career to it. What has kept you passionate about it through your career? Oh yeah, that's a great question because there's not usually a degree that you get in in regulatory science. But most of my life I grew up in the Washington, D.C. area, so I was always around the federal government regulations and just you know, had a passion for Washington. So I started right out of school at the fda, the Food and Drug Administration. And there I was able to interact. I was down on the NIH campus, so I was interacting and working with some of the best scientists, both at nih, but also at fda. So I have huge passion for FDA employees. Still do. And just watching over the years, I mean, I worked in cber, the Biologics Center. I've worked in the Office of Policy and the Office of Commissioner, things like that. Never worked in the Food center, but it's just watching how public policy was made, which I found very fascinating. Very passionate about it, especially in that foods area, because people tend to find food very sacred, where they may be more willing to take risks when it comes to a prescription than it does biting into their pearl. So that's kind of where I got into it. And then when I went into industry for the latter half of my career, it just was a natural fit to get into the regulatory science. Very cool. Was there a defining moment at, you know, either the FDA or in one of your roles after the government that started to shape how you look at the role of regulation in innovation. Right. So, like, two thematics that attend that can tend to be seen at odds. Right. But arguably not. And so was there a time in your career that you felt like you started to shift your view on that? Well, there was a couple things that happened when I was at fda. We had the mad cow crisis, or bse. And then there was also, at the time, it was, like, groundbreaking that we did a joint press conference with the EPA on mercury and fish. And those were really interesting subjects to work on or to kind of regulate and put a policy around, because people were very passionate about it. To me, it was the risk communication that was involved. So, say, mercury and fish. EPA's mission was to reduce mercury levels in the environment, whereas FDA is trying to protect public health. And it's sort of a hard thing to communicate that you need to eat fish for a normal, healthy pregnancy, but you gotta avoid certain fish for a normal, healthy pregnancy. So kind of grappling with how do you do that and make policy around that. And the same with the bse. I mean, we could have gone very precautionary like the UK and other countries and just said, all right, we need to take everything out of this. But the more we listen to this is where I got to hear the size of the industry. You know, the more you listen to all the people involved, from the ranchers to the cattlemen. To the renderers, you realize it was very complex, could cost a lot of money, and you could accidentally overregulate where they could maybe bury cows on their land because they didn't want to deal with this thing. But it's getting, you know, these bses and these prions are getting into the soil. So, again, it was fascinating to see how that policy was made. In terms of innovation, I'd say maybe the GMO issue was another defining moment. And in this case, I'd say FDA didn't really come out of the gate with a definition. Neither did usda. Everybody kind of had their own definitions of it. And so in the absence of sort of that level playing field, that kind of, as I said, the train left the station, so people sort of walked away with their perceptions of GMOs, consumers and others had different definitions of it. So it was just. To me, those are all fascinating examples of how important this is. Many companies, right, they look at regulatory and regulation not necessarily as a check the box, but at times they can see it as this kind of final checkpoint in the process. From your perspective, what shifts when it's integrated, at the very start of innovation. So innovation rooted in regulation, to me, everything changes. I think that's probably. If you, if you go on LinkedIn or you talk to any regulatory folks, you'll see a lot of passion around that from regulatory professionals, like, bring us in early. And I find, though, that we're kind of. We're preaching to ourselves, right? So we're falling on deaf ears. The biggest change you could make probably, is to have the leadership understand it, to perceive that regulatory function as a strategic function, and we'll probably get into that competitive advantage later and to bring them in early. So not because they're going to say no, but because you're getting an idea of the boundaries you can work in, the types of risks that you can take. But also there's some early signals that they can watch and say, hey, we should be filing for a grass notification or a food attitude petition or new dietary ingredient. There's things, if you get started earlier, that the flow is going to be a lot better. But I think what happens is that perception, like you said, it's very much prevalent still today that regulatory is sort of seen as a checkbox. So we'll just check them off at the end. And I think that's the wrong question to be asking. It should be, you know, how can you help us? Here's where we want to go. What can we do? What can we say? And when you do that checkbox at the end, you're probably just, you probably are going to get a no or you know, in some cases, you know, companies can kind of persuade people to go ahead with the flow and then you're putting yourself at risk and you know, there's just a lot of animosity or like some tension there. So I think the best thing to do is bring in early and then kind of bring them along the game, you know, bring them along the strategy with you and it's easier said than done. I know a lot of teams in regulatory maybe don't have the most strategic component based on years of doing this sort of checkpoint mentality. So you know, that's important to invest in the team and make sure that they're looking for the strategy and looking for the bigger picture. Looking to improve your supply chain. At TrustWell, we've been connecting the dots between food industry and data for over 40 years to give you more control and visibility. Our comprehensive food logic platform sets a new standard for compliance, transparency and quality in the food industry. Request a free demo. The link is in the show notes. Well, you bring up a very important point too around either it's, let's say just in a product development or you know, novel product development that waiting until the end can I think significantly increase your likelihood that it gets shut down or significantly delayed. Right. So seeing regulatory as a partner that can help navigate some of those things that when it comes to the, whether it's state or federal government can take some time. Right. And so getting, getting those things woven in at the beginning, much smarter. And just to add on to that, there are things that the regulatory team would be monitoring right. Externally so they would know what's the trend in enforcement, what's going on at ftc. So not to always come in saying, oh no, we can't do this, but you might be walking into a business and not even know it in worst case scenarios. I've seen quite often in ingredient type companies maybe where customer commitments are made long before we have a path forward and then you're left sort of in a bad spot with your customers. It's not a good, good place to be. No, absolutely. So what does true regulatory readiness look like in practice? So whether that's a packaged food manufacturer or you know, you mentioned the ingredient companies. What does true regulatory readiness look like in practice? I think you will always have the compliance piece of it. Right. I mean that kind of goes without saying and I've always de. Emphasized that side of regulatory not because it's not important. But it goes without saying, it's just part and parcel of what we do. I think that having that is one, but also having that strategic capability. And again, you know, I mentioned before, if the company doesn't have that traditionally, then we need to build that into your regulatory team. But strategic, meaning you have a business mindset, you understand where the business is going and you know, how do I help them get there? You are looking externally. You're not just looking at your documents and your technical data and you know the labels and doing the calculations. You're looking externally at signals such as we talked about. It could be enforcement, it could also be consumer trends. What are the regulations that are coming out locally or within your region or your country? What are the global regulations? Where do you see things moving? Because you really want to take in all that information constantly and analyze it and then you can sort of be a much better predictor of where you should help the company innovate. So that to me is true readiness. It's a hard skill. Right. So some people that are strategic tend to be big picture and get concepts and people that are in the compliance realm are very detail oriented and tactical. So it's hard to have both. But you can put both of those in a team. And if anything, I'd say to me, a big passion of mine was always this policy and intelligence role. So last couple of places I've been in industry, I kind of instilled that as a full time team or role. And UBMA is like, you know, the company is like, why would we need that? That's not your job. But it's so needed because you're out there trade associations, you're advocating for what the company wants. And if you're not out there advocating for it, then your competitors are. It's not a good place to be. Great point. So you talked about this earlier. Let's touch on. How can that regulatory strategy become a source of competitive advantage rather than perhaps what it's seen as a cost center? How do you position regulatory as a competitive advantage? Yeah, that's a good question. Because I think especially with digital enablement and now AI being everywhere, a lot of functions are being looked at as cost centers. So I think you do need to go into it in today's world with AI like eyes wide open, that there could be a percentage of that work that could be replaced or simplified or optimized through digital enablement and that you do need to invest in that strategic side, the competitive advantage. I think if you're not using your team wisely and they are just seen as a checkpoint or a cost center, you're kind of losing out where another company might be bringing them in early in the strategy. Another place that we would be a competitive advantage is how you talk about your product. So all the communications, whether it's the, you know, the ingredient deck, even though there's rules about that, but sort of what we're calling it, the labeling and then the claims and the, what they call the romance copy from marketing, these are all how you talk about your product and probably the biggest, biggest differentiator to having a competitive advantage over other products. So it's important to see regulatory in that kind of light. But I think in order for all that to work, your leadership really has to understand that it's a strategic advantage, but also perceive it that way and help sort of cascade that thinking down so that people across organization recognize it as a, as a valid strategic partner in the business. I've worked at a couple CPGs where there's the regulatory was part of the leadership, the executive leadership team. It works very well. And then I've worked where they're not at all part of that or even invited to be part of it. Weigh your options as the leaders and see what works best. But I think it's better when they're perceived as part of equal partner and all this because you're going to get them over time to have that business mindset like, oh, yes, this is where we're going. So I got to get on board and figure out a way to get there for them. Well, I think it brings up an important point around my next question, which is the just alignment across the organization. So if you've got certain teams that perhaps don't have a seat at the table from a leadership perspective, it's difficult to get alignment across all of those functions. We see that at times with food safety, where if they're not at the table and not seen as a part of leadership, it can feel like an afterthought. And then that comes out in issues. If food safety is seen in that way. So you know from your experience, how should all of these different functions, right, Whether it's the R and D regulatory, food safety, the commercial teams, operations, how should they collaborate and more effectively come together? Early in that development, first year food safety, I was going to mention that, I was going to say, do you remember when food safety was. It was always a thing, but it wasn't part of a leadership team until there were all These high profile outbreaks and now the chief food safety officer should report right to the CEO. And people have come over to time to accept that. And I think it's a similar trajectory. Regulatory doesn't have to be the chief safety officer, you know, the most important person on the team, but being part of that leadership team I think is huge. It makes a big difference. And I think the way to cascade that and make it stick is, you know, how the top leaders act and perceive us as a function. It's really respect a little bit too, you know, respecting the decisions and it doesn't mean you gotta agree with them. But if your regulatory person says, you know what this one feels, this, you know, not so great or whatever, just at least have some respect for the decision whether you go with it or not. Don't just kind of push them out. I think the best way to probably do that is to redefine your operating model in a business and really make sure that those functions, and that can include across supply chain too, are part and parcel of how business is done. I'm trying to think of the type of job, an industry that you would just check off, like maybe, maybe you go to packaging and say for the most part you really want them as part of that cadence of meetings. I would say probably for commercial R and D and regulatory working together seems obvious, but you'd be surprised. It's still that traditional kind of when you learn about it back in the old days of organizational design, that they would just, you know, one takes the idea, tosses it over to this one, and then they toss it to regulatory for this. But there's no. If you're all in the same room and you're all respecting each other, you can get so much more done. You can bring them to customer meetings with you, the regular commercialization or project meetings. The cadence of those meetings make sure regulatory is part of that. There's all different ways that you can kind of bring them into that model and have everyone kind of collaborating a little bit better. And again, I've seen it on both sides when they're together. The best that I've seen is doesn't necessarily mean that everything has to be holding hands and like everything stops until you can find everybody. It's just a mutual understanding that, okay, well wait a minute, I'm getting your opinion, but I need to go get regulatory or I need to go get quality or whomever. So that way there's more accountability at the end with signing off on the risk too and everybody kind of goes into it, eyes wide open, like, all right, we're doing it much better informed and much better planned. Yes. Just transparency and open communication. And to your point, maybe not having. There's things that are very clear that we can and can do. Right. In the food industry to a certain extent. Right. But like making certain decisions that are going to, you know, fast track something, but understanding what those, you know, the risk balance with the rewards. Making all of those decisions in a very informed way. I think that's also critical and that regulatory should have a very prominent voice on the risk side so that it's balanced and making sure that it's not just we promise the customer X. Yeah. And making sure that the company itself is understanding the risks as well. I think the hard part sometimes is novel ingredients or novel technology. That might be a long game. Right. It's not a short game. So if you're trying to appease a customer, that might just be claims or the use of certain ingredients which should be. You can check some of those things off with regulatory, but you shouldn't exclude them. But those longer term games like hey, I want to go global, I want to introduce this ingredient in China and they don't have an approval for it yet. That might be a two to three years out. But you're planning intentionally and you know what you want to get the investment that or the return that you'll get in that investment later on. Let's shift to that. We have many customers and listeners of the podcast who are part of either companies that want to expand globally or are large multinational companies and so either want to expand in countries that already have a presence in or additional countries. So when you think about global regulatory needs, how do you global regulatory differences impact innovation and commercialization strategies as you're trying to balance not just say the US but other regulatory bodies as well across the globe? It's very important because there used to be somewhat of a harmonization of regulations. It's so unharmonized, if that's the right word, that even it used to be sort of regional. So you could say maybe Asia Pacific. They all kind of had the same regulation viewpoints. Now every single country is different. I'm thinking specifically with my background in flavor regulatory, it's gotten almost impossible. Each country has a different where it used to be, you know, if it was FEMA grass or FDA grass, most countries accepted that. So less and less we're becoming more unharmonized. So it's important to understand those nuances. And you might have something that's ready now for the US but maybe three years ready for a different market. And you have to, you have to think through that. And then of course, and in the United States, you have your state by state, which is a whole nother mess. But all of that global market through the lens of a consumer, as you might see now, even the US Consumers are saying, how come in Europe that's banned, but in here it's not? So there's a lot of complexity in public opinion that's, that's starting to drive how people are innovating and how they, what their pathway forward is. So it's an important one for sure. Yeah, especially, I mean, some of the colorings where it's, quote, not allowed in another country, but it's actually just called something different. And it's, you know, it's the same thing. And so it is difficult because, you know, there has been for the good and good and bad, there's just a lot more consumer engagement and attention on these issues and companies have to navigate them on top of the regulatory shifts and yes, the volume of state level shifts that are coming from, you know, all angles, whether it's, you know, seafood or colorings and additives in other areas. There's just so much, so much going on. And this is an area that we see huge opportunity for AI to quickly scan and understand, okay, here's what's going on. Here's the latest information as opposed to, I think now you're just trying to compile a lot of different sources and just staying, you know, keeping your head above water. Very hard to do globally to keep track of all that. Usually a good pressure test is to ask your family because, I mean, I still struggle to this day, like, well, how come, you know, they'll ask that question, this titanium dioxide or whatever, how come this. And when I start trying to explain it, I've already lost them. And they're like, yeah, it doesn't sound like the US is doing the right thing and you can't change those opinions very easily. So I do think the idea of AI for some of that horizon scanning, as they call it, is good. But I also think the interpretation of regulations is so important because again, it's nuanced. I learned early on that just because FDA doesn't say you can't do it doesn't mean you can. So there's certain things like, oh, they didn't say no, but there's just different ways to interpret things and again, against risk and how often they're looking, or is this a Huge risk or is this a low risk? Is there enforcement around it? Because otherwise you won't have a need to have people understand regulations if you can just cite them out of an AI database. Yes, absolutely. And I think that's something else we talk about a lot, is that making sure that there's always still that human in the loop. It's just the condensing of the amount of time that it takes to gather that information, but then giving a recommendation that then still there has to be some level of intellect and decision making and just also collaboratively across the organization. To your earlier point about saying, okay, yes, we're going to move in this direction, but here are the known risks. You have worked both on the government side, on the regulatory side, and then in an industry as well. You know, you bring a very unique perspective, I think, for many of our listeners who are in industry. What advice or, you know, how can companies better engage with regulators to help shape outcomes? I think we've seen this on traceability and FISMA 204 more public meetings and calls for engagement, which is really, really great to see. What advice do you have for companies on how to just best engage with regulators? So I think in the US and in Canada, we really do have unique advantage in that they're very open to meeting with industry, with all of their stakeholders. Whereas my experience with EFSA and Europe, I mean, you'd be lucky to even get a meeting, but you're certainly not going to get opinions and any kind of direction. They kind of hold their cards and it's just set up differently. So first of all, if you're doing it for those two regions here in North America, you have a great advantage to take advantage of. I find too that when I went to industry, in all of my experiences, people tend to be still a little leery about going to the fda. They're afraid. For what reasons I'm not quite sure. But that's because, you know, I came from there. So I'm like, oh, no, you can do this. I think having discussions with them, getting relationships with them is important too. Just being seen as a trusted industry member. If you can get a relationship, and I don't mean like social, I mean just they know you in conferences or they see you out and you say hi, then you become more trusted. And then when you do need to call them and say, hey, this doesn't look right, or this is a situation, they're more likely to respond than if you're just calling, hey, do this a favor for me. So I strongly advocate for advocacy with the fda. I also think they're going to give you some direction in some places, you know, if you ask for certain feedback, maybe, you know, not all the time, but it just creates that trust like that I was talking about. The other advantage to that is you get to hear some of their current thinking. And going in, you can go in by yourself, or you can go in with trade associations. That sometimes is a better way because you can ask, if you're afraid of exposing too many, you know, corporate secrets or something like that, then go in with the trade association and you can really use that to your advantage because everybody's there with a common goal. So that's another place that I see it. I think it's just people tend to be just a little bit leery of going, which they really shouldn't be. Like I said, I've just seen the amount of engagement, public speaking and there for a little while, I think, you know, there was some restrictions on travel and other things like that. But now lots of the trade shows and conferences and such, which is great because, you know, offering a venue to ask questions. Right. That isn't perhaps, maybe as intimidating as, you know, competitive Maryland. Let's wrap up here with just a couple of questions about. I love these questions. So what has been the most rewarding impact that you've had helping companies navigate complex regulatory challenges? So when you think back, what's the most rewarding impact that you've had? Oh, goodness, probably my role in infant formula a few years back, maybe a decade back, and it was a really interesting scenario where FDA had come out with a proposed regulation about 20 years before it. So they collected all the comments and rulemaking, but they never finalized it. So 20 years later, they come out with this thing called an interim final rule, which I actually hadn't really heard of. And that an interim final rule means we were very close to doing it. So we're just going to do 45 days here, done, and we're just going to publish it. Well, you know, then everybody's looking at it. 20 years is a long time. And especially in technology for food. So, you know, looking at the regulation, it was major impact to the industry. So, as in capital investments, like 10 millions annual testing investments of 2 million, and the companies had come so far. The idea is that we were already doing things and testing and protocols and all the things we had within our companies that had the same kind of outcome for protecting public health that they were proposing. So 45 days you have. And I Use that time when you talk about advocacy, I literally flew in. I called them drive bys, but I went to FDA, I interacted with them seven times in 45 days, several at the agency and then some at like pediatric conferences, and just kept, you know, like, hey, what are you guys doing? You're killing us. Like, this is. We're doing the same thing until we finally, you know, made some impact now. But the other, what was interesting about it too is that there's only really about four companies in the United States that make infant formula. So when it comes to working through the trade association, not as helpful as some of these major ones, because nobody was sharing, because you kind of. There's only four of you. Like, oh, they must be doing that wrong. Or they must be doing that wrong. So it was really hard to figure out that point of view. And then one of the biggest losing ways to go in to advocate for yourself is to go in and say, this is going to cost us a lot of money. What are you doing? So the idea was to, we worked very hard in that time to put the science together to show that and demonstrate definitively that we were already protecting public health at that level that they were proposing. And so what they were proposing would be undue burdens. And these are things they consider, whether it's economic burden or environmental burden. So in the end, we were able to persuade FDA about 12 points of this rule. We were able to make an impact on 10 of them, which was massive win for us and for the industry. And again, it wasn't going around anything or doing, you know, anything that wasn't for the public health. But to me, that's the ultimate goal is you're pay, you know, you're paying off, you're doing what's right for the industry, what's right for the public, and you're using those relationships in a good way instead of in an adversarial kind of way. That was one that I think was a defining moment and one that I was very proud of. So for perhaps some of our listeners who are navigating their regulators or maybe NRD and trying to coordinate and work with regulatory. If you could give one piece of advice to leaders building the next generation of food innovation, what would it be? I mean, I think it's a lot of what we've talked about, but I would say the biggest piece of advice is bringing them in early, as we said. And really, if you think about it, your regulatory team, if they're being strategic and doing, you know, monitoring those external signals. They're already mapping out what the headwinds are, what the tailwinds are. They've probably already look at, you know, sort of a SWOT analysis of like, oh, this one's more likely to come, this one's not going to come. You know, all those same nuances in the circles that we're running in. If you're not including them early, you're completely, you know, missing out on some of that. To me it's, it's sort of like if you were to invest in a really new, a new car that's like heavily diesel gas. I don't know much about cars but you know, this is the new technology. But you've ignored the fact that somebody in your company was out there and knows that. Well, there's an electric piece, there's a new generation now, the Gen Z. I think they're very environmentally conscious. There's environmental reasons, there's tax, maybe there's tax cuts, maybe there's tariffs, maybe there's incentives. There's all these reasons why you might consider something else and you're just going into it blindly doesn't mean that you have to go with the flow. But you know, you wouldn't innovate with that much void of knowledge. So I'd say keeping regulatory in there and getting their advice early and it sounds really silly but just planning, planning really makes a difference and when you get everybody aligned in the same direction, it's pretty amazing how fast it can go, your innovation and it goes much more smooth for everybody involved. Great points Susan. Thank you so much for the insights, the stories and just, you know, sharing your expertise with us on the podcast. Really appreciate the time. Thank you. Katie, thank you for joining us for another bite sized nugget of food tech talk supply chain insights from farm to fork. Make sure to subscribe and if you love the podcast, leave us a review on Apple Podcasts, YouTube, Music, Spotify or wherever you get your podcasts. To learn more about TrustWell and request your free demo of our technology platform that connects food formulation products, nutrition analysis and compliant labeling with traceability, recall, readiness and supply chain transparency. Please Visit us at www.trustwell.com and click Get Started or click the link in the show Notes to learn more. Thanks for listening.