Bring Us In Earlier: A Regulatory Career Built on Curiosity

Kristin Allen, Co-Founder and CEO of ENTR Technologies, a software platform for ingredient data management, product formulation, and compliant nutrition labeling for food, beverage, and supplement companies, recently sat down with Madeline Jurch, Regulatory Affairs Manager at Danone, to talk about her career leap from Capitol Hill to in-house regulatory leadership and dig into what it actually takes to get regulatory right.

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Kristin: Madeline, you have had this fascinating career arc, going from policy and government affairs work to CPG regulatory leadership. What made you want to cross over into the food industry?

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Madeline: When I worked on Capitol Hill, the senator I worked for chaired the Health, Education, Labor and Pensions Committee, so a lot of what I worked on touched health policy, FDA, and nutrition. I became genuinely interested in watching big-ticket reform efforts move through Congressional oversight of FDA and HHS, and it was fascinating to be up close to that.

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From there, I moved to Kellen, a consulting firm, where I focused on government affairs work coming off the Hill and got sectioned into their food and nutrition clients. I worked with a lot of different organizations, mostly in the food and nutrition space, and that's when I started figuring out where I actually wanted to focus. Danone and Nutricia were both clients of mine at Kellen, so I got to know a lot of people there. When a regulatory role opened up at Danone covering medical foods and infant formula, I was already doing a lot of that work through Kellen. It felt like the right way to go deep on one topic - one company, one set of priorities - instead of spreading myself across a dozen clients. That's how I landed at Danone, and it's turned out to be a great path. I think I just prefer working inside a company rather than around one.

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Kristin: When you first arrived at Danone, you were working specifically on Nutricia’s specialized nutrition products - medical foods, infant formula, and foods for special dietary uses. That's a very different regulatory environment from mainstream CPG. What are the similarities and differences, and what should companies pay attention to in each space?

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Madeline: There are real differences, some I expected and some that surprised me. The interesting thing is that all of these products are still regulated as "foods", but there's enormous variety within that category. Medical foods, for example, are exempt from NLEA (Nutrition Labeling & Education Act and don't require a Nutrition Facts panel, so they often have different labeling than most foods, but they're also still required to meet a lot of conventional food labeling rules. It's an interesting in-between.

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Then you've got infant formula, which is the most highly regulated food category there is. It goes through FDA pre-market review, which is completely different from conventional foods and medical foods, which are regulated post-market. In between those two, you've got things like oral nutritional supplements or oral rehydration solutions, which are not exempt from NLEA, so do have a Nutrition Facts panel but serve a completely different consumer base than, say, a yogurt.

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Jumping between those categories means constantly recalibrating your mindset - for example, going from a Nutrition Facts panel to a label that needs to account for every individual fatty acid for a very specific patient population. I think the throughline is really asking: who is the end consumer, and what population are we serving? The regulations all sit within the same general subset, but how you apply them depends entirely on that answer.

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Kristin: Would you say you start with the same basic regulatory review framework for every food product, but then diverge into a different set of processes depending on the end consumer?

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Madeline: Yes, especially at the start of a product innovation. You're looking at the same things regardless of category - raw material specifications, nutritional ranges, supplier ingredient naming conventions, flavor types. Everyone goes through that same process at the front end. Where it starts to diverge is around production: how often is this product made, what testing regimen does it need, where will it be produced, is it a liquid, a powder, a semi-solid? That's when you start getting into the specifics of how you treat the product, which regulations apply in this circumstance, and how often it's tested.

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The timeline tells the story, too. A yogurt innovation might take two months. An infant formula innovation might take five years. So while the beginning of the process looks similar across the board, you're managing very different review timelines with your cross-functional partners depending on where you end up.

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Kristin: Label claims are where regulatory and marketing collide most visibly. Walk us through your review process, from a marketer bringing a claim idea to the table, to that claim making it onto packaging. What gets killed, and why?

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Madeline: It's a great question, and honestly a fun one - it's different every time. We have a claims review process that involves a lot of cross-functional partners: medical and scientific affairs, marketing, legal, and regulatory. Those are the key decision-makers who come together to look at the claim, the supporting data and evidence, and really ask whether the claim "has legs". Can we validate it, justify it, and defend it if we're challenged by a competitor or regulators?

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During that process, we might tweak the wording to get to something that works for every function at the table. A lot of my job comes down to highlighting the level of risk based on where the claim is going to live. For example, will it be placed on the front of the packaging, where everyone pulling the product off the shelf will see? If so, that is a very different risk profile than a claim used in a sales aid or a conference presentation.

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I try not to think of my role as "killing" a claim. We're always striving to get to a positive outcome for the business, and not to shut things down. But if the evidence isn't robust enough to back it up, that's a real risk-versus-reward conversation: is the upside worth exposing the company to potential litigation or a challenge? At that point, it becomes a business decision for the brand. Sometimes they move forward and accept the risk. Sometimes we go back to the drawing board and figure out where we can strengthen the evidence or revise the claim. It's not a unique process; a lot of companies do some version of this, but it can take anywhere from a week to several months depending on how much rationale we need to build.

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Kristin: We see some small and emerging brands, and sometimes even larger ones, treat regulatory as a checkbox - something you look at right before launch. What's the cost of that approach, and what does it look like when a team gets it right by bringing regulatory into the innovation process early?

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Madeline: If you follow food law news at all, you see recall notices and legal challenges pop up constantly. That's the cost, right there. It could be millions of dollars in legal fees, or a full recall. Anyone who's been through a recall knows it's not something you want to go through twice. It's disruptive to supply, it damages your reputation, and it can damage your relationship with regulators, like the FDA. The absolute worst case is seeing consumers get sick or hurt, which is the scenario none of us ever want to see.

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If you don't have your dossiers and your evidence put together, you can land in hot water fast. I don't think regulatory should be treated as an end-of-process checkbox - it should be part of the innovation and strategy conversation from the start. I've actually seen it propel timelines faster, not slower, because bringing regulatory in last is what creates compliance issues and stalls. The sooner we're in the room highlighting risk and opportunities - are we in compliance, what does our packaging look like, what will our label claims say - the more we can help shepherd innovation out the door quickly instead of getting stuck.

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Ultimately, getting it wrong can cost you your reputation, or kill a brand entirely. Every large CPG company has experienced some version of that, and it's hard to bounce back from. For smaller companies, it can be the difference between making it and not. Bring us in earlier rather than later - that's what I always tell people.

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Kristin: Moving into specialty medical foods - you contributed to the Healthcare Nutrition Council's position paper on "distinctive nutritional requirement", the threshold concept for whether a product should be treated as a medical food. Can you explain what that term means?

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Madeline: This is a category I'm genuinely passionate about, especially having seen the patients who use and rely on these products. It's a unique category with a lot of gray area. The Healthcare Nutrition Council (HNC), which includes basically all of the major medical food manufacturers, including Danone/Nutricia, wanted to advocate to the FDA for a more modernized approach - the way the FDA has historically looked at this category can feel pretty antiquated, because it hasn't been revisited in a long time. So we broke the definition down term by term and built a position paper around it.

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DNR - distinctive nutritional requirement - ended up being the crux of the paper, because it's really the crux of what can or can't be considered a medical food in the FDA's eyes. In plain language, DNR hinges on a specific nutrient need that stems from a disease state requiring dietary management, as distinct from something like diabetes or weight management, where the FDA views you can simply modify a standard diet. 

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Kristin: How long did that paper take to put together, and when was it published?

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Madeline: Honestly, five to seven years. I worked on it while I was working at Kellen, who managed HNC; then the paper transitioned with me as an author when I moved to Danone, and we finally published it. Remember, we're all competitors, so getting to uniform language and a shared position took a lot of talking, a lot of meetings, and a lot of revisions. We also wanted it to be a genuinely comprehensive look at the category, not a quick summary. When it finally got published, we were thrilled - it's one of the only comprehensive medical food publications out there, so we still point people to it if they want to understand the category, because it reflects perspectives from all the major players in the space.

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Kristin: You've worked both inside the policy process and inside a company that has to comply with the output of that process. Are there regulatory changes on the horizon that food, beverage, and supplement manufacturers should be paying attention to?

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Madeline: Working both sides is genuinely useful - I'm tracking what Congress and state regulators are putting out and thinking through how it could affect Danone's product portfolio, alongside a broader team that helps disseminate that across our brands, since every brand is affected differently.

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Infant formula is going to remain a focus for this administration - we've seen a lot of legislation, guidance, and positions specifically around infant formula and baby food, given how vulnerable those populations are. I wouldn't be surprised if the FDA sets heavy metal levels for infant formula next; they've already set them for baby food, so it feels like it's coming. Congress has also been very prescriptive lately, with specific directions for manufacturing plants - food safety plans, sanitation break requirements - that could apply across every facility, which is challenging because every facility is different.

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The other big thing we're watching is what individual states are doing. We're seeing a huge uptick in states taking food safety and transparency labeling into their own hands - state-specific disclosures, banned ingredients, warning labels that go well beyond federal law. That's genuinely hard to manage: most companies aren't selling state by state; they're selling through a distributor, so one state's law can end up covering your entire national footprint. Keeping track of that state patchwork, and figuring out whether a given bill will actually pass, has been a lot of work this past year. If it's a challenge for a company our size, I can't imagine how hard it is for smaller companies to keep up with and implement.

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Kristin: It seems like the federal government hasn't actually moved on creating regulations, even though it signals that it might.

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Madeline: Right, and that's part of why states are stepping in - they want changes faster - so they're doing it themselves. Speaking for Danone, we'd much rather have federal preemption, so there's one clear standard instead of a patchwork of state laws and requirements that aren't aligned and aren't talking to each other. As a company that has to account for every state and distributor, it's nearly impossible to keep track of it all. It's a real challenge.

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Kristin: How should regulatory affairs teams think about that risk, and manage strategy around a patchwork of state laws that keeps shifting?

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Madeline: It forces us to prepare for a range of scenarios and try to stay ahead of the curve, without causing supply disruption or unnecessary alarm. It's also a reminder of how important this role is right now, especially with FDA under pressure to enforce and scrutinize food safety more closely. We're seeing more inspectors and experts on-site asking tough questions - which means we always have to be prepared, including running our own internal audits and keeping a close relationship with our on-site manufacturing teams, so we're treating every day as if FDA could show up.

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We want everything documented and prepared so we never have to deal with a recall, a Form 483, or a major supply disruption. Practically, that means engaging with FDA proactively - asking questions when we don't have clarity, establishing contacts, submitting comments, voicing disagreement or an alternative suggestion when we have one, and generally showing that we're a good-faith player. FDA is under pressure to enforce, especially after a major recall anywhere in the industry, and there's a trickle-down effect from that.

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I'd say it's important for companies to bring on real regulatory and quality expertise - people who stay on top of whether you're abiding by the right regulations, and whether you're ready at any moment for FDA to pull a product, show up on-site, or request a document. A lot of these requests come digitally now, so it's really about balancing all of that with good operating practices and food safety fundamentals.

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Kristin: Let's say you're the first regulatory hire at a growing food or supplement company. Where would you start? What are the first three things you'd do to understand where the company stands?

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Madeline: The first thing I'd do is really understand the products. We've done a lot of acquisitions recently, so we go through this exact exercise with companies we bring in - essentially unpeeling the onion. What do we have? What are our suppliers telling us they're providing, and are they actually providing it? Where can we optimize? Sometimes that leads to a reformulation, sometimes it's just a label update, sometimes it's a new monitoring program because things already look good. So I'd say those are the first things I'd do: understand the existing products, figure out where to optimize, and then think about where we want to go next in terms of quality, accuracy, and new innovation - once the current portfolio is buttoned up.

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Kristin: R&D and regulatory teams can have real tension - R&D wants speed and innovation, regulatory wants rigor and structure. What does a healthy working relationship between those two functions look like, and what could break it?

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Madeline: Honestly, I consider myself a bit of a pseudo R&D professional at this point - I spend so much time with our product developers. I'm lucky to have a close working relationship with a lot of them, built on trust and transparency about what they're doing and how they're putting formulas together. That's something we have to understand. Speed to market matters, but we're really trying to take a first-time-right approach when it comes to quality and regulatory, so there's a happy medium between getting an accurate label, meeting consumer needs, and meeting the needs of our business and sales partners.

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When you rush and skip steps, it almost always comes back to bite you - it causes further delays and further issues down the line. So it's important to genuinely understand what software we're using, how we're periodically testing products, how confident we are in a given label claim, what the shelf life degradation looks like, what real-life data we actually have. There are a lot of questions to work through, but that should happen openly, in partnership with R&D.

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Kristin: For someone early in their career who wants to work in food regulatory - whether in-house, in policy, or in consulting - what's one piece of advice you wish someone had given you earlier?

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Madeline: I think I was lucky to have a fairly natural progression, but the advice I'd give is to find an industry or topic you're genuinely passionate about - and that can come from experience. I actually went back to school while I was working, and that's what pulled me toward nutrition, food, maternal health, and infant health specifically. Whatever that is for someone else - a specific drug, a supplement category, medical devices - finding something you're genuinely interested in matters, because regulatory work involves a lot of deep diving, reading, and interpreting, and it helps enormously to actually care about what you're reading and what you're hoping to see come out of it.

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The other piece is something I wish I'd learned earlier: how to navigate a larger company. It's a real skill to establish mentors, build a development path, and find your place inside a bigger organization - and it often doesn't just fall in your lap. You have to intentionally seek out mentors and people who can help guide your career.

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Lastly, be a genuinely great communicator with your cross-functional partners - internal and external, policymakers, researchers, product innovators, scientists, healthcare professionals. You have to be open to those conversations and build that network, because you're contributing to the regulatory space in all of those relationships. We tend to be analytical, detail-oriented people who want to stay behind the scenes, but I've found it's more valuable to put yourself out there - explain what you do, how you're here to help, and that we're all working toward the same goal. Once people understand that regulatory isn't "the bad guy" - we're not here to get anyone in trouble; we're here as part of the team - it makes it a lot easier to move around a large organization where people don't always know exactly what your function does.

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Kristin: Thank you so much for sharing your insights with us, Madeline!