Ep. 211. Kathy Sanzo: The Implications of FDA's Synthetic Food Dye Phase-Out

Summary

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Podcast Summary: Food Safety Matters, Ep. 211

"Kathy Sanzo: The Implications of FDA's Synthetic Food Dye Phase-Out"

Date: February 10, 2026

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Episode Overview

This episode of Food Safety Matters dives deep into the state and federal movement to phase out synthetic food dyes and certain additives in the U.S. food supply. The focus is on regulatory drivers, industry and legislative response, supply chain challenges, and potential legal and practical implications. Editorial director Adrienne Blum interviews legal expert Kathleen Sanzo (Morgan Lewis LLP), unraveling the complexities facing food manufacturers amid rapidly shifting rules.

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Key Discussion Points & Insights

1. FDA’s 2026 Priorities & New Initiatives

• FDA’s Priority Deliverables (05:47–08:31)

  • Removal of petroleum-based food dyes from U.S. food supply.
  • Strengthening oversight of food additives; new review processes for chemicals of concern.
  • Key initiatives: updates to food code, infant formula safety requirements, reducing contaminants, new nutrition labeling and guidance.

• State & Federal Dynamics (32:33–35:59)

  • Simultaneous push at federal (voluntary industry action) and state levels (prohibitions, warning labels).
  • Secretary Kennedy of HHS uses the "Make America Healthy Again" (MAHA) agenda as a key driver.

Notable Quote:
“The voluntary cooperation is a great approach...it allows [industry] to do it in a timeline that makes sense from both an economic perspective and from a supply chain perspective.”
— Kathleen Sanzo, 33:52

2. Shift to Voluntary Industry Phase-Out

• Voluntary vs. Mandate (32:58–35:59)
  • FDA seeks voluntary compliance—the majority of large manufacturers are cooperating.
  • Over 19 companies & major trade groups (Consumer Brands Association, Dairy Association, Bakers Association) are participating.
  • This route softens impact on cost, supply, and consumer access.

3. Patchwork of State Laws

• Acceleration at the State Level (35:59–38:39)
  • States like California, Utah, and West Virginia already enforcing bans; 30+ states considering similar actions.
  • States move faster than FDA due to fewer bureaucratic hurdles.
  • HHS Secretary is encouraging governors to press ahead independently.

Notable Quote:
“It’s just impossible to sell 50 different products in 50 different states...what that means is that the companies ultimately have to produce a product which will meet all 50 of them.”
— Kathleen Sanzo, 38:58

4. Operational and Legal Challenges for Industry

• Logistical Reality (38:58–42:52)

  • Manufacturers face “impossible” logistics if states diverge in specifics.
  • Realistically, products must meet the strictest requirement to be viable nationwide.

• Supply Shortages & Price Pressure (43:04–45:11)

  • Swapping to natural colors will spike demand—potential shortages and higher costs likely.
  • Natural alternatives (colors/preservatives) may impact product shelf life and customer experience (e.g., bread going stale, color/taste/texture changes).
  • Shortages and high prices expected for certain natural colorants as compliance deadlines hit.

Notable Quote:
“There could be ripple down effects in terms of the overall price of foods...and food is going to last less long.”
— Kathleen Sanzo, 43:04

• Legal Risks (45:27–49:11)
  • Regulatory enforcement (compliance penalties, bans, fines).
  • Liability for inaccurate labeling (“all natural,” “healthy”) if reformulated products fall short.
  • False advertising and product liability exposure; risk of lawsuits if banned ingredients remain or substitutions cause harm.
  • Compliance failures may also damage brand reputation (“court of public opinion”).

5. Recommendations for Industry

• Minimizing Disruption (49:22–52:22)

  • Stay closely informed as state laws can shift or delay.
  • Secure robust supply contracts and cultivate alternate ingredient suppliers.
  • Double-check labels for ingredient/claim consistency.
  • Prepare consumers (especially loyal ones) for potential changes in appearance/taste/pricing.

• Broader Policy & Consumer Impacts (52:36–55:12)

  • State bans starting with school feeding programs (“the largest restaurant chain in the country”)—expectations will shift from schools to home.
  • State legislatures will respond to public and price pressures—potential for new legislation to blunt increased costs.
  • Full impacts—especially regarding cost, access, and nutritional value—will emerge over next 1–3 years.

Notable Quote:
“Parents are going to be the first ones to feel the effect...they’re going to take those expectations to the grocery store.”
— Kathleen Sanzo, 52:36

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Notable Quotes & Memorable Moments

• On Industry Adaptation:

  “Trying to do it more quickly, more abruptly, would certainly increase the cost...which would not necessarily be a benefit to consumers.”
  — Sanzo, 33:52

• On State-Federal Patchwork:

  “Just from a pure logistics perspective, it’s impossible. In as large a country as we are...”
  — Sanzo, 38:58

• On Price & Shelf Life:

  “You’ll have a loaf of bread that is not going to stay as fresh for as long...does that create increased food waste?...The long term consequences...could have consequences that we haven’t even thought about or seen yet.”
  — Sanzo, 43:04

• On Legal and Public Opinion Risks:

  “The court of public opinion is also one that you have to worry about...if they miss those dates, then you have credibility problems with the marketplace.”
  — Sanzo, 49:11

• School Lunch Ripple Effect:

  “The school lunch program is...the largest restaurant chain in the country...That’s a lot of food.”
  — Blum, 54:33

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Timestamps for Key Segments

| Time | Segment | |-----------|---------------------------------------------------------------------| | 05:47 | FDA Priority Deliverables/Guidance for 2026 | | 32:33 | Intro to interview with Kathleen Sanzo | | 33:52 | Voluntary industry phase-out approach | | 35:59 | State action & acceleration | | 38:58 | Patchwork legal/logistics challenges | | 43:04 | Supply chain repercussions & price impacts | | 45:27 | Legal/compliance risks for industry | | 49:22 | Practical steps for minimizing disruption | | 52:36 | Broader implications for schools, consumers, and policy development | | 54:33 | School lunch program ripple effects | | 55:12 | Ending remarks; ongoing policy shifts |

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Conclusion

This episode provides a comprehensive look at the U.S. phase-out of synthetic food dyes from legal, regulatory, and industry perspectives. With FDA using voluntary compliance but states accelerating action (often outpacing federal efforts), industry is under pressure to reformulate, switch to natural ingredients, and overhaul supply chains—all while monitoring legal risk and managing new consumer expectations. The conversation underscores the complexity of food regulation in the U.S.—and the critical need for manufacturers to stay agile and informed as the ground continues to shift.

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Transcript

[A]

The presenting sponsor of Food Safety Matters is Cintas. With a managed apparel program from Cintas, you can be confident that your production team's uniforms are laundered in a hygienically clean process, helping to ensure everyone is in the proper garment and ready to perform their task. Learn [e-mail] foodpro and get ready for the workday. Hello everyone, and welcome to Food Safety Matters, the podcast for food safety professionals. I'm Stacy Atchison, publisher of Food Safety magazine, and I'm here along with my co host, Adrian Blum, our editorial director, and Bob Ferguson, president of strategic consulting. So welcome back as always, you guys. So we'll just go. We're just gonna go, go, go, go. Adrian, you want to tell us a little bit about your interview today?

[B]

Yeah. So today I'm talking with attorney Kathleen Sanzo about the growing state and federal momentum to eradicate synthetic food colorings and other additives of concern from the US Food supply. And we discussed the current situation, including the approval of some new natural color additives, as well as all the implications of this for industry. So don't miss it.

[A]

I like that the current situation, it is a situation, a long, a long term situation. We're embroiled in here. All right, well, thanks, Adrian. And as usual, I have a couple housekeeping items. You know, we like to keep things ship shape around here. Ship shape. I had to look that up this morning. I won't do. I won't, I won't. But it was interesting. Where did it come from? Why did it say it? So as we start to walk out into 2026, I wanted to remind everybody that Food Safety magazine offers an incredible array of resources and learning opportunities for our community. Of course, our flagship bimonthly magazine now digital newsletters reimagined for 2026. I talked a lot about that in the last episode. Daily News produced by our digital editor, Bailey Henderson. And some web only articles. Food Safety five twice monthly videos and incredibly informative webinars moderated by our very own Adrienne Bloom. And so much more. So all of those come together on our website, food-safety.com and you'll need to register to get into the site, but it's free and that gives you access to all of our content. Let's see, 30 years of unmatched food safety content. And from there you can subscribe to our free E magazine and our weekly newsletter and then return often to get your food safety fix. And what would a dynamic community be without an in person event? To bring us all together once a year, like only the food safety community does, right? Where food safety is not a competitive issue, but an opportunity to learn and grow together. So you are warmly invited and encouraged strongly to join us in person because it's so great. It is. It's a big love fest, frankly, when we all get together in person at the Food Safety Summit Conference and Expo being held this year, May 11th through the 14th, 2026, in easily accessible and affordable Rosemont, Illinois. And as always, we've got an amazing agenda that you can [e-mail] so just in the last couple of weeks, we have confirmed a few key elements, like the participants of our 15th annual town hall, sponsored this year by one of our gold sponsors, Sherwin Williams, featuring live and in person, Dr. Mindy Brashears, Under Secretary for Food Safety at USDA Kyle Diamantis, Deputy Commissioner for Human Foods at FDA Megan Nichols, Director of CDC's Division of Foodborne, Waterborne and Environmental Diseases, plus Steve Mandernach, Executive Director of afto. The interactive session will be expertly moderated by the summit's eab. That's Educational Advisory Board Chair Gillian Kelleher, who always does an amazing job. So it's an honor to be able to bring together this stellar panel of regulators and public servants to help our community stay up to date with and in conversation with these important agencies. So there's always a great Q and A.

[B]

So.

[A]

So you wanna come there and ask your questions. So Again, please visit foodsafetysummit.com so you see all the great session certification courses and networking events that we have lined up for you. We have new courses, new speakers, and way too much for me to talk about right now. So go, go, go. Foodsafetysummit.com now remember, as a Food Safety Matters podcast listener, you save big when you register, especially before March 31, when the early bird ends. Because when you do it, then you get the discount plus the early bird. So you really save. You get 20% off registration fees whenever you register. Like I said, but before March 31, that's on top of the early bird. Just use a discount code, fsmatters20, and that'll get you that 20% discount. Okay, I did that pretty quick. That was pretty good. But I kind of throttled myself about, don't go too deep. Don't go too. Go on and on. So now we can get to some news.

[B]

Yeah. So first up in news, on January 23, FDA's Human Foods Program, or the HFP, released its Priority Deliverables and its Guidance Agenda for 2026, sharing more information about the agency's major food safety and nutrition work for the year ahead. So the Priority deliverables build on last year's progress and align with the Make America Healthy Again or MAHA goals under the current admin administration. And they're centered around the HFP's three core risk pillars of microbiological food safety, food chemical safety and nutrition. So on the priority deliverables front, FDA plans a number of significant initiatives. They include an effort to remove petroleum based food dyes from the US Food supply, strengthen oversight of food additives, including revisiting how generally recognized as safe or grass substances are handled, and rigorously reviewing and or banning chemicals and additives of concern, including under FDA's new post market Chemical Review program which was announced last year. There are also plans for a comprehensive review of infant formula nutrient requirements, continued work on food allergen regulation and transparency, and a front of package nutrition labeling program designed to help consumers make healthier choices. Expanded facility inspections in partnership with state resources, reducing child exposure to contaminants like lead and cadmium through food, addressing ultra processed foods and improving recall communications are also on the agenda. Plus, FDA intends to release an updated food code in 2026 to support food safety and retail food service operations. Now, alongside these deliverables, the HFP's guidance agenda for 2026 targets industry support across the risk pillars. Plan guidances include draft documents on microbiological contamination responses in low moisture foods, fresh cut produce hazards, enhanced sanitation under the Hazard Analysis and Risk Based Preventive Controls for Human foods rule and FSMA 204Q and A's. On the chemical safety side, draft guidances will propose action levels for contaminant metals on poppy seeds as well as guidance on natural food colors and new dietary ingredient notifications. Nutrition focused guidances include updates on olive oil identity, food labeling for online grocery shopping platforms and protein quality studies for infant formula. Through its 2026 priority deliverables and Guidance Agenda work, FDA aims to better protect and promote public health through science based approaches aimed at preventing foodborne illness, ensuring the safety of chemicals in food and reducing diet related chronic disease.

[C]

So there's a lot here and there's a lot to discuss and particularly with the priorities on what they do and what happens and what the impact would be. So there could be a lot to discuss. But I went through this and I have a few comments on some of the priorities and two things happened. One is just some ideas I have for comments on each one of the priorities. But also I noticed that some of these are most likely to have a fast impact. In other words, it could impact the market and it could impact food safety very quickly. Others are going to have a bit of a slow impact, so I kind of categorize them that way. Just to look at the idea that if it's 2026, how much of this is going to have an impact in 2026? How much is maybe years in the future? So I just thought I'd go through this.

[A]

I'm on the edge of my seat.

[C]

The big reveal is coming up. It really is post market reviews. I mean, that makes sense to me. These should be occurring on a regular basis anyway. Things like the additives that we've been talking about for months now. As new information comes forward, new science comes forward that should be reviewed. That to me has a potential to be fast. If something could be taken off the market, something that should be taken off the market could happen if it's discovered. If they don't discover much, it depends upon what happens. But that could be something that has a pretty quick impact. Microplastics. I think this is a very good initiative to have. It's good to have a better understanding of the actual exposure risks and I'll say, you know, not hype and noise around microplastics, because I think a lot of it is not really understood. And a lot of the major organizations say that there still needs to be more known about toxicology within humans. But I think this one could be slow. It's going to be very difficult to get through that, those studies and find out exactly what needs to be done. And because of the nature of microplastics, actually doing something about it. So this one may not have an immediate impact. Dietary supplements modernization Part of me wants to say about time, but dietary supplements are really regulated like food. Some of this is a. Is possible for the FDA to do something fairly quickly with existing authority. Things like mislabeling adulteration, imminent hazards, those type of things. But the FDA doesn't really have a lot of authority to do much with dietary supplements as far as premarket approvals or these kind of things. No mandatory product listing exists without additional legislation. That's going to be a longer, longer time frame. So depending upon what they look at and how they work on labeling and what they do, they may be able to do it quick or it may take a really long time. We'll have to see what happens there. But there's a lot of stuff on the market that's in my view, a little curious. So I have to see what happens there. Nutrition, some of the nutrition guidelines and there's a number of initiatives. I'm going to cover this in one title under nutrition. This could be very slow without people buy in as far as reducing salt, reducing sugar, labeling on packages so people make better selections. What is a healthy designation? These could all work really quickly if people buy in pretty quickly. I know that doctors and nutritionists will say that if somebody is overweight and they lose 10% of the body weight, they have amazing outcomes with blood chemistry and cardiovascular risk and all these other things that could occur quickly if people buy in on this. On the other hand, it could be fairly slow if people don't buy in depending upon what the FDA does to try and promote some of these things. So it'll be interesting to see about that. I've said this before. I believe that people either have to buy in on this or it's not going to happen. But we'll see what happens with micro One of the things they said under the microbiology was better inspections by moving the inspections locally, taking them down to and we mentioned that Steve Manderknock is going to be at the summit. This is a good question for him. What's it take to bring the FDA inspections local? In the interviews I do for the Insights articles, I get a chance to talk to some of those inspectors because they'll answer the surveys and I get a chance to talk to them. And nothing negative about FDA inspectors. But if they get to a plant one, two, three years, there's a lot that can change in a plant if you don't get there. But there's several inspectors I talked to that just stay within their state and they can get to these plants multiple times, get to know the people there, understand the processes better. I think this may be a better process locally and I would bet and I'm not going to put words in Steve Mondernach's mouth because he knows this. He's forgotten more about this than I know. But only if the funding follows along with the dishing this out to the states. Otherwise it's just another unfunded mandate being pushed on the states. And that doesn't necessarily help anything. So it's really going to depend on upon what happens there.

[A]

Well, we've, I mean to cut you off, but no, you know, we've been hearing Steve talk about his funding fights for a few years now.

[C]

Right.

[A]

Even under Jim Jones. So it'll be interesting to get that update as far as where that stands.

[C]

Yeah, the next one. Two more Fisma 204. I was glad to see that was a priority. I think later in the podcast we're going to talk about some supply chain things that are going to be key to have better Fisma 204. So we'll have to see what happens there. That's going to be a little bit slow because of the legislative deadline that's been pushed out. But I have one more.

[A]

That's what kind of made me smile. It's like, okay, well, we'll just do Q and A, right? We won't do it. We'll just do Q and A, right.

[C]

So it depends upon what they do with supply chain. But so my, my award winner for the one that's going to be the slow, the one that has a slow impact is one of the priorities they have is the 2026 Food Code. Now we've talked about this before. The food code is updated every four years and then it has to be adopted by the state. So I've got a quiz for everybody and everybody you can play at home. Just yell out the, yell it out while you're in the car driving. Just yell out the number. How many states or localities are still using the 2009 food code?

[A]

Oh, wow, that's very specific, Bob. Yep. Or I thought you were going to say has your state updated or what's the most recent food code your state has?

[C]

You could look that up too. You could look that one up too.

[A]

And. Or has it only been parts of things because.

[C]

Right, that's right.

[A]

It's dealer's choice.

[C]

Yep. Okay, I'll stop the, the anticipation according to a 2023 email.

[A]

Bob, your answer.

[C]

Yeah, email your answer. Okay, I'll wait till next time. Food-safety.com we won't hold you. We won't hold you up on that. According to an FDA adoption study that was done in 2023, the 2009 food code is still being used by seven states and the District of Columbia. So the process to write these into local code, which is where they're enforced, is not so fast. And so if you imagine if 2009 still be using by eight, eight states D.C. and then you still have 13, 17, all these other ones having a new 2026 food code, probably a good idea. Some people will adopt it depending upon what it says. It's not going to be fast. But as far as keeping that up to date, it's probably a good idea.

[A]

Well, I think too, in talking to some folks that sometimes you Know, organizations will. Will do it. Right. So they don't need to, they don't need to wait for the state to do it. You know, certain restaurants and so on will say no. Our standards are, you know, in accordance with or we're adopting this part of the new food code. Right. So it really, it's, it's really quite a patchwork.

[C]

Yeah, but they have regulatory authority so that a health inspector can.

[A]

Yeah.

[C]

Shut down a restaurant. It has to be the code that they have to follow. Right.

[A]

Yeah, yeah, yeah. But just know that there are restaurants out there. Well, all of our other ones know that. Right. Yeah, they know. I'm kind of preaching to the choir here. I forgot where I was.

[C]

That's it for me. I'll stop. I've caused enough trouble.

[A]

Oh, wait. I was going to remind everybody, but I guess I covered it before all that FDA stuff and usda come to the summit, ask your questions. And I was going to say, when I talked about Steve being on the panel, I was going to refer to him as our returning champion because he's always stirring stuff up and it's really great. And then also Megan Nichols from CDC on our panel for the town hall. She was unable to come in person last year, but she was, you know, zoomed in, but did so great. I, you know, it's hard to really have a presence like you're on the panel when you're, you know, on a screen in a room like that. But she just did great. So I can't wait to have her in the room. It's going to be wonderful. Anyway, sorry, I digress.

[C]

Stacy, you just, you just reminded me of something. And tell me if I remember this right, but I was going to say when I mentioned about the food code. Oh, I'm sorry about pushing the inspections out to the states. You know, you could ask Steve Mandernock that at.

[A]

Yeah.

[C]

Town hall. And I thought, well, maybe we don't want to get him in between him and Kyle at the time while they're up on stage. But if I remember last year, this subject came up last year, and Steve kind of leaned forward, looked over to him and said, are we going to get funding? And kind of made it into an issue. And then Steve went and kind of made his pitch for funding, which he should be doing, but also one of the reasons why the town hall is so fun.

[A]

Yeah, it's great.

[B]

So moving on to some more FDA news. The agency has shared more information on the ongoing investigation into an outbreak of infant botulism associated with by heart whole Nutrition powdered infant formula so FDA testing has identified Clostridium botulinum toxin type A in both finished formula and now organic whole milk powder, which is an ingredient in their formula. So whole genome sequencing shows the isolates from the milk powder match those from the contaminated product and from clinical cases. This strongly implicates the organic milk powder used in Bihart's formula as a contamination source. Although the investigation is still ongoing, the Associated Press reported that Organic West Milk, Inc. A California company, is the supplier of organic whole milk powder to Bihart and the ingredient is processed at a Dairy Farmers of America cooperative facility in Fallon, Nevada. Dairy Farmers of America confirmed that Organic West Milk was the source of the milk powder for the positive samples. Organic West Milk supplies milk from 55 different farms and said that it has not sold organic whole milk powder to any other infant formula maker besides By Heart, the company also paused sales of its organic milk powder until more is known about the source of the contamination. FDA's investigation into the source of the outbreak, which has been linked to at least 51 hospitalizations across 19 states, is ongoing. The FDA has also set up an information page to track response efforts as more data emerges and you can find more info on that in the article link in our show Notes I'm just.

[C]

Going to lead into a comment, I'll say one thing and I'll lead into a comment later is it looks like this is linked back to one supplier. So while we're talking about Fizzba 204 and being able to track your supply chains, you know I'm probably preaching to the choir here, but all the listeners, but that's one of the reasons why this is so important.

[B]

Yep, absolutely. And so we have more infant formula news for you this week, unfortunately. So over recent weeks, several major manufacturers including Nestle, Danone, Lactalis, Hochdorf, Swiss Nutrition and others have voluntarily withdrawn or recalled batches of infant formula. Tests have revealed the presence of cereulide, which is a heat stable toxin produced by Bacillus cereus, bacteria, an arachidonic acid oil, an ingredient used in the formula. Nestle says the presence of cereulide is uncommon and it's working with its oil supplier to conduct a root cause analysis. So cereulide can trigger rapid onset gastrointestinal symptoms such as nausea, vomiting and diarrhea, particularly in vulnerable infants. So far, health agencies like the European center for Disease Prevention and Control have reported only mild cases of illness tied to these recalled products and serious outcomes remain unconfirmed. However, the Deaths of two infants who consumed recalled Nestle and Lactalis products are under investigation by French authorities, although no causal link has been scientifically established to date, according to the French Health Ministry. And in the uk, a mother reported that her baby developed meningitis after consuming formula from a batch that was recalled by Nestle. However, the company says there is no evidence linking the product to meningitis and and medical experts note that sirulide typically causes gastrointestinal symptoms and not meningitis. So per a request by the European Commission, the European Food Safety Authority, or efsa, has established an acute reference dose for cereulide in infants of 0.014 micrograms per kilogram of body weight. EFSA has also determined that the concentration of the toxin that poses a potential safety concern in infant formula is 260ml per kg of body weight. EFSA has also established acute reference doses for follow on formula and reconstituted liquid formula and can find more info on those limits in the article in our show notes.

[C]

All right, so the comment I'll make is on the first one we mentioned that it goes it probably goes to one supplier that's not been proven yet, but it looks like that's the case. This one goes back to one supplier in China of the oil that most of these infant formula companies have been using. So with one supplier in each one of these, you have an issue where you've got an issue that needs to be solved in the US and an issue that needs to be solved in Europe. And now you have kind of a mismatch between the requirements for infant formula in the US And Europe. Not that they were always perfectly matched. But if we have another infant formula issue like we did some was a year ago or so where the US Was bringing in infant formula from overseas. Now you have completely different parameters that have to be tested for that either need to be waived or need to be harmonized in somewhere. It really, really gums up the supply chain all because of two suppliers and nobody, it seems like, had a secondary supplier. Another reason why you may say supply chain is a logistics issue or a business issue, but it's really a food safety issue too, because all of these things come into play and it could one day, if this doesn't get solved and harmonized before too long, result in another really impactful shortage of infant formula. And again, there's not a substitute for this. If there's a shortage of infant of hamburger, there's chicken, or there's a shortage of something else. It's not a substitute for infant formula. This is a difficult supply chain issue.

[A]

Yeah, that's what I thought too. First of just was so sad knowing that there were deaths and but exactly that point is there aren't that many people who are supplying who make formula. It's not like you know, there, there are a lot of options. So yeah, let's hope they get to the bottom quickly.

[B]

Okay. So next up in news, a recently published study on a Norwegian smoked salmon processors Listeria monocytogenes control efforts share some interesting insights for environmental monitoring and response. So following two listeriosis outbreaks linked to the same facility, the company implemented an intensive seek and destroy process combining increased sampling, deep cleaning equipment adjustments and whole genome sequencing over the course of 11 weeks. This investigation pointed to a skinning machine with hygienic design flaws as a persistent harborage site for Listeria. The machine's conveyor belts featured a rubber like surface over a woven fabric layer, going against hygienic design principles that recommend impermeable coated belt materials that prevent fluid absorption. Also, the mixed material junction in the machine's air filled roller which had a plastic core with metal end fittings, also had the typical characteristics of listeria harborage sites. Even disassembly and aggressive disinfection of the machine failed to eradicate Listeria. Heat treatment was found to be partially effective but could only be applied to parts that could withstand high temperatures. Ultimately, the processor replaced the skinning machine and tightened its hygiene protocols and subsequent testing showed no presence of the outbreak strain in samples. So this study shows the importance of hygienic equipment design, the limitations of chemical cleaning alone and how targeted sampling and testing strategies can help guide effective remediation.

[A]

Well, these researchers should if they didn't see it, they should be very happy to know that none other than Dr. John Butts reposted this story on LinkedIn with a note that said outstanding research demonstrating the strength, rigor and practical application of the quote seek and destroy process. His process. The investigators are to be commended. So kudos to is it NOFEMA for their research.

[C]

Yeah, well John Butz doesn't need any congratulations from me, but I couldn't agree with him more. When I read this and when we had our planning session, I hadn't read it yet, but when I read this, the first thing I thought is this is a perfect textbook case that everybody in food safety should be taught. And a couple of things that jump out at me from this is first off, none of this could have been solved without whole genome sequencing because they would not have been able to find the harborage organism. They had periodic hits on Listeria and even after they moved the machine out and replaced that, they had periodic hits, but they weren't the same. And so they were able to find out that they removed the harborage organism when they removed the machine and cleaned it out. But they would not have known that before. So this, the whole genome sequencing technology is changing things so dramatically from 10 years ago to be able to solve these things. And this thing would have gone on periodically for a really long time. The other thing is the importance of hygienic design. I mean it leaps off the page with this particular one. One of the things they found that the machine was not cleanable. We've talked about before about disassembly and reassembly and making it available to people and the things that we've talked to experts about hygienic design before, but even after they did this, it was, did that, it wasn't cleanable. I also remember talking about this when I did the hygienic design survey. And this problem was only solved with replacement no matter what they did with that machine. Simply the way it was, was designed. And one of the things in that survey that people said was we're always careful with used machinery being moved from one plant to another. And one person told me, do not accept somebody else's problem. So they removed this and I'm assuming just got rid of that machine. But this is the kind of thing where somebody has a periodic problem and they get rid of it and the machine moves to another plant. This just would have been recreated somewhere else. But now that they know the source of this, because they wouldn't have known this without whole genome sequencing. And the things that we just talked about, know the source of it, you know, that that machine can't be reused. So it doesn't recreate its somewhere else either, which would have been recurring, you know, 15 or 20 years ago. Somebody would have just moved the machine, got a new one and somebody else would have picked up using it maybe. So I think that's key and I think it's the reason why I always believe that food safety and what we're doing is constantly getting better, Even though the data doesn't always show that because we're adding more cases to the, to the file, so to speak. But I keep that in mind that these things would have been going on and not solved not very long ago.

[A]

Yeah, that one always makes my Head hurt. Because it's like, I feel like, you know, you're chasing these unknowns. Right. But the thing that is known is how expensive it is to replace old equipment, right? Oh, yeah. And I think that that's because again and again, you know, I've been hearing about food safety professionals talk about hygienic design for 30 years now, and yet it seems like it's so slow to be really universally adopted. And it's just unfortunate. But I think that the data is in, Bob, on how quickly you can recoup your investments and mitigate risk with hygienically designed equipment.

[C]

This particular plant had had listeria in the past that even showed up in end product, but they could never pinpoint where it was coming from. And with that technology, they were able to pinpoint where it came from and solve the fact that it was indeed the equipment that that just wouldn't have been known.

[A]

And I like it that they said heat treatment was found to be partially effective, but they couldn't. So they couldn't do the old John Butts. Let's, let's take, let's put it in the smoker.

[C]

They said they dunked all, they dunked the machine essentially, and still couldn't eradicate it.

[A]

Yeah, yeah.

[C]

It's amazing. It's amazing to me.

[B]

Yeah, that was definitely a really interesting study. And I think in our article too, you can, there's Bailey, our digital editor has a link to, to the original study. So if you want to read more about the intricacies of, you know, the equipment, what they did and all that stuff, you can, you can read the original study. So before we go today, we want to let you know that FDA is convening a virtual public meeting on food allergen thresholds, bringing together regulators, industry stakeholders, consumer groups and researchers. The sessions will be held on February 19th and 20th and they'll explore allergen requirements, risk assessment methodologies and how risk based thresholds might inform communication, labeling and regulatory approaches in the U.S. there will also be listening sessions for stakeholder feedback and a docket opening for public comment through May. So if you want to join in on the listening sessions or submit a comment on the meetings, please find more details on how to do that in the article link in our show notes.

[A]

Okay, well, like Adrienne said, there will be links to all of the articles that we've referenced in our show notes. And if you don't already, we invite you to follow us on our social channels. LinkedIn X, Facebook, Instagram and YouTube. Just search for Food Safety magazine and to take a deeper dive, which is where we started with my Housekeeping Today into all the great conferences content that we offer. Just Visit our website food-safety.com and just like that, it's time for Adrienne's interview with attorney Kathleen Sanzo, who is co Chair of Morgan Lewis Life Sciences Industry Team. She centers her practice on regulatory and compliance issues connected to FDA related products. She leads and counsels clients on all legal and regulatory issues concerning food, dietary supplements and cosmetic product manufacturer approval, marketing and distribution, food, drug and device compliance and enforcement matters and consumer product issues regulated by the U.S. consumer Product Safety Commission and state enforcement agencies, among other areas. A frequent author and co author on publications related to FDA matters, Kathleen regularly speaks on these issues at industry events. She serves as Vice Chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice and and is a member of the Food and Drug Law Institute's Medical Products Committee and after a very quick break, you'll hear their discussion with a managed apparel program from Cintas. You can be confident that your production team's uniforms are laundered in a hygienically clean process and delivered back to your facility every single week. Cintas has been outfitting workers for over 90 years and the Cintas network includes hundreds of locations across North America. Together, we can ensure your team has the hygienically cleaned garments they need when they need them. Learn [e-mail] foodpro and get ready for the workday.

[B]

So a topic we've all been following closely over the past few years is the growing momentum at both the state and federal levels to eradicate synthetic food colorings and other additives of concern from the US Food supply. And here with me to talk about that movement and its implications for industry is Kathleen Sanzo of Morgan Lewis llp. Welcome to the podcast, Kathy.

[D]

Thanks. Very nice to be with you today.

[B]

Yeah, great to have you as well. So earlier this year I know the FDA approved several new naturally derived color additives as part of Health and Human Services Secretary Kennedy's push to replace petroleum based synthetic dyes with natural alternatives under that Make America Healthy or MAHA agenda we've all become very familiar with. And this follows an FDA announcement in April of last year to phase out synthetic food colorings from the US Food supply with voluntary cooperation from industry. Now, since that time, we've seen a number of major food processors and retailers announce their intention to phase out artificial food colorings and other additives of concern from their US Product lines. So what are your thoughts on the administration's approach to securing voluntary cooperation from industry, you know, rather than enacting enforceable mandates for this phase out?

[D]

So first of all, I think voluntary cooperation is a great approach to this sort of difference in how we're approaching both food and color additives for that. And so when you allow the industry to undertake these sorts of various significant changes voluntarily, it allows them to do it in a timeline that makes sense from both an economic perspective and from a supply chain perspective. Meaning there are certainly going to be consequences of making these kinds of changes, both from a formulation perspective, from a labeling perspective, just from a pure do we have enough natural flavorings and colorings to take the place of the synthetic ones that are being now either banned or suggested for removal from food? So taking all of that into consideration, sort of working down that pathway on a voluntary perspective really makes a whole lot of sense, both from the industry and the consumer's perspective, because trying to do it more quickly, more abruptly, would certainly increase the cost of food formulation and food distribution, which would not necessarily be a benefit to consumers. In my end at this point is there's approximately, I mean, if you look at FDA's tracker for those companies voluntarily approved or agreed to take many of the colors that the administration is concerned about out of their food products, there's about 19 companies at this point. There are three major trade associations, including the Consumer Brands association, the Dairy association, and the Bakers Association. So sort of pulling all of that together, that represents a lot of the food manufacturing companies in the United States and includes many, many, many of the most significant manufacturers. So it really has resulted in a very robust industry response.

[B]

Yeah, yeah. And you know, there's also a lot of movement happening at the state level with food colorings and additives. You know, we've seen states like California and ut, West Virginia, passing bills restricting synthetic dyes, and compliance deadlines for those begin as early as August of, or began as early as August of last year. And you know, nearly 30 other states have introduced similar bills ranging from school based bans to broad retail restrictions and warning label requirements too. So what factors are driving such widespread state level action, especially when these matters have traditionally been under federal authority?

[D]

So I think there's a couple of reasons why this effort has picked up momentum since the change in administration. The Secretary, Secretary Kennedy has made it quite clear that he's very interested in ensuring that the colors and the additives that are used in the food are the most appropriate ones and for the healthiest outcome for consumers. He's appeared at a number of different conferences, both the National Republican Governors association, the Governor's association of the United States, where he has actually encouraged states to take a close look at this and to take action more quickly, if possible than what he can possibly do under the federal regulatory regime. And one of the reasons I think he's encouraging that sort of action is that the fda, obviously, under the Federal Food, Drug and Cosmetic act, has very many limitations and procedures that result in it sort of taking a long time to get any particular regulatory changes, especially ones that are so as significant as the ones that we're discussing actually accomplished. I mean, it takes years and years. There's rulemaking, and there has to be opportunity for the industry and for consumers and other groups interested in the regulatory change to comment and for FDA to respond to those comments. So the states really have been able to move this along much more quickly than FDA ever possibly could under the current regime. So I think that's possibly one of the major factors, is to sort of expedite this whole process in a way that makes sense. Now. It obviously creates some consequences, but we can talk about that down the road. But there certainly are reasons why you'd want the states to move quickly on these kinds of issues.

[B]

And, you know, speaking of consequences. So for food manufacturers that are selling products nationwide, how challenging is it to navigate this kind of patchwork of state laws that has emerged? And, you know, if you have any examples of major operational or legal hurdles you've seen, you maybe share those.

[D]

I mean, it's a major hurdle. This is why whenever you have any sort of regulatory change that results from a number of different states taking a different, even a slightly different approach to the regulatory issue, at the end of that process, typically you will see the industry come together and try to suggest, why don't we approach this on a federal. From a federal perspective so that we can avoid having the patchwork of laws that you're describing. And the consequences of having that patchwork of laws is that from a logistics perspective, it's just impossible to sell 50 different products in 50 different states. I mean, you can't have, you know, one kind of food product, I don't know, you know, some sort of snack food that's labeled differently, that has different ingredients, that's formulated differently depending on what the state requirements are for the particular ingredients in that state, or even for the sorts of labeling and warning statements that are on the product. So just from a pure logistics perspective, it's impossible. In as large a country as we are, with the complicated distribution system that we have for food products in the United States through wholesalers and retailers and organic stores and online even, it's really just sort of impossible. So what that means is that the companies that are subject to these various state laws really have to ultimately produce a product which will meet all 50 of them. So if that means one state requires a warning statement on the front of the package, they're probably going to sell that product with that warning statement on all of the products sold in all of the states. And you can see that that really has occurred with result. The same result has occurred with regard to products that are subject to Proposition 65, for example. I mean, there's not many, many products that are sold in states that do not have laws like Prop 65 that are labeled for Prop 65. So I think just from a pure logistics perspective, it's an impossible task to try to meet even 30 states different requirements. And for these kinds of changes also, it's obviously not just labeling, especially for those states that are restricting various types of ingredients that go into food products, whether it's a preservative or a food color, changing out those supplies or those ingredients to use different ingredients that will be compliant with the state law requires formulation changes, research about whether or not the new ingredient will produce effects in the food that the prior ingredient that can't be used, now produced, does it have the same look and mouth feel as the product that previously used, you know, the old color? So it really is a pretty laborious process to switch out ingredients just from a formulation and manufacturing process. And that even assumes that there's enough substitutable ingredient. Right. To go around. So once, you know, a particular color stops being used, and let's say you have to use some sort of natural color in its place, all of a sudden there's market demands on that color that the market may not be able to meet automatically. Right. I mean, it takes time for particular manufacturers to get up to capacity and to meet market demand. And so all of those limitations make it very difficult to market food products in 50 different ways, or 30 different ways, or 25 ways. I mean, it just. It's really sort of impossible.

[B]

Yeah, absolutely. And so what impact do you think that the removal of these synthetic dyes will have on the supply chain and also the availability of substitute colors?

[D]

So I think the, the demand obviously for natural colors is going to increase rapidly and substantially. And whether or not the market's going to be Able to meet those demands is still not absolutely clear because many of the commitments that have been made to voluntarily switch out these ingredients for the natural ingredients, the commitment is to start at the beginning of the 2026 school year. So I don't really know yet the full impact of these changes on the marketplace, but I suspect that there is going to be some shortage of some of these colors in some marketplaces in some regions of the country. And also the price of them is likely to go up substantially. There's, you know, we live in a system where the more demand there is and the shorter the supply, the higher the price. And so there could be ripple down effects in terms of the overall price of foods with regard to the increased cost of these ingredients. So I think that's one possible issue. The other issue, and this isn't specifically for colors, but also for other sorts of ingredients that are included in some of these state bans, which are preservatives. You know, food is going to last less long time. You'll have a loaf of bread that is not going to stay as fresh for as long potentially. And so that ends up affecting how often people shop. Can, you know, is does that create increased food waste because product is going, you know, is not staying as fresh for as long. So I think the long term consequences with regard to the substitutions that are being proposed could have consequences that we haven't really even thought about or seen yet. And, you know, those are all come down the road in the next 12 to 24 to 36 months, I think.

[B]

Interesting. And you know, so looking toward the future here, what kinds of legal risks do you think industry stakeholders should be most concerned about with these changes? And you know, how might they differ across states, particularly around reformulation and labeling and liability?

[D]

Yeah, well, there's obviously two kinds of risks that occur. The risk of regulatory enforcement, for example, the product doesn't comply with the current state law and therefore the state regulatory authorities authorities take enforcement action. And the state laws have various approaches to penalties and disciplinary actions. And so that certainly is a risk. And that's probably a risk that the states in the initial part of the enforcement of the laws are going to look at carefully with regard to which actors in the marketplace they take action against. Because obviously it's difficult to take action against everybody who may not be in compliance. I mean, FDA has the same issue with its level of enforcement against companies. And so I think there's going to be an initial period of sort of robust enforcement. A signal will be sent to the industry about what the level enforcement will be in a particular state, and then people will react accordingly. So that's one sort of risk. The second sort of risk is obviously with regard to label claims that are made on these. If the product does not comport with state law, or if the claims on the product, for example, you have a reference to healthy, or you have a reference to safe, or you have, have a reference to all natural and the ingredient list doesn't comport with those claims and, or the product doesn't comport with state law, which in some cases will define products that contain these banned ingredients as resulting in an adulterated product. Then all of a sudden you have liability for potentially false and misleading claims, which always leads to false advertising cases. And those can become quite costly depending on the amount of revenue achieved through the sale of that product. I mean, those cases normally end up settling off. The settlement amounts are based on the amount of product that has already been sold with the allegedly misleading or inaccurate statement. So that's the other, that's the other area of risk. And then product liability risk is where consumers sue companies based on an assertion that the consumption of the product actually caused them personal harm. They had some sort of gastrointestinal distress or some other kind of personal injury from consumption of the product. So for those products that continue to contain the ingredients that have been banned or restricted, there certainly is a basis for consumers to take action if they believe that the product has caused them personal injury. So those typically are the three legal types of risks that can occur. Obviously, companies have compliance programs. They don't want to be in violation of their own compliance programs. Just perspective. And then of course, the court of public opinion is also one that you have to worry about. And companies that make commitments to attain certain goals of removing certain ingredients by a date certain, if they miss those dates, then you have credibility problems with the marketplace. And so I think all of those types of issues are swirling around the, you know, in the thoughts of the people who are having to make these changes over the next really six to nine months for those that have, have agreed to the commitment for voluntary removal.

[B]

Certainly a lot of things for processors to keep top of mind right now. How can companies prepare now to minimize disruption from these diverging state and federal rules?

[D]

So I mean, the only thing you can really do is to make sure, number one, that you stay abreast of what's going on. Some of these laws, it's always the case with state laws. Sometimes they are a state or sometimes there's an enforcement policy whereby the compliance state is pushed out. So it's important for companies just to stay abreast of that, make sure they understand where the state is with regard to implementation of the law. Obviously, any new laws that come into place where it's January, many state legislative bodies are now beginning to meet again. And although we've got a lot of pending legislation in states in the, you know, the other 20 states that haven't considered similar laws are likely to be pushed to think about similar laws. So it's going to be an arena for high activity, likely in the next six to nine months in the legislative, in the state legislative arena. So companies have to stay abreast of that. Obviously, for those that have already agreed to change, ensuring you have a very robust and reliable supply chain for the substitute ingredients that you're going to have to use to make the changes that you've committed to make is going to be important in ensuring that you have, you know, great supply contracts with very strong safeguarding provisions for supply. Because, you know, a lot of companies, especially smaller food companies, buy supplies based on purchase orders. They don't have robust supply agreements. And so in that regard, you know, it is important to ensure that you have protection around your supply chain for these substitutable ingredients because there are going to be shortages and some of these ingredients come from abroad. And there's a lot of disruption going on in the world around us right now in ensuring that you have alternative suppliers as well, not just your principal supplier, but having backup suppliers, substitutable ingredients is going to be very, very important down the road. So I think from an ingredient perspective, you can do all of those things. Obviously looking at your labels, making sure they're consistent with your ingredient list is going to be a big issue. And then also just ensuring that from a marketing perspective, right, you've done the work to ensure that your consumers, the people who buy your brands, and have certain expectations about how it's going to look or how it's going to feel or how much it's going to cost, you've done all of the work to ensure that consumers understand that these changes are coming and that there are going to be differences in the, in the products that they buy and they're ready for those differences so that, you know, people are not surprised when they end up at the grocery store or their online supplier and see products that look potentially very different than they've bought in the past.

[B]

And so kind of with that guidance in mind, how do you see state legislation on color additives shaping consumer expectations and industry innovation and, and just broader food policy over the next five to 10 years.

[D]

So I think it is going to have an effect on consumer expectations. And as you know, many of these state laws that have gone into effect really are targeted towards school feeding programs, whether it's school lunch, school breakfast products, even summer programs that provide various meals for kids during the summer. And so parents are going to be the first ones to feel the effect of these changes. And there is going to be an understanding by parents that they should have different expectations for the food that their kids are eating based on these new laws. And so I think there's going to be sort of a trip up effect from parents having expectations for the products that their kids are seeing at school. Then they're going to take those expectations to the grocery store and the retail distribution chain and they're going to expect the food products that they see in those distribution channels to be the same or better. And so I think that that's the way that this is going to roll out from sort of the school, the school community to a broader community within the purchasing audience in the United States. And so I do think there's going to be different consumer expectations. I think legislatures are also going to be on alert for how consumers are feeling about these laws and the effects that the laws are having. For example, if the cost of products start going up substantially because of the increased cost of ingredients, legislators are going to hear about it. And then I think there's going to be different laws to combat the price increases that we're seeing. So I think there's a lot of follow on effect that we can't really predict right now, but will be forthcoming down the road as these laws unfold.

[B]

Yeah, and I mean, as you pointed out, you know, a lot of the stuff is starting with the school meals and the school lunch program is, I've heard it referred to as the largest restaurant chain in the country because when you look at it from that perspective, it truly is. That's a lot of food. And you know, we'll see probably changes in that program not only because of what we've talked about today with these, you know, different policies and rules on additives and food colorings and things like that. But of course, we know the Dietary Guidelines for Americans, the revised DGAs were just released and that will also have an effect on school lunches. So I think we're going to see a lot of changes come out coming up in several different areas.

[D]

So yeah, I think, yeah, the school lunch program in particular I think it's not subject to these laws per se. Right. It's a federally run program that makes certain kinds of products available to states to buy through the school lunch program. But the suppliers to those, to the USDA school lunch program, they don't, they're not required to comply with the state product. But the states that either use those products as, receive them as donations from USDA or buy them can no longer buy those products if they're not compliant with state law. And so the effect on the school lunch programs in particular states, I think, is a very interesting issue that we're going to have to follow resulting from these laws, because I think the products that those schools buy now are going to be more expensive. So that's going to eat up more of their budget. Right. I think something like in West Virginia, I think more than 70% of children who go to school in West Virginia are eligible for school lunch program benefits. That's a huge population of kids and it's also a huge budget item for that particular state. So having to go out and source more expensive products for the program, use your money differently, is going to require all sorts of changes at the state level in that program. And so again, I don't think we fully understand yet what these restrictions, what sort of consequences these restrictions are going to have on those feeding programs. So that's something we have to watch carefully as well.

[B]

Absolutely. And I mean this, you know, this is such a dynamic area for food policy and food safety and something we're continuing to watch. And we appreciate you coming on the podcast today to share your perspectives on this. And you know, what you kind of think where you see things heading in different directions with this. So thank you, Kathy. It's been a pleasure to have you on today.

[D]

Thanks very much and was very honored to have the opportunity.

[A]

Thanks again to Kathleen Sanso for joining us on the podcast today and of course, thanks to all of you for listening. A very special thanks to our sponsor, Cintas. With a managed apparel program from Cintas, you can be confident that your production team's uniforms are laundered in a hygienically clean process, helping to ensure everyone is in the proper garment and ready to perform their task. Learn [e-mail] foodpro that's C I N T A- dot com foodpro and get ready for the workday now. You know, we love hearing from you and you know you can always respond to Bob's question about the food code.

[D]

So, you know, that's right.

[A]

Don't hesitate. Never, ever hesitate. Send us your questions, suggestions, or answers to pop [e-mail] or post a note on our social channels. We always love hearing from you. And to make sure that new and bonus episodes magically appear in your podcast player, all you have to do is click that Follow or Subscribe button in the player of your choice and presto. Bingo. All the episodes appear. And while you're there, throw some stars our way by rating the podcast, especially if you liked it. It only takes a moment, and it's good for everyone. And that's it for us today. Our next regular episode will post on February 24th. Oh my God, 2026 is already flying by. And in the meantime, take good care of yourselves and those around you, and we'll talk to you then.