C (4:41)

Okay, so first up in news, we have some more updates on the USDA's approach to Salmonella, which appears to be heading in a little bit more of a hands off direction. So after withdrawing the previously proposed regulatory framework for salmonella in raw poultry in April of This year, the USDA's Food Safety and Inspection Service, or FSIS, said that it will delay sampling and verification activities for Salmonella in raw breaded and stuffed chicken products. FSIS also said it's exploring alternative strategies for reducing salmonellosis cases attributable to poultry. So back In April of 2024, FSIS finalized its ruling to declare Salmonella an adulterant in raw breaded and stuffed not ready to eat chicken products when present at over one CFU per gram. Now, this determination was made because studies had shown that these types of products are disproportionately represented in poultry associated salmonellosis outbreaks. Now. But in April of this year, at the same time as FSIS threw out the wider salmonella framework for poultry, the agency said it would delay verification activities for the determination on raw breaded stuffed products by six months. Now FSIS is again delaying verification activities, but this time without setting a new implementation date. According to the agency. The delay is due to limitations in available test methods, including concerns about accuracy and unacceptably high false positives. And instead of moving forward with its former plans for salmonella and poultry, which were developed after years of research and stakeholder consultations, FSIS is starting anew with an upcoming public meeting to explore what it calls practical strategies for reducing salmonella illnesses attributable to poultry products. That meeting will be hosted in person in Washington, D.C. and also online on January 14th of next year. More details on meeting topics, registration and public comment opportunities are expected to come out soon.

A (6:45)

So this issue of salmonella, and particularly in these products that people weren't really cooking, they were putting them in the microwave for a little bit, which is not adequate cooking. So there's a lot of issues with this. There's a lot of issues with salmonella. It's complex because of the number of serotypes, all of them, most of them are not pathogenic. So you're really interested in a couple of what some people call the big five and, and these type of things. So it's a fairly complex issue. So to fold on top of this, this idea, Adrian, that you just mentioned, that some problems with the enumeration of the measurements that they're going to have to regulate to. So in the Federal Register, the official announcement that was issued Yesterday, Federal Register, December 2nd. Yesterday, now that we're recording, the USDA mentioned this issue about the available test methods for enumeration, showing that there was a high rate of false positives, not for presence absence, not for whether or not there is salmonella, but false positives as far as being above or below that 1cfu per gram level. Research that the USDA published in October showed that there's a 50% probability of a positive result when a sample contained 0.2 cfu per gram. So 1/5 of the 1.1cfu per gram still would indicate that it's above that regulated level. So the issue that the USDA would have is can we regulate at that level? Are we going to be citing people for being below the level? Because there's a big chance that it's above. The research also described the modification of this enumeration method that they call CAT or confidently above the threshold. So how do you have a measurement that statistically will show that you are above this 1 CFU per gram level? The cat process, which I won't go into, would cut this 50% probability of a false positive up to 0.6 CFU, so three times the level. But you still have essentially a coin toss on being if you're under the level or at the level at these very low levels. The FDA also mentioned in their Federal Register notice that at 0.5 CFU there would still be a 40% chance. So still not much more than a coin toss. The USDA further indicated that because the agency has never before used a quantitative standard, only presence absence, they had a quote in there that said, given the implications of enforcement based upon a scientifically, a scientific numerical threshold, FSIS needs more time to reevaluate the testing program and determine its viability going forward. So I talked to a couple of people who are salmonella experts and use these kind of enumeration tests and they described it with an S word that I'll say the methods stink. People don't really like the way these methods work and how accurate they can be. So what the USDA is saying is, is proven and a problem. And I don't know what they're going to find as far as the answer to this. A lot of these new ways of enumerating bacteria are generally what most people would think of as an approximation, as a microbiologist would think of this is how we measure it. So there's what's called the MPM method, which is most probable number. Now notice it doesn't say the exact number. And generally these things are considered to be accurate in orders of magnitude. You know, I can tell 1 from 10 or 10 from 100, but being able to tell 1 from 1.2 or 1 from 2 is scientifically difficult. So they're gonna have to struggle with this a little bit. But I think what you're gonna see between the changes in the regulations, the delay and this discussion about this technical issue is I think we're gonna see some fireworks at this meeting in January. So it should be fun.

B (10:11)

Well, what I guess what I don't really understand is the fact that.

C (10:16)

I.

B (10:16)

Mean, this is going back a few years now. There's a lot of research, there was a lot of comment, there was all of this. Right. And in speaking, you know, with folks, myself in back.

B (10:29)

When they were doing all this research that, that there was a feeling that, you know, that it's kind of an excuse at this point that, that the, that that the tests were like within 0.03%. So what's changed between now and, you know, except for a more sympathetic ear?

A (10:46)

Well, the one thing is the research that they published in October, which they were looking at some of these other methods and getting more statistical validity to what the methods are. I don't know what they had two years ago when they first set out to set this number, but I know that what they found is, is the statistical chance that you're going to have a regulated level or from a USDA standpoint that they're going to be able to cite somebody who's not in violation of the rule. And I'm not sure how they handle that. I think that's one of the things that they're concerned about.

B (11:18)

They're concerned about citing people who so erroneously.

A (11:23)

Yeah, let's take the microbiology for a second. You're driving on a road, it has a 50 mile an hour speed limit. The officer has a radar gun that at 35 can say that you're going over 50. Do they write you a ticket? Did they not write you a ticket? If you get a ticket and you can show you were going 35, do you contest the ticket or you pay it and which. And, or. So in this case, do I contest the ticket or do I throw out the chicken? Do I cook it off? Do I get rid of that product? Is it an adulterated product? Is it not an adulterated product? They'll be battling with all those without a better measurement.

B (11:56)

Well, it seemed to me, and I looked up to some of, to find out what Mindy Brashear's standpoint, you know, stance on some of this was, and it seemed that she takes issue with targeting the raw breaded, whatever that, you know, to say one is more likely than another or that chicken is more likely than pork or, you know, whatever. I think she, that was what I gleaned from, from her comments.

B (12:24)

But I.

B (12:28)

Yeah, I guess, you know, when something has been shown to be more, more deadly, you know, or create more illness, why not address it? But I guess the idea of, you know, that started out, the statement is that Adrian said a more hands off direction. It's like, well, okay, our hands are off.

B (12:48)

So.

B (12:51)

You know, and infrastructure week is next week. So I'm not really sure, you know, what this means. Even though they're going to be having public comments and Mindy hasn't been put in place yet. She hasn't had her. Are those hearings. We still. Are those hearings scheduled, do you know, Bob?

C (13:05)

I don't know.

A (13:05)

I've not looked, I've not kept up on that.

B (13:08)

I think, I think I lost a thread on that during the shutdown. I need to get back on that and see what's what there. But I don't know, it's a shame to see when you know, and so I'll be. When you know that there's a problem and, and you know, they're not, it's not being solved and consumers are at risk.

B (13:26)

And we see how effective, you know, identifying E. Coli as an adulterant was in saving lives full stop. Right. To move off of this and to find out, well, what are more, quote, practical solutions? My.

B (13:47)

My, I don't hold high. I don't have a lot of. I wish I had more faith, but hopefully they can prove me wrong. I want to be proven wrong. Right.

A (13:57)

One of the reasons why this one is complicated is so first off, you mentioned E. Coli. So there's a serotype, there's a 0157 that makes it an adulterant. That is one of the other threads in the salmonella regulation is there's. What is there, 250. I'm trying to remember the number now of salmonella. Right.

B (14:14)

That really cause.

A (14:15)

Right. And there's only a few that are pathogenic. So now you're going to test for salmonella. But if it's not a pathogenic salmonella, it's not the same thing as the E. Coli regulation. So that's one complication. I'm not arguing against it. I'm just saying that salmonella makes it very complicated.

B (14:31)

Yes. The second thing, which has always been the argument.

A (14:33)

Right. And the other thing with this product is this is one that people aren't preparing at home, following the directions. They're thinking that it's something I just microwave as opposed to putting in a cook step. Another way to control it, particularly with this set of products, would be to have better adherence to the cook step. So that's another issue here. So are we going to be throwing these out or regulating something that, you know, it'd be the same as putting a regulation on raw chicken and saying whether or not somebody cooks it or not, we need to make sure that it's the producer saying, no, you have to cook your chicken. You don't, you clean up after it. You don't splash things around on the counter. You cook the chicken thoroughly to 165 degrees. 160 degrees. So those are the type of things I think if they applied to these kind of products as well. So there is, there's a handful of solutions here.

B (15:23)

And I don't think say the same thing about beef. Well, you could ground beef.

A (15:27)

Right.

B (15:28)

But they regulated it nonetheless.

A (15:31)

Well, but, but you know, but again, you're, you're selling a product that it, you're anticipating will be cooked These products are being misinterpreted as already cooked. They're ready to prepare, but they're not ready to eat.

B (15:43)

But even the raw chicken versus raw ground beef, right. It still is an adulterant if it's present in the pre cooked product.

A (15:53)

And that's not part of this regulation. But that's a good point to say if you wanted to regulate it in the same way you're regulating beef, but not up for discussion, which I thought.

B (16:02)

We were on, which it seemed like we were on the road to that, but it was, you know. Yeah, yeah, not so fast.

C (16:09)

I think you're kind of like Bob was just talking about is, you know, I think it's important to, you know, note that so with these products, you know, because consumers aren't cooking them correctly or aren't reading the instructions and they are getting sick, doesn't. It doesn't mean there's more salmonella in these products than in, you know, other types of raw, raw chicken products and all that stuff, or raw poultry products. But then the question becomes, you know, I guess for the AGENC is do we do more consumer education, do we do more with the labeling or do we try to get the salmonella out of the product in the first place? Because people just can't seem to cook these right. And it is a conundrum and it does make it complex. And I don't think Mindy's been confirmed yet. Dr. Bashir's nomination has moved forward, but she hasn't been.

C (17:00)

Officially confirmed. I believe she did have a hearing, but I, I think that's the last place we left off with Dr. Beshear. So as soon as we get word of that though, we will let you all know.

A (17:10)

So, Adrian, if I can, Adrian, just summarize this, I think perfectly. And also in the news report where she said the USDA is looking for practical strategies, do you go with more consumer education to say this is not a ready to eat product, it's a ready to cook product and really it should be treated no differently than a raw chicken. But that's not how it's being treated, or at least not how people are looking at it or presuming it should be treated?

C (17:35)

Yeah, I think there's a lot to be said about consumer education versus trying to make the product more safe. And what route USDA FSIS takes with that will, I think, depend largely on.

C (17:53)

What we see from Mindy when she does get confirmed, which I'm sure will happen. So definitely a developing topic and certainly the agency has decided to completely revise the approach from, you know, the approaches that were put forth in the salmonella framework and, and other things like this breaded stuffed. Breaded stuffed, raw chicken determination. So we'll see how things kind of develop with this. But certainly, you know, we're looking at a whole new approach here. So I guess we'll be looking to see what comes out of that January 14th meeting and letting you all know what was said, what was laid out. Okay, so moving on to some other news.

C (18:42)

A story that we know that you've been following closely. The infant botulism outbreak associated with Bihart powdered infant formula. And we discussed that on our last podcast episode. This outbreak has expanded so By Heart stated that it has found widespread contamination among unopened product samples per third party laboratory testing results. And the number of infant botulism cases in the associated outbreak has grown to at least 37 cases across 17 states. Now you'll remember that previously by Hart had said that had denied any link with its products because it had said that only, you know, the testing was only found botulism in unopened containers. And I think there is some, you know, maybe validity to that claim. There could be cross contamination, other things, but unopened product, you know, that kind of seals the deal. So anyway, the testing that was done by a third party laboratory returned positive results for Clostridium botulinum Type A in five of 36 samples across three lots. And the company also stated on November 24 that it could not rule out the risk that all by Heart formula across all product lots may have been contaminated. And so it's initiated a voluntary recall of all of its products. And the company also stated that it's conducting a supply chain wide root cause analysis which will include additional product testing. And FDA has also released by heart facility inspection reports from as early as 2022 that show history of food safety and sanitation failures, including the presence of mold, dead insects and leaking roof issues. FDA also issued by Hart a warning letter in 2023 for the presence of Cronobacter sakazaki in its product, which led to the shuttering of its Reading, Pennsylvania production facility. So furthermore, customer information provided to FDA by Amazon shows that a limited quantity of recalled By Heart infant formula was distributed globally to 21 countries in north, south and Central America, Asia, the Middle east and Africa. So we will see if any reports emerge from any of those areas about additional cases. Hopefully not this.

A (20:55)

This one gets me as being a bit of a mess and I started to read through some of the 43s and the details. And I came to the conclusion that unless you're going to read every single line of all of them, you'll never make any sense of what's going on here because it's fairly complicated.

B (21:10)

I like the part where they tried to blame the lab.

A (21:12)

Well.

A (21:16)

They were looking for false positives. Absolutely. They did. They did.

A (21:21)

The findings go back a fair way. So I think this one is probably vastly underreported. The other thing that fascinates me a bit is that the California Department of Public Health and that botulism center was the one that found most of these reports and really pulled a lot of this out. You've got not only the older cases, but you've got the Reading facility that was closed, and then the fda. Some of the inspections were of the fda. I'm sorry, Some of the other inspections were from the Reading facility after it had stopped producing, which I didn't quite understand. I think there's more to come because in some of the reports, they're talking about how it was sold through, sold online. The formula was sold internationally. I think we'll probably see more there. But botulism and clostridium is difficult to detect, and things being detected in powdered media of any kind, but particularly baby formula, are hard to find because they're difficult to sample for. So I think this one is a long way from over. I think we're going to learn a lot more about what's happening and what's been happening particularly. So with that background of the 483 inspections that were, frankly, a mess.

B (22:29)

Well, so the 483, they were back in 2023. This company doubled their.

B (22:36)

Production in 24. Right. By getting big retail contracts. And I guess I'm just kind of curious.

B (22:45)

What are the retailers looking at? Right. We know that they're, you know, gfsi, you know, audits and things like that. But are they. Are they checking to see when these violations are through their own audits or whatever? Certainly some of these things have, you know, bubbled up. But you take something that, you know, Corona back there and some of the. The other, you know, leaks and this and that, you know, things that are clearly very problematic.

B (23:16)

And systemic. Right. At what point do you go, oh, yeah, that's fine, or. Or are they seeing them? And I. So, because it got my attention here, FDA has released the BIHARP facility inspection reports. It's like, well, aren't those just public information anyway? So, you know, on the Google machine and no, they're not Necessarily. And it said, and maybe I'm wrong, but the, the response, or the response said that some state inspections are excluded from public records, public data databases, which then made me think, but now we're in this big move, right, to shift these inspections to the state. Does that decrease the visibility of these reports? I don't know, Bob, do you know anything about how any of that works?

A (24:03)

No. I know there's a lot of specific laws about what gets released and not released. There's a lot of proprietary formulation and proprietary production information that can all be redacted.

C (24:13)

So, yeah, yeah, I think it's interesting with this outbreak in this case because first of all, you've got 37 cases that are definitively linked to, you know, these infants were definitely consumed by heart formula. But then as we've seen, beginning in August, there's been a larger number of infant botulism cases, over a hundred of them that has been, you know, this California Department of Public Health has been tracking. And there, I believe that, you know, so you've got, let's see, 60 something cases that presumably, or at least not that we can tell, are not necessarily implicated with Bihart. But no other infant formula manufacturers have been implicated. Now I know that the California department that tracks infant botulism says that there's usually in the US around I think it was less than 200 cases. But there are cases every year, a certain number of cases. But that hundred plus cases over a span of a few months was, you know, quite a lot. We now know that Bihart is behind, you know, a number of the illnesses, a percentage of the illnesses. But what about those other cases? And also I thought it was interesting. So, you know, reading through those 483s, I believe the company has at least I know there's three plants that I read in the 483s, and I know the Redding plant that had the, possibly the worst violations that, you know, we've just discussed here, that was.

C (25:51)

At least temporarily closed in 2023 after receiving that notice, after FDA issued the warning letter to the plant for finding Crotobacter. So that was a, that was a different thing. But the plant has been inspected, I guess with the hope of reopening it since that time. That's why there's other inspection reports for that plant. The two other plants that they released inspection reports. I forget, I can't remember exactly what towns they're in in the United States, but one of them did also have some violations, not quite as serious as the Redding plant, but still something to take note of things that could lead to foodborne illness. And I believe the third plant pretty much didn't have. They didn't have anything to say about it. So I found all of that very interesting when kind of like going through all the information that's been coming out about this outbreak and about this company.

A (26:40)

Yeah, the, the one, one of the things that you mentioned as far as the previous botulism cases where there was, I think, a higher number than before, but not linked back to by heart. But some of the parents. There was an AP article where a lot of the parents were saying, you know, we were wondering about this, we wondered how this could possibly happen. Then we saw this with the formula and the question is, is do they get counted towards this outbreak? I guess they would be presumptive because you'll never really be able to link it back without having some sort of samples from that point to get the genetic matches and things. But there was in the AP article, they asked Frankie Annis and also Sandra Eskin if they should be counted, and they both said absolutely, they should be counted because it's most likely the cause. One of the things we've talked about this before with baby formula is it's a little bit easier to trace the cause because babies only eat formula up until a certain age. I, I understand from some people and talking to about this that many parents are starting to feed their kids formula older than they have been in the past, but even so, it's easier to track because of this. So if they were infants and they got botulism and it was an unusual case, it's probably linked to this, particularly if they were by heart purchasers. So I think, like I said, there's more going to come out of this because right now it's a little, it's a little hard to track.

B (27:57)

And it would seem that the company's been less than transparent. I mean, they haven't really been proactive.

C (28:03)

Yeah. I think now that the, that the botulinum toxin has been found in the unopened cans, they have been more forthcoming. But before that they were. The, the statements they issued were a little bit resistant. Well, not a little bit. They were resistant to being linked with this outbreak. So. But, you know, as I said, the finding it in unopened cans of formula, that kind of seals the deal there. So. Yeah.

A (28:30)

Okay, for what, for what it's worth, the next story gets murkier, so just hold on.

C (28:35)

Yeah, yeah, murkier.

B (28:37)

I. We've really been down to even murkier.

A (28:40)

More More murkier.

B (28:42)

We'll call this the murkish episode.

C (28:46)

The unfortunate thing about foodborne illness outbreaks is that there can be a lot of murky details to sort out. So going across the pond here in European news, there's been an ongoing outbreak of foodborne enterohemorrhagic E. Coli O4.5 H2 or E HEC infection sweeping Germany, and it's the most significant EHEC outbreak the country's seen since 2011. Now, as of November 20, Germany has confirmed 199 outbreak cases, resulting in 53 instances of hemolytic uremic syndrome, or HUS, and three deaths. The total case count, including probable and possible cases, stands at 428. So quite a large outbreak because as we know, not everybody needs to go to the hospital or does go to the hospital when they get sick. So people began falling ill between August 11th and October 16th of this year. And of the 16 German federal states, nine have reported four or more cases of illness, with the most cases reported in two northern states. Now, the source of the outbreak hasn't yet been confirmed, but epidemiological interviews suggest foodborne transmission, with analysis of clinical isolates showing a distinct genomic cluster and greater genomic variability within the cluster compared to previous EHEC outbreaks. So I think there's still quite a bit of work to be done on this one, but certainly a lot of sick folks in Germany.

B (30:06)

Yeah, those numbers are big. And then also, is this across the board that basically only 3 to 6% of all illnesses are even reported? Right. I mean, not every illness is reported.

C (30:20)

I think, in the U.S. isn't it, at least for. Is it the stat for salmonella or E. Coli? It's for every one person that goes to the hospital and has a laboratory confirmed case, there's 28 more that are likely sick that don't go to don't seek health care or don't seek analysis.

B (30:38)

So 1 in 28?

A (30:40)

Yeah, yeah, that sounds about right. Yeah. The one thing about this one is, like Adrian mentioned, it's they don't really have a source yet. One reported source I read said that they were looking for some contaminated food items such as meat or sausage. But the one thing that surprises me about this is, first off, this strain is rarely detected in Germany and it's not really been found often. And the serotypes and the genomic matches that they're finding at this one don't match any of the previous ones. So we don't know if this is something new. We don't know if it's something particularly unusual, but it's not very frequently found. The other thing is the median age of all the confirmed cases is four years old. So what is it that little kids are eating that maybe somebody else isn't? Or, you know, what type of clue does that have? And all the HUS.

A (31:32)

Cases, I think as of last week in November when I read this, all the HUS cases were also children. So that's one of the things that's really issue here. You know, first off, there are more. A more vulnerable population could be that. But why are most of the cases so young? Which is also kind of curious here. And like Adrian said, this one is significantly going to show significant underreporting. So I think this one's still going to grow as people come forward and say, hey, me too.

B (32:01)

Wow, I didn't know the part about.

A (32:03)

The age that's now there were people as old as 90. There was a wide variety of ages, but most of them bring the median down. Most of them were very young children.

B (32:13)

Wow, that's just devastating.

C (32:16)

Yeah. Well, we certainly hope that a, you know, a food vehicle is linked to the soon so that, you know, it can be addressed. But this is an ongoing developing outbreak. It's been going on for some time. And so hopefully there can be a resolution here, some more information to shed some light on what is going on and making all these poor folks sick. All right, so. And before we go today, we want to let you know about some of the topics that were discussed at the recent 48th session of the Codex Alimentarius Commission in November in an effort to advance international food safety standards. So the CAC 48 meeting led to the official adoption of several new, revised and updated standards standards, including new maximum levels for lead and cinnamon and dried herbs, the first international standard for fresh dates, and updates to the general standard for food additives. Other standards that were adopted included a revision of the Code of Practice for the prevention and reduction of aflatoxin contamination in peanuts, as well as updates to the recommended methods of analysis and sampling guidance, the adoption of guidelines for monitoring the purity and stability of reference materials and related stocks, solutions of pesticides during prolonged storage, and also the adoption of a new regional standard for Castilla lulo fruit in Latin America and the Caribbean. In other Codex work that was done at the meeting, the Committee on Fish and Fishery Products is advancing key initiatives like the conversion of the regional standard for Lavar products for Asia into a worldwide standard. The committee is also considering new work on other seaweed and aquatic species and reviewing marine biotoxin provisions updating standards for fisheries and aquaculture products to ensure accuracy and alignment with recent Codex texts. And lastly, a new proposal was submitted by the Regional Committee for Africa for the development of a Regional Standard for boiled, salted and unsalted dried fish. So you can read more about the work accomplished during the CAC 48 meeting at the Article links in our Show.

B (34:17)

Notes all right, well thanks to you both and as always, and as Adrian just noted, there are links to our all of the articles that we've referenced in our show notes, so check those out if you have any questions you want to do Deeper dives if you don't already, we invite you to follow us on our social channels, LinkedIn X, Facebook and Instagram. Just search for Food Safety magazine and to go deep on all the great content that we offer, Visit our website food-safety.com and just like that, it's time for Adrian's interview with Brian Sylvester, a partner in Morrison Forster's FDA and Healthcare Regulatory and Compliance Group. He's the head of Food Regulatory and an influential thought leader and practitioner in food tech regulation. Brian counsels clients across the food life cycle of regulated products, serving global brands, startups, life sciences companies, investors and trade associations. In the area of food and beverage, Brian develops regulatory strategies to commercialize a range of food tech innovations including transgenic crops and alternative proteins such as cultivated meat and fermentation derived food ingredients, among others. He has been recognized by several legal industry awards and publications such as Chambers usa, Bloomberg Law, and the National Law Journal. All right, so let's hear their discussion.

C (35:44)

Well, welcome back to the podcast, Brian. It's great to have you back.

D (35:48)

Thanks a lot. It's great to be back with you guys. Looking forward to diving into today's topic.

C (35:54)

Yeah, absolutely. And you know, the last time we sat down to Talk on episode 167, all the way back in January 2024, we were primarily looking at the California Food Safety act and how it might affect companies food formulations nationwide. And that legislation, which was passed in October 2023, was the first of its kind in the country at that time, and it kicked off a wave of similar bills in other states earlier this year. For example, Texas and Louisiana passed laws requiring label disclosures on foods containing any one of more than 40 additives. And West Virginia also passed a law banning the sale of foods containing any one of seven dyes or two additives by 2028. And then other states that have enacted bans on foods containing certain Colorants and additives from being sold in public schools include Arizona, Delaware, Louisiana, Tennessee, Texas, Utah and Virginia. So a lot of different things at play. And, you know, while many of these dyes and additive bans are in alignment with the principles of the Make America Healthy Again, or MAHA, movement, the states have faced some backlash. And most recently by a newly formed coalition of industry giants called the Americans for Ingredient Transparency, or afit. I guess we could abbreviate that, which has launched a campaign urging Congress to, quote, correct a maze of state by state laws. So with all that said and all that background laid out, I guess I'd like to start by asking, you know, from your point of view as a legal expert, are you surprised at how much has changed since the passage of the California Food Safety Act? And I mean, what's your reaction to the industry's recent pushback on these state additives bans?

D (37:37)

Absolutely. Great question. So back in 2023, when the California Food Safety act passed, I predicted we would see a patchwork of state legislative activity ripple outward. And that's exactly what happened. But what I did not predict was the concept of Make America Healthy Again, led largely by non blue states, and how that agenda would turn what began as scattered state action into a coordinate national movement. So we can basically say that California wrote the first chapter here and MAHA gave it the political engine. And as of this year, states like Texas, Louisiana and West Virginia, as you just pointed out, have quickly followed. Texas with an on pack warning for 44 additives, LA with a QR code disclosure requirement and school meal bans, and West Virginia with a phased color additive and preservative ban. So then we have Virginia, Arizona, Utah, which are advancing restrictions on color additives and other substances in school settings. I think the school setting laws are an interesting one. They're not the end game. They're basically the on ramp. They acclimate voters to maha's message that synthetic additives are quote, unquote, toxic or foreign, and they build a political comfort one could say needed to move from school meals to retail more broadly. And I think once the electorate accepts that premise in, like, the school meal context, it becomes far easier to make the case for extending those prohibitions to grocery shelves and restaurant menus. So what we're really seeing is the next phase of activity at the state level where health driven consumer protection is being redefined state by state. Industry recognizes that. And through the coalition you mentioned, it's pushing hard for a single federal standard, which would of course be more manageable for food manufacturers. And it would actually work to the benefit of the American consumer to have one national federal standard when it comes to.

D (40:08)

Labeling and also restrictions around substances that are authorized for use in food and any corresponding disclosures that should be required if there is a legal and scientific basis for it.

C (40:25)

And you know, as you said, consumer health concerns are being redefined and a lot of that is being led by the Maha movement which is, you know, kind of rooted in red states. All this is very interesting and you know, we're obviously in a very different policy landscape now than when we, than where we were when we recorded our last interview in January 2024. So I guess how would you characterize the current landscape on food additives given these actions by the states and the Maha movement's focus on, you know, getting these so called toxic elements out of the U.S. food supply and also revisiting the graphs process us too?

D (41:00)

Absolutely. I would say that the federal picture has completely shifted under Maha. So earlier this year, President Trump signed an executive order creating the Make America Healthy Again Commission chaired by HHS Secretary RFK Jr. The commission's job is to help the President tackle the childhood chronic disease crisis and rethink how the federal government manages food and nutrition policy. And just this past September the commission released its Make Our Children Healthy Again strategy report which is a sweeping blueprint with 128 actions. And so from that report there are three areas that stand out. First, FDA reform. The strategy directs the FDA to close the so called GRAS loophole by moving to a mandatory GRAS notification system, ending the practice long standing practice of companies making self determinations of GRAS without the need for formal pre market FDA review. FDA is also building out a post market chemical assessment program to re evaluate additives, color additives and contaminants already in the food supply. And it's expanded a public list of chemicals under review, adding bha, BHT and certified synthetic colors, which is a clear signal that the agency intends to revisit its legacy authorizations. Second, we have labeling and color policy. The strategy calls on FDA to continue developing and to finalize its front of pack nutrition rule, ensuring it aligns with the new forthcoming dietary Guidelines for Americans. Secretary Kennedy has said he wants FOP identifiers for sugars, sodium and possibly ultra processed foods. FDA is also fast tracking petitions for natural source color additives, phasing out synthetic color additives and giving companies more flexibility to use claims like no artificial color without enforcement risk, essentially rewarding early reformulators. At least that's my perspective. And third, we have federal nutrition programs. USDA will prioritize whole foods across nutrition programs. They will pilot MAHA boxes for SNAP recipients and work with states on waivers restricting junk food purchases.

D (43:48)

Hhs, USDA and FTC are also exploring new limits on marketing unhealthy foods to children. So it's an all agency alignment around food and health. In early November, Senator Roger Marshall from Kansas, Republican from Kansas, introduced the Better Food Disclosure act, also known as the Better FDA Act. And it would serve to modernize grass oversight by requiring FDA review for anything considered generally recognized as safe. So on November 6th, Senator Marshall, who's a member of the Senate Health, Education, labor and Pensions Committee and the MAHA Caucus, introduced this highly anticipated bill. It aims to close the quote, unquote grass loophole. And although the bill was developed with input from industry stakeholders and the MAHA community.

D (44:51)

It was expected to establish a uniform national standard for food substances to address the patchwork of state laws. It does not contain a preemption provision. And although it's anticipated to be bipartisan, the bill as of early November was co sponsored only by Republican senators. So it would amend the Federal Food, Drug and Cosmetic act to deem any food substance generally recognized as safe to be adulterated unless it is either included in a newly established grass listing system or under review by the agency. So we're going to be, you know, keeping our eyes peeled for that bill as well as other developments on Capitol Hill.

C (45:41)

Yeah, absolutely. There's so much to keep our eyes on. Right. And wow, everything you just named just kind of took me through a very quick time journey here because there's been so much movement in this space, you know, in within the last.

C (45:56)

1112 months or so. But I guess looking at some of these state laws and all these things that have ARISEN since that 2023 passage of the California Food Safety act, what legal questions or challenges have arisen as a result of all these state laws that are either passed or trying to get passed? And how is industry responding to those?

D (46:20)

Absolutely. I would say that there are three main fault lines that are defining this next chapter. So first, there's preemption and compelled speech. State laws like the Texas law with the onpac warning requirement and the Louisiana QR Code disclosure compel manufacturers to make state specific statements about ingredient safety beyond FDA's federal labeling requirements. And that raises classic FDCA preemption and First Amendment questions. Are these warnings purely factual and uncontroversial or are they policy messaging dressed as disclosure? That's the litigation pressure point. Everyone is Watching. Second, interstate commerce burden. Each state's list, timing and definitions differ. That means extra SKUs, duplicative packaging and added logistics costs, accumulative drag on interstate trades, essentially. And when compliance becomes economically prohibitive across states, dormant commerce clause challenges start to look viable. Third, federal layering. Federal changes do not automatically override the state measures. So, for example, the better FDA act and FDA's forthcoming proposed grass rule would seek to impose a requirement that all grass assessments are notified to the FDA. But because neither includes any discussion of preemption, especially the bill in Congress, the states would retain the authority to regulate disclosures and bans. And the result would be that companies must comply with both.

D (48:14)

So industry is adapting by building integrated food additive registries, mapping ingredients against each jurisdiction's list, each state's list, coordinating R and D and regulatory teams on reformulation or possible reformulation, and developing litigation strategies in parallel. And so this is a holistic approach. Compliance and legal risk management are happening side by side.

C (48:44)

Yeah, and that makes sense that companies are being really thorough in this way and looking at that legal risk management piece as they're looking at how to comply. Because, I mean, when you look at the text of some of these laws, either the past or proposed ones, the penalties can be quite harsh. And in some cases, I believe there's even criminal penalties for not adhering to these additive bans, coloring bans, and other things. So it's definitely a lot for companies to, to, to watch out for. And you know, I mean, you counsel clients on how to remain compliant with evolving regulations on food additives and labeling laws and other things. And I guess I'm wondering, how do these moves by the states create a more complex labeling reality for food manufacturers and importers and retailers across the country?

D (49:31)

Yeah, definitely. I mean, compliance today is multi dimensional, for sure. It's about design, data and documentation. We have the state layer. So if we're taking Texas and Louisiana, for example, West Virginia with its color additive bans.

D (49:50)

There'S a federal layer where FDA is modernizing on two tracks. Essentially, they're tightening oversight and removing outdated standards of identity. But then they're also looking to implement mandatory GRAS notification and also expanding their list of chemicals under review and fast tracking natural color additive petitions. On the modernization side, FDA has taken action to revoke 52 standards of identity that the agency has deemed to be obsolete or otherwise not needed. And so that's a clear message in my mind that innovation and reformulation are welcomed by this fda. And then we have the congressional layer. We have Acts that have been bills that have been proposed over the summer and then more recently in early November regarding grass and food additives generally. And we have like the food chemical reassessment acts for example, from the summer, which would require FDA to review 10 chemicals every three years based on public health priority. So we're keeping a close eye on the state layer, the federal layer and the congressional layer. And the major brands in this space are very busy looking at all of these dimensions to stay proactive and on top of all of the changes that are really day to day changes in some cases. So in practice, all of this means that companies need a SKU level additive database tracking each ingredient's state and federal status, modular label art files with switchable warnings and QR elements given the environment that we're living in. And then you know, version control systems to prove when a label was developed or printed because some of the state laws, that detail becomes important so that you can have an understanding of by when you can sell through particular products. Right. And then generally just having cross functional teams linking regulatory, legal and supply chain decisions. So compliance is no longer a checklist as it may have once been. It's really a living system that has to update as the law does and as the policy and the discourse does in this current environment.

C (52:21)

Well, that's some great guidance and I appreciate you sharing all that with our listeners. Now you mentioned when you were talking just now about FDA welcoming innovation and reformulation. That kind of leads into the next question I have for you about the agency fast tracking the approval of at least four natural color additives for industry, which is in line with FDA's plan to phase out those synthetic petroleum based dyes from the food supply. So how are these substitutions and the fast tracked FDA approval process being received by industry? You know, given that FDA's phase out plan for synthetic dyes is currently voluntary.

D (52:56)

Absolutely. The the natural color transition, one could say, is a clearest window into where the current FDA is headed. Since spring of 2025, FDA has approved four natural source colors, including gardenia blue and encouraged companies to phase out FDC red number three well before its January 2027 deadline. The agency is also reevaluating the remaining synthetic additives under its new post market chemical assessment program. So this is a policy reset, not just a safety update and FDA signaling that, you know, synthetic color additives no longer fit its current view of a safe food ingredient. At least that's the message that the FDA is currently sending. And it's using both regulatory pressure and market incentives to push industry towards natural colors. And under maha.

D (53:58)

USDA is aligning federal procurement rules so that school meals and snap pilots prioritize foods free of synthetic color additives. So I think for industry, the takeaways are clear. The timelines are tight, especially if you're selling into schools or child focused categories. So your reformulation needs to be completed pretty much as soon as practical.

D (54:25)

Risk has flipped. So using synthetic color additives is now being viewed more and more as a commercial liability, even if it's still technically legal. You have to consider the PR perspective, not just what the law technically authorizes. And I do think that another takeaway is that early movers in this space win. So companies that generate stability in shelf life data for natural colors, for example, will secure regulatory credibility and consumer trust. And we're also seeing that a lot of major brands are making statements demonstrating they're removing synthetic color additives from their foods. And I mean, those are the early movers that want to.

D (55:11)

Ride the MAHA wave and ensure that consumers understand that they understand where consumers are coming from and what they're looking for in their foods today. So while FDA is calling the removal of certain synthetic substances from the diet voluntary, the combined force of federal policy, state bans and the procurement rules are making this transition essentially inevitable. And so the smart strategy for brands would be to lead and not to follow.

C (55:49)

Yeah, and we've certainly seen a number of major, you know, food companies, processors and retailers announce, you know, their intent to remove these synthetic colorings from their, and other chemical additives from their, from their foods. And so that's, you know, the big names are definitely being leaders in the space. So we'll definitely keep watching to see how this all evolves. But I want to go back to California. We, which was where we started our conversation come a little bit full circle here. That state has been a trendsetter in the food legislation space. And you know, as we mentioned, the 2023 California Food Safety act and then the California School Food Safety act was passed in 2024 and that was before MAHA was a household term and prior to the Trump administration and Secretary Kennedy taking office. Most recently, California's forayed into other categories of food legislation. It passed the Real, Real Food Healthy Kids act recently to establish a legal definition for ultra processed foods or UPFs, and also phasing out so called harmful UPFs from California schools. And we also know that Secretary Kennedy and the Maha Commission have tasked FDA and USDA with establishing an authoritative legal definition for UPFs with, with public input. So I guess my first question related to all this this is, could California's move to establish the first ever statutory definition of UPFs, which does differ from the globally referenced NOVA classification system for upfs, could that serve to complicate or inform The FDA and USDA's development of a federal definition?

D (57:30)

Yeah, great question. And absolutely, I think, you know, the California law that was just passed defining UPFS in the school meal context will certainly serve to inform the conversation unfolding at the federal level. As you mentioned, we had the RFI back in July of this year where fda, HHS and USDA issued that request for information to collect information and data from stakeholders on how to define EPFs. And the RFI asks six sets of questions covering existing systems like Nova, which ingredients or processes should count and whether ultra processed is the right term, how nutrient content should weigh into the analysis, and how any definition could be integrated into federal nutrition programs. And so with California becoming the first state to define the term ultra processed foods in a state law, that is a very important economic force in the United States, I think there will be certainly a lot of weight placed on the California definition.

D (58:58)

And I do think that the California law itself could inspire the development of a patchwork of UPF laws across states. And certainly that would have more influence if there's like multiple states with the same or similar definition, more influence on any future policy changes at the federal level in relation to the assessment that FDA and USDA will be undertaking in the next few months as they review the comments received to the UPF rfi.

C (59:39)

And you know, you mentioned something that was really interesting to me, saying that, you know, this legislation from California, the Real Food Healthy Kids act that does establish a definition definition of UPFS in relation to school foods could, you know, as we saw with the California Food Safety act act, possibly inspire a wave of other state legislation on UPFs. And I think that's really interesting and I guess I'm curious about your thoughts on the legal implications of that possibility and also the legal implications of an eventual federal definition for UPFs, and you know, how. How would you see that being used to shape food regulation under the MAHA agenda?

D (60:19)

Absolutely. I do think that, you know, if the federal government ultimately develops a final rule that defines ultra processed food, then they should then preempt any conflicting state definition of upf. And I do think that, you know, there would be a lot of work between and engagement between industry and the FDA and USDA before any federal definition is agreed upon, just given the fact that there's so many different definitions being assigned to the term right now. And given the nature of the questions that the regulators were asking in the rfi, it's clear that it's not going to be an easy road to establish a definition. And I think there are examples, even with the California law, where there are certain foods that everyone would consider to be healthy that may get swept into the definition in California of ultra processed foods. One thing I'm looking forward to is the regulations that are developed in the coming years that's required under the California bill because that'll give us some more color and indication as to how that UPF of concern terminology is going to be applied in the state of California. And in that way we'll see how it'll really play out in the federal discourse. Although I know like the FDA in this current administration especially wants to move very quickly, I think they have to also be very mindful certainly of applicable law and science and.

D (62:18)

Take account very carefully of what stakeholders have to say. And so I don't know how quickly we would actually see a proposed rule, for example, following this rfi. And even if they get to a proposed rule pretty quickly in the same way that they got to the proposed rule stage for grass pretty quickly, it's not clear what the timing would be to get to the final rule stage. So I do think that we have a couple more steps to take before we could talk about preemption at the federal level.

C (62:55)

Yeah, I mean, you know, takes some time to even establish a definition. And then once that's established, well, how do you act on that? That takes more time. So, yeah, definitely a few steps left there. But I guess I'm also wondering how is industry generally responding to all this increased regulatory scrutiny of UPFs?

D (63:13)

Yeah, I think industry is really just keeping track of the different statements being made by important officials at the fda, keeping track of any bills that are being proposed at the state level, and certainly keeping track of what will be unfolding in the state of California as those regulations come about. Right now, it's hard to really assign specific risk to the terminology and linking it to your business. I think it's fair to say that most or all companies would not want to have their products categorized as an ultra processed food. And so I think the way that companies are navigating this current environment of where we currently sit is to emphasize.

D (64:13)

Moving away from synthetic food additives, color additives, and emphasizing the healthfulness of their food offerings. And we're seeing, you know, line new product lines that are, you know, Clean, labeled, even more so than before, to kind of ride the MAHA wave and the consumer sentiment around that.

C (64:40)

And, you know, so given the broadening patchwork of state legislation on food additives and the priorities of the MAHA movement and all this growing federal and state concern over UPFS and other things, how can manufacturers and importers and retailers remain compliant in today's constantly shifting regulatory landscape? I mean, you talked about being a leader, not a follower. But what are some other points that maybe people could take away from, you know, the perspective of a legal expert?

D (65:11)

Absolutely. And I think, you know, a lot of this comes down to a company's appetite for risk, certainly. So these are just, these are just going to be general kind of considerations to keep in mind. But I think it's a no, no brainer that you would centralize all of the intelligence that is out there. Right. So you want to maintain a combined kind of MAHA folder, really, keeping track of state and federal activity, any bills that have passed, any timelines that are out there, keeping track of the latest on upfs, again at the state and federal level. You want to make sure that for.

D (65:55)

Policy cycles and Congress that you're tracking those bills in particular. So I'm talking about the better FDA act, the Food Chemical Reassessment act, and the forthcoming rule on grass FOP rulemakings. And you want to make sure that you have talking points as well as a business on how you're.

D (66:22)

Navigating the current policy environment, being prepared to respond to anything that the FDA may put out as a statement.

D (66:36)

Along the lines of maha when it comes to food chemicals and safety generally, and anything relating to school meals and, and healthfulness of foods for children in particular. And I know that some companies are looking to formulate to the strictest standard that's out there that's not going to be really practical for every company, and it's not necessarily recommended. But I think at least understanding what is the strictest standard, if we look at all the different states, are we actually able to practically formulate in a way that would meet the requirements in West Virginia, in Texas, in Louisiana, in California and other states?

D (67:26)

Is there a way to engineer or formulate products so that we don't have to make disclosures that we don't really want to have to make in some of these states, barring any kind of preemption that would occur through, for example, maybe.

D (67:49)

An update to these laws that would provide more preemptive effect?

C (67:54)

Well, I think those are really good points and certainly, you know, important things for companies to Keep in mind as they. As they navigate this, as we said, quickly changing landscape. And I like the idea of having a Maha folder ready and in order. That's a good.

A (68:09)

Good.

C (68:09)

I like that. That's a good point. But, Brian, it's been wonderful talking to you again, and thank you so much for bringing your legal expertise to our listeners and your knowledge of all the different regulatory changes and movements that are happening right now between the states and the federal agencies and the Maha movement. There's a lot to keep an eye on, and we always appreciate you coming on the podcast to kind of sort this out for us. So thank you once again for coming on and sharing your expertise. Expertise with our listeners. It's been a really fascinating discussion. I think it's very helpful also for our listeners. So thank you.

D (68:43)

Yeah, absolutely. My pleasure. I would say, like, the bottom line is, you know, Maha has set the compass. FDA and Congress are redrawing the map, and states are testing the terrain. So there's a lot of work out there, a lot of monitoring to do, and it's really important to stay proactive. So thanks again for having me, and I look forward to another chat with you in the future.

C (69:07)

Yeah, me too. Thanks, Brian.

D (69:09)

All right, thanks.

B (69:11)

Thanks again to Brian Sylvester for joining us on the podcast today. And as always, thanks to all of you for listening. You know, we love hearing from you, so don't hesitate. Send us questions or suggestions to podcastood-safety.com or post a note on LinkedIn, X, Facebook, or Instagram. We always love getting your feedback. 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 at Presto. Bingo. All the episodes appear. Unless you've taken a little break and you're listening, then not all the episodes appear. So remember that if you've, you know, no harm, no foul, but you may have missed some stuff, so you might want to go back and check to see the list of what you might not be downloaded for. For you. Okay. Where was I? Where was I? Oh, and while you're there, throw some stars our way by rating the podcast, especially if you enjoyed it. It only takes a moment, and it's good for everyone. And that's it for us today and almost for the year. Oh, my God. Our next regular episode. I've. I've, like, stopped myself from saying that all year long. Can you believe it's already this? But here we are. All right, our next regular episode will be our special, special Year in Review podcast that's very popular, that will post on December 23rd. So if you need a little something to get you through those family dinners or, you know, drives or whatever, we've got you covered. In the meantime, take good care of yourselves and those around you, and we'll talk to you then.