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Calley Means & Kyle Diamantas: On MAHA, Food Dye Reform, GRAS Loopholes & US Food Crisis

61m 52s

Calley Means & Kyle Diamantas: On MAHA, Food Dye Reform, GRAS Loopholes & US Food Crisis

In this podcast, Gary Brekka discusses U.S. food system reform with FDA's Kyle Diamantis and HHS's Cali Means. They highlight systemic issues like the GRAS loophole, which allows over 90% of new food additives to enter the market without FDA review, and the prevalence of ultra-processed foods in government programs. Since early 2025, the MAHA agenda has achieved notable wins: removing artificial dyes from children's food, banning soda from SNAP, and overhauling hospital nutrition to combat chronic disease. The FDA is shifting from a reactive to a proactive stance, creating a post-market review system to re-evaluate additives approved decades ago. Despite challenges like the Administrative Procedures Act, the administration is fostering collaboration with big food companies, which are responding to consumer demand for healthier options. Means emphasizes that this is a cultural and generational shift, not just a regulatory one, with consumer spending driving corporate change. The conversation underscores that while government action is crucial, individual choices—like buying whole foods and reducing snacking—are equally vital. The hosts express optimism about the momentum, noting that Americans are increasingly rejecting ultra-processed foods and embracing real food, signaling a transformative movement in public health.

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English
It is absolutely disgraceful what hospitals are serving patients and we have asked a simple question to hospitals Which is why is the government paying you? Trillions of dollars to serve food that is fueling the chronic diseases part of it Is just the lack of education that some in the health care space don't have when it comes to nutrition I don't subscribe to the theory that there's an evil wizard behind the curtain that is intentionally trying to make people sick What people might call big food is also largely partnering with us on this They want that level of oversight and reform The political coalition that Bobby Kennedy and President Trump put together allow us to ask common sense questions And it allows Kyle to call the food industry to the table and these movements don't turn that fast So it's important for people to understand that the momentum is moving in the direction of the American people The Maha argument is that this is not an issue of rejiggering Medicare and Medicaid reimbursement rates to solve what's happened to America health There's something deeply cultural here It's very multifaceted and we've opened up that conversation that view of keeping the food supply safe behind the curtain That no one hears about is the most important job we have in FDA What has transpired since early 2025 and where are we going with this the most revolutionary thing everyone can do is I want you to buckle up for this one because today I'm sitting across from two people who are inside the machine And they're tearing it apart from the inside out Kyle Diamantis is the head of human foods at the US FDA Cali means is that HHS leading the Make America Healthy Again agenda And what they're about to tell you is going to make you furious And then it's going to give you hope Did you know that over 90% of novel food additives in this country were never reviewed by the FDA That there's a 65 year old loophole that lets food companies skip safety testing entirely That the same chocolate bar on your shelf was found to contain undisclosed Viagra and Cialis These are the people fighting to end it And in just 15 months they've already ripped artificial dyes out of kids food Pulled soda from government food programs and overhauled hospital nutrition This is the most important food safety conversation happening in America right now Stay right here Hey guys welcome back to the Ultimate Human Podcast I'm your host human biologist Gary Brekka Where we go down the road of everything anti-aging biohacking long-jevity and everything in between And today I'm sitting back down with two of my favorite favorite guests from the government Because I want to talk about where we started and where we are And maybe even where we're going in the world of food The US FDA at Health and Human Services I want to talk about Bobby's agenda where it's succeeding Where there's some snags and what you could do to help this movement succeed Because remember it's not just up to our government it's up to us Consumer spending and behavior will drive corporate behavior There's only so much you can do from the regulatory environment and from the top down But if we cooperate and make a cooperative sandwich we can squeeze out highly processed foods And we can make a real impact in this country So thank you guys for coming back to the Ultimate Human Podcast Kyle DiAmontas and Kali Means You both become really good friends of mine You know over the past few years I'm deeply appreciative of the work that you're making Because when you leave the private sector and you parachute into You know public sector life That's got to be just a major transition You know going from in front of the curtain to behind the curtain And I wonder if you both would just talk about that dichotomy for a minute Yeah, I mean I'm happy to start Gary. Thanks for having us by the way Of course to officially be on we had my second appearance Yeah, we lost your audio We lost the audio the first appearance so it's officially my first appearance We were hacked by the Russians I think that's right It is a change I can tell you I spent my entire career and private practice in my first step in the government And it's I'll start by saying it's an honor It's a real honor and privilege to be able to serve the administration and serve the American people And it's it's certainly Different you know, there's a lot of rules a lot of responsibilities a lot of regulations And a lot of processes and maybe that's something that that I didn't appreciate is The amount of processes to make sure that we get things right and do things the right way You know a lot of people have a perception that when you come into the government or a new administration comes in You can just turn the tide overnight take action You know but there's a lot of laws regulation something called the Administrative Procedures Act There's a lot of things that have to be done boxes checked and so you know these things take time to do We're seeing that we're experiencing that and and really that's by design Right, I mean that's the way the system has been designed and so These things do play out over a number of years they take time to do important things but You know and what we're doing them we're doing things not because they're easy But because they are hard and they do take time and we're really committed to making sure we do these things right I really appreciate that and and maybe if you could just elucidate You know specifically what your role is that the us FDA is as head of human foods Because you know some people might see that title and feel like it's a little nebulous But what is what is your role and what are your duties and objectives in that in that position? Yes, so it's got a vast remit the FDA regulates about 80% of the us food supply The USDA has about 20% so they're the regulating beef poultry Similar products whereas everything else comes to the FDA including fish package food dairy all other products and so it's a vast remit and within that We sort of operate and what I like to call three pillars So we have a microbiological food safety pillar a nutrition pillar and a food chemical pillar And so you know the microbiological food pillar That's where you you know you open your internet browser and you see something's been recalled. Yeah, right? There's you know whether it's some contamination a bacteria There's a lot of work in fact that work is almost exclusively behind the scenes you hear a lot in the media About our work on nutrition and food chemical safety But the reality is our work in microbiological food safety is about 55 to 60% of our budget Wow, and about 55 to 60% of our people and this is just keeping food safe keeping food safe We've got eight labs across the country. We've we do about 30,000 regulatory samples a year over 500 recalls a year 20 to 30 major nationwide outbreaks that we investigate with CDC a year And so really that prospect or that that that view of keeping the food supply safe behind the curtain Then no one years about is the most important job we have in FDA But that's just one of three ill three pillars for us the other Nutrition right that includes our office of critical foods, which is where infant formula is it's where all of our labeling work happens out of We have an office for labeling and then our third pillar is food chemical safety Yeah, and that's focused on pre-market and post-market work So pre-market side would be grass generally recognized to safe and submissions to the FDA or food additive submissions Color additive submissions And then our post market office is also in that pillar and so historically When it comes to looking at chemicals and additives in the food supply FDA was really reactive. We never had a systematic process for post-market review We were really only looking at things if there was a citizen's petition Outbreak an outbreak a number of adverse event reports congressional inquiries Then we might look at an ingredient that's already in the food supply Traditionally, it's been that once it was in It was sort of in and there was not a process for FDA to really systematically re-evaluate those things So we've created a new systematic post market review framework in FDA So under this administration under President Trump and Secretary Kennedy And I think that that will be a legacy item for this administration is really being able to stand up that post market office And have that robust framework in place to really assess and review chemicals Many of which may have been introduced 30 40 50 years ago And you have to make sure that's science-based that it's robust that it's subject to public comment and engagement Yeah, and that's that's something we're really proud of at FDA I think this proactive approach is something that you know, maybe a lot of the citizens don't or even aware is going on You know, I remember when I was in the mortality space We used to have these things that would show up in medical records called anchor diagnoses And what it meant was if a if a physician at some point in your medical history diagnosed you with hypothyroid or hypertension Or any number of conditions and it made it into the record What happened was every doctor that you saw thereafter Accepted that diagnosis and carried it forward and very often when when they would go back and review These diagnoses they would say they actually got this wrong. They didn't you didn't have rheumatoid You didn't have the right said rates or refectors or you actually didn't have this Hashimoto's you had mildly elevated You know antibodies that didn't qualify for this diagnosis and I feel like this is the same thing You know not just accepting what's been in the record because it's in the record Um, and this sort of nebulous definition of grass But now actually going back and doing a systematic review to me that is such a proactive approach And it it shows that this administration is is not only wanting to make systemic change They actually want to look at how the system has behaved up to this point and make corrections And to me that is that is so pro-American consumer and I really congratulate you guys for that Well, I appreciate a Gary and I will say you know what people might call big food Is also largely partnering with us on this they want that level of oversight and reform They want to be engaged in these processes These companies have been following the law law that our predecessors put in these ingredients are lawful, right? They've been lawfully permitted in the food supply. And so, you know, big food, and I use quotation marks there, I think it's been a great partner to this administration. They've led on things like die reform. Walmart has their great value brand, one of their house brands, the largest single food company in the world, and I think they did 27 billion last year in sales, which is larger than many of the sort of household brands combined. They made a commitment at the end of last year to remove 30 different additives from that brand. That's the dies, it's federal preservatives, sweeteners, a number of ingredients. And so, to your intro point, companies are responsive to consumers. Consumers make their voices heard with their wallet, and the big food companies are responsive to those consumers, even more so than they are to what we preach or what we try to do from a regulatory standpoint. So, I think that the consumer momentum will continue to drive change in the food space, maybe more so than any other space that we regulated FDA. - That's so good, man. And Kelly, rewinding the clock a little bit, before you were on my radar screen, my wife comes into the kitchen one day, and she's like, "Have you seen this Tucker Carlson interview with Casey and Kelly means?" And I was like, "No, who's Casey?" Who are Casey and Kelly means? And she's like, "It's literally the best podcast I've ever seen." You gotta watch this. These guys are so in your wheelhouse. And I watched that Tucker Carlson podcast. And here I am on the Ultimate Human podcast, I'm recommending that you watch another podcast. But if you haven't seen that Tucker Carlson interview, it really laid the foundation for the level of corruption in our food supply and our nutritional research. It really laid the foundation for me for how intentional a lot of this activity had been. And I found it fascinating, your sister, the Stanford trained surgeon, you coming from the political side of the spectrum, and sort of you both having this epiphany, which was manifested in this book, which I would recommend that you read. And I'm gonna put a link to it in the show notes. And it shifted my entire mindset on how and why we got to where we are. And now you've moved from the private sector into the public sector largely because I believe that you feel like you had a calling and you wanna make an impact. And I would love to talk about what has transpired since early 2025 to today. And what are some of the big wins that have occurred over the last year? And where are we going with this agenda? - Yeah, on that podcast back, see you're in half go. I never expected I would be moving to DC and going on. (laughing) The reason I had to do it is 'cause I think we are still in the moment of a generational opportunity. It is impossible to describe how a custom DC is to protecting the status quo. And as Kyle said, it's not one individual evil person, but there are trillions and trillions of dollars that are current system fuels. And there's so much inertia in DC to keep that system the way it is. And there's such a lack of common sense in DC to not step back and ask common sense questions like why don't we have safety testing on our food and we don't. We do not have appropriate safety testing of our food today due to the perversion of the grass loophole. It's almost the assumption DC is the food industry doesn't have to do safety studies. Common sense questions like, well, we spend $120 billion on SNAP, we spend tens of billions of dollars to procure meals for our schools and our military. Why is 70% of the food that we procure for children, ultra-process food? Why is that? Is that the right thing to do for children's health? Now that we're going bankrupt with Medicaid costs, it flows to that 80% of kids on SNAP or on Medicaid. Does this make sense? 80% of the kids on SNAP or on Medicaid. - What we're doing with the hundreds of billions of dollars of incentives for ultra-process food is we are poisoning our children's mitochondria, we're fueling inflammation, we're fueling insulin resistance. What we have to understand one year into Maha is what I tried to say on Tucker, what Bobby Kennedy has tried to say, I think what a lot of voters have been waking on is just true. Our incentives are broken. And the reason we're in such a generational moment, and I see this every day at the White House, is that the political coalition that Bobby Kennedy and President Trump put together allow us to ask common sense questions and it allows Kyle to call the food industry to the table. And I have to agree with Kyle, I am very inspired by what's happened in the past year with these conversations with the food companies, 'cause we do, we sit them down at the White House, and we don't point fingers. We talk 10 years from now, and we say, do we all agree that we need to be eating less ultra-process food in 10 years? Yes. Do we agree that it doesn't make much sense that SNAP, the top item on SNAP, food stamps is soda and this third item is potato chips, and we're fueling disease. Does anyone disagree with that? And that's a problem. No, nobody did agrees with that. Do we agree that we should have improved safety studies of our food? Yes. Actually, everyone agrees. Everyone we talk to is a parent, is a human being. These are the things that are impossible to disagree with. You know, the challenge is the short to medium term. How do we change that? And we're engaging in those conversations. And this has always been this master strategy in the plan, and this is not to make an excuse, but these are generational long-term issues. This is going to be a 10-year journey, but what we have done in the first year is absolutely extraordinary. Taking soda and candy off SNAP and the majority of US states, flipping the food pyramid upside down. And this, I don't think people understand how important this was, and how much work it took from Kyle's team, and the whole team from Secretary Kennedy to put real food at the top of the pyramid. That goes directly into government procurement guidelines. Until this year, the US government of the United States has never said real food is healthier than ultra-process food. And until this year, with skyrocketing rates of diabetes in obesity, the United States government has never took a strong line on added sugar, particularly recommending added sugar for kids. They've done that for the first time. And then we're fine carbohydrates. So fine carbohydrates have never been called out in a US dietary document. So when, so I think that's having a force. I was just on a plane yesterday. The flight attendant said that the amount of soda that they're serving has gone down 50%. That everyone's ordering sparkling water. Snacking has gone down by some measures, nine percent just in the past year. Americans are actually waking up radically changing their diets. They're buying more beans. They're buying more whole food protein. They're buying more beef. They're buying more foods and vegetables. All that's going up, snacking is going down. So there is something happening. I'll call consumption going down. And I think that's from the messaging, whether you're liberal or a Democrat, whether you're liberal or conservative, whether you don't like present Trump and Bobby Kennedy or like them, I think we can all agree there's something happening in this country. I think that's been fueled by this union of present Trump and RFK. And I think what we've done with the food pyramid, with the food dies, with grass reform, with looking at school lunches, baby formula, revamping those which Kyle's working on. I mean, it is a unprecedented level of success. And I think it sets up, you know, in the coming years to just do more and more. And if we were to sort of stretch out the year from early 2025 to today, what are some things that the American public had latch on to to say, okay, we are making progress. What you just said is very impactful, but at a government level, where are the big wins for Mahan, the agenda with the government, the grass reform, we would remove black box warnings from female hormone therapy, we got rid of the red dies, you made snap reform. And, but we're not stopping there. - No. - Right. So we've got three more years, and you know, with this administration, and with your 10 years. And hopefully Bobby will outlast that three years, 'cause my understanding is he actually wants to stay on and make a meeting of an impact for a longer period of time. One of the things I will say, being affiliated with the Mahan campaign and being on the Mahan calls every week, attending a lot of these big legislative wins in different states, is that people are beginning to recognize that they also have a role. You know, because it's more than just government regulatory guidelines going from the top down. So consumers can't just sit back and hope that things happen. Like you said, consumer spending drives corporate behavior. But even showing up to some of these hearings, we're going over to, you know, can we talk about the announcement today? - Yep. - Okay, great. Because my wife did a post about a year ago. I had a best friend of mine from college who sadly passed a state-of-war calling cancer, called it very, very late. And this was a very, you know, personal journey for me. And I remember we were sitting in the ICU in the oncology area of Mayo Clinic in Scotts, Celi, Arizona, you know, top medical institution. And, you know, they brought in the tray of food and it was, you know, pure apple sauce, Jello, which actually still had the red dye for, it was being phased out. There was a certain period of time to like, gotten it out. And it was like a sea grems ginger. So 52 grams of sugar, no protein, no fats, like no nutrition. And sage, my wife did a post about it. And it went very viral and people were really upset about it. And from that day to today, to me, is a landmark change coming from our government. Because today, can you talk a little bit about what Bobby's going to be announcing at the hospital? - Yeah. This announcement is an example of what Kyle's team and secretary of King's team throughout the government is doing. So we ask, you ask about on Rahaw Framework. We asked, where is government spending money and how can we influence and nudge the system into a better direction? So we've talked about school lunches. We've talked about military food. Hospitals are a big one. So hospitals are dependent on Medicare Medicaid funding. Their lifeblood is government funding. And if you go to, every patient knows, as you've talked about it, I was at Stanford Hospital with my mom, the Mayo Clinic with my mom, they served her Coca-Cola and she was a diabetic, dying of a metabolic condition from cancer. It is absolutely disgraceful what hospitals are serving patients. And we have asked a simple question to hospitals, which is, why is the government paying you trillions of dollars, over a trillion dollars, almost two? - Wow. - Why are we paying you this to serve food that is fueling the chronic diseases that 90% of those payments are going to, 90% of healthcare spending, of the government healthcare spending goes to treating metabolic chronic diseases that are highly tied to ultra-process food and highly preventable food. - Highly preventable food. Sugar-y drinks, refined carbohydrates, fried food, it's what hospitals are serving. So what can happen? CMS can issue conditions of participation. They can write letters saying what we expect for paying these trillion dollar plus of government money. And for the first time, the government is issuing a letter to hospitals saying, if you're gonna take government money, you cannot be serving diabetic and obese patients, sugary drinks, cut down and eliminate the refined carbohydrates, serve whole grains. And cut, you look at the food, it's all fried inflammatory food. Let's get whole food protein. So it took the principles of the dietary guidelines and we're pushing that on hospitals. And the hospitals are billing, Medicare, and Medicaid up to $400 per day for food, the government. So this is not an affordability issue. This is just a common sense issue. And frankly, as Kyle said, and I credit the hospital CEOs, they've come to us and he said, this is ridiculous. They've actually welcomed it. And we're working with them on voluntary commitments for just general food that they serve at the hospitals. Hospitals are the largest employer in the United States. More Americans are employed in the healthcare hospital system than any other industry. So we see this trickling into the cafeterias. Yeah, it trickles into healthcare workers being sicker than the average American. And that's tens of millions of people. So this is a very important act for patient health, but also just general American public health because tens of millions of Americans are eating at hospitals every day. And to your point, Gary, these are the sickest among us. And they're getting terrible nutrition in many cases. And they're captive too. Like that's right. They don't have a choice. They're being a Disney world. Unfortunately, there's a lot of sick people to go to the hospital. They don't have loved ones there. They can bring them a home-cooked meal. They're forced to eat what's delivered to them. And part of it, you know, your story about, about sage's post and part of it is just the lack of education that some in the healthcare space don't have when it comes to nutrition. That's another area that Secretary Kennedy and the administration has been focused on is nutritional education and medical schools. But today's announcement by Florida, which is a voluntary commitment that they're making to sort of take the lead on this program is to get foods into the hospitals here, spearheaded by Nicholas Children's Hospital right here in Miami. That will focus on matching the dietary guidelines. So the foods served in the hospitals here in Florida that are making this pledge will meet the heightened standards of the dietary guidelines that's focused on more fresh fruits and vegetables, more health foods, proteins, whole grains, minimization of things like sugars and ultra-process foods. So a massive win for these hospitals and for patients in Florida. - Well, Kyle, it just makes a great point about how we think about things. So we have the letter to nudge on the macro incentives. Then we had hospitals in Florida step up. They're doing local food procurement. They're doing really interesting food as medicine things, better food at the hospitals. As this momentum happens, we have really interesting conversations and these public-private partnerships along with taking a firm stand and work on money should go. It's having a huge impact. It's exactly what's happened where we nudge on the dies, but then Walmart comes calling, target comes calling. And they know this is the right thing to do and they're making voluntary commitments. That's the flywheel that we're trying to create. - Yeah, I'm really happy to hear that too. The actual level of corporate cooperation that you're getting because I don't subscribe to the theory that there's, you know, an evil wizard behind the curtain that is intentionally trying to make people say that they're not hostile actors. - Yeah, they're not hostile actors. And they're working the system, right? I mean, they are playing by the rules, the existing rules, the rules needed to change, which you're changing them. And it's no different than a professional sports. You know, somebody pulls off this amazing play and scores a touchdown or a goal and you go, how are they able to do that? Well, they would sit within the rules, you know, and these corporations are navigating this and they're just driving trucks through the whole, holes in the regulatory environment. And the fact that you are re-evaluating those, closing some of those, expanding other areas, this is what's in the best interest to the American people. I want to shift to talking about the grass guidelines because I think generally regarded as safe is something that most Americans don't capture an understanding of. Can you give us a little bit of context on what are they and what are some of the positive changes that you're making in grass guidelines and why should American people, we care about that? - Yeah, grass is a really complicated subject that goes back to 1958. Okay, so if you go back to 1958, we were at a time not totally dissimilar from now where there were concerns among the American people about a number of incidents that had happened where people have gotten sick or died because of additives that were found in food. And so Congress said, we need to address this. So we're gonna pass this new law, these food additive amendments as they're called, which is gonna require any new food additive that's gonna enter the food supply to file a formal approval, a petition, a food additive petition with FDA if a formal review and approval. Can't go to market until FDA has reviewed it and approved it. The problem is that same law that 1958 food additive amendments had an exception in there that said if you're generally recognized as safe or grass, you don't have to go through that food additive petition process. Right? - And at the time, go back to 1958 Gary, we did not have the complex supply of ingredients that we now have with all sorts of manipulations and precision changes to ingredients that we have now. Right? At the time, Congress was thinking about things like salt, vinegar, pepper, flour. Those were the grass ingredients that had been in the food supply generally recognized as safe among qualified experts. And so unfortunately that exception, which was intended to be an exception, became the tail that wagged the dog and became a pathway that some would say has been exploited for now seven decades or close to seven decades. And there's been different iterations that FDA has taken to try to regulate these substances that was a period under Nixon, where FDA was affirming these and codifying grass subsets and statute. There were other ways, most recently, there's been a voluntary grass process that a lot of companies use where they can voluntarily come in and ask FDA to give what we would call a new questions letter, a good day letter, basically saying we agree with their conclusion that it's generally recognized as safe. But the statute, unregulatory framework has permitted this process to continue on. And it's something that this administration, the Secretary of Kennedy's been very passionate about. We are in an interagency process to try to change how FDA regulates grass substances. And so that's something that's been under deliberation literally since I believe last March, maybe May. It's an absolute priority for this administration, the work continues. And we're hopeful that one way or another, we'll see meaningful change when it comes to grass standards here soon. - Yeah, I think, yeah. When we think about these issues at the White House, this is not a new regulation. I would characterize this as fixing the perversion and corporate capture of an existing regulation. It is not right and no Ameriac would think it's right that over 90% of new ingredients in the food supply, which we can't pronounce, which are totally novel compounds, are designated by industry as generally recognized as safe, which then means that the FDA does not have a record of that ingredient being added in the food supply and has no record of safety studies whatsoever. It's a perversion of the regulation. - So I'll give you an example, Gary. There's an ingredient called tariff flour, which-- - It already sounds that bad. - Yeah, I believe it comes from some South American plant. And we had no record of this. We all of a sudden getting got a number of adverse event complaints around 400 of them with a lot of reports of basically gallbladder exploding or failing. And we do investigations and we're trying to do trace back, trace forward, understand what's happening, what did these people eat? What's, is there a common food they eat? Again, we identified a frozen product and we looked at the ingredient list. And ultimately we see this ingredient, tariff flour, that we had never heard of before at FDA because it didn't come through a formal process. It was a self-crastic ingredient. And so we had no record of this. I would like to think that had there been a requirement that they bring that to FDA through an approval process that we wouldn't have allowed it on market because we would have seen the potential dangers that this ingredient ultimately posed. And so in this case, these illnesses and injuries were totally preventable, but we didn't know about the ingredient in advance. And so that's sort of a prime example of some of the downfalls here. now. now grass isn't incredibly complex, there's a lot to it. There's other machinations of it that we're working through. There's impacts on things like dietary supplements we're thinking about. There are codified substances that there's a really complex array of ways that ingredients can actually get into the market today. Yeah. And so there's a lot going on in that space and we're really working hard through the process. You know, I woke up this morning and there was, oh, my phone was looking at the news and there was an FDA recall on a chocolate company and they had these different iterations of chocolate and one was like, you for you, another one was sexual and they actually found the Dalifil in Saldana Phil. Yeah, absolutely. Pharmaceutical compounds in the chocolate which would be under the brand names, Cialis and Viagra. It was in Cialis and Viagra, it was Tadalifil in Saldana Phil but the erectile dysfunction drugs and people were having these hyposistolic episodes where their blood pressure would drop. I mean, because they're vasodilators. So there you are thinking that you're gonna have, you know, a nice bar of dark chocolate, we had some polyphenols and it's the sexual version. You're like, hey, why not? And, you know, you experience this rapid drop in blood pressure. So you have the bad actors which wasn't even on the label by the way. So you know, hats off to the FDA for this but I was just, my head just exploded. You'd be surprised how often we see that. Whether it's chocolate or some of these supplements sold in gas stations, we see that a lot where an API in active pharmaceutical ingredient is placed in some of these products. And it's nowhere on the label. Yeah, I mean, so because you know, there are a lot of contraindications to those drugs and they're prescribed for a reason. And you know, you imagine that you're getting a prescription drug compound from, you know, just a whole food product that, you know, you're taken to enjoy your life. And it wasn't, I feel like there's the errors of omission and then there's the errors of commission, right? I mean, nobody has errors in commission insurance, right? The commissive error, so are the ones where you intentionally, you are well aware of what's going on. You put it in there anyway, the lead from the label and you, you know, and so I mean, again, hats off to the FDA for catching that, for recalling that and then for holding them responsible for that. Yeah, and I would say on, when it comes to grass, just to round out the discussion, you know, most of the food industry would like to see grass reform. You know, these are companies that, that, that, by and large, believe FDA is the premier authority in the space and FDA review an ingredient, they believe is good for their own business, right? So you think about a large, you know, serial company, for example, if they want to innovate and put a new ingredient in their food supply, they've got to buy that, you know, on a multi-year contract in large volumes, right? So they want a binding ingredient that's been through FDA's review process. Very few of them will actually buy a significant scale, a self-grasp ingredient. And so when you talk about large food companies, and then the companies we're talking to, overwhelmingly supportive of grass reform, because they understand that having that additional level of transparency is actually not only good for consumers, but good for industry as well. - Yeah, I mean, it can, the people that are going to play by the rules and do things right, and elevate their manufacturing to meet these standards or exceed these standards, you know, they're the ones that are going to thrive. And, and, and I don't think anyone is against big companies making a lot of money. They employ a lot of people, they pay a lot of taxes, they feed the system. We want to see the most profitable, most impactful companies in, in the world, be companies that are in service to humanity, they care about the ingredients that go into the people that they serve. - We're building a bridge. - Yeah. - And I think the, it's not government regulation building that bridge. Americans are demanding a change to our food system. It's existential to our country. What we're reflecting is the voter market impulses that have been reflected through the Maha movement. We have to improve this. And, you know, one last thing I'd add to the, to the grass, and again, this isn't pointing fingers, but I think that's just stating facts of where we are. But, but I think most Americans would agree this is reasonable and it's under current law. The food industry is these weird sounding ingredients, but they're also responsible for having safety studies of the ingredients at the amount that they're being put in the product and recommended to consumers. And I think this is an important conversation that we need to have. Big brand name products in America have foundation different ingredients than other countries, including sugar content. If you look at major soda brands, major candy brands, major cereal brands, the exact same product has marginally to substantially lower amounts of sugar often in other countries. You know, if you are a cereal with 20 grams of sugar, marking that cereal to five year olds for daily consumption, I law you're actually required to understand the safety and efficacy of that product that's intended to use. - No, addicted to the amount of the amount of the time. - You know, if a candy brand, if their slogan is everyday, you know, use every, it has everyday in their slogan, it's a fair question to ask, well, where's the safety study of, you know, this product with 40 grams of sugar, you know, that spikes blood sugar being used every day. So again, this is just a reminder, I think for the food industry, this is not mass finger pointing, but I do think we all need to have an incremental conversation here about what the law currently is, about what's happening in the country, and about how we need to build a bridge to the future where we're not systematically by design, spiking our children's blood sugar every single day to diabetic levels, in causing a mass and unique situation in America of inflammation insulin resistance, which then leads to devastating rates of obesity, you know, diabetes and et cetera. So that's the conversation we're fostering. It's been one year, I will say, you know, to voters, whether they supported President Trump Bobby Kennedy or not or wherever they are, I think we should be actually very excited where we are right now. - I think so too. - And I think one of the most important things that's happening is every single boardroom in America of a food company, frankly, of an agricultural company, you know, thinking about their inputs of healthcare companies, they are all talking about chronic disease and they're talking about how they can steer their business models more towards longevity, prevention, addressing the root cause disease. This is absolutely happening 'cause I think whatever happens to this maha movement in its current constitution, and it needs to continue succeeding and it must, and it deserves to, but this is conversations out of the box. And I think that's a real accomplishment and a historic accomplishment of President Trump in Africa. - Those conversations happening are almost just as important or maybe more important in the work we do in a regulatory landscape. I mean, the reality is the consumers that purchase products, food products in America have way more power than Kali and I do or the administration does when it comes to influencing corporate behavior. And one thing I'll say about maha in whatever form you wanna call it, if you go back and look at successful societal movements and I'm not equating maha to the civil rights movement or woman's suffrage, but if you look at things like that, they don't happen in one year. They're a decade. They're a generational movement. - And the message almost gains more momentum after the movement has quote unquote ended. - Yeah, right, me think about that. - That's right. - That's right. King today, maybe even more impactful than during his lifetime. And I agree with you. - Yeah, and one thing I will give President Trump in Secretary Kennedy a lot of credit for, is that historically in DC, there's been a view that if you can't get a benefit from an action within two years or four years, talking about elections, then it's kinda put on the back burner. Why do it if the benefits in 10 years? President Trump and Secretary Kennedy have embraced the maha movement and these reforms, understanding that these things will take time. You might not see chronic disease rates dramatically fall off by this time next year. But if you look in 10 years, at the movement and what it's done and where it's changed and where we've gone, you'll see substantial benefits to children, to adults across this country when it comes to things like chronic disease rates. And so they've really bought into this thing that while this absolutely has two and four year wins, and absolutely is a benefit to the American people in the short term, there's also a long tail on this and there's gonna be benefits for generations and decades. - The maha movement, it's absolutely correct, is an invitation by President Trump and RFK for a grand long term nuance to conversation. We are talking about the foundations of the US economy. The maha argument, which everyone knows is true, is that this is not an issue of rejiggering Medicare, reimbursing race to solve what's happening to American health. There's something deeply cultural here, there's something spiritual, it's very multifaceted and we've opened up that conversation and listeners of your podcasts, listeners of other great podcasts understand this is a very, very deep issue and Secretary Kennedy and President Trump tap something very powerful in their conversations. - Yeah, we monitor media attention because attention in my opinion is more important than capital. Right, because capital will follow. attention when we look at where audiences are paying attention to certain topics. This is in the top three to five in category of top 25. I mean, there is an mom in America that isn't concerned about what's going into a child's body. There is a mother or father in America that isn't concerned about the life expectancy of their child being less statistically speaking than their own life expectancy. And there's this inherent desire, I think, and most people that leave the next generation better off than the generation that we found it. We don't even talk about the financial impact for our country by reducing the cost of chronic disease care and keeping people out of the system for lack of better words in mass. So they don't enter this system of over-benicillization and adding to this burdensome snowball of health care. Because 80-85% of these chronic diseases are entirely preventable. It's interesting that it's called the Food and Drug Administration because the food leads to the drugs that lead to the expenses. It's got this snowball effect. And winding that ball of yarn, I think voters very often, in my opinion, one instant, right? Start to work and the work. We should be able to stop this and start this. And these movements don't turn that fast. So it's important for people to understand that the momentum is moving in the direction of the American people. The momentum is. And it's also important for people to understand that these processes that take time or design that way intentionally, right? And so we have to go through a formal process that involves rulemaking, commenting. But that's designed to ensure it lasts. So that if in five years someone else says that was a terrible idea, they've got to unwind it through a similar process. Right. Right. And so while these things do take time, they're designed to be that way legally through a framework to ensure that they can't just be reversed on the right-on spot. And so some of the frustration we hear, we get to your point, or one year in, a little over one year in. Right. But this has a long tail on it. The Mahat movement, I think, is one led by consumers. It's led by, obviously, President Trump and Secretary Kennedy have coalesced a significant amount of passion in this area. And I really think this is here for the long-term success. Yeah. I do too. I want to switch gears to another topic that's recently become very near and dear to my heart. We've had three babies in the ultimate human team. And 2025 was a very fertile year for us. I mean, half my executive team is having babies. And as such, they're concerned about, well, what am I putting into my babies? You know, body and most of them are sourcing their infant formulas from overseas. And not too long ago when you were here at the house and we were talking about some of the initiatives at the FDA, there wasn't the right time to talk about Operation Stork and what's going on with baby formula. But I wonder if we just speak to the moms across America now about what kind of initiatives are going on around Operation Stork and where do you see us going with, you know, foundational baby formula formulations? Well, infant formula is maybe the most important single food item that we regulated FDA. And it's regulated very tightly, closer to a drug than a food product in many respects, which is good, right? You know, the reality is that infant formula is sole source nutrition for a number of infants, the only source of nutrition that they're getting. So you have to make sure they're getting the right amount of macro and micronutrients. You've got to make sure that these things are not contaminated. And so when you're giving something, a baby, one thing for however many months, it's the most vulnerable time in the world. You have to get it right. There's no room for error. And so we regulate infant formula really tightly. We also have not taken a hard look at the nutrients in infant formula in a long time. In fact, the last time FDA looked at nutrients in infant formula. So right now there are 30 mandatory nutrients that must be an infant formula. Ten of those have maximum levels to prevent things like toxicity, certain vitamins and iron, right? You don't want to have too much of those. So there's 10 of those 30 that have maximum levels. We are undertaking for the first time since 1998. And by the way, back in '98, when we did that, we didn't make any changes. So it's actually been longer since this has happened. So under under Operation Historic Speed and President Trump and Secretary Kennedy's leadership here, we are looking to come. We have comprehensively assessed in review the nutrient requirements in infant formula. We've already started that work. We put out a request for information last year. We got a ton of good information. Who do you put that request for information out to? So that goes out publicly. Okay. Anybody can provide information. Researchers. Researchers, moms, dads, caregivers, industry, everybody can provide comments. We got a ton of comments on that. We're working with world-class experts. We're talking to other countries as part of the process. And so we're really excited about being able to, and we're going to have to do this through rulemaking. So what we do is we put out a, what's called an NPRM and notice of proposed rulemaking. And that's sort of the process that FDA uses to put regulations in place. And so we ultimately want to, depending on where the evidence and science shows, update those nutrient standards for infant formula in the US to make them more modern. I mean, again, it's been over 30 years since there's been any changes to those. Now, we've added a couple of nutrients since that time, but we have not had a comprehensive assessment or review of the nutrient requirements in infant formula. So we're really excited about that. We think it's going to be a game changer. We think that moms and dads, caregivers are really passionate about this. And it's one of the most important things that we can do at FDA under my tenure. And I'm really excited about doing that. But that's not all we're doing on stroke speed. We've also engaged in comprehensive testing to look at things like PFAS, BALAIDS, any number of heavy metal pesticides. And we're going to be releasing data on that in the near term, showing what we've found. And I will tell you, Gary, that we're in a pretty good spot. I mean, thankfully, the infant formula market has come a long way in the past several years and by and large on its own, I guess, on its own. These are very tightly regulated products, held to very high standards. FDA inspects the facilities every year. In fact, it's the only food facilities that we're in every single year. We have an our own cadre of investigators that only do infant formula work. And so we're in their facilities every single day, both foreign and domestic. And these companies are held to incredibly tight and sophisticated standards. And the good news is the testing we've done shows that these products are in good shape. The levels are low, much lower than you look at EPA levels for things like bottled water or water levels for heavy metals. Overall the infant formula supply in the United States when it comes to contamination levels isn't a good spot. And we're really thankful for that. We didn't want to see bad levels. We wanted to see good levels. And thankfully, that's what we've seen. So we're going to be putting out data on that. We're also reassessing safety when it comes to microbiological contamination. So there's been a number of issues over going back to 2021, 2022 on chronobacter. That's why the supply chain, right? And that's where the 2022 shortage happened because of the chronobacter issues as well as COVID supply chain disruptions. So we've done a ton of work to ensure the stability of the market. We allowed importation, personal importation of foreign formulas. We also started a process to allow foreign companies to move into the US and we've permitted 13 different formulas that were not previously allowed in the US to now be lawfully sold in the US market. Most of those from Europe, Australia, New Zealand are coming here to manufacture formulations here. It's a mix. I would say, I would say, no, it's not manufactured here, but you're still spot checking those guys even though they're really okay. Absolutely. So if they're manufacturing in Australia, we're on the ground in Australia at their facility. So they're held to the exact same standard to our domestic manufacturers here. And so we're going to tighten up and see what else we need to do when it comes to microbiological food safety as well. There was an issue earlier this year, late last year related to infant botulism. And so we're taking a really hard look at ingredients that could be subject to that to see if there's new procedures we might need to put in place from manufacturing perspective. So formula is top of mind for us. We have an entire team here in DC doing that work daily. We have the cadre that's out in the field investigating daily. We're leaving no stone unturned to try to ensure the safety and nutrient stability of infant botulism in the US. That is incredible. I think that this is the kind of messaging that drives the consumer support. And I think it also, eventually this will be winning political messages. These will show up at the ballot box when different political figures are running for office and they stand on the foundation of making America healthy again, making us as healthy as we possibly can, supporting some of these legislative changes. I think you're going to have consumer behavior and consumer spending driving from the bottom up, you'll have consumers widely aware of these things. I mean, some of the million moms across America that are probably ecstatic about Operation Stork, you're going to have them start voting with their hearts. And I think that's where you get that final piece of change in a real movement that really makes long lasting change. But surprised you the most, Kelly, when you joined HHS and you started this fight, what surprised you the most was it the lack of cooperation, the time it takes to get things done, the support that you received, when you got inside, you know, when you got behind the curtain, because, you know, going back to that podcast and your book, you're in your sister wrote, to me, it's the most apolitical common sense issue, maybe to ever land in the political arena. Like there should be zero disagreement on this. Like who is taking the opposite side of that coin? Right. What surprised me is how much frankly hate there is in Washington DC towards this administration, towards President Trump. And I wrote that book and went on those podcasts, Casey and I had an expressly nonpolitical and didn't think about those political terms. I met with Nancy Pelosi. I met with progressive Democrats. I met with Republicans. Democrats were passing the book around. We were meeting with everyone. This was really exciting. We were going to red states, blue states, both sides were passing. And then President Trump started talking about these issues and Bobby Kennedy started talking about these issues on the campaign trail. And Kamal Harris did not talk about the issues. And then President Trump and Bobby Kennedy over hours and hours of conversations talked about how they had a historic opportunity to go down in history for reversing the childhood of Christ's crisis and bonded over that issue and united. So as somebody that cares about these issues, as my life's work, how can, and I think a lot of people felt this way. That was the side that is channeling this conversation, which is inherently nonpolitical. The media has an absolute immune response to look at anything good and find the problem. Bobby Kennedy doesn't talk much about vaccines quite frankly, but every single article will is about vaccines. My sister has only talked about chronic disease every single podcast, 400 podcasts. In the last 100 articles about her, the words chronic disease don't appear. It's one offhand comment on raw milk that she made. They, they, there's a meba that tries to focus and divide the America people. And that's fine. But the most surprising aspect to me and I want to be clear whether somebody watching supports President Trump doesn't support President Trump. You're right. This isn't political. But I am trying to drive political change and federal policy change. And what is demonstrable, true to me is that Democrats put their hatred of President Trump above these issues. I have reached out to Democratic staff and Democratic senators and did not receive one response. People that were passing around my book and very passionate about these issues and friends with Bobby Kennedy in the past, they do not respond to us. The Democrats did nothing to help the food pyramid and flipped that upside down. The Biden administration said that ultra-process food was healthy. They were totally co-opted. They have not done a lot to help on these issues. We are begging them and we are hopeful. And I truly, this is good faith. We are asking them to work with us on some of these no-brainer 95 percent issues. But the level of hatred and a leading reporter, a friend of mine, a leading reporter told me this that the culture in the media is that they want to destroy President Trump and Bobby Kennedy and that goal is more important than children's health. They actively see their job. These people need to be destroyed and they cannot get a win. Frankly, it's the culture of a lot of the government bureaucracy. There aren't that many political appointees that Bobby Kennedy and President Trump chose at HHS or the government. 95 percent of the staff is in trench-care bureaucrats. A lot of them, quite frankly, think they're protecting science against President Trump and Bobby Kennedy. So this is all stuff I talked about before coming in. The weight of the division in the country is pronounced. And the weight, again, not putting a finger at any individual one person, but the weight that the FDA regulates trillions of dollars of the U.S. economy, quite frankly, through drugs to Paco. I mean, it's actually unbelievable. Kyle and Marty McCarry go up against making daily decisions that impact market caps. It's all finding good. But there's a lot of force there that wants to keep things the way they are. So we're up against a lot. It's not an excuse, not anything. I think it's, frankly, what everybody needs to understand. There's a unique, rare moment where people voted in, folks, to go nudge this in a different direction. We have done so much in the past year. You really have. The food pyramid, the food dies, grass reform, school lunches, resetting the NIH to actually study food as medicine, study the root cause of disease. You just go down the list, operation stroke speed, but there's so much left to do. And I really do think this group of insurgents at HHS trying to push for reversing chronic disease is worth continuing. And we're heading over to this announcement today at the hospital, which is just a phenomenally short time frame from when my wife did this post to when we're hearing this announcement. But we're looking at the folks that are listening to this podcast right now and do if they want to be, I don't want to say a part of the movement because that makes it sound like they're a part of some, you know, some political operation, which is not. How can they support some of these changes? How can they support the Maham movement, the A political Maham movement? How can they get involved in helping you both with state regulatory or federal regulatory issues? Because, you know, I think very often people just say, well, I'm just one voice, you know, I'm just one vote. I'm just one call to a senator. Is there an activity that they could, if they're fired up about this and they go, you know what? This momentum has legs. I care about the future of our country and our children and my family. What can they do? You want to start? Galley. The first thing is Kyle said the market is all the matters and what individual decision. At the end of the day, we need to change, you know, people need to, it's personal responsibility. They need to choose different items that they buy. What our argument is is personal responsibility isn't really the issue. The choices Americans are making are dramatically impacted by the recommendations and massive incentives that the government has instituted, which are very corrupt. It's not a full personal responsibility issue that 70% of a child's diets, ultra-processed food, but that's 10% in other countries that comes from school. Lunch incentives, snap incentives, recommendations, the lack of oversight from the FDI and grass. We have more addictive chemicals in our food. So I think everyone should understand that we are fighting to change those incentives. But there is this awakening happening from the bottom up and I just cannot, from being in the government, I cannot encourage people more to understand that the government has not had your back. There are tremendous forces that profit on sick addicted children. It is true. Nobody will dispute it. It's dark. And the most revolutionary thing everyone can do is really be conscious of what they're eating, read your food labels, try to eat, mentally process food, think about what your food is sourced. I know it's tough for people out there. We're trying to put content out there about how cooking at home, you know, it can actually be very affordable. These are basic things and continue on that track. Because that's what's really going to change the world. On the policy level, it is so important. A hundred calls on an issue actually make a huge difference. Most people don't pick up the calls. We have had 30 states do Mahabals on getting cell phones out of schools, improving school lunches, getting food dies out of schools, snap waivers on the soda. This has all happened because Mahamams, Mahasapporters called their local legislators for these bipartisan bills. So I really do think finding state or federal issues if there's various discussions on things like grass, call and say you support it. It does make a huge difference. Yeah. Thanks so too. One final thing I want to close out on is with a little of the momentum on our side. We know that again, consumer spending is going to drive corporate behavior. How do you feel people can participate? Yeah. Look, I think the reality is one, more so than what Callie and I can do or the White House or the administration can do when it comes to changing regulations, changing the law. We know where Congress is, not a lot's gotten done there. It is the day-to-day activities of consumers that will drive change in this country. And I would tell people, don't get discouraged. The movement takes time. We're a year-end, 15 months-end, whatever it is. It takes time to get things done. We're working day in and day out on these issues. The president cares about these issues, the administration cares about these issues. These issues are good for everyday Americans. These policies will help children stay healthier. It'll lower cost for Americans. Americans will feel better. They'll eat better. They'll put more money in their pocket. the Trump administration is absolutely committed to these issues across the board. And I think people just need to stay engaged in the process and understand how it works. You know, there was a bit of a euphoria moment, I think, when Secretary Kennedy endorsed President Trump and President Trump won and sort of a historic landslide election. And that momentum last, but it only lasts so long. And now you're coming up against a midterm election. And you know, you hear the rumblings, but elections are often won on small margins. You know, I read up the road in Boko Reton, I think the mayor up there just won as a race by like nine votes or maybe it's not. But you know, the reality is that yeah. And so when it comes to engagement, every voice does matter. Whether it's a letter, you know, you're voting, engaging in the public process, submitting comments to FDA, being vocal, all of those things matter. And the movement itself is one that grew out of sort of populist consumer voices and wanting change. And I think we'll continue down that path. Guys, thank you so much for coming on the ultimate human podcast. There's so much more that I wanted to cover. We didn't have the time today. So I hope that you'll come back on. I want to talk about food deserts and some of the other things that come across our platform. But I hope that this is a shot in the arm for the American people to not only see that there's been real change and we have moved the be, you know, ball a pretty good distance down the field. The fight is still on. But your voice really matters. Your phone calls, your letters, your participation really matters. And most importantly, where you're spending your dollars really drives the corporate behavior that drives the change. So thank you so much for coming on the ultimate human podcast. Thanks, Gary. Appreciate you both. And until next time, guys, That's just science.

Podcast Summary

Key Points:

  1. The FDA and HHS are working to reform the U.S. food system, targeting ultra-processed foods, artificial dyes, and lax safety testing.
  2. A major focus is closing the "GRAS" (Generally Recognized as Safe) loophole, which allows companies to bypass FDA safety reviews for new additives.
  3. Key wins include removing artificial dyes from kids' food, pulling soda from government food programs (SNAP), and overhauling hospital nutrition.
  4. The "Make America Healthy Again" (MAHA) agenda aims to address chronic disease by changing cultural and regulatory incentives, not just reimbursement rates.
  5. Big food companies are partnering with the administration on reform, driven by consumer demand for healthier products.
  6. The FDA has created a new post-market review system to re-evaluate chemicals that entered the food supply decades ago.
  7. Consumer behavior is shifting, with soda consumption down and purchases of whole foods up, reflecting growing public awareness.

Summary:

S. food system reform with FDA's Kyle Diamantis and HHS's Cali Means. They highlight systemic issues like the GRAS loophole, which allows over 90% of new food additives to enter the market without FDA review, and the prevalence of ultra-processed foods in government programs.

Since early 2025, the MAHA agenda has achieved notable wins: removing artificial dyes from children's food, banning soda from SNAP, and overhauling hospital nutrition to combat chronic disease. The FDA is shifting from a reactive to a proactive stance, creating a post-market review system to re-evaluate additives approved decades ago. Despite challenges like the Administrative Procedures Act, the administration is fostering collaboration with big food companies, which are responding to consumer demand for healthier options.

Means emphasizes that this is a cultural and generational shift, not just a regulatory one, with consumer spending driving corporate change. The conversation underscores that while government action is crucial, individual choices—like buying whole foods and reducing snacking—are equally vital. The hosts express optimism about the momentum, noting that Americans are increasingly rejecting ultra-processed foods and embracing real food, signaling a transformative movement in public health.

FAQs

The three pillars are microbiological food safety, nutrition, and food chemical safety. Microbiological food safety, which handles recalls and outbreaks, makes up about 55-60% of the budget.

The GRAS (Generally Recognized as Safe) loophole allows food companies to skip safety testing for new additives. Over 90% of novel food additives in the U.S. were never reviewed by the FDA due to this loophole.

Soda and candy have been removed from SNAP in most states, and the food pyramid has been flipped to prioritize real food over ultra-processed food. The government also recommended limiting added sugar for kids for the first time.

Many large food companies, including Walmart, have partnered with the administration to remove additives like dyes and preservatives. They support increased oversight and reform to meet consumer demand.

The FDA has created a new systematic post-market review framework to re-evaluate chemicals introduced decades ago. This proactive approach replaces the previous reactive system that only reviewed additives after complaints.

Artificial dyes have been removed from kids' food, and companies like Walmart have committed to removing 30 additives, including dyes, from their store brands. This is part of broader efforts to improve food safety.

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