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“Senator Tuberville was shocked to learn that we haven’t evaluated the safety of R-40 in more than a decade and that we are at least 20 years behind Europe in our food safety evaluation standards. He wants to see increased attention to our food safety evaluations, especially when it comes to food coming from places like China. Senator Tuberville looks forward to working with the incoming Trump administration to Make America Healthy Again.”
“In the U.S., all color additives must be approved for use before they can be used in food, drugs, or cosmetics. The FDA regulates the safety and labeling of all color additives, and it does so based on scientific evidence. As such, the FDA has determined and continues to maintain that FD&C Red No. 40 is safe. In 2011, the FDA Food Advisory Committee, an expert panel that included pediatricians, psychiatrists, and behavioral and developmental specialists, reviewed all other relevant science purportedly linking consumption of Red No. 40 to neurobehavioral effects in children with ADHD and the general population, concluded that there is no causal relationship, and voting against a warning label requirement. FDA also monitors and evaluates any new available evidence on an ongoing basis. Most recently, in October 2019, the FDA Science Board similarly concluded that there remains insufficient evidence to establish a causal link between synthetic color intake and adverse behavioral outcomes. Since U.S. regulations already require that every color be listed by name on the ingredient list, parents can easily identify and avoid them if desired.
Notably, other international expert bodies, including the European Food Safety Authority (most recently in 2009) and the FAO/WHO JECFA Expert Committee (most recently in 2016), have conducted comprehensive risk assessments on FD&C Red No. 40 (known globally as Allura Red), concluded that current evidence does not establish a causal relationship between consumption of the color and adverse behavior, including hyperactivity.”
Reassessing the safety of chemicals in food as new, relevant data become available is a priority for the FDA. The agency has continued to assess available new information about color additives including FD&C Red 40, also known as Allura Red AC. The FDA will continue to assess the emerging science and ensure the safety of approved color additives.
In 2011, there was a Food Advisory Committee Meeting March 30-31, 2011, that assessed children’s consumption of food dyes and its possible association with hyperactivity. The Committee concluded that, based on all available data, no causal link could be established between children’s consumption of synthetic color additives and adverse behavioral effects including hyperactivity, and that additional labeling information on foods containing color additives was not necessary. One of the committee’s research recommendations was that FDA conduct an exposure assessment of consumption of certified color additives from foods.
In 2016, the FDA performed an exposure assessment related to all seven FD&C color additives (which included Red 40) and found the exposure estimates for these color additives, including for children, are well below the FDA’s established acceptable daily intake levels for these color additives. See: Exposure Assessment for FD&C Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, and Yellow 6 levels in food.
For more information, see: https://www.fda.gov/food/food-ingredients-packaging/color-additives-information-consumers.
In 2019, the FDA conducted an updated review of the data and information and presented its findings to the Science Board, an independent advisory committee of scientists that advises the agency, to discuss the latest science on a potential link between children’s consumption of color additives in food and ADHD. A limitation noted at the Science Board meeting was that many of the available studies had several deficiencies limiting their use, for example some were performed using mixtures containing color additives not approved for use in the U.S. The Science Board concluded, based on the available scientific evidence, that most children have no effects from consuming foods containing color additives, though some evidence suggested that certain children may be part of a sensitive subpopulation.
David Kaslow, FDA
Second, and I want to be clear about this, none of the RSV vaccine candidates based on live attenuated RSV vectors, are currently on clinical hold.
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Sarah Long, VRBPAC
So the mother who is immunized passes on the antibody to the baby and she has received a prefusion vaccine that is not unlike nirsevimab, which is a prefusion antibody. But you said the maternal would more simulate the response of infection in the mother? Why would that be?
Natalie Thornburg, CDC
Ah, because, by the time a person is an adult, they have had many infections. And there is data to suggest that through repeated infections upon your, in your lifetime, you get a very diverse antibody response that includes neutralizing antibodies against site zero. It’s not a single antibody.
So nirsevimab is one single antibody that binds to prefusion F, a very specific part of prefusion F. A person might have one antibody that looks like nirsevimab, but it’s one in ten thousand antibodies. So that’s just one antibody that gets boosted.
A mother gets that vaccine, and they will be boosted presumably against prefusion F, but they should have many antibodies that bind prefusion F. So all of those antibodies should be boosted against prefusion F.
And so a maternal vaccination would not exactly mimic infection, but it would be a lot more like infection than just receiving a monoclonal antibody, because it would be a very diverse antibody response.
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Jay Portnoy, FDA
One other question, the infants who did have the severe disease and were hospitalized, were there any risk factors for those infants that differentiated those from the ones who weren’t hospitalized other than getting vaccine or not? Like, did they have atopic dermatitis? Was there a family history of allergy? Were they predisposed to a TH2 type of response?
Matthew Snape, Moderna
Just to look at these children again, I can tell you that all children were – the inclusion exclusion criteria were very strict. These children did not have underlying conditions. They were all born at term. They did not have any history of wheezing or any individual concerns at that level.
And I’ll actually bring doctor Saez-Llorens if you want to comment further about the medical history of these participants.
Xavier Saez-Llorens, Moderna
Hello to everybody. They were previously healthy infants. And exclusion criteria were very clear and not enrolled patients with risk factors.
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Matthew Snape, Moderna
We – the numbers are small, we agree. It was clear there was a trend here that meant that we couldn’t progress further dosing and enrollment, I think that was the right decision, but the numbers are small.
We’ve not found any likely mechanism, we’ve not found the likely mechanism of action for these findings, if they are confirmed. And we are gathering more data to understand these findings and we’ll be sharing the data with the public as it becomes available.
And we welcome the input of the VRBPAC today for suggestions for possible further research to elucidate mechanisms of action and we’ll be engaging with the broader scientific and regulatory community to understand these results.
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Mark Connelly, FDA
At the time of the study pause, part B cohorts 3 and 4 were fully enrolled and participants had received 2 of 3 study doses. Part B cohorts 5 and 6 and part C were enrolling and participants have received one study dose. The DSMB was convened for an ad hoc meeting and recommended continued study pause.
The FDA was notified of the study pause and the IND was placed on clinical hold.
A partial hold on enrollment of children less than two years of age and RSV naive children 2 years to less than 5 years of age was implemented for all pediatric studies under U.S. IND with the exception of studies using live attenuated RSV vaccines.
The sponsor at the DSMB’s recommendation established a blinded clinical assessment team to monitor for additional cases of significant RSV disease and a post hoc definition for cases of clinically significant severe or very severe RSV lower respiratory tract infection, which I’ll refer to hereafter as severe slash hospitalized RSV cases, was established to better identify new RSV cases of interest.
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Mark Connelly, FDA
In one clinical study, a numerical imbalance in severe slash hospitalized RSV cases was observed in children 5 months to less than 8 months of age who received an RSV only vaccine or combination RSV plus human metapneumovirus vaccine, as compared to placebo.
Nonclinical and clinical safeguards were in place for this study, based on our understanding of VAERD following the formulin inactivated RSV vaccine.
The mRNA vaccine construct was designed and non-clinical data were assessed prior to the clinical study to mitigate the risk of VAERD.
Preliminary immunogenicity data suggest differences in the severe slash hospitalized RSV cases observed in the study, as compared to formulin inactivated RSV VAERD cases. Again, characterization of these cases is not complete.
The implication of the observed imbalance for other pediatric RSV vaccine programs are uncertain.
The partial hold on enrollment of children less than 2 years of age and seronegative individuals 2 through 5 years of age remains in place for pediatric clinical development programs for RSV vaccines under U.S. IND, other than live attenuated RSV vaccines.
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Adam Berger, VRBPAC
I’m curious if you’ve actually evaluated any of the other development programs to see if they’re having similar results to what we’re hearing today.
Mark Connelly, FDA
As of today, we have not been notified of anything in the other development programs, but of course, we are monitoring and in contact with them as well.
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Arnold Monto, VRPBAC
I think we are confronted by a very complicated situation.
We know that passive acquisition of antibody is protective, highly protective, and does not produce severe disease in any way.
We now have a platform which should be only inducing antibody formation, which I think it’s pretty– the right antibody, the prefusion antibody. I think it’s very clear that there is a safety signal and the trials cannot continue, at least in the youngest age group.
I don’t see this, based on our understanding and our ability to develop any kind of new markers for severity, that we can stop or should stop development of potential vaccines using other platforms because we really don’t understand the relationship of the platform to the severity, nor different antigenic conformations. Certainly the stabilized prefusion would be the one to follow.
Therefore, just cutting to the discussion topic, I think this needs to be done a vaccine platform by vaccine platform basis, and to continue with the very careful age deescalation and pre-infection, previous infection approach, but to do it with great caution and to make sure that if there is a signal, it is caught and appropriately handled.
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Sarah Meyer, CDC
I think my takeaways from today are we had some very well thought out safeguards put in place that were based on prior experiences of vaccine candidates, multiple global groups looked at this issue, all came to kind of similar recommendations around how to study these vaccines. So this was a very well thought out process.
But again, as others have pointed out, here we are talking about a safety signal and we don’t really understand the mechanism why. So for me, it makes it very difficult to comment on the second question about what additional safeguards or what new ways to study this we can put in place without really understanding what we think may have happened here or why or – why the safeguards we’ve put in place didn’t necessarily predict severe outcomes.
So I’m really hopeful that some of the additional investigations that Moderna has discussed can shed some light on this and some of the other studies that my colleagues have recommended.
So for me, it makes it very difficult to really comment on that one.
In terms of the first question though, I’ll add my input on this, I do think we saw some data presented today during the open public hearing around the live virus vaccines and I think if I understood our Sanofi colleagues correctly, thousands of children have already received a vaccine in those trials and not found a safety signal.
And I found that reassuring, because where we have detected safety signals, it’s been in pretty small numbers of kids. And so I think that was good signs that we can develop – that there are different vaccine technologies that may have different outcomes. So I think I would agree that we need to kind of look at these.
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Hana El Sahly, VRBPAC chair
This was a very involved and very stimulating discussion to a very vexing question given the small numbers, the data being not finalized in terms of the evaluation of these adverse events, etc.
Since the committee that these potential safety signals, although small in numbers, however, RSV associated severe LRTI and HMPV severe associated LRTI in an HMPV slash RSV vaccine is rather compelling, as opposed to the fracture or the Kawasaki.
So there is the potential safety signal, especially in the history of the 1960s, is rather compelling that the signal is likely true. But not final, but likely true, and should have been addressed with the urgency that it was addressed in terms of the sponsor and in terms of the FDA.
The committee, after review of the data of the mishap or the tragedy of the 1960s, the predictive model was followed however, did not really predict what the outcome would be once the vaccine moved into the seronegative infants who do have a predilection of differing immune response with potentially (inaudible) bias in general.
What does it mean for different vaccine technologies? Certain technologies like the live attenuated has a track record in the thousands already and with in various I guess minor changes to the constructs and in various medical institutions or centers, so there is a reassurance that potentially it can carry its own weight so to speak, given the existing data and moving it forward with the less anxiety provoking than subunit vaccines.
Subunit vaccines have been tested in humans of all ages, whether it’s the recombinant prefusion, the one that is just the recombinant F, and there was no safety signals in adults, a couple are already licensed, but to my knowledge none were in seronegative infants.
How do the events of the last few months what needs to happen for these particular vaccines to go into that sliver of the population? I am not sure, however maybe the additional data that is forthcoming from the collected samples can guide, if they do shed light, onto what was different in the immune response there.
Different antigenic conformations is a little harder. The stabilized pre-F is the one that is in the constructs under consideration today and it didn’t seem to predict the pre-F post-F ratio was of course in favor of the pre-F but it didn’t seem to have aggregated this particular signal.
And based on the currently available evidence, when it comes to the clinical information, so for example the clinical trials that will be resuming I’m assuming at the minimum the replicating ones, the safeguards in place seem to catch such an occurrence. I’m pretty sure all the DSMBs of those trials are on the lookout even more so now.
But what additional nonclinical information should be considered is unknown at this phase. It is something that potentially can be amended once more data from these infants and toddlers are forthcoming and unless I’m – and then we touched upon the new lay of the land, which understand the risk benefit which all IRBs need to know going forward when they review these vaccine studies. We commented that this is an evolving field and our colleagues in the CDC and colleagues in the FDA who will see the subsequent season’s data from the clinical trials are also will be analyzing those data and these will also be informative of the risk and benefit going forward.
We are just following up to see you in you need any additional information for your reporting on this possible case of avian flu. I think our press release answered your initial questions. We were contacted by a local ED physician to investigate a suspect case of avian flu in a child who presented with fever and vomiting after drinking raw milk. The patient was not hospitalized. If CDC can sequence the specimen, we should have the results by tomorrow. Thank you for ongoing coverage of this emerging public health issue.
Since announcing multiple recalls of raw milk due to contamination with bird flu, state and local public health experts have received reports of illnesses from 10 individuals who reported drinking raw milk. Initial county and state public health laboratory testing has not identified any positive bird flu infections in these individuals. One child in Marin County tested positive for influenza A and has recovered from their illness. Additional testing is underway to assess whether this infection was bird flu or seasonal flu. The California Department of Public Health (CDPH) and Marin County Health and Human Services are working with the Centers for Disease Control and Prevention (CDC) on this investigation and will provide updates as they are available. A robust history of scientific study has documented that pasteurization kills bacteria and viruses, like influenza, in milk. Choosing pasteurized milk and products made with pasteurized milk is the best way to keep you and your family safe. For more information see recommendations from the California Department of Public Health.
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The child in Marin County was among the 10 who reported illnesses after consuming raw milk.
USDA expects first round of samples to be submitted the week of Dec 16th. We also expect the first silo sample results before the end of the calendar year.
“The samples were positive for H5, well beyond the level of detection.”
Calley Means [00:13:42]
As my sister and I started talking with Tucker about this, talking with Megyn Kelly, going on the podcast, seeing it resonate, we met Bobby Kennedy and Susie Wiles and Vince Haley from the Trump campaign, more than a year ago, reached out.
They said the president’s focused on this. We’re thinking about it. And my sister and I shared some talking points. So many people don’t know this, but your dad spoke extremely eloquently about this issue, about why kids are getting so sick throughout the campaign. Actually worked with Vince and Susie and they were really inspired by your dad’s focus on this. But he was saying that since the beginning that we got to figure this out.
And then got to know Bobby as well. Obviously Bobby, to me, he was hitting on a MAHA MAGA message. I mean, to me, there were two candidates in this campaign that were talking about a much wider thing than partisan politics, but really just the corruption of our systems and what Bobby did really well is talk about this incentive of kids to be sick and how that’s actually representation of the swamp.
So there was a moment, after the Butler shooting, I was actually talking with Tucker and I’ve become really– Tucker, as you probably know, is really focused on this issue. And we had an idea of, maybe Bobby and your dad, maybe that was the moment where they could talk.
So was able to facilitate that connection to talk about unity right after the Butler shooting had a small insight into those discussions. And Don, you were much closer to this, but from my limited vantage point, it was pretty inspiring just seeing them connect on this emotional level about why so many kids have prediabetes, about why we have the most obese country among kids in the world, about why we spend three times more in healthcare about have six years less life expectancy.
They really talked about these issues. And then I think what you saw with this MAHA movement. I mean, when Bobby Kennedy came out there on the stage in Phoenix, it was the loudest cheer I ever heard. And the way the MAGA movement embraced Kennedy was not surprising to me. But certainly, I think a shift in American politics.
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Calley Means [00:18:44]
We bureaucratically have outsourced our medical codes to the American Medical Association. This is not in a law. It’s just what bureaucrats have decided to do over the previous decades.
And the American Medical Association is a pharma lobbying group. That’s what it is.
So we have outsourced on a bureaucratic level, the biggest part of our economy to a pharmaceutical lobbying group that just demonstrably profits when people are sick.
So that to me, Don is what the big promise of MAHA is before we get into any bans or any type of real policy change.
We don’t need to talk about Obamacare. Let’s just get the corruption out of our scientific regulatory and government bodies, hopefully working close with the Vivek and Elon.
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Calley Means [00:23:41]
So we need to start asking why?
Well, you just look at the basic pillars. Obviously, we look at our food, 70% of our food that a kid eats and what we eat in America is ultra-processed.
Now nobody’s trying to ban our sodas. You know, nobody’s trying to take anything away.
But it is worth asking, should we be subsidizing this stuff? We subsidize it hundreds of millions of dollars. Should we be recommending it? The USDA actually issued a report just a year ago saying that a child’s diet 93% in ultra processed food could be healthy and they recommend added sugar as a healthy part of a two old’s diet.
So before we get into any questions of bans whatsoever, I think it’s conservative, liberal, whatever, it’s just common sense that we shouldn’t be recommending or subsidizing. When you talk about the subsidies, I think the numbers now 18% of SNAP, our food stamp programs, which is actually the fourth largest government program entitlement program after Social Security, Medicare, Medicaid, it’s a huge program. 18% of the entire program goes to sugary drinks.
Okay, no other country’s doing that. So we’re basically subsidizing and recommending food that’s made in a lab. And my big point there, Don is this is by design. I mean, again, we’re all free market people, but like it’s also incumbent to call this out.
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Calley Means [00:25:45]
We could be incentivizing American farmers to reverse prediabetes and get people on better food programs. Like, it’s not ideological to just ask if people are sick, what’s the best way to reverse why they’re sick. Drugging everyone is not the answer, but that’s what we do right now.
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Calley Means [00:26:22]
So we’ve got the devils bargain between the food industry making us sick and the healthcare industry profiting.
I think frankly, this could be a golden age for pharma and health innovation with deregulation, but, there’s going to have to be some conflicts attacking there.
When it gets to the food side. When it gets to your question, I think this is my message, Don. We are on the verge of a golden age of American farming.
We are in the verge of a golden age. No farmers happy. I’m speaking to the lead lobbyists for the farm bureau. They’re attacking Bobby, you know, publicly. They all think, you probably talked to them, nobody’s really happy with what’s happening to American farmers. Whether you’re a big farmer or small farmer.
So behind closed doors, everyone’s kind of scraping for pennies with the current subsidy system, but the farm bill, our subsidy system, again, the U.S. Department of Agriculture, 85% of budget is SNAP, right? It’s basically a subsidy department, right. We have massive subsidy structures for food. Nobody agrees that it’s right.
So, my personal vision with Brooke Rollins and Bobby and various stakeholders in your dad’s administration is we can actually bring stakeholders together. This is not brute force. This is not coming down hard on farmers.
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Calley Means [00:29:29]
I think there’s been calls to maybe do a one year extension of the farm bill and just think about how to change the incentive and regulatory system.
The fact of the matter is we have a rigged market right now with hundreds of billions of dollars of agriculture incentives.
You know, the Bobby Kennedy vision, what President Trump’s talked about is actually redefining healthcare to get to the root cause I actually think more healthcare dollars could go to food. You know, we actually have to support American farmers.
When you start peeling the onion and Don, I talk to members of Congress, senators, they don’t even understand this. A lot of our meat processing is coming from China. Most of the pesticides we spray on our crops are coming from China.
There’s really dark forces here that nobody’s really that happy with. So as long as the message is let’s support American farmers, the simple inescapable reality is that we’ve got to rethink about the subsidies and my pitch there would be absolutely, we should hold bad actors accountable, but I think we need a forward looking agenda where we kind of have some grace looking backwards on how we got here.
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Calley Means [00:31:08]
When you get into tactics there, where my head goes, GRAS standards, I encourage everyone to look them up. They make no sense, it’s not conservative or liberal free market and that we have self-policing or chemicals in our food.
I think I’m optimistic that actually a lot of stakeholders are going to come to the table and just self-police themselves and say we shouldn’t be having some of these toxic ingredients.
And then I know Don you’re excited about Jay Bhattacharya, I think I cannot overstate how important having a fearless leader at the NIH is. Because before we get into bans, before we get into any policy discussion, let’s just get a report on glyphosate. It’s being phased out of countries?
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Calley Means [00:32:36]
So having someone come in just before any policies, just like, Hey, can we figure out what’s going on with the pesticides? Hey, can we figure out what these 10,000 chemicals are doing?
Getting the truth then changes the policy options.
So I think Jay at NIH is an absolutely transformative move. That’s going to impact policy in the years to come.
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Calley Means [00:34:49]
As Bobby said, your dad has kept every single promise he’s made and he is so committed to this issue.
It’s just having his light on the issue, having him say the words childhood chronic disease crisis, it gives an ability– we’ve heard from senators who are really excited.
It just like, almost like they can blame him for like maybe going against farm a little bit and maybe changing the paradigm a little bit.
His focus on these macro big issues is paradigm shifting. So that’s where I think the opportunity is. And, what the long term goal is? The long term goal is we have a healthcare industry that’s not incentivized for Americans to be sick. That doctors are talking more when a child’s depressed about going outside and exercising and eating healthy.
That we’re working closer with small and large farmers, to make American food, the most nutritious in the world and change our subsidy system.
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Donald Trump Jr [00:35:58]
I was actually with Bobby earlier today, briefly. It’s great to actually see that, because I was one of those guys again, behind the scenes, like you were, and then Tucker and I got together to really try to solidify that relationship and make it happen. And they got along great.
And then I’m sitting there be like, okay, now I made a promise. I made a handshake. Like you’re going to be like in this thing. And like, and he is.
So it’s not like one of these, well, the way we see in politics, so much where you make a promise and then you have no intention of delivering, right.
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Calley Means [00:37:24]
We’ve got to deliver unimpeachable wins for the Trump administration in the next, in the first hundred days. And I call the goal of the next four years is changing consciousness.
The biggest win is that we basically this kind of MAHA feeling, I think you’ve had, so many voters have had, they’ve been brought in the fold. They just feel like something isn’t right. And if we can change, you know, in the next couple years that we really can’t go back to this sick care system, but really have a healthcare system and incentives that prioritize health will be in a victory.
So what can we do? What, what can we do immediately?
I think it starts with getting the research right, and getting the conflicts out. And those are two principles we’re talking about that we’re talked about a lot in the campaign, so I’m just going to list some potential ideas.
Obviously Bobby and his team and President Trump’s team are working on the specifics, but I’ll just give a couple ideas.
Like why does the CDC have a nonprofit that allows pharma to bribe that agency hundreds of millions of dollars? That can be cut immediately. Why does the FDA and NIH have the same nonprofit that you can bribe it?
Why does the USDA, as I said, allow their nutrition guideline committee members to receive money from food and pharma companies? Why does the FDA guidance panels that approve our drugs have no conflicts of interest rules to speak of at all?
Why is there no revolving door where a lot of people from the first term, who are telling your dad probably that they’re going to fight the good fight and fight the MAGA way, they go straight to industry, right? You can actually disclose some of these loopholes.
And I can’t stress there’s enough. If you change the incentives of these industries, there’s no bigger swamp than healthcare. HHS is the largest and most expensive and fastest growing department budget in the government. This is the center of the swamp.
The second I’ll just reiterate is the NIH.
Before talk of major policies, people are like, oh is Bobby gonna be doing some bans? Well, some of this stuff, frankly, probably it’s not the free market that the stuff is even in our food. I mean, I think correcting a broken market isn’t anti-free market, but like before, even any talk of that, let’s have Jay Bhattacharya shift the NIH budget to answer the simple question your dad asked during the campaign, why are we getting sick? That was really powerful.
I almost was brought to tears when I saw your dad, like, say that in front of Bobby, why are kids getting sick? Now that’s a simple question. But the NIH, 90% of their budget right now goes to pharmaceutical, basically R and D. It’s basically saying everyone’s getting sick, but we’re going to figure out this bandaid for Alzheimer’s. We’re gonna figure out this bandaid for diabetes. This– pharma should like– pharma’s great. Like they can do their own R and D.
What Jay is talking about doing is he’s gonna steer the entire agency to answer that question.
And then, there’s these hot topics and get into the food. Is it the over prescription of pharmaceuticals? Is it our sleep? Is it very, you can do studies and actually get definitive statements on why we’re getting sick.
What’s going to happen, Don, is people are going to go, that’s anti-science to even ask that question, we’ve settled that issue. It’s all these people that have already made the dietary guidelines. They’ve already made the pharmaceutical guidelines.
So I think one thing Bobby and Trump are saying is like, listen, we’re not trying to take any drug away. We’re not trying to take any– but we should get to the truth. Like, that’s a principle. We should have unbiased.
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Calley Means [00:41:11]
The other thing, Jay, and this is getting into weeds, but I think it’s very important. It can happen day one, is establish the center at the NIH, just do replicability studies, 50% of studies that underlie drug approvals in this country can’t be replicated. They can’t redo the study.
It’s basically we have an epidemic. This is Jay, really talk about this, a fraudulent science.
So, you know, your dad is attacked and I’m sure in many cases for being anti-science. And I’ll tell you Don, from my limited vantage point behind closed doors, I have never heard an ideological statement ever uttered in a Kennedy meeting or meeting with the Trump staff.
It is literally people trying to figure out how to get back to foundational science. It is literally trying to figure out with the NIH budget, how to arm the best scientists in the world and unburden them from any restrictions in academic freedom to get to core questions.
There’s so much bureaucracy right now, preventing that from happening. And it truly is– it’s getting back to science, because I think the enemies hide in complexity and the enemies hide and you know, I think all these DEI rules in science that you have to study certain areas and study certain– we should just figure out why we have a 50% childhood obesity or overweight rate, things like that.
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Calley Means [00:42:26]
Dr. Oz is working with a lot of people. He gets it. And that’s the biggest part of the federal budget. That department.
So just figuring out how to basically change the standard of care to where your kid, if you have a kid in high school, you probably see this right.
That doctor’s going quick to the prescription pad. Right. You probably see with your high school, it’s just like SSRIs prescribed like candy, statins, it’s just like, that’s because of CMS. That’s because of Medicare Medicaid, which then goes to private insurance. And it all comes from the standard of care.
So when you have the right research, I don’t know, maybe that kids are getting obese, because they’re eating too much ultra processed food and then you have more standards of care. Okay. Instead of jamming an Ozempic into kid’s arm, who’s obese, maybe we can put them on a dietary intervention. Maybe we can put them on an incentivized exercise. You can start then changing the standards of care. So that’s really important.
And the last thing I’ll say the other major agency, the CDC can’t stress this enough. Infectious disease is important. Infectious disease is important, but that’s 8% of deaths, right? 92 percent’s chronic. They have a mandate on chronic disease, the chronic disease and their mandate is, infectious and chronic disease.
So of course having the best standards on infectious disease and being prepared for future pandemics is important, but steering the overall posture of the CDC and our overall health authorities to reversing the chronic disease crisis as a general policy emphasis, that will have a big impact as well.
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Calley Means[00:59:56]
Americans, listen to doctors and the surgeon general, I don’t think we, many of us would disagree that the surgeon general report saying smoking isn’t great.
Probably, that wasn’t– that led to a plummeting of smoking, right? That led to various policy makers to make decisions. We haven’t banned it, but it’s led to, and that was just one government bravery.
The food pyramid, our diet radically changed when the government said to eat more carbs and sugar, it went up 20% in the next 10 years.
So, I can’t emphasize enough with Jay and with Marty at the FDA. And with this day one initiative your dad’s talked about with the chronic disease reversal panel, just bringing attention to this issue and actually just giving the right guidance.
I’m telling you if Dr. Fauci or ever, people like that yeah, stood up during COVID with the head of the NIH, the head of Harvard medical school, and they said, we’re dying at 16% rate of worldwide COVID deaths, 4% of the population because of our immune system. And we got to harden up and think about our metabolic health, we would’ve had a transformation. We listened to medical leaders.
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Calley Means [01:01:21]
I just ask everyone to keep up the good vibes for Bobby and your dad. I think we have this positive, just incredibly optimistic vision on health.
And just so grateful to be a small part of knowing Bobby and the Trump team and seeing them just absolutely crank on this issue.
Donald Trump Jr [01:01:37]
Hopefully you and your sister become a big part of that team and I think that’d be awesome and I really appreciate the time and everything that you’re doing.
Calley Means [00:01:00]
Those are not ingredients by and large, that are in Twinkies that are made in any other country.
I want to be clear, Bobby Kennedy’s not saying he’s gonna take the Twinkies away, but we should be starting to ask questions, as 77% of young adults aren’t eligible to join the military in the United States due to metabolic health, due to food.
We have these things called GRAS standards, no other country has them, food companies can self police. You know, that’s not conservative, it’s not liberal. It just doesn’t make sense. We have 10,000 ingredients that aren’t allowed in European foods.
Even more alarmingly. Rachel, we subsidize this food. Again, Twinkies should exist, but I was just on Amazon right before this show, they’re available for SNAP. You can buy them with food stamp dollars right now, Twinkies.
Additionally, Twinkies actually qualify for federally funded school lunch programs. There’s no nutrition or sugar limits on federally funded school lunches.
The last thing I’ll mention, the USDA essentially recommends Twinkies for two year olds. The USDA, right now our guidelines, which are very corrupt say that 10% of a two year old’s diet can be added sugar.
So by the letter of the nutrition guidelines, we’re actually recommending Twinkies to kids.
So as you said, there’s a real optimistic vision here. I think the food industry’s not fully understanding what President Trump and RFK are saying. They’re saying, let’s get all stakeholders together. Let’s have American food be the most nutritious food in the world and the best food in the world.
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Calley Means [00:02:48]
I don’t think it should be called red 40. It should be called crude oil. That’s what red 40 is. It’s crude oil with a couple other molecules.
Let me get into this corruption, because as Donald Trump and– President Trump and RFK have said, the first step is to get corruption out of the science.
So the USDA nutrition guidelines committee. You can’t even believe this, but they’re able to accept money from food and pharma companies, 19 out of the 20 advisors in that committee accept money from those industries.
You can’t even make this up, but 30% of President Biden’s committee accepted money from GLP-1 makers from Ozempic, from a Danish pharmaceutical company, Novo Nordisk.
So you have just innate conflicts of interest that infect the USDA nutrition guidelines, infect our federal school lunch guidelines, infect our SNAP program.
So before we talk about any policy whatsoever, let’s just reconstitute that nutrition guidelines committee and say you cannot accept money from food or pharma companies, if you’re going to
be making recommendations for our kids.
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Calley Means [00:04:07]
I think the connection between MAHA and DOGE is a huge opportunity. Elon Musk at Vivek Ramaswamy have been tweeting about this, actually.
The biggest part of our budget and the fastest growing part of our budget is healthcare costs. And that is because we’re getting sick.
It’s not the technicalities of policy. We’re the sickest country in the world and that’s what’s driving up so much inefficiency.
So actually making our healthcare system more efficient, asking how we can spend money more effectively, that’s actually asking how we can get healthier.
So I think this connection between the DOGE effort and Bobby Kennedy’s HHS with incredible picks like Jay Bhattacharya, Marty Makary, Jim O’Neil, we can really do a lot and I can tell you there’s close collaboration happening between those two organizations.
00:05:37 Natalie Brand
So President-elect Trump’s pick for HHS, RFK Jr’s food policy and taking on the food companies is something he’s talked about. Do you think that you could work with him on this issue?
00:05:51 Sen Bernie Sanders
Well, look, from what I– I’ve not talked to Mr. Kennedy, in a number of years actually. I think what he’s saying about the food industry is exactly correct.
I think you have a food industry concerned about their profits, could care less about the health of the American people. I think they have to be taken on.
I think on the other hand, when you talk about, when Mr. Kennedy talks about taking fluoride out of our water system, I think what scientific community will tell you that would be a disaster, in terms of dental health in this country.
His views on vaccine, very wrong, in so many ways. So we will see how the process unfolds.
So I think what he’s saying about the food industry makes sense to me, a lot of other things that he’s saying are extremely dangerous.
00:06:41 Natalie Brand
How are you preparing for confirmation hearings?
00:06:44 Sen Bernie Sanders
Well we are preparing. We’ll be prepared to ask the right questions and it’s not only the confirmation hearings, it will be discussions that we have behind close doors as well.
00:06:58 Natalie Brand
At this point, have you made up your mind or you’re going to go through the process?
00:07:01 Sen Bernie Sanders
No, I haven’t.
00:07:01 Natalie Brand
Any other health related, as the chair of HELP, are there any other health related picks, agency picks that you’re concerned about?
00:07:10 Sen Bernie Sanders
Well, I think I know Kennedy, somewhat over the years. I do not know his other picks. I’m going to have to sit down and talk with them.
The other thing I think that’s important is Trump over the years, and Kennedy himself has talked about as a health problem, the fact that we pay by far the highest prices in the world for prescription drugs.
And if I’m not mistaken, Kennedy has talked about the need for Americans not to pay more than the people in other countries. I think that’s exactly right.
And I hope Trump keeps his word in terms of going forward in something that he has talked about for years, substantially lowering costs of prescription drugs in this country.
00:07:46 Natalie Brand
Are you hopeful or prepared to work with the Trump administration on those issues?
00:07:49 Sen Bernie Sanders
We work with people who have good ideas. We will vigorously oppose them when they’re wrong.
And there are a lot of things that come, that Trump has proposed that are dead wrong.
We do not need at time with massive income and wealth inequality, more tax breaks for billionaires, we do not need U.S. military to be dragging people out of their homes in a kind of deportation process that we have never seen, etc.
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00:13:15 Question
If you wouldn’t mind, I was curious what your thoughts are on what Senator Markey said–
00:13:19 Sen Bernie Sanders
No, I don’t want to get into Kennedy. I think I indicated that.
Question [00:02:17]
Do you have any big ticket items that you’re trying to accomplish in the month and a half left that you have the FDA?
Robert Califf [00:02:23]
Well, some of them were here, front of package and healthy. The nicotine standard is another big one that’s in play right now. You’ll hear more about that.
And, this sounds kind of, so what, but we have many, many guidances that the industry is dependent on that need to get through the system.
Not because any one of them is– but they’re just making it possible for industry to do its work in a way that’s safer and more effective.
So I wouldn’t pick one of those specifically, a good example would be the issue of hair straightner and formaldehyde. It’s a pretty basic thing.
So just needs to get done.
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Robert Califf [00:00:30]
It’s very difficult to give a specific amount of money because the work needs to be adjusted for the specific purpose that Congress wants us to do, but in the area of chemical safety, it would at least take a doubling of the budget to just really begin to address the numerous chemicals that derived food and make sure that they’re safe.
And when it comes to nutrition, we have a very meager budget for nutrition. Yet, as we discussed today, this is harming a lot of people, the food that they’re eating. So it would a large amount if we really want to address nutrition.
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Question [00:02:19]
Is it frustrating that only now food is such a big topic? I remember a year or two ago you were at hearings complaining nobody was asking you about nutrition. So is it frustrating that it’s only a big issue now?
Robert Califf [00:02:30]
Well, in my job, I don’t– I can’t allow myself to get frustrated, but this is the issue of nutrition and the diet of Americans has been a hot button issue for me for over two decades, because I’m a cardiologist. You see it.
So it’s great that now attention is coming to it. I’ll just take it as a good thing that we’re finally getting to where we need to be.
10:06:10 AM SANDERS: Time is long overdue for us to pose some very simple questions, and that is what this hearing is about today.
How did it happen that according to the CDC, the rate of childhood obesity in America has tripled since the 1970s. And it’s gotten so bad that one out of every five children in our country is now obese. How has it happened that over 40 percent of adults in the United States today are obese?
In my view, the answers to these questions are not very complicated.
For decades, Congress and the FDA have allowed large corporations to make huge profits by enticing children and adults to consume ultra processed foods and beverages loaded up with sugar, salt, and saturated fat.
There is growing evidence, including testimony that we have heard right here in this committee, that these foods are deliberately deisgned to be addictive, similar to cigarettes and alcohol and lead to a higher rate of type two diabetes.
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10:18:31 AM CALIFF: While all the work FDA does is crucial, the greatest public health advancements we can make would be to improve the diet of Americans and eliminate the use of tobacco.
The food we eat is contributing to America’s unfortunate position with the lowest life expectancy among large high income countries. I want to stress, this, last place among large high income countries in life expectancy.
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10:21:24 AM CALIFF: There is good reason to be concerned about the chemicals that are routinely included in much of our food.
FDA has limited resources to deal with this issue, despite repeated requests for funding for much needed additional experts to do the evaluations.
There are years of work under each of these initiatives that are performed by highly qualified and dedicated staff in the face of multiple limitations in the existing science, extensive legal hurdles, and direct opposition from powerful industry forces.
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10:22:22 AM CALIFF: As you know, I’ll be leaving FDA at the change of administrations.
But I can assure you that our people at FDA want to do more. And we need your partnership.
As a cardiologist, I’ve spent most of my career dealing with the tragedy of premature death and disability. But my time in Washington has made me aware of how hard it is to address these policy issues.
Our nation’s complex financial and industrial interests combined with our national instinct to favor individual freedom to choose, even if the choice is one that impairs health, make it difficult to take actions that have been successfully deployed by many other countries.
And I believe these differences directly lead to better health and longer life in every other large high-income country compared with ours.
In my opinion, finding a better consensus on these issues in America, it’s not just an opportunity, but a necessity for the future of our country.
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10:25:45 CALIFF: You asked, how long does it take? Let’s talk about tobacco.
We were instructed to do that many years ago. We have lost in court on that issue. And we’re finally winning now, it looks like.
But the point I want to make is, what sounds simple, given the current state of judicial affairs, First Amendment rights, the fact that corporations have the same rights as individuals, every little thing we do, unless specifically in detail instructed by Congress, it’s not just that we lose in court, but we lose years when that happens.
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10:26:40 SANDERS: We have got to act. And have you pointed a finger at those people who are the cause of the problem? Have you had the courage to take on a very powerful food and beverage industry?
There are 15 teaspoons of sugar in this product. How many parents in America know this when they give it to their kids? Say, here, have a Coke. Go out and play ball.
Have you done your job and your predecessors, not just you, have you done your job in alerting the American people to the danger and rallying members of Congress to stand up to the special interests who are causing these problems?
CALIFF: With all due respect, I’ve been working on this problem for all of my career. This is what I’ve done. And I think I have talked about this very specifically.
I think we all wish that we had gotten to the goal sooner, that you described. I’m not contesting that.
But I do believe, in an appropriate discourse with this committee, we need to carefully reflect on the issues in play right now that would allow this to happen, and I’m really heartened to hear the bipartisan support for htis, because much of what we try to do, frankly, gets blocked along the way.
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CALIFF: Well, I’m not going to contest your comment about the amount of money spent on lobbying. I think it’s probably accurate. I don’t have figures on that.
But a lot of the changes, those of us who are interested in better health would like to make are blocked at the level of legislation, for reasons that you have to tell me.
SANDERS: But I’m still not hearing you. What is the reason that our kids are unhealthy? What role does this industry play? Even now, you’re getting out of office.
Are you prepared to tell us that this committee, this Congress needs to take on the food and beverage industry whose greed is destroying the health of millions of people?
CALIFF: Well, I’m not going to castigate the people that work in the food and beverage industry. They’re not–
SANDERS: That is your job.
CALIFF: No, it’s not. It’s not to castigate. It’s to point out how to make progress in this area.
We have an industry that if you tried to change it overnight, there are farmers all over the United States who would not be able to grow the crops they’re currently growing.
So there needs to be a plan and it needs to be implemented in a mature, thoughtful way across the country.
I’m 100 percent in favor of the change.
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10:30:58 JONES: So, Red 3, we have a petition in front of us to revoke the authorization for it, and we are hopeful that within the next few weeks, we will actually– we will be acting on that petition and a decision should be forthcoming.
TUBERVILLE: Tell us that process. How does that work? The timeline, you know, if we know something’s deadly for anybody that ingests it. How do we continue just study that, and not just say, hey, enough is enough.
JONES: So Red 3 presents an interesting example for us.
It is actually known to be cancererous in laboratory animals, rats. But the scientific consensus is that the mechanism of carcinogenicity in rats is not applicable in humans.
However, under the FFDCA, which is the law that we implement, any chemical that is shown to be carcinogenic in animals or humans, or should I say humans or animals, cannot be authorized by FDA. It’s called the Delaney Clause.
And so even though we don’t believe there is a risk to humans, under the Delaney Clause of the FFDCA, red dye because it is known to cause cancer in laboratory animals, should not be authorized.
And so that is what has been challenged FDA for many years is how to manage around the Delaney Clause where you have a scenario where, although there may be cancer evidence in animals, there is also evidence that is not harmful to humans.
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10:33:23 CALIFF: We have a very small staff that can do this based on the budget. We have repeatedly asked for better funding for chemical safety.
I brought Mr. Jones in to head the human foods program because of his history of working on environmental issues, I think it is a huge priority. He’s an expert in this.
Please look at our request for funding for the people who do this work.
Remember that when we do ban something, it will go to court. And if we don’t have the scientific evidence, it will stand up in court, we will lose in court.
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10:34:19 JONES: The biggest distinction between the U.S. and Europe is that they have been doing post-market review of chemicals now for over 20 years.
In the FDA, although we have authorization to do post-market reviews, there’s no statutory mandate to do them.
One of the things that Dr. Califf mentioned is that as part of this reorganization, we are dedicating an entire office whose job is to do post-market chemical reviews.
But we are several decades behind Europeans and our Canadian counterparts because they have legal mandates to reevaluate chemicals that have been authorized at some point in the past.
We don’t, but we are going to undertake it. But we are going to definitely struggle with the resources necessary to do that.
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10:35:08 CALIFF: There’s a real lesson here from, I don’t know if you eat Froot Loops. I grew up every once in a while eating Froot Loops.
But there’s a real lesson here, and I haven’t verified this myself, but it’s widely written that when the dyes that make Froot Loops bright were taken out for the reasons that you give, the sales went straight down and they were put back in.
So as long as we have a consumer-driven system, where what people like in the short term is what drives the system, unless we have help from you all, that is clear direction from Congress, particularly given the recent Supreme Court decisions, it’s going to be really hard for us to mandate things come off.
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10:42:38 CALIFF: Let me tell you, I’m hyper aware of this.
With permission, I have a brother who has pancreatic cancer who was just in the hospital. I was there and he got one of the two bags of IV fluid he was supposed to get because of the shortage.
So I’m very aware of it.
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10:56:54 CALIFF: One noticeable thing to me, and I readily admitted when I took the job, I was not an expert in food. I’ve learned a lot in my two stints at FDA.
But one really big difference is, when the medical products industry does research by law, if it’s done on human beings, it is made public. And we have access to it. And we look at the raw data and analyze it ourselves at the FDA.
The food industry does massive amounts of research that we have no access to. And we don’t know what they’re doing. We don’t know what’s guiding their decisions.
It would be a lot better if the research that was done on human beings by the food industry was made public.
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11:15:27 CALIFF: This is a systemic problem that does need to be addressed. And it would actually be great.
I’m on record, I’ve been quoted on this. I’ve had this nightmare that I was head of this agency that my great-grandkids read about called the FDA, where a society let people gain essentially a pound of weight every year, and then to fix it, they invented a drug at $20,000 a year to try to deal with it.
And that would be a very bad legacy to leave behind. So I hope this will be fixed.
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11:38:15 MARKEY: We have a potential nominee for Secretary of Health and Human Services who has talked a lot about nutrition and chronic disease. Some would say what he says on diet and importance of healthy foods is reasonable.
However, one reasonable opinion does not qualify someone to run the United States Department of Health and Human Services.
What should be disqualifying to run the Department of Health and Human Services, that oversees every aspect of our healthcare system and whose actions will impact healthcare costs, access and innovation, is a nominee who has been proposed by President Trump who has spread misinformation about vaccines and fluoridation of our water, questions the well-proven conclusions that HIV causes AIDS, and falsely claim that medication for depression is linked to mass shootings.
What should be disqualifying to run the Department of Health and Human Services is a history of spreading misinformation about public health measures like vaccines that result in a measles outbreak. For example, in the deaths of 83 people, many of whom were children and babies.
If we are serious about addressing chronic disease. If we are serious about closing gaps in healthcare access and moving towards a healthier America, the Senate should only confirm nominees to serve in the Department of Health and Human Services who are prepared, qualified, and serious about the responsibility of their roles.
In my view, Robert F. Kennedy Jr. has disqualified himself to serve as Secretary of Health and Human Services.
Pertussis can be cyclical. After seeing lower numbers of reported cases in the past few years – during and after the COVID-19 pandemic – nationally, pertussis is now returning to pre-pandemic trends.
Ohio is no different. So far this year, Ohio has seen over 1,200 cases. This is higher than we saw last year and is consistent with some years prior to the COVID-19 pandemic.
Between 2010 and 2014, for example, Ohio reported an average of 1,285 cases annually, including over 1,600 cases in 2013.
State data on pertussis and more than 100 other infectious diseases can be found on our dashboard, Summary of Infectious Diseases in Ohio.
You can sort the timeframe, specific disease, county and demographic profile. To find pertussis, under “Reportable Condition” unclick “all,” select pertussis from the dropdown menu, then click “Apply.”
We would recommend going back and selecting a longer timeframe, perhaps even back to 2001, the earliest data we have available, to see the longer-term trends for pertussis cases. Click on “epi curve” after you have selected a timeframe to see this.
The Ohio Department of Health (ODH) has been working with local health departments by providing guidance and support on responding to individual cases and outbreaks of pertussis.
ODH encourages individuals to stay up to date on vaccines to help prevent pertussis, which can be especially dangerous to infants. Additionally, everyone should stay home when they are sick, cover any coughs or sneezes, and wash their hands frequently.
For more information on pertussis, visit https://odh.ohio.gov/know-our-programs/vaccine-preventable-diseases/resources/pertussis
Can you clarify if any of the cows at Raw Farm have been identified to be symptomatic or tested positive for H5N1?
Is it known if the milk that tested positive for H5N1 from Raw Farm by CDFA’s testing was infectious?
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Alex, we have not seen symptomatic cows at Raw Farm.
Could you clarify your second question?
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Thank you for getting back to me.
On the second, wondering if there’s a way to describe the amount of virus that was found in the milk.
I saw that Raw Farm said it was only a very small trace amount, too little to be infectious.
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There is lab testing pending to learn more about that.
Just checking in again to see if any update on whether additional cases have been identified, and if the exposure to wild birds is still being investigated.
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Thank you for your email. Our investigation is complete, and no other cases were identified. The source of the exposure remains unknown.
Pet food products are not affected in any way because they were produced far before this event occurred.
Regulators test our milk, and all was clear when these products were produced.
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Thanks for getting back to me.
Does that mean there are pet food lots that did test positive but have not been distributed yet?
Sent from my phone (202) 381-7107
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No…
We don’t make batches of pet food regularly. We make them based on orders and demand.
We stopped producing batches long before this event occurred. None are in distribution.
Dr. David Weldon is not currently employed by VA. He previously practiced at a VA facility in Florida in a “Without Compensation” capacity, meaning he provided services without compensation. Due to the transition from paper to digital systems for maintaining employee records, VA is unable to provide specific dates and details of his prior employment. This change is part of VA’s ongoing efforts to modernize its HR processes and systems.
QUESTION 1: Will CDPH test either of the positive samples to see if they are infectious? Or is it known if either are infectious?
California has secured a broad, voluntary recall of all Raw Farm, LLC raw milk and cream products due to possible bird flu contamination. While no human bird flu cases associated with the product have been detected at this time, health experts have long warned consumers against consuming raw milk or raw milk products due to elevated risks of foodborne illness, including Salmonella, Listeria monocytogenes, toxin producing E. coli, Brucella, Campylobacter, and others. Raw milk products are not pasteurized, a heating process that kills bacteria and viruses such as bird flu.
No human bird flu cases associated with the product have been confirmed to date, and the state is working closely with federal and local partners to investigate the situation and better understand how it might impact consumers. Bird flu virus levels have been demonstrated to be high in raw milk from infected cows, and sporadic human cases identified in workers in close contact with infected dairy cows and their milk indicate that raw milk is infectious to humans.
QUESTION 2: Is it known if any of Raw Farm’s products were sold outside of California?
Federal law does not allow interstate sales of raw milk for human consumption, so the recalled product was only sold within California.
It is possible that raw milk intended for pet consumption was sold to customers outside California. Interstate sales of raw milk for pets is legal, as long as vendors abide by the FDA pet food labeling requirements (21CFR Part 501), Raw milk for pets should be handled with the same caution as raw milk for human consumption.
QUESTION 3: Have any symptomatic cattle been identified so far at Raw Farm’s premises
RESPONSE: As previously noted, please contact the California Department of Food and Agriculture for this question.
The FDA and RAW FARM, LLC (f/k/a Organic Pastures Dairy Co., LLC) are involved in an ongoing enforcement action in the U.S. District Court for the Eastern District of California, United States of America v. Organic Pastures Dairy Co., et al., 1:08-cv-1786 (E.D. Cal.). Per agency policy the FDA does not comment on possible, pending or ongoing litigation.