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We hold our suppliers to the highest expectations and standards of food safety. Prior to this inspection, and unrelated to its findings, McDonald’s stopped sourcing from Taylor Farms’ Colorado Springs facility.
You can read more about the swift action the company took during last year’s outbreak on our newsroom: https://corporate.mcdonalds.com/corpmcd/our-stories/article/always-putting-food-safety-first.html
Taylor Farms is confident in our best-in-class food safety processes, and in turn, the quality and safety of our products. As is common following an inspection, FDA issued observations of conditions that could be improved at one of our facilities. We immediately took steps to address the three observations made in the report and responded with our corrective actions.
The FDA has since classified this inspection as “voluntary action indicated,” meaning the agency “is not prepared to take or recommend any administrative or regulatory action.” This is consistent with the fact that no illnesses or public health threat has been linked to these observations.
We know that maintaining trust with our customers and consumers is essential and we are committed to preserving that trust. Our vision of creating healthy lives continues to be important, and we remain deeply committed to delivering the safest, healthiest fresh foods possible to our customers.
There has not been any additional cases linked to the Northwest Naturals recall. This is an evolving situation that the FDA will continue to keep the public and companies updated on. The FDA continues to recommend avoiding feeding pets any products from affected farms, if those products have not been thoroughly cooked or pasteurized to inactivate the virus. Animals should also be kept from hunting and eating wild birds.
I wanted to check in to ask if the department has heard of any additional animal cases or deaths were identified linked to the Northwest Naturals product that was recalled? Also, do you know if the genotype was B3.13 or D1.1 in the pet food?
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The FDA has taken over as lead agency on the Northwest Natural recall. For updates, please contact the FDA.
The genome found in the Northwest Naturals product was B3.13.
Calley Means [00:28:21]
What do we do? I don’t think the plan is any bans to start. I don’t think we need to talk about banning food. Although I do think things like high fructose corn syrup, we might need to get there eventually, but I think phase one of MAHA is just getting to the truth and there’s two areas what I recommend.
The USDA nutrition guidelines are up for review early in Trump’s term. Right now, the USDA nutrition guidelines recommend added sugar for two year olds. And they say that ultra processed food is healthy. Literally you can’t even make this up.
So 19 out of the 20 advisors on the USDA nutrition guideline committee, which set standards for our kids are paid for by food or pharma companies.
So President Trump and Bobby have the opportunity to throw the corrupt recommendations of the Biden administration, which say ultra processed food could be healthy, throw those in the trash and issue simple guidelines.
And it’s, I think conservative, before we get in into any bans, Americans should have the truth. This scientists should give the truth.
One problem with the guidelines is they take into DEI parameters. They actually say, well, we care about affordability. We care about the Americans can only afford all to process food.
That’s not the scientists job. The nutrition guidelines should say what American children should be eating, which is avoiding all added sugar and eating whole food. That’s their job to say.
It’s policymakers job then to do what they will with that information. But the first step is we need truth from our scientists.
Question [00:16:05]
What are the top reforms, like if you were going to give me line items, okay, that could actually shift this and kind of restore a more reasonable set of incentive structures?
Calley Means [00:16:17]
Directing the NIH to no longer be a pharmaceutical R and D factory. Propelling research, directing them to study what glyphosate is doing, studying what atrazine is doing, other food chemicals that we allow that no other country allows.
Studying various pharmaceutical standards. Doing, reproducing FDA studies that are underlying the built trillions of dollars we spend on pharmaceutical products. So reproducing studies, getting to the root cause, getting the science right.
Throughout the orgs, but particularly the FDA, getting conflicts of interest out of the agencies. Just why is the FDA funded by pharma? 75% of drug approval budget is funded by pharma. Why don’t people have access to better diagnostic technologies?
Let’s let patients work with their doctors. Let’s have Medicare money go to food, if somebody’s obese, instead of straight to Ozempic. So loosening up, making flexible these Medicare, Medicaid standards to help patients make the best decisions with their doctors.
So what are the principles? Transparency, reducing conflicts, flexibility for patients, medical freedom, trusting patients. Those are the principles that are gonna be guiding a flurry of agency actions from Bobby Kennedy.
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Calley Means [00:24:17]
I’ve been an informal advisor. I’ve been helping however I can.
I mean, my good friends, Jay Bhattacharya, and Marty Makary, are going to be leading the NIH and FDA. Dr. Oz is, has become, a great ally and friend.
I mean, we’ve got great people in there. I’m trying to support them however I possibly can, you know, during this very quick transition period.
And I don’t have any announcements on specifically what I’m going to be doing.
Of the 7 cats confirmed with H5 Bird Flu in LA County, 5 of them have been linked to Raw Farm, LLC milk product and 1 has been linked to Monarch Raw Pet Food. The source of infection for the 7th cat is still under investigation.
Please note additional cats in households with these confirmed cases may have fallen ill or died, but testing was not possible for all cats.
There has been no clear demonstration of transmission of H5 bird flu virus from a sick cat to another cat or animal in these cases, nor have there been any known cases of transmission of H5 bird flu from cat to human in these cases. We strongly recommend that pet owners do not consume nor feed their pets raw milk, raw dairy, raw meat, raw poultry, or raw pet food.
Mandy Cohen, CDC [00:14:38]
I think CDC has been on this journey to learn a lot of lessons from the COVID pandemic.
Look, we know that there were ways in which CDC did not do what, all of what it needed to do. We’ve taken accountability for that, particularly in the lab space, in the communication space.
And, you know, I– we have very much, and I personally have done a lot of listening and learning. And I think the organization has as well.
And so what I’m hopeful for the team that is coming to HHS, coming to CDC, is to make sure that they know this to your point, the baseline, what is the status of things at CDC right now?
And of course there needs more improvement. We should always be an improving learning organization, but where are we?
And I just wrote an op-ed in the Financial Times where the headline was, right, CDC needs a scalpel, not an axe.
And so what, because I want folks to know the improvements we’ve made.
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Mandy Cohen, CDC [00:21:37]
I’m proud of the work. We’re not done. We have more to do, but I think we’ve learned a lot.
And I want to make sure, again, the incoming team knows that the team that they remember in the CDC, that they interacted with in 2020, is not the same organization that we are now.
And there’s always more to do.
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Mandy Cohen, CDC [00:30:00]
So as we think about what are the right structures to bring people and keep and retain your workforce, I want to make sure we’re thinking about it again, not with broad brushes, but to be specific.
So we are very lucky to have some incredible data scientists, that folks who are working on our data. They may reside in California, to do that work because they have done great things in their first parts of their career. And then they come to CDC to give back, to do public service, but they’re not willing to move their family. I want that talent.
I want that talent at CDC. We should want it to protect. So just, we need to think about, as we think about making sure we can retain the talented workforce that we need, not everything can be painted with one broad brush.
And I will say though, it’s hard to– you don’t do lab work from home. Our team’s been in, doing the work in person, for a very long time. And that hasn’t changed.
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Mandy Cohen, CDC [00:46:09]
We take our job very seriously at putting out solid information, but part of what we have to do is also move faster. And share information. But we need to do it in a way, like this is what I know today that may be different. Right? We’re trying,
I hope folks are seeing us communicate differently about avian flu. Like this is what we know today, which is there’s no human to human spread that we have vaccine candidates ready, that we are, you know, ready and prepared.
However, we’ve all learned that these viruses change. And so I want folks to also hear the statement that things could change in the future, and that’s not making public health wrong now. Right. That doesn’t mean we made some mistake now. It just means things change. And then you have to react to those changes and make different.
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Mandy Cohen, CDC [00:47:23]
I do want to push back a little on the premise that, on the trust premise, because actually we see people polled, quarter over quarter on trust in CDC. And I’m really proud that actually over the last 18 months, we’ve seen that trust in CDC go back up.
And I think it’s because we’re communicating differently. We’re focused on priorities that matter for people in their everyday lives.
And so I think we’re on that journey every day. We rebuild trust.
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Mandy Cohen, CDC [00:59:16]
We have been working on this issue for a long time, meaning that we have very different infrastructure around avian flu than we have almost on any other pandemic potential pathogen.
We, you know, we have waste water infrastructure. We have the ability to see into our emergency rooms. We have laboratory tests that are not just in public health, but are in the commercial labs already. We have Tamiflu and a treatment that maps to the pathogen. We have vaccine candidates, not just candidates. We also have 5 million doses, already in our stockpile that going up to 10 million.
But that all said, right, those are a lot of great things like we already, but we have to stay ahead of the virus. As we were saying, things can change. And it doesn’t mean we didn’t do all the right things right now to be prepared. It just means the virus can change. Which means then we have to make sure that our therapies and our vaccines still map to those changes in the virus.
So we do not– so the things that I look at and want to be evaluating, in terms of do we need to step up and do something? Is there human to human transmission? No. We haven’t seen that yet, but if we were to see that that is a change.
Are we seeing severity of disease? Now we’ve had this one case where it was, we know it was from a wild bird, from a bird flock. And an older gentleman did pass. That was our first death, but all of the other cases have been very mild, like not even hospitalized, right. Some pink eye.
So we look at severity of disease and we look at the genetics, are the genetics changing. And do we know if they map.
All of that work? That’s hard like to be able to do that assessment work over and over. We do it literally daily. Are– we’re looking at it over and over and over. So we cannot to your point have a ball drop because we need to continually assess.
And so if there was a change in any one of those things, then we would want to think about stepping up our work. And I– and then we need to make sure that the incoming team knows that there is that potential, right? That of the things that I worry about, what could create the next pandemic avian flu of course, is at the top of the list. It’s why we’ve been focused on it for 20 years. We’ve been watching it for a long time.
And now we have more of that circulating in our animal population than we have seen before, which means more exposure for humans, right. Just more opportunity.
And so, again, we’re a low probability event, but could have outsized impact. So you need to highly manage some of these big impact, even low probability events. Got to be ready. You gotta keep that funding there to do this important work.
Peter Marks, FDA [00:11:15]
One of the issues comes up about is how often should we change these vaccine strains? And there are really some practical considerations that limit our ability to change vaccine composition.
One of them is just manufacturing constraints. You can only change the process so many times, and because there’s a whole process involved, and that limits things.
And the other issue though, it’s true, is that we, it’s hard to get data to suggest when you should actually do so, because in many cases, as we’ve seen already with the XEC variant, an existing vaccine seems to cover them pretty well. So you don’t want to change until you have data that suggests that your current vaccine is not actually working well.
So this is some of the challenges that we deal with.
Right now we are anticipating that we will continue to update these vaccines and we’ll be choosing a strain next May, June for next year.
With the obvious caveat that if something were to materialize that were a very serious escape variant, we could potentially mobilize to pick a variant more rapidly in a similar way that we’ve done for influenza viruses in the past, where, in part, because of the rapidity of the mRNA process, it could potentially only take a few months before we could have a new vaccine, if we needed to deploy one on the order of about three months, if it were necessary.
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Demetre Daskalakis, CDC [00:27:32]
So this is a comparison using our national immunization survey of what we are seeing among older adults.
This is 75 plus in the United States this year in terms of vaccination coverage. The light blue line is last season. So 2023 and 24. And you can see that we plateaued somewhere around 40% for coverage all said and done in the season.
And so when you are looking at this slide, a couple things are notable.
One because of the earlier availability of vaccine, these individuals were able to start getting vaccinated in early September rather than late September. And we are seeing climbs that are higher than what we saw last year. So in fact, today we’re at about 49%, which is higher than the plateau for last year. So that is a really encouraging trend.
And that is especially encouraging, given the data that I showed you previously about the risk of death and hospitalization for individuals who are more advanced in years. And we’re going to define that, for the purpose of this presentation as over 75.
So there’s a lot of reasons that this may be going on.
Again, first it could be because of COVID vaccines were available several weeks earlier this season. That may mean that folks were able to sync this closer to their flu vaccine.
Second, our early data from September suggest that more older adults are receiving both of these together. So in fact, we do have some data that COVID and flu vaccines, co-administration at least in pharmacies also appears to be increased compared to last year.
And then additionally, we are seeing, in our national immunization survey from October that older adults have increased concern about COVID 19. So the findings that we have about severe outcomes, like those are passing over to them because of their concern. They have a greater intention to receive the vaccine.
And then lastly, because of the work that you do, healthcare providers are increasingly recommending the COVID 19 vaccine to this population. And so all really important and also really important to protect one population that may have a risk of some of the worst outcomes of COVID 19.
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Question [00:38:33]
Do you have any forecasting when it’s likely that the pediatric COVID 19 vaccines will get full FDA approval?
Peter Marks, FDA [00:38:40]
It’s always, this is all obviously commercial confidential information, but I would suspect that we’re looking at something that’s on the matter of months away, not years away.
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Question [00:44:09]
Peter, can you comment on the LP.8.1 variant? Do we know how it compares with XEC and whether we expect different protection?
Peter Marks, FDA [00:44:19]
So we’ll need to get that. That’s one where we’re going to need to get data.
And that’s part of what I was talking about. This challenge for us is to keep up with this.
We do keep up, which is that as we get these variants, we start to test them and get them into the testing process.
But again, we will keep– and we’ll keep chasing them.
So far we’ve been pretty lucky in finding that these have been generally covered by the current strains that we’re covering with with either JN.1 or KP.2, but we’ll keep testing.
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Question [00:52:32]
There have been some concerns about vaccine being available in the summer surge of disease. Do we foresee any further changes in kind of the timing of our recommendations, authorization of new seasonal vaccine for COVID vaccine going forward?
Peter Marks, FDA [00:52:51]
Yeah, so, I mean, this is something that we will, this is why we monitor the epidemiology pretty closely.
I think if we were to, as we come into the May June timeframe, if we were to start to see a surge, with a new variant that we did not think was well covered, we might try to move up as much as we could the availability of the next season’s vaccine.
So there’s a little bit of an art to this still because it’s not perfect seasonality as Dr. Daskalakis showed. So we’re just gonna have to watch this closely.
We may get lucky, and if there’s a summer surge, it’ll be with the same, something that’s covered well with the same vaccine. If not, we have this opportunity, particularly with the mRNA vaccine technology to really crank out vaccine pretty quickly, in order to try to address an emerging variant a little sooner.
Of the 7 cats confirmed with H5 Bird Flu in LA County, 5 of them have been linked to Raw Farm, LLC milk product and 1 has been linked to Monarch Raw Pet Food. The source of infection for the 7th cat is still under investigation.
Please note additional cats in households with these confirmed cases may have fallen ill or died, but testing was not possible for all cats.
There has been no clear demonstration of transmission of H5 bird flu virus from a sick cat to another cat or animal in these cases, nor have there been any known cases of transmission of H5 bird flu from cat to human in these cases. We strongly recommend that pet owners do not consume nor feed their pets raw milk, raw dairy, raw meat, raw poultry, or raw pet food.
1) I know several states have reported large increases in norovirus outbreaks compared to previous years. Is that the case in Idaho?
We have observed a considerable increase in the cases of norovirus reported during 2024 compared with previous years.
2) Has Idaho also seen an increase in GII.17 outbreaks, as has been reported elsewhere?
We don’t have enough laboratory characterization data to confirm whether the increase in cases is caused by the norovirus GII.17 strain.
2025-01-08_fda_foia-2023-1766_enc4_300.pdf
2025-01-08_fda_foia-2023-1766_enc3_300.pdf
We do indeed see that there is a genotype of norovirus (GII17) that seems to become dominant this season. It also has been observed in Europe. There is insufficient surveillance (in my view) to really make the case that this is causing an increase in the number of cases, as we have a lot of norovirus infections each winter and the surveillance is rather patchy.
What we are seeing has happened before for noroviruses. Noroviruses are very diverse. Based on the virus composition, they are grouped into genotypes. Over the past decade, genotype GII4 viruses have been observed most often as causes of outbreaks, for instance (although if you do more in depth studies, a greater diversity of viruses is seen). Recently, viruses of a different genotype, GII17, have started to take over. It is possible that that is associated with an increase in illness reports, but we would need studies to actually proof that that is the case.
The new dominant strain is norovirus GII.17[P17] – speaking out loud, you would say “G two seventeen, P seventeen.” The previous dominant strain was norovirus GII.4 Sydney[P16].
I checked with Dr. Roberts, who says the names of specific subtypes of norovirus are usually only helpful for epidemiologists and folks that do research on norovirus. For all intents and purposes, there is little/no difference between norovirus strains. They all cause the same symptoms, have the same incubation period and length of illness, etc. The primary reason we keep track of these strains is so we know what is circulating so that when a new strain pops up like this one, we can catch it. Historically, a new strain can be associated with more cases and outbreaks, but it’s not because new strains cause new symptoms or have new features. It can be because folks in the community will not have any immunity to a new strain, making it easier to spread and easier to make more people sick.
It does not change any recommendations about prevention or spread. It just means we have a robust outbreak season and therefore an opportunity to really emphasize the importance of handwashing, staying home while sick and until at least 48 hours after recovery, etc.
Here are the latest data (September 1, 2024 – December 31, 2024 uploaded to CaliciNet https://www.cdc.gov/norovirus/php/reporting/calicinet-data.html which is our national norovirus surveillance system based on lab-data including typing of the viruses, which during the last couple of months is dominated by GII.17. During previous norovirus seasons (since 2012/2013), GII.4 Sydney was the predominant norovirus strain associated with at least 50-60% of all norovirus outbreaks every year. It is too early to tell if this strain is associated with more severe norovirus disease but likely lower population immunity is the reason for the early surge of an otherwise seasonal increase of this virus. Hope this helps.
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Very helpful, thank you. If you’ll permit a follow up: do you know if there is any regional difference for GII.17[P17]’s dominance this season so far, or does it appear to be prevalent around the country?
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It’s everywhere including on cruise ship outbreaks
The FDA and state authorities routinely work together to surveil the animal food supply, including pet food. This includes conducting risk-based facility inspections and collecting animal food samples to help ensure safety. The FDA may also collect samples “for cause,” such as when a pet food is suspected of being associated with human or animal illness. State authorities also regularly collect samples from retail settings and share test results with the agency. HPAI is an emerging contaminant in animal food. Analytical capacity is limited and pathogens like H5N1 can be difficult to detect because they might not be evenly distributed throughout the product (increasing the possibility of a false negative result).
Part of a pet food manufacturer’s responsibility is to bring a safe, wholesome product to market that is not adulterated under the Federal Food, Drug, and Cosmetic Act. As we learn more about the transmission of H5N1 in animal food, there are several practices that the FDA is encouraging pet food manufacturers and others in the supply chain to use to prevent HPAI transmission through animal food. These practices could include seeking poultry from flocks that are documented as having remained healthy throughout processing, and taking processing steps, such as heat treatment, that are capable of inactivating viruses and other hazards.
All recent detections of H5N1 in cats had these things in common: the infected cats ate wild birds, unpasteurized milk, raw poultry, and/or raw poultry pet food. We know that cats are particularly sensitive to HPAI, and that very young, very old or immune-compromised animals are at greater risk of infection. The FDA continues to recommend that consumers avoid feeding pets any products that are recalled or from affected farms if those products have not been thoroughly cooked or pasteurized to inactivate the virus. If consumers are unsure of the origin of those products, it’s safest to follow the USDA guidelines for handling and thorough cooking before feeding. Animals should also be kept from hunting and eating wild birds.
Hi, Alexander: Below please find a graph showing the OHSU Health system daily census for patients with the flu, from 11/1/2018 to present. You can see that in Dec. 2022, we also had a very large spike in flu cases, but this year has been significantly higher than last year. Below the graph is a chart with real numbers from the different facilities that make up OHSU Health. You can see that in 2023, the system treated 251 cases of flu, and in 2024, it jumped to 1,101 cases.
In 2022, the combination of RSV, flu and COVID led to a public health emergency and crisis standards of care among hospitals in the region. We have not experienced that, and do not currently expect to, this year.
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One more piece of data that I just received to home in on just the OHSU hospital emergency department: The ED saw a big jump from 2023 in December alone.
Data from the NoroSTAT network are typically released monthly online; we expect to release the next update mid-month.
NoroSTAT figures represent the total number of suspected and confirmed norovirus outbreaks reported each week to CDC by the state health departments in Alabama, Colorado, Massachusetts, Michigan, Minnesota, Nebraska, New Mexico, North Carolina, Ohio, Oregon, South Carolina, Tennessee, Virginia, and Wisconsin through the National Outbreak Reporting System (NORS). CDC does not routinely publish the location of norovirus outbreaks and defers to state and local health departments for additional data and messaging on outbreaks within their jurisdictions.