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A doctor cracked open an airplane emergency kit and found a sticker saying there was no epinephrine inside. Lianne Mandelbaum, president of No Nut Traveler and airline correspondent for Allergic Living, has spent a decade collecting accounts like it. This episode is based on her article “Epinephrine on airplanes should not depend on the airline,” published on KevinMD. You will hear what a proposed federal rule would change, replacing the required medication list with a flexible one and stripping the exemption paperwork that was the only record of which airlines carried nothing. She explains why antihistamines do not belong under an anaphylaxis heading, why one auto-injector is not enough when two passengers react to the same meal, and why nobody knows how often it happens. You will also hear how a food label can look complete, satisfy federal rules, and still omit the allergen. Press play to hear what she is asking people to send the agency before the comment window closes, and the eight cents per at-risk passenger she says the fix would cost.

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today we welcome back Lianne Mandelbaum, food allergy advocate and president of The No Nut Traveler. Today’s KevinMD article is “Epinephrine on airplanes should not depend on the airline.” Lianne, welcome back to the show.

Lianne Mandelbaum: Thank you for having me. Always a pleasure.

Kevin Pho: So you come with some news and some recent events, right? So tell us what your latest article is about, for those who aren’t following this new FAA proposal.

Lianne Mandelbaum: Well, basically, just to take it back a second, we had a lot of hope about this NPRM ruling that was listed, because a little bit over two years ago Congress directed FAA to revamp the emergency medical kits on planes, and that it needed to be sufficient for a whole bunch of conditions, and one of them was anaphylaxis.

So many in the food allergy world were hopeful that this would translate to a specific requirement for easy-to-use auto-injectors, nasal sprays, or whatever comes down the pipe that’s FDA-approved to be on there. And because right now, first of all, the EMK contents haven’t been formally updated since 2004, and nobody heard me wrong. Which is kind of absurd, because if you think about the medical conditions that are prevalent now compared to 2004, we have a very different population. And we have different disease prevalence rates, and so the medical kit should reflect the period of time that we’re living in.

So we were very, very hopeful, and our hopes are sort of dashed at this point, but there’s still hope, so that’s what the article’s about. So basically there was a prescriptive list, and they’ve slashed that completely and they’ve replaced it with what they are calling modern and flexible. And I go through in the article why that’s not necessarily a good thing as it’s written, but yet it could be, because comments are open to the public until October 5th.

And so there is still a chance to make this document what I think it should have been in the first place. And so I can go through all the concerns I have and why everyone in your audience, physician, medical professional, and layperson alike, should be alarmed about this.

Kevin Pho: So can you do that?

Lianne Mandelbaum: Absolutely.

Kevin Pho: And just contrast that with what the current state is, because not everyone, of course, follows and listens to our podcast and follows what you do on social media. So what’s the current state and what are some of the proposed changes?

Lianne Mandelbaum: So the current state is, for allergies specifically, because obviously that’s what I’m honed in on. There is a requirement to have vials of epinephrine in the cardiac form and in the allergic concentration. And those are required. It is a prescripted list, just like the FAA says.

Except for the fact that I have been documenting over the past decade physicians answering the call to help. And I think of Dr. Anna Nowak-Wegrzyn, head of NYU Allergy. And she actually cracked open a kit and found a sticker that said, “No epi in kit.” I think of Donald Stark, who told my editor at Allergic Living, Gwen Smith, that he cut his finger on a vial when he was trying to open it to treat a child during turbulence.

I think of people who have come up to me at medical conferences and told me they found the vial but no syringe. I think about the 11-year-old who had a first-time reaction, not to a food, but to a drug in the air, and that they had some sort of esoteric cardiac device that had to be re-titrated, and then the gauge didn’t fit her wrist, and she was bleeding, and her pulmonary function was, like, going down until they got the epinephrine in her. And it was touch and go for that situation.

So the current situation is the reason we were lobbying, right? Because the right medications weren’t necessarily there. And there is an exemption process, and I got into that in my article as well, where if you’re not carrying one of the required medications, you have to submit a form. The thing is, every time a doctor reported to me that there was no epinephrine, I went to the FDA and there was no shortage. So these exemptions weren’t being used correctly. But this new plan gets rid of them completely, so there’s no paper trail at all. So that’s not good either.

So the problem is we need a recommendation, and what FAA is saying is that by making it flexible and letting airlines choose what they can stock their kits with, that’s what’s hampering the airlines from carrying, for example, the auto-injectors, that it’s the fact that there’s a prescribed list. Except that’s false on its face, because we know that Southwest and JetBlue, for example, do voluntarily carry them. The list is not what has stopped people from stocking them. The fact that FAA doesn’t require it is what’s stopping them.

And so they need to take a hard look at that, because you should not, as my title suggests, be able to fly one airline in the United States and suffer a food-induced anaphylactic reaction, and another one, and actually have a better outcome on one versus the other because one is carrying enough of what you need in the right form, in the right concentration, in the right amount of doses.

Kevin Pho: So what I’m hearing from you is that the FAA is leaving it to the airlines as to whether or not they carry epinephrine. Is that correct?

Lianne Mandelbaum: Not exactly. So there’s a circular that comes with it, and it’s not a binding list. That’s the problem. And in that list, it suggests that they don’t stock the vial and that they carry the nasal spray or the auto-injector. But when I wrote to them to ask if it was binding, they couldn’t answer the question. And that should send alarm bells. Like, we should not just take it on its face that this is what is going to happen if they can’t confirm it, which they won’t.

And the other problem is, in this list, it’s under a category of anaphylaxis, and they list antihistamines, which should never be a treatment for anaphylaxis. So if they don’t explicitly explain to an airline that, “No, this can’t be used as a treatment,” an airline could stock an antihistamine and potentially be in compliance with this new law. So we don’t want that.

We want antihistamines stricken insofar as a first-line treatment for anaphylaxis, and we want auto-injectors or nasal sprays or whatever comes mandated, yes, mandated, to be there on planes, just like the defibrillator, just like they are now putting even opioid reversal drugs even in the first aid kit, because they know it’s a time-sensitive medication, and the flight attendants can use them. Well, guess what? The same system of delivery is in the auto-injector and the nasal spray. So why aren’t those being trained for in flight crew and available easily, and why aren’t they required?

So there’s so much to unpack, but the long and the short is we need requirements, we need specific doses, and we need amounts. And that’s what’s missing, and we need people to write in their comments.

And if someone is listening and thinking, “Well, this doesn’t really affect me,” you could be the physician, if you’re a physician or medical professional listening, that is called up to help someone with a kit that does not have the right medications. If you’re just someone who listens for Kevin’s great content, you could be a person who’s bitten by a tick and develops alpha-gal and has a steak dinner. And I’m saying this not as a made up. This actually happened to someone, that they ate a steak dinner hours before their flight and went into anaphylaxis, had no known food allergies, but had been bitten by a tick. And ended up having alpha-gal. And on that plane was only the cardiac concentration of epinephrine. And I interviewed that physician, and he told me it was like fighting a fire without water.

So you could be one of those people that is going to get bitten by a tick. And the CDC has, I think, the new prevalence of 450,000. And ER visits this summer, like, skyrocketed from tick bites. It’s not so far-fetched. You also could be one of the unlucky adults to develop an adult-onset food allergy, which we still don’t have an explanation. And it could be your child or your friend or your spouse or your loved one’s first time reaction, and it happens in the air. All of those scenarios apply to anyone who flies. So everybody should be concerned.

And here’s the other thing that I think we have talked about this on this podcast before, but like you said, I don’t know who’s read and what information you have, but it bears repeating nonetheless, because it needs to be hammered in, is we have incomplete labeling laws up in the air. So Dr. Nowak-Wegrzyn sent me a patient who went into anaphylaxis from pasta and red sauce, and it actually had a label. The label appeared to be complete, and it said, “May contain eggs, milk, and wheat.” And it ended up carrying tree nuts, her allergen. So I went to the FDA, assuming this would absolutely be illegal. And they told me they like transparency, but they don’t require it, and that it’s a perfectly legal label.

So there are people out there, and I would venture to say most, that don’t know that this is the case, and they see a label, have a false assurance, take the food, and then the right medication is not on the plane. And so when I wrote in 23 pages to the FDA, for my FAA, sorry, for my comment, I referenced that this is a foreseeable and predictable emergency based on the fact that we have these catering loopholes that allow what looks like a labeled meal to be assured as safe. And we just recently found out about a death in the air.

And you could say to me, and many people do, “But the statistics. We’ve seen these headlines that say you’re more likely to have a reaction on the ground than on the air. These reactions aren’t taking place.” Well, first of all, where does the data from those reactions come from? It comes from medical kit providers, and it comes from the airlines. Yet the FAA has told me over three times in writing that they don’t collect any of this data. They don’t require it. The airlines are not required to file any sort of report. And the air emergency medical kit providers are collecting data from when their kits are used.

But I was part of a study out of CFAAR at Northwestern, and we showed that actually it was 8.5 percent of 4,704 people that had reactions, and over 90 percent of them used their own auto-injector. So that’s not being counted in the kit data. So just because there’s an absence of data doesn’t mean there isn’t a problem.

And when we look at the recent death that just happened, we just found out about it a month or two ago. It was a 16-year-old from Pennsylvania, very, very sad, that was given a sandwich that he was assured was safe. Now, I am positive that that flight attendant did not want that child to die. So either that flight attendant was assured by a label or by somebody else that this meal was safe. I don’t believe, given the list of allergies that she was given, that she would’ve given him a sandwich knowing it was unsafe. So that’s what can happen when you have a system that allows these kind of labels.

Then the medical equipment apparently, allegedly, on this plane was not working, so the oxygen mask malfunctioned, and whatever epinephrine they had on there, the lawyer I spoke to said he believes it was epinephrine, didn’t work. Now, did it not work because it was in vial form? Did it not work because it was in the wrong concentration? Did it not work because it was a failed device? Those things will come out.

But the key is, this happened over two years ago, and we’re only finding out about it now, so we’re not capturing the data. How many other deaths have there been that we don’t know about because there hasn’t been a lawsuit, because there’s been a settlement, because there’s been arbitration? How many diversions do we not know about because the FAA doesn’t track them, so how could we possibly know about them?

So yes, physicians should be concerned. Laypeople should be concerned. Everyone should be concerned. This is a system deeply in need of reform on many levels, but at the bare minimum, we should have the right medications to hand to the good people that volunteer to help save someone in the air where resources are limited.

Kevin Pho: Now, if this proposal passes, who’s going to make that ultimate call whether to include nasal or auto-injector epinephrine on planes?

Lianne Mandelbaum: FAA. If it passes as it is now, the call will be pretty much for the airlines. And we won’t even know how to track it because the exemption process has been stripped. So the only monitoring system, flawed as it was and is, is going to be taken away. So I don’t know who’s going to be monitoring. And I don’t know how, if we’re ever going to be able to know what airline carries what.

And at least the exemptions were actually pretty secretive, and it was myself and a staffer from Senator Duckworth’s office that picked them up. And how did we pick them up? So Frontier Airlines didn’t file their exemption papers by accident. And someone went into anaphylaxis on one of their planes, and they were fined. And that fine showed up on the docket. And that’s how we found the exemption. If there was no exemption process, we never would have found that they weren’t carrying. So how are we going to know now when an airline is not carrying?

And it shouldn’t be for the patient to have a different outcome. It also shouldn’t be that if you’re a physician on one airline versus another airline that you’re given a kit that has the right medication. And we also know that from a practice parameter that was released in 2023 that 8 percent of reactions are biphasic. So they need a second dose. So it also does matter having the right amount of the medication on the plane.

And I just took a testimonial on No Nut Traveler that I included in this piece where two people went into anaphylaxis from a meal on Alaska Airlines. And the label was complete in this case, so they say. And both people asked before they took the meal. But apparently there was a last-minute label change. And so the five-year-old and the adult woman went into anaphylaxis because cashew oil was substituted into the salad.

Now, if you only have one auto-injector or nasal spray, and that’s how it’s written right now. It’s not written with a quantity. It just says on that circular auto-injector or nasal spray. So no quantity specified whatsoever. No pediatric versus adult versus infant. Nothing’s there. Who do you give it to if you’ve got two patients on the plane? Like, that shouldn’t be a decision.

And then I didn’t even mention this. So I told you at the beginning of this that there’s a prescriptive list with the vial, the one-milligram vial for allergic emergencies. They’ve taken that off because, and I think it’s well-intentioned. I think they want to encourage the airlines to carry the newer, more modern versions that are easy to use. But what if you need backup? Like, that’s the only backup. Now the cardiac vial is still listed, so now we’re going back to, like, the physicians having to titrate and only having cardiac. And then if you need it for a cardiac emergency, you don’t have that.

So we need the right medications. We need people to write in, and we need them to specify why this is important to everyone, I believe.

Kevin Pho: So can you speculate as to why the FAA is going down this path? Why are they doing what they’re doing?

Lianne Mandelbaum: All throughout the document they talk about reducing costs to the FAA, reducing paperwork, reducing costs to the operator. I think they feel with a flexible system there’s less paperwork, you can substitute medicines for other medicines, which you couldn’t necessarily do before without filing a report. And that might work for other conditions, but it doesn’t work for anaphylaxis where there’s only one medication.

And so that’s why I really feel in my comment, I really think it should be on parity with the opioid overdose medication. It should be in the first aid kit. It should be part of crew training. We know they’re serving meals. I’m not telling them not to serve meals. We know you are going to continue to serve meals on planes. We know that the labeling system is flawed. And again, so you can foresee medical situations like this happening, and so you must stock the right concentrations.

Kevin Pho: We’re talking to Lianne Mandelbaum, food allergy advocate and president of The No Nut Traveler. Today’s KevinMD article is “Epinephrine on airplanes should not depend on the airline.” Lianne, as always, we’ll end with your take-home messages to the KevinMD audience.

Lianne Mandelbaum: Remember that a passenger can suffer anaphylaxis for the first time and may not be carrying their own medication. Remember that tick bites are on the way up, and first time reactions are on the way up in both adults and children. So think about those patient populations.

You as a medical professional I’m talking to now may step on the plane and encounter someone that doesn’t have backup medication of their own. So this could concern you. If you’re a person and listening, this could concern you because food allergies could affect many people around you and in your world. And we should have the right medicine for you and your loved ones if you find yourself in these kind of untenable situations on a plane.

I think, again, we need to broaden out and see that when we look out for one another, we look out for everyone. You never know who it’s going to be. You don’t know if you’re going to be the medical professional called out. You don’t know if it’s going to be your child or spouse or a loved one that does react to a meal or, as I’ve talked about before, to a drug or a delayed reaction.

There are so many reasons for the right medicines to be on planes. And Shaker and Greenhawt did a study in 2019, and they found it was, I think, eight cents per at-risk passenger to put the right medicines on board. So there’s literally no excuse for how this is written, unless you think about maybe someone misunderstanding anaphylaxis and just not seeing it. And why? Why, and we talk about this over and over again, you and I, why are we not seen with the same severity as other diseases?

We may not have the best data, but we do have data that these reactions are taking place in the air. I don’t know of a lot of data or any data about opioid reactions, yet that is being put in. And I think they should be there, don’t get me wrong. But in the same vein, we need to advocate for the right medications for an allergic reaction, because food is served on every plane.

Another thing, comments are open until October 5th. And if you read my KevinMD article, there’s a link at the end that gives you access to the portal. It matters. Complacency, not good. Silence is complacency, and once something happens to someone you love and this rule is done, there’s not much we can do about it. This is an aperture that’s open for a short while, and I would urge you to write in, and I give you some guidelines in the article, so please go read it.

Kevin Pho: Lianne, thank you again for sharing your perspective and insight. Thanks for coming back on the show.

Lianne Mandelbaum: Thank you, Kevin.