Your Voice Matters: How to Comment on the FDA’s Food Allergen Thresholds Document

13–19 minutes

Understanding ED05: The Threshold That Could Shape FDA Policy

My goal with this explainer is simple: to give a clear breakdown of ED05 and the FDA’s food allergen threshold proposals in a way anyone can understand, because I needed this myself and couldn’t find it. Right now, there’s a lot happening in precautionary allergen labeling (PAL) policy, and historically, the people shaping it have been allergists, immunologists, and food corporations, not the people living with food allergies day to day, IgE-mediated or not. I’ve been in rooms where ED05 was discussed, and not a single person with lived food allergy experience thought ED05 would be helpful; in fact, many of us worried it could create confusion, false trust, and potentially lead to more allergic reactions instead of fewer.

This focus on ED05 and threshold-based labeling is part of an effort to create a standardized approach to precautionary allergen labeling (PAL). The goal, according to proponents, is to make PAL “required” and more consistent across products, so that labels can move beyond voluntary wording like “may contain” or “processed in a facility that also handles…” Instead of relying on voluntary disclosure, the idea is to set numeric thresholds to trigger advisory statements. While this may sound helpful in theory, it also shifts control away from the people living with allergic conditions every day and replaces transparent information with assumptions and calculated limits.

If you manage a food allergy every day, please read this, review the FDA agenda, and leave a comment before May 19, 2026 so our voices are heard. It is best to submit your comment sooner rather than later. We really need to be accounted for. Policy led by anyone other than people with food allergies is exactly what we do not want, yet our perspective is still too often missing from these conversations. If you do not manage a food allergy but want to make an impact, thank you! Please read this and submit your own feedback as well on behalf of the food allergy community.

The Science Behind Eliciting Doses

ED01 and ED05 are now commonly used in food allergen risk assessment and terms you will continue to see being used at a global scale. They refer to the “eliciting dose” predicted to trigger objective allergic reactions in a certain percentage of the allergic population:

ED01 = the dose predicted to cause reactions in 1% of allergic individuals (per product serving size)
ED05 = the dose predicted to cause reactions in 5% of allergic individuals (per product serving size)

These values come from averaged oral food challenge data and statistical modeling used internationally in allergen risk management discussions. It is based on a single oral food challenge in a clinical setting, one controlled exposure. It answers: “What single dose would 5% of allergic individuals react to when eating this one product?” ED05 has been discussed very seriously as a possible regulatory threshold concept, one that’s a significant concern to me as someone living with a food allergy.

My stance: I understand how ED05 came to be, it’s helpful data to have. However, letting it inform allergen labeling on foods doesn’t make any sense to me. ED-based threshold systems as a whole are per individual food serving, not cumulative across multiple foods or multiple exposures, and not even during one eating occasion. That’s simply not real world eating behavior.

ED-based risk assessments do not model:

Eating multiple products in one sitting
Eating the same product repeatedly in one day
Small exposures accumulating over hours
Variable serving sizes

Real-life example:
Imagine a breakfast meal where the ED05 for peanut is 2 mg:

~0.8 mg peanut in chocolate chips
~0.7 mg peanut in oats
~0.9 mg peanut in a freeze-dried berry snack

None of these individually exceeds 2 mg, so each product would carry “no advisory” under a 1-tier system. Meanwhile, the total intake is 2.4 mg of peanut, which is over the “threshold.” A threshold system that looks at each product separately misses the whole point.

Do you see why this is concerning? Threshold-based labeling is actually a step backward for transparency compared to the clear information some food companies already provide. The solution could be simple: require laws that prevent vague or misleading phrases, and prevent over-labeling to get out of labeling.

1-Tier vs 2-Tier: Breaking Down the FDA’s Framework Options

As I’ve said, in an ideal world, I do not support any ED-based threshold system. Still, anyone managing a food allergy should understand the terms “1-tier” and “2-tier.” It took me a long time to wrap my head around these concepts, so I want to break them down here. I am also opening the comments section of this article so others can share their perspectives on the tier and threshold framework.

1-Tier vs 2-Tier Explained

1-Tier System: The ED05 is used as a single decision point for labeling. If a product contains less than ED05, it gets no advisory label. If it contains more than ED05, it gets an advisory. Each product is judged individually, so a person could eat multiple items that are all below ED05 and still exceed the threshold without any warning.
2-Tier System: The ED05 is still used as one decision point, but there is also a second, more conservative level (usually based on ED01). This second tier considers cumulative exposure across multiple products or more sensitive individuals. Even if each item is below ED05 individually, the combined amount could trigger a precautionary advisory under the second tier.

Real-life example:
Imagine the same breakfast I shared earlier, with chocolate chips (0.8 mg peanut), oats (0.7 mg), and a berry snack (0.9 mg). Individually, each is below the 2 mg ED05.

1-Tier: Each product has no advisory label, but the total peanut consumed is 2.4 mg — over the threshold.
2-Tier: A second safety level could flag this combination as risky, helping prevent accidental overexposure.

Instead of a clear-cut “Safe / Not Safe” answer on a food product label, a threshold-based system gives a risk tier such as “Very Low / Low / Higher.”

For some people, like me, even the “Very Low” tier could mean a risk of anaphylaxis, a potentially life-threatening reaction. I don’t see how “Safe / Not Safe” would not be the preferred approach over this confusing, convoluted, and often inaccurate tier model. Let me explain why the “not accurate” part matters next.

“For some people, like me, even the “Very Low” tier could mean a risk of anaphylaxis, a potentially life-threatening reaction.”

How Thresholds Hide the Information People Need

When I first learned about ED05 and allergen thresholds at food allergy conferences in 2025, I was appalled, and my jaw actually dropped. I personally asked allergists and food company representatives how ED05 is actually determined, and the answer still haunts me: it is all math, not facility testing or swabbing of production lines. Meaning, again, that threshold-based labeling is actually a step backward for transparency in precautionary allergen labeling.

That’s a HARD NO from me, as many food companies I rely on today already provide transparency voluntarily, such as “manufactured in a facility that also processes milk, egg, or tree nuts.” This kind of labeling is clear, honest, and empowers consumers to make their own decisions. ED-based thresholds do not use that real-world data. They rely on ingredient information and estimated calculations, ignoring swabbing, dedicated lines, or cleaning practices that many companies already track and disclose in their website FAQs.

Imagine this: Under a 1-tier ED05 system, a product could contain oats contaminated with peanuts or tree nuts, yet if the estimated exposure is below ED05, nothing is disclosed. All the precautionary allergen information that some people rely on, such as line testing, dedicated facility information, and cleaning validation, is lost. This is why I oppose ED-based thresholds entirely. What we need instead is maximum transparency: mandatory disclosure of all top allergens in a facility, shared equipment, and validated cleaning practices.

For the purpose of an example, a product label could say:

Contains: Milk.

Facility handles: peanuts, tree nuts.

Shared equipment with: peanuts.

Cleaning validated: Yes.

And with the above, consumers could then make their own informed choice. This transparent model is already used successfully in restaurants through allergen menus, and in countries like Ireland and across the EU, where law prevents vague or misleading phrases. California’s new SB 68 moves in this transparent direction, requiring clear disclosure of allergens in each dish.

Thresholds, by stark contrast, hide information, rely on food companies’ assumptions, and ignore the realities of U.S. healthcare access, leaving both IgE- and non-IgE-allergic individuals at risk. People may worry about over-labeling increasing, but laws can be implemented to limit it. Rather than relying on thresholds, facility-level transparency gives control back to the people living with food allergies, empowering them to make informed choices every meal, every day.

“Rather than relying on thresholds, facility-level transparency gives control back to the people living with food allergies, empowering them to make informed choices every meal, every day.”

Why ED05 Can’t Capture Real-World Risk

On top of what ED05 doesn’t model, we also have to acknowledge the reality that allergy testing is not perfect science. Food allergies are still not fully understood, and we don’t even know the cause. So how is someone like me, an adult with a life-long peanut allergy, used to navigating my allergy, supposed to know what my eliciting dose is? The truth is, I can’t know what my risk-level is, and no one does.

No one leaves an allergist’s office with a specific number they can rely on with certainty. All I know is that my allergy is severe, the amount that can trigger a reaction is microscopic and invisible to the naked eye, and it has been enough to put me into anaphylaxis in the past. So why would I take any risk? I don’t, and I won’t.

I ask you: How would someone who has never had allergy testing know their risk? They wouldn’t, and they don’t. Whether or not someone sees an allergist regularly, no one truly knows their personal threshold, which can change any moment, as is the reality of allergies. That is why I am so baffled that this is being considered as a contender for policy on precautionary allergen labeling (PAL).

This doesn’t even account for the lack of healthcare access or the fact that there are not nearly enough allergists in the U.S. for the people who need them. Right now, many people with allergies are not getting tested because it is too expensive, and many are not carrying epinephrine because it is cost-prohibitive. That is the reality we face today. ED05 and ED-based thresholds don’t cut it and aren’t helpful.

“How would someone who has never had allergy testing know their risk? They wouldn’t, and they don’t. Whether or not someone sees an allergist regularly, no one truly knows their personal threshold, which can change any moment, as is the reality of allergies. That is why I am so baffled that this is being considered as a contender for policy on precautionary allergen labeling (PAL).”

ED05 and the Gap for Non-IgE Conditions

Furthermore, chronic inflammation isn’t measured by ED05 and not all allergic conditions fit the ED05 model. As ED05 is based on data from immediate, IgE-mediated allergic reactions measured during oral food challenges, that means it predicts the dose that would trigger objective symptoms (like hives, vomiting, wheezing, or anaphylaxis) in 5% of people with IgE-mediated food allergy only.

Celiac disease is not a food allergy but an autoimmune condition triggered by gluten. Because ED05 modeling is designed around preventing immediate IgE-mediated allergic reactions, it does not apply to celiac disease, which involves immune-driven intestinal damage rather than acute allergic symptoms.

Non-IgE–mediated conditions such as Eosinophilic esophagitis (EoE) operate differently. They are delayed, cell-mediated immune responses that are not dose-predictable in the same way, and symptoms may develop hours to days later with chronic inflammation rather than immediate reactions. Because ED05 modeling is built on acute reaction data, it does not account for inflammatory threshold responses, cumulative exposure effects, or tissue damage patterns seen in non-IgE conditions.

Alpha-gal allergy is another example where ED05 fails even in an IgE-mediated way: reactions are delayed by several hours, thresholds vary widely between individuals, and exposure cannot be precisely measured, so a numeric ED05 value cannot safely guide labeling. According to the CDC, “People with AGS might not react to every product containing alpha-gal, and some people can experience different symptoms or reactions each time they are exposed to alpha-gal, even when it is the same product.” The bottom line is that threshold-based labeling cannot protect people with this food allergy.

In short, ED05 is designed around preventing immediate systemic reactions, not chronic, delayed, or inflammation-driven disease activity, so it does not meaningfully protect people with non-IgE–mediated allergic conditions.

Turn Your Food Allergy Story Into Impact: Comment on the FDA Proposal

Below is a comment I left in a flurry after my friends at the ADINA Act shared the FDA document open for comment with me (check their site to take action if you aren’t familiar with them! They are another organization and family advocating for plain language and transparency). I am so grateful to the food allergy community online for helping all of us stay on top of the many policy developments happening right now.

I plan to leave additional comments on this FDA document emphasizing the importance of clear, facility-level transparency, as I do here, but first I wanted to put together this guide so others can understand the issue and take action, too. That felt like the most important step!

“As an adult with a life-threatening food allergy, I am on the more “sensitive” side of reactivity spectrum and have gone into anaphylaxis from cross-contact with my lifelong allergen. I am extremely passionate and care greatly about precautionary allergen labeling (PAL) and the FDA’s focus on food allergy thresholds as a method for labeling. I have major concerns around the current risk-based labeling being focused on. I really hope people with life threatening food allergies as well as non-IgE allergic conditions are the ones able to be leading the charge on this, and will be given the platform to lead the direction, as WE are the ones who are impacted by this policy and the people relying on it. I personally do not think a 1-tier system would be beneficial at all, it would need to be at least 2-tier system, as the more reactive side of the allergy reactivity spectrum would not be able to utilize a 1-tier at all, in addition to the non-IgE allergy community who are needing this information. 1-tier protections aren’t protections at all and is, sorry to say, useless and a waste of time to put into place. The amount of effort being put towards 1-tier would do nothing for the majority of the food allergy community, and I know this as someone in it. The allergy population being focused on with this threshold focus are the same people not needing to check ingredient labels carefully anyway. I feel STRONGLY that the FDA and those in charge need to stop looking to the food corporations and allergists on this topic of thresholds, and begin asking the actual people living day to day with allergic conditions about what would help them. Here is the thing: I need to know what top allergens are in the facility, plain and simple. If all labeling were transparent about this, that would help EVERYONE. Threshold-based labels means nothing, as there’s no way to find your “threshold” as an allergic individual, and the very real accumulative eating of these “thresholds” is not taken into account and makes this method unrealistic and unreliable. We need TRANSPARENCY of ingredients in the facility, and then from that, we can ALL make educated decisions on how to proceed. Thresholds for allergens makes everything more confusing, and more dangerous for someone to feel they may be able to take risks when they should be avoiding. As we have no known cause for food allergies and no cure, the main way those with food allergies are operating: strict avoidance. PLEASE do not proceed with a 1-tier system, and go back to the drawing board after talking to an extensive population of those LIVING with food allergies themselves. We simply need to know what top 9 allergens are in the shared facility of a food product, it really is that simple. And if food companies don’t want to do that, that’s the problem and should be the focus, not continuing to come up with alternative solutions that aren’t going to provide the transparency people need. Let consumers determine what they’re comfortable with with information, there’s no need to provide us a risk-level “threshold” we can’t even determine, or have determined at an allergist, and which doesn’t factor in the accumulation of cross-contact factor.”

Have a food allergy? Make your voice heard! Comment on the FDA document before May 19, 2026: https://www.regulations.gov/commenton/FDA-2026-N-1304-0001

You can view the additional comments made on the FDA document here: https://www.regulations.gov/document/FDA-2026-N-1304-0001/comment

Download the two FDA Attachments: How to Submit Comments to the Food and Drug Administration Regarding Food Allergen Thresholds and Their Potential Applications and the Agenda for the U.S. Food and Drug Administration (FDA) Virtual Public Meeting Food Allergen Thresholds and Their Potential Applications 2-18-2026

a confirmation image showing my comment was left for the FDA

If there is anything to take away from all of this, it is this: tell the FDA please do not proceed with a 1-tier system. Go back to the drawing board and consult extensively with people actually living with food allergies and non-IgE allergic conditions. What we need is simple: clear disclosure of the top nine allergens present in the shared facility of a food product. If companies will not do that, that is the real problem and should be the focus, not creating alternative solutions that fail to provide the transparency we rely on.

Let consumers decide what they are comfortable with using real information, not a risk-level threshold we cannot know, cannot measure in an allergist’s office, can change in our bodies at any moment, and that ignores cumulative cross-contact.