"Together we will end the chronic disease epidemic and keep our children safe, healthy and disease-free." -- President Donald J. Trump
FDA's Final Food Allergen Guidance Fails to Make America Healthy Again
Just days before President Donald Trump was sworn into his second term, the FDA released its deeply flawed, biased and unfair Final Guidance: "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for FDA Staff and Interested Parties, January 6, 2025 ("FDA's Final Guidance").
A Flurry of Rulemakings & Guidance Documents Days Before Trump Took Office
According to Sidley Austin, "starting at the end of 2024 and continuing into January 2025, the FDA's Human Foods Program released "a flurry of rulemakings, guidance documents, and other initiatives." The timing of the release of the FDA's Final Guidance suggests that the FDA was trying to usher this in before President Trump took office and Robert F. Kennedy, Jr. became the Secretary of HHS overseeing the FDA.
"In some categories, there are entire departments, like the nutrition department at the FDA that have to go, that are not doing their job, they're not protecting our kids!" -- Robert F. Kennedy, Jr.
In order to Make America Healthy Again, Jax Bari filed a Citizen Petition with the FDA to require the labeling of Gluten on all packaged foods in the US, just like Gluten must be declared on all food labels in 87 other countries. Gluten is a protein found in Wheat, Barley, Rye and most Oats. Since 2006, only Wheat has been required to be labeled in the US, but Barley, Rye and Oats have not been required to be declared.
The FDA's mission is to protect the public's health. However, the FDA’s Final Guidance will not keep 729,000 Celiac children safe, healthy and disease free.
FDA's Final Guidance Gaslights Gluten as a Second Class Allergen
The FDA's Final Guidance dismissed the seriousness of Celiac Disease, a potentially life-threatening food allergy and auto-immune disease by gaslighting Gluten a second class food allergen. The FDA's Final Guidance failed to follow evidence based science for which there is global significant scientific agreement on requiring the labeling of Gluten. Here are just a couple of examples of the deeply flawed science and rulemaking frameworks in the FDA's Final Guidance:
"Since some foods may cause both IgE- and non-IgE-mediated reactions, we may consider severity of non-IgE-mediated reactions (e.g., severe diarrhea associated with celiac disease) as supplemental evidence in evaluating overall severity."
"Because some foods can cause both IgE-mediated and non-IgE-mediated reactions, evidence of non-IgE-mediated reactions (e.g., severe diarrhea associated with celiac disease) can be useful as supplemental information in an evaluation of the public health importance of such a food allergen (see discussion in section VI.A.2)."
Note the emphasis on the word "and" which strongly suggests that the FDA "may consider severity of non-IgE-mediated reactions" only in foods that “cause both IgE- and non-IgE-mediated reactions." The FDA just does not get it -- the FDA's Final Guidance does not mention other adverse health effects associated with Gluten ingestion by Celiacs including cancer, villous atrophy, anemia, malnutrition, other auto-immune diseases, immunological scarring, etc.
Prior to issuing the FDA's Final Guidance in January 2025, the FDA issued Draft Guidance in April 2022 - "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for FDA Staff and Stakeholders." In total, there were 1,903 comments submitted to the FDA's Draft Guidance, and of those, 1,576 comments mentioned Celiac and/or Gluten as a food allergen. In other words, 82.8% of all of the comments received on the FDA's Draft Guidance were about evaluating the public health importance of requiring the labeling of Gluten on all food products. While the FDA's Final Guidance included some changes, these changes were not meaningful.
"While U.S. consumers' reactions to a top 9 Major Food Allergens and Gluten vary, their consumer habits are the same, they avoid purchasing foods that contain the allergen(s) that cause a potentially life-threatening immunological adverse reaction. They rely on food labels to know what is safe to eat." -- Dr. Virginia Stallings
The FDA’s Requirement is Arbitrary, Outdated & Dangerous - It Does Not Follow Gold-Standard Research
In FDA double-talk, the FDA's Final Guidance states in a footnote that "Rye and barley were found to show weak evidence of causing IgE-mediated food allergic reactions." Celiac is not a footnote!
In other words, the FDA may consider Non-IgE-Mediated immune responses as supplemental evidence in evaluating overall severity of IgE-Mediated immune responses. However, Rye and Barley were found to show weak evidence of causing IgE-mediated food allergic reactions. This suggests that the FDA has already put its thumb on the scale to pre-determine that Barley and Rye should not be required to be labeled.
I hope that we are wrong. However, history suggests otherwise based on a 2008 Citizen Petition that the FDA summarily denied after a 10-year delay. In addition, the FDA has a 40+ year track record of othering the consumer protection needs of Celiacs in spite of issuing a Final Rule in 1985 where the FDA stated that labeling Gluten ingredients is more "desirable" than Gluten Free labeling, and moreover that all Gluten ingredients must be declared on all food labels!
Spoiler Alert - That Final Rule was issued 40 years ago, but to this date, the FDA has never enforced this, and the labeling of Barley, Rye and Oats remains voluntary in the US. As recently at April 2023, the Center for Science in the Public Interest stated that Gluten containing grains "are currently not clearly labeled on most foods and beverages." This has endangered Celiacs with every bite, every day for the past 40 years!
Based on the FDA's 1985 Final Rule and Supplementary Information related thereto (along with the FDA's existing statutory authority to require new food allergen labeling under the Food Allergen Labeling and Consumer Protection Act (FALCPA)), the FDA should immediately grant Jax Bari's FDA Citizen Petition.
A Tale of Two Evaluation Frameworks Whereby FDA's Final Guidance is Unfair. Rigged & Biased
It is instructive to review the differences in the language between the following frameworks:
FDA's Final Guidance - "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for FDA Staff and Interested Parties," Food and Drug Administration, January 2025.
2022 FAO/WHO Risk Assessment - Food and Agriculture Organization of the United Nations and World Health Organization, 2022 Risk Assessment of Food Allergens. Part 1 - Review and validation of Codex Alimentarius Priority Allergen List Through Risk Assessment.
2021 FAO/WHO Expert Consultation - Food and Agriculture Organization of the United Nations/World Health Organization, 2021 "Summary report of the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Part 1: Review and Validation of Codex Priority Allergen List Through Risk Assessment."
Both the 2022 FAO/WHO Risk Assessment and the 2021 FAO/WHO Expert Consultation were chaired by the FDA’s Dr. Lauren Jackson and included the FDA’s Dr. Luccioli. We met with Dr. Luccioli and other senior FDA officials, and Jax asked Dr. Luccioli to support Gluten labeling requirements in the US, just like Dr. Luccioli recommended to the rest of the world that Gluten should be required to be labeled. Crickets! Total silence fell on the room. Jax just stared across the conference table at Dr. Luccioli in disbelief over Dr. Luccioli's indifference to Jax's in-person pleas for help and Jax's recommended common sense solutions.
"The difference between the right word and the almost right word is the difference between lightning and a lightning bug." -- Mark Twain
With respect to the consumer protection needs of the Celiac community with food labeling, Celiac Disease is a food allergy and Gluten is a potentially life-threatening and life-debilitating food allergen. Period. Full Stop.
Let's review how the FDA's Final Guidance requirement for the evaluation of the public health importance of labeling food allergens other than the Major Food Allergens is a function of the food allergen being capable of triggering anaphylaxis through an IgE-Mediated mechanism. The FDA's requirement makes sense for IgE-mediated food allergies, but not for Non-IgE-Mediated food allergy like Celiac Disease. Therefore, with regard to Celiac Disease, the FDA's Final Guidance is arbitrary, exclusionary, outdated and dangerous.
Dr. Jackson’s 2021 FAO/WHO Expert Consultation found:
"The Expert Committee determined that only foods or ingredients that cause immune-mediated hypersensitivities such as IgE-mediated food allergies and coeliac [Celiac] disease should be included on the list of foods and ingredients included in section 4.2.1.4 of the GSLPF [General Standard for the Labelling of Prepacked Foods]," and that the GSLPF list includes Gluten.
"Based on systematic and thorough assessments which used all three criteria (prevalence, severity and potency), the Committee recommended that the following should be listed as priority allergens: Cereals containing gluten (i.e., wheat and other Triticum species, rye and other Secale species, barley and other Hordeum species and their hybridized strains), crustacea, eggs, fish, milk, peanuts, sesame, specific tree nuts (almond, cashew, hazelnut, pecan, pistachio and walnut)." (emphasis added)
In other words, these global experts (including 6 Americans and FDA officials) recognized the significance of the Non-IgE-Mediated immune response as equally important in terms of consumer protection to those who suffer from IgE-Mediated food allergy to the "Big 8" including: wheat gluten, crustacea, eggs, fish, milk, peanuts, sesame, and tree nuts. The 2022 FAO/WHO Risk Assessment stated,
"Criteria for the addition of foodstuffs to the list of the Codex Committee on Food Labelling… Products of rye, barley and oats would not be required to meet the criteria set out in (i) and (ii) [for IgE-Mediated allergic reactions] above because IgE-mediated allergic reactions to these cereal grains are uncommon." (pages 1- 2)
The FDA's Final Guidance was Misleading Since it Omitted Important Information on Oats
Our research informs us that Oats Must be Considered a Gluten-Containing Grain Due to Inevitable Cross Contamination.
However, the FDA's Final Guidance made a material omission when referring to the 2021 FAO/WHO Expert Consultation’s findings on Oats, and excluded the information – Oats "may be considered for inclusion on priority allergen lists in individual countries."
The FDA's Final Guidance misrepresented and dismissed the potential dangers of Oats to the Celiac population when it stated,
"The [2021 FAO/WHO] Expert Committee found that evidence was available for wheat, rye, and barley to meet key criteria for inclusion on the updated Codex priority list, while insufficient evidence was available for oats... Oats were recommended by the Expert Committee to be excluded from the Codex priority list because of a lack of key criteria data showing this food to be a prevalent or important cause of IgE-mediated food allergies or celiac disease."
Additionally, the FDA's Final Guidance omitted critical research cited in the 2022 FAO/WHO Risk Assessment,
"It might be considered that oats should be on a regional priority allergen list because oats are generally contaminated, and often at significant levels, with gluten containing cereals. In Canada, taking into consideration lot-to-lot variability, approximately 88 percent [88%] of commercial oats samples (n=133) were reported to be contaminated above the Codex-recommended gluten-free level (20 ppm), gluten concentration ranging from 21 to 3800 mg/kg of oats (Koerner et al., 2011). If oats are not on a priority allergen list, the possible presence of (contaminated) oats as an ingredient remains, and several products may cause reactions in consumers with coeliac disease. For this reason, oats are included in Canadian legislation." (emphasis added)
According to General Mills, "absent dedicating land, harvesting equipment, transporting vehicles, storage units, packaging and production facilities, and the like only for use in connection with oats, cross contamination is inevitable."
On April 4, 2023, Gluten Free Watchdog published that "At this time (April, 2023), Gluten Free Watchdog cannot recommend any brand of gluten-free oats. This includes products that are certified gluten-free or made using purity protocol oats. We will issue an update when the situation warrants."
In November 2023, Frontiers in Nutrition published the following study: "It is long-established that oats are at substantial risk for cross contact with gluten-containing grain… Patients with celiac disease will likely be asking questions now and in the future about whether oats should remain a part of their gluten-free diet. Uncertainty regarding how best to answer this question will likely remain for practitioners."
FDA's Final Guidance is Inconsistent with Gold-Standard Findings from FAO/WHO Expert Committees Including FDA's Dr. Lauren Jackson (Chair) & FDA's Dr. Stefano Luccioli
The 2021 FAO/WHO Expert Consultation and 2022 FAO/WHO Risk Assessment were comprised of 20 (twenty) "scientists, regulators, physicians, clinicians and risk managers from academia, government and the food industry were selected to participate in the first meeting of the FAO/WHO Expert Consultation on Risk assessment of Food Allergens." These "experts" from around the world included four experts from the United States, two of whom work for the FDA:
Dr. Joseph Baumert, Professor and Director of the Food Allergy Research and Resource Program (FARRP), Department of Food Science and Technology at the University of Nebraska-Lincoln; (Pictured in top row of photograph, 3rd from left)
Dr. Lauren Jackson, Chief, Process Engineering Branch, Food and Drug Administration. Division of Processing Science & Technology, Institute for Food Safety & Health, who served as Chairperson of the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens; (Pictured in top row of photograph, 1st person on left)
Dr. Stefano Luccioli, Medical Officer and Allergy Specialist at the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, and Board-certified doctor in allergy/immunology -- sees patients at the General Internal Medicine clinic at MedStar Georgetown University Hospital in Washington, D.C.; and Chairperson of Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens Part 3: Review and establish precautionary labelling in foods of the priority allergens (Pictured 2nd row of photograph, 4th person from left).
Dr. Stephen Taylor, Professor and Founding Director (Retired) of the Food Allergy Research and Resource Program (FARRP), Department of Food Science and Technology at the University of Nebraska-Lincoln. Dr. Taylor was also one of six scientists who served on the Ad Hoc Panel on Food Allergens met in Geneva, Switzerland in February 1999 to provide advice to the Joint FAO/WHO Expert Committee on Food Additives about criteria for labelling food allergens. Their treatise was memorialized in the 1999 FAO/WHO Expert Consultation, also referred to as the "1999 Codex Criteria". (Pictured in bottom row of photograph, 2nd person from left).
In addition to these experts, the 2021 FAO/WHO Expert Consultation was comprised of 10 (ten) “resource persons” including two from the United States who work for the USDA and FDA:
Dr. J. Emilio Esteban, Chief Scientist of the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), who serves as the Codex Committee Chairperson from the United States; and
Dr. Douglas Balentine, Senior Science Advisor, Global Nutrition Policy Center for Food Safety and Applied Nutrition, FDA, who serves as the U.S. Delegate on Food Labeling on the Codex Committee.
In the 2021 FAO/WHO Expert Consultation, these experts relied on a different criteria (from the 2022 FDA's Final Guidance) for their systematic and thorough assessments to evaluate the prevalence, severity and potency of adverse health impacts of ingesting Gluten to those with Celiac Disease.
What is Food Allergy? The Similarities and Differences Between Non-IgE-Mediated Mechanisms with Celiac Disease & Typical IgE-Mediated Mechanisms
According to the National Academies of Sciences, Engineering, and Medicine, Committee on Food Allergies, "Food allergy has two key classifications: immunoglobulin E (IgE)-mediated or non-IgE-mediated."
There are several very important near-peer similarities between a Celiac food allergy with Non-IgE-Mediated Mechanisms (Gluten) and typical IgE-Mediated Mechanisms (Milk, Eggs, Fin Fish, Crustacean Shellfish, Tree Nuts, Peanuts, Wheat, Soybeans & Sesame): potentially life-threatening, the only treatment is to strictly avoid the food allergen(s), and consumers’ reliance on food labels to know what is safe to eat. Importantly, unlike traditional food allergies with IgE-Mediated mechanisms, there is no rescue medicine (i.e., adrenaline or antihistamine) to treat accidental ingestion of Gluten and the start of the auto-immune cascade in food allergy with Non-IgE-Mediated mechanisms such as Celiac Disease. Additionally, those with a Non-IgE-Mediated food allergy to Gluten cannot outgrow their food allergy – Celiac is lifelong (until such time as any treatments or a cure may be developed).
Barley, Rye & Oats Can Be Considered Proteins Derived From Wheat, a Major Food Allergen
In the FDA's Final Guidance Q&A document, "Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)", the FDA's new thinking entails expansion of Major Food Allergens classification from food ingredients that include proteins derived from a Major Food Allergen,
"Food ingredients that include proteins derived from a major food allergen (e.g., through chemical, biochemical, mechanical, fermentation, or bioengineering processes) may be capable of eliciting an allergic reaction, and their presence is not obvious without declaration of the allergen."
Based on the FDA's rationale, Barley, Rye and Oats are "food ingredients that include proteins derived from a major food allergen" -- Wheat -- through processes including mechanical processes. As a result of the way in which Oats, Barley and Rye are grown, harvested, transported, milled, stored and merchandized which can can cross contact with Wheat, Oats, Barley and Rye "may be capable of eliciting an allergic reaction, and their presence is not obvious without declaration of the allergen."
Jax's Meeting with FDA Deputy Commissioner Was Fruitless
When Jax met with Jim Jones, FDA Deputy Commissioner of Human Foods, in August 2024, Jax asked for the FDA to announce intended rulemaking on requiring the labeling of Barley, Rye and Oats. Initially DC Jones seemed amenable to bypassing the Request for Information stage and addressing the lowest hanging fruit of requiring the labeling of Barley, Rye and Oats. Mr. Jones even said that he wanted to streamline processes and not "elongate" them, and this was in the context of our request to issuing Rulemaking.
Then the FDA's staff lead Pat Hansen, Deputy Director, Office of Nutrition and Food Labeling, CFSAN, said she would like to issue a Request for Information, and Jim seemed to quickly change his tune. Even Jax picked up on this change. As a former USDA regulator, Brian Ronholm, Director of Food Policy for Consumer Reports, called this out and tried to get a timeline pinned down, but he was unsuccessful in doing so. Mr. Ronholm said that all of the information is already known and tried to get some clarification as to what the FDA might want to still learn, but Ms. Hansen could not even give one example of more information that they may want.
The FDA has not ever understand that the Celiac community is in crisis - every bite every day! The FDA has no urgency and no willingness to even say when a simple Request for Information might be published, which appears to be another example of why we are hopeful for meaningful change under Secretary Kennedy.
"Jax's Citizen Petition represents a perfect opportunity for the FDA’s Human Foods Program under Deputy Commissioner Jones to lead by example and break away from the Reagan-Udall Foundation’s finding that the FDA's 'culture creates an environment where decision-making is unacceptably slow' and from an external perspective appears 'sluggish and non-responsive to public health concerns.'" -- Brian Ronholm, Director of Food Policy, Consumer Reports
On February 17, 2025, FDA Deputy Commissioner of Human Foods resigned and claimed that "indiscriminate" layoffs would make it "fruitless for him to continue." The irony is that the FDA's indiscriminate decision making in the FDA's Final Guidance has made us feel at times that it is fruitless for us to continue in our efforts to require the labeling of Gluten on all packaged foods in the US, just like Gluten must be declared on all food labels in 87 other countries. Unfortunately, we cannot just quit our fight when it comes to the health and well-being of 729,000 children with Celiac Disease like Jax.
Supporting Comments from Dr. Virginia Stallings
It is instructive to read Dr. Virginia Stallings' supporting comments to the FDA dated November 29, 2023 and her comments dated August 4, 2022. Dr. Stallings is board-certified nutrition pediatrician, Professor of Pediatrics and Director of the Nutrition Center at the Children’s Hospital of Philadelphia. In addition, Dr. Stallings served as the Editor and Chair of the National Academies of Sciences, Engineering, and Medicine, Committee on Food Allergies: "Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management and Public Policy." This was published by the National Academies Press, 2016 and cited as FDA Ref. 2 in the FDA’s Final Guidance.
According to Dr. Stallings’ comments to the FDA,
"While U.S. consumers' reactions to a top 9 Major Food Allergens and Gluten vary, their consumer habits are the same, they avoid purchasing foods that contain the allergen(s) that cause a potentially life-threatening immunological adverse reaction. They rely on food labels to know what is safe to eat.
However, the key difference from a consumer protection standpoint is that under FALCPA, the labeling scheme for the top 9 Major Food Allergens in the U.S. is mandatory, but the labeling of Gluten is voluntary. Just because something is Wheat free does not mean its Gluten Free. In other words, whereas sufferers of the current top 9 Major Food Allergens in the U.S. rely on what ingredients are expressly included in required labeling disclosures of packaged foods, the Celiac community cannot rely on manufacturers to declare Gluten on food labels. This must change.
I believe that a Gluten Free diet is not all that is needed to treat Celiac Disease; rather a Gluten Free diet is all that has ever been historically available to treat Celiac Disease. Additionally, with respect to labeling food products in the United States, the voluntary Gluten Free labeling scheme does not sufficiently protect consumers who are on medically required and very restrictive Gluten Free diets. I am respectfully requesting that the FDA change the voluntary labeling rule to a mandatory labeling rule to keep 3.3 million Americans with Celiac safer."
Supporting Comments from Dr. Kirsi Jarvinen-Seppo
It is instructive to read the supporting comments from Kirsi Jarvinen-Seppo, MD, PhD, Chief, Founders' Distinguished Professorship in Pediatric Allergy and Immunology, Professor of Pediatrics, Medicine, Microbiology and Immunology, Director, Center for Food Allergy, Golisano Children's Hospital, University of Rochester Medical Center. Dr. Jarvinen-Seppo is also the author of UpToDate's "Grain allergy: Allergens and grain classification" and "Grain allergy: Clinical features, diagnosis, and management."
"I am writing to express my enthusiastic support for Jax Bari's FDA Citizen Petition... I have close to 3 decades of clinical experience in treating children with food allergy to cereals including wheat, barley, rye and oat... Throughout my clinical training I have learned that many wheat-allergic children are also sensitized by skin and serum specific IgE testing as well as clinically reactive to other cross-reactive grains in the Graminae grass family including barley, rye and sometimes oat. This is due to the similarity of the protein structure of these related grains... Wheat allergy is often responsible for severe, life-threatening allergic and anaphylactic reactions and therefore strict avoidance of any amounts including cross-contact to wheat and related grains is recommended and strongly urged in patients allergic to wheat."
The Bottom Line
The FDA's Final Guidance provides an unfair and biased framework that misleadingly others the consumer protection needs of Celiacs. The FDA's Final Guidance focuses on IgE-Mediated food allergies when the FDA should not discriminate between IgE-Mediated and Non-IgE-Mediated food allergies. The FDA must be stopped from continuing to gaslight Gluten as a second-class allergen and Celiac as a non-potentially life-threatening food allergy.
These are examples of how the FDA has continued to dangerously perpetuate flawed scientific, governmental, and societal biases against Celiacs including:
A Gluten Free diet is all that is needed to treat Celiac Disease, as opposed to all that has ever been historically available to treat Celiac Disease.
With respect to labeling food products in the United States, the voluntary Gluten Free labeling scheme sufficiently protects consumers who are on medically required and very restrictive Gluten Free diets, as opposed to all that has ever been historically utilized labeling-wise in the U.S.
Othering the consumer protection needs for Celiacs in the United States by not evaluating the public health importance of Gluten as a food allergen because the Non-IgE-Mediated food allergy with Celiac is not capable of triggering anaphylaxis and being immediately life-threatening, while seemingly ignoring that Celiacs face potentially life-threatening and severe adverse health effects that can arise through Gluten ingestion, including by way of example and not limitation: anemia, cancer, heart disease, immunological scarring, intestinal damage, malnutrition, other auto-immune diseases, etc.
It's time to Make America Healthy Again and material changes at the FDA cannot come soon enough!
Resources
One Sheeter - Celiac Journey, Make America Healthy Again, FDA Citizen Petition to Require the Labeling of Gluten
Jax's FDA Citizen Petition - Require the Labeling of Gluten on All Food Products in the US, Just Like Gluten Must Be Declared on all Food Labels in 87 Other Countries, FDA-2023-P-3942
"Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for FDA Staff and Interested Parties," Food and Drug Administration, January 2025.
"Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry," Food and Drug Administration, January 2025.