"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." -- General Mills
Overview
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 article below focuses on Oats and why Oats must be required in order to protect Celiacs.
Oats Are Required to be Labeled in Canada & Across Europe
Oats are naturally Gluten Free. However, Oats cultivated in North America and Europe are commonly contaminated by Gluten containing grains, including Wheat, Barley, Rye and Triticale. According to General Mills, cross contamination of commercial Oats with Gluten "is inevitable." The reason for this is the manner in which Oats are grown, harvested, transported, milled, stored, and merchandized.
That is why Oats are required to be labeled as a priority allergen (major food allergen) in many countries, including in Canada, in the United Kingdom and across the European Union. It is a matter of label transparency for Celiacs to know what ingredients are in their food and what foods are safe to eat.
"Some Oats may be safe for Celiacs to eat, but all Oats must be clearly labeled so that we can know what's safe to eat." -- Jax Bari
The FDA's Misleading Final Guidance on Oats
Just days before President Trump's Inauguration, the FDA issued deeply flawed Final Guidance on evaluating the public health importance of food allergens other than the Top 9 Major Food Allergens. The FDA's Final Guidance made a material omission on evaluating the public health important of requiring the labeling of Oats.
Oats 101 - All Oats are Potentially Cross Contaminated with Gluten
The potential for Oats to have cross-contact with Gluten is a very serious issue that impacts all Oats including regular Oats (sometimes referred to as commercial Oats) and Oats that are marketing as Gluten Free Oats. There are two ways that Oat manufacturers try to produce safe Gluten Free Oats:
Oats can be mechanically or optically sorted by a combination of machines and humans to remove errant Gluten-containing grains.
Purity Protocol Oats are manufactured following a set of processes designed by the company to prevent Oats from coming cross-contact with Gluten at all stages of the manufacturing process. "It’s important to note that there is no standard definition for purity protocol and the standards vary by company."
According to the Celiac Disease Foundation,
"Oats are found in many gluten-free products like granola bars, cookies, baked goods, granola, veggie burgers, and cereals. Historically there have been concerns about patients with celiac disease eating oats due to cross-contact with gluten and a possible immune response leading to intestinal damage. Although oats themselves do not contain gluten, they are often grown, processed, and transported alongside wheat, barley, and rye, which do. Additionally, some patients with celiac disease report experiencing symptoms similar to a gluten exposure even when eating gluten-free oats.
Significant Scientific Agreement - Oats are Cross Contaminated with Wheat, Barley & Rye
In answering the question, "What is Gluten?" the NIH's National Library of Medicine stated that Gluten is a food protein, and that Gluten containing grains include Wheat, Barley, Rye and Oats.
According to the Institute of Agriculture and Natural Resources, Food Allergy Research and Resource Program at the University of Nebraska-Lincoln, "oats are often contaminated with wheat; this contamination occurs through shared agricultural fields, harvesting equipment, transportation vehicles, and on-farm and off-farm storage facilities. Thus, celiac sufferers should exercise caution with respect to the ingestion of oats."
Due to the potential for cross-contact and other cross-reactive reasons, commercial Oats and Oats marketed as Gluten Free Oats have been causing fear, uncertainty, doubt and danger for many years for Celiacs like my 11-year-old son.
The 1999 Codex Criteria from the UN's Food & Agriculture Organization (FAO) and World Health Organization (WHO) stated,
"The revised list of those foods and ingredients known to cause food allergies and intolerance and whose presence should always be declared was identified as the following: Cereals containing gluten (i.e., wheat, rye, barley, oats, spelt or their hybridized strains) and their products." (emphasis added)
The 2021 FAO/WHO Expert Consultation evolved its global guidance on Gluten containing grains with respect to Oats,
"Due to the lack of data on prevalence, severity and/or potency, or due to regional consumption of some foods, the Committee recommended that some of the allergens,... oats, ... should not be listed as global priority allergens but [Oats] may be considered for inclusion on priority allergen lists in individual countries." (emphasis added)
The FDA's Misleading Final Guidance Omitted Oats
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 in the preceding paragraph – Oats "may be considered for inclusion on priority allergen lists in individual countries."
In turn, 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."
To reiterate, the FDA's Final Guidance unfairly omitted that according to the 2021 FAO/WHO Expert Consultation, Oats "may be considered for inclusion on priority allergen lists in individual countries."
Additionally, the FDA's Final Guidance omitted critical research cited in the Food and Agriculture Organization of the United Nations and the World Health Organization's 2022 Risk Assessment of Food Allergens, Part 1 - Review and validation of Codex Alimentarius Priority Allergen List Through Risk Assessment, Meeting Report, Food Safety and Quality Series No. 14, Rome,
"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)
On April 4, 2023, Tricia Thompson from Gluten Free Watchdog published,
"In early January of 2022, Gluten Free Watchdog issued a statement warning the community about supply chain issues with oats. At Gluten Free Watchdog we have seen an increase in oats testing with quantifiable gluten either at/above 20 ppm OR above the level of gluten allowed by their certifying organization. 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." (emphasis added)
Take it from General Mills - Cross Contamination of Oats is "Inevitable"
It is instructive to read the following from General Mills about the inevitability of Oats being cross contaminated with Gluten,
"Oats themselves do not contain gluten. However, oats cultivated in North America, Europe and even other parts of the world are commonly contaminated by gluten containing foreign grains, including wheat, barley, rye and triticale. This contamination is commonly known to come from various sources, mainly from the rotation of small grain crops on the same land, with residual contaminating seeds germinating with a seeded oat crop. In addition, contamination from other grains which are harvested, transported, stored and merchandized in common with oats is a contributing factor. As a result, it is not uncommon to find from 0.5% to 5.0% of these other grains mixed with commercially marketed oats. Therefore, 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." (emphasis added)
General Mills is a Worldwide Market Leader in Grains
To really understand the gravitas of General Mills' statement on the inevitability of Oats being cross contaminated with Gluten, it is important to consider the market position and expertise of General Mills in the food industry. According to General Mills' 2021 Annual Report,
"We are a leading global manufacturer and marketer of branded consumer foods sold through retail stores. We also are a leading supplier of branded and unbranded food products to the North American foodservice and commercial baking industries. We are also a leading manufacturer and marketer in the wholesome natural pet food category. We manufacture our products in 13 countries and market them in more than 100 countries. In addition to our consolidated operations, we have 50 percent interests in two strategic joint ventures that manufacture and market food products sold in more than 120 countries worldwide." (emphasis added)
Gluten Free Watchdog - Oats are at Substantial Risk for Cross Contact
In November 2023, Frontiers in Nutrition published the following study, "Gluten cross contact in oats: retrospective database analysis 2011 to 2023," by Tricia Thomson and Amy Keller which found,
"It is long-established that oats are at substantial risk for cross contact with gluten-containing grain. Specially processed gluten-free oats, whether purity protocol or mechanically/optically sorted, made it possible for this grain to be included in a gluten-free diet in the U.S. Gluten Free Watchdog (GFWD) (Manchester, Massachusetts, United States) has been assessing the gluten content of labeled gluten-free foods since 2011. In 2022, there was an apparent increase in the number of oat products testing with quantifiable gluten at or above 5 mg/kg or parts per million (ppm)… At the farm level, this risk [of oat cross contact with gluten-containing grains] may be due to crop rotation with wheat, barley, or rye, proximity to fields growing gluten-containing grain, and/or shared harvesting equipment, among other things… 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." (emphasis added)
On January 20, 2025, Tricia Thompson published the Summary of 2024 oat testing data from Gluten Free Watchdog,
"Twenty-six products (representing 1+ packages of each product) were tested in 2024 that contained oats as an ingredient. Five of these 26 products tested with quantifiable gluten in at least one test portion (3 of these products were from the same store brand—Trader Joe’s). Three of the 5 products tested out of compliance with the gluten-free labeling rule (2 of the 3 products were from the same store brand—Trader Joe’s). The 3 products testing out of compliance listed an oat ingredient as the only or first ingredient."
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 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."
Grain Allery Expert Warns that Wheat-Allergic Are Clinically Cross Reactive to Barley, Rye & Oats
According to Dr. 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,
"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."
Oats are Triggers for Food Protein-Induced Enterocolitis Syndrome (FPIES)
In addition to Celiacs avoiding Gluten, there are other medical reasons why people must avoid Oats, and why Oats must be labeled. For example, according to UpToDate, "Food protein-induced enterocolitis syndrome -- Grains, especially oat and rice, and occasionally wheat, barley, and corn are among the most commonly reported triggers after cow’s milk and soy in food protein-induced enterocolitis syndrome (FPIES), typically seen in young children, which can present in one of two ways… Chronic exposure to the offending allergen may present with vomiting and diarrhea, failure to thrive, and hypoalbuminemia."
Bottom Line - Oats Must Be Required to be Labeled
The bottom line is that some percentage of Celiacs can safely eat Oats that are not cross contaminated with Gluten. But given that Oats have such a high likelihood of being cross contaminated with Gluten, the FDA must require that Oats are declared on all food labels as a Gluten containing grain. Manufacturers always have the option to declare that that they are using safe Gluten Free Oats, that their product is certified Gluten Free, and then let the consumer decide if they want to eat that product with Oats.
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.