Top 10 Reasons to Require Gluten Labeling to Help Make America Healthy Again for Millions of Celiacs

Jax Bari at the FDA: Label Gluten as a Major Food Allergen

2026 Public Policy Goal

As we head into 2026, we are asking Secretary Robert F. Kennedy, Jr. to take next steps following the September 2025 release of the Make Our Children Healthy Again Strategy Report (MAHA Strategy Report).

The MAHA Strategy Report includes language on Celiac Disease and requiring the labeling of Gluten as a food allergen:

"Food Allergies: FDA will develop guidance on diagnostics and treatments for food allergies. FDA will also make recommendations about requiring transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with Celiac disease, and other established food allergens."

Here are the Top 10 reasons for HHS and the FDA to address this critical consumer protection issue with the urgency it requires and issue rulemaking requiring the labeling of Gluten as a "Major Food Allergen" based on the Secretary of HHS's existing statutory authority under the Food Allergen Labeling and Consumer Protection Act of 2004:

1) Common Sense Solution is Actionable, Bipartisan and Not Controversial

The MAHA Strategy Report details policy reforms that will make a meaningful difference in the lives of 3.3 million Americans with Celiac Disease, including about 729,000 children like Jax, the MAHA Kid.

Since 2006, only Wheat has been required to be labeled in the US, but Barley, Rye and Oats have not been required to be labeled. This has created a massive safety gap.

For 26+ years, there has been significant gold standard scientific agreement that Gluten should be required to be labeled to protect Celiacs. 87 other countries require the labeling of Gluten grains (Wheat, Barley, Rye & Oats)! The United States is a global outlier among peer nations. In other words, the United Stated is so far behind!

Americans are demanding transparency. According to an Axios Poll, "Americans embracing food regulation: 87% of respondents said the government should do more to make food safe through guidelines, labeling or reduced pesticide exposure."

2) Senator Dave McCormick, Senator John Fetterman and Bruce Blakeman Support Common Sense Solution to Require Gluten Labeling to Protect Americans with Celiac Disease

Senator Dave McCormick and Senator John Fetterman support Jax's common sense solution to require the labeling of Gluten as a Major Food Allergen in the United States.

"Dear Commissioner Makary and Secretary Kennedy: I write to ask you to give your full and fair consideration to using your existing authority to require the labeling of gluten as a 'Major Food Allergen.'... Under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the FDA is not precluded from requiring the labeling of gluten as a 'Major Food Allergen.' Notably, 87 countries including Canada, Mexico, Australia, and much of the EU already require gluten labeling on packaged foods. I respectfully urge your agency to give full consideration to using this authority to improve the lives of individuals with Celiac disease."-- Senator Dave McCormick

This is a national issue of critical importance. Bruce Blakeman, Nassau County Executive and candidate for Governor of New York, supports the effort to require the labeling of Gluten as a Major Food Allergen. In addition, there are thousands of supporting comments from leading food allergen authorities, doctors, organizations and consumers.

3) 1985 Final Rule: Wheat Gluten and Other Gluten Sources Must be Identified by Name When Used in Food

In 1985, the FDA issued a Final Rule which found that labeling Gluten ingredients is more "desirable" than Gluten Free labeling, and moreover that all Gluten ingredients must be declared on all food labels!

"The agency finds that labeling packaged foods as 'gluten free' would not be as desirable as actually identifying on the food label the source of the gluten that is used in the food. Under 21 CFR 101.4(a), wheat gluten and other gluten sources must be identified by name when they are used in food." -- FDA Final Rule, Supplementary Information, March 6, 1985.

That was 41 years ago, but to 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 41 years!

4) American Celiacs are Forced to Rely on Ultra-Processed Foods in the Absence of Mandatory Labeling of Gluten

Since Gluten is not declared as a Major Food Allergen in the United States, Celiacs have been forced to rely on products that are voluntarily labeled Gluten Free. Often times, these products are ultra-processed foods that have been specifically created to be marketed in a premium marketplace of high-priced Gluten Free food items.

According to The New York Times, "because use of the gluten-free claim is voluntary, many foods that are in fact gluten-free might not be labeled as such."

Celiacs spend 2x-6x more on Gluten Free food products when compared to those food products' Gluten containing counterparts, on both a per unit price and per ounce price. My analysis and opinions are informed by my experience. I earned my MBA from Columbia Business School), and I teach at Wharton. By requiring the labeling of Gluten as a Major Food Allergen, the availability of Gluten Free food items will increase, and Gluten Free food will become more affordable.

5) The Global Food Industry & Food Regulators Support Mandatory Labeling of Gluten on Packaged Foods

The global food industry and global food regulatory agencies support the mandatory declaration of Gluten on all food labels. It's instructive for the FDA to review the following best practice guidance from the Food & Drink Federation ("FDF") in the United Kingdom entitled, "Gluten Labelling Guidance: Best Practice for Prepacked Foods which Include or Exclude Cereals Containing Gluten ("Gluten Labeling Guidance")." 

6) By The Numbers: Food Allergies & Celiac Disease

• 25.7 million Americans have some type of food allergy or intolerance to eating Gluten, a protein found in Wheat, Barley, Rye and most Oats (through cross-contamination with Wheat, Barley and Rye).

  • 3.3+ Million Americans have Celiac Disease, including 729,0000 Children. This represents greater than 1% of the general population who have Celiac in the United States.

  • 2.4 million Americans - IgE-Mediated food allergy to Wheat and cross reactivity to Barley, Rye and Oats (potentially life-threatening)

  • 20+ million Americans with Non-Celiac Gluten Sensitivity (NCGS) or intolerance (non life-threatening). It's important to note that NCGS is a digestive system response to Gluten and not an immune system response.

• No Medications - there are no pharmaceutical treatments or cures for Celiac Disease

• No Rescue Medicines - 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

• 44% of people with Celiac Disease who follow a strict Gluten Free diet still get glutened once a month. That's why we need mandatory labeling of all Gluten grains in the United States. 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.

7) New Research Finds High Risk of Digestive Cancers in People with Celiac Disease

In December 2024, the Clinical Gastroenterology and Hepatology journal published in-depth research that confirms high risks of lymphoma and small bowel cancer in Celiac patients, as well as indicates increased risks of pancreatic, esophageal, gastric, and colonic cancers. Additionally, the research demonstrated significantly increased risk for Celiacs to develop Type 1 diabetes, thyroiditis, rheumatoid arthritis and osteoporosis. The research also found that Celiac patients had a higher risk for pernicious anemia, Crohn's disease, ulcerative colitis and noninfectious enterocolitis, which included microscopic colitis as well as nonalcoholic chronic pancreatitis.

Until there's a treatment for Celiac Disease other than a Gluten Free diet, we believe that requiring the labeling of Barley, Rye and Oats will have the greatest impact on improving safety and quality of life for 3.3 million American Celiacs and their loved ones. Requiring the labeling of Gluten will also reduce the adverse health effects of chronic diet-related disease and decrease the risk of cancer for those who suffer from Celiac Disease.

8) Glyphosate is Used on Cereal Grain Crops Including Wheat, Barley, Rye & Oats: Americans Have the Right to Know Whether Gluten is an Ingredient in Their Food

Glyphosate is the active chemical in the weed killer Roundup, and it is the most widely used herbicide on the planet. According to Bayer, which acquired Monsanto and its Roundup products in 2018, "Preharvest glyphosate is a tool for managing perennial weeds in cereal crops (wheat, barley, and oats)." This is consistent with Oklahoma State University's Division of Agricultural Sciences and Natural Resources, "Glyphosate is labeled as a pre-harvest weed control treatment in wheat and other cereal grains."

Given the adverse health effects that 3.3 million Americans with Celiac Disease face from Gluten ingestion as well as the potential adverse health effects for the general population, all Americans have a right to know what ingredients are in their food, including Barley, Rye and Oats (none of which are currently required to be labeled on packaged foods in the US). It's about transparency.

9) The Biden Administration Failed to Protect Celiacs by Refusing to Require the Labeling of Gluten Grains as Major Food Allergens

The Biden Administration failed to protect 3.3 million American Celiacs, including 729,000 children. Watch this video for just one example. The Biden Administration FAILED to enact Celiac Journey's common sense solution to require the labeling of Gluten grains on all packaged foods in the United States, just like Gluten must be declared on all food labels in 87 other countries (FDA Citizen Petition, FDA-2023-P-3942).

10) Supporters of Donald Trump are More Likely to Identify as Avoiding Gluten, According to Michigan State University & Oklahoma State University

A 2019 study from researchers at the Department of Agricultural, Food, and Resource Economics, at Michigan State University and the Department of Agricultural Economics, Oklahoma State University found that "supporters of Donald Trump are more likely to identify as avoiding Gluten, relative to non-supporters." (Source: Malone, Trey & Norwood, F.. (2020). Gluten aversion is not limited to the political left. Agriculture and Human Values. 37. 10.1007/s10460-019-09958-7.)

Thank you for your attention to this important matter.