American Celiacs are Forced to Rely on Ultra-Processed Foods in the Absence of Mandatory Labeling of Gluten as a Major Food Allergen

Jax Bari and Kyle Diamantas, FDA Deputy Commissioner of Human Foods

Celiac is a Disease, Not a Diet

Celiac Disease is a potentially life-threatening food allergy and auto-immune disease that is triggered by eating Gluten, a protein found in Wheat, Barley, Rye and most Oats. In addition to vomiting and diarrhea, individuals with Celiac may experience many adverse health effects from eating Gluten including anemia, immunological scarring, additional auto-immune diseases, intestinal damage, malnutrition and cancer. A 100% Gluten Free diet is the only existing treatment for Celiac Disease.

Given that there is no treatment for Celiac other than a strict Gluten Free diet for life, Celiacs must remain vigilant in maintaining their Gluten Free diet. Celiac is a really challenging disease to manage since it's estimated that 80% of food items contain Gluten.

There's no medicine (i.e., EpiPen) to take in the event of accidental ingestion of Gluten. Just a crumb of Gluten can cause Celiacs to get violently sick. 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 U.S., but Barley, Rye and Oats have not been required to be declared. This has created a massive food safety gap, and a market opportunity for food companies to profit from the medically required diet that Celiacs must follow.

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."

The Celiac community just wants to know whether Barley, Rye and Oats (in addition to Wheat) are in food products so that we can make informed and safe choices. This is about transparency.

"A critical feature of the celiac experience is that unless people have the time, skill, money, and inclination to prepare all their meals from basic ingredients, they must rely on an industry that has minimal interest in their well being." -- Emily Abel

Dr. Emily Abel, Professor Emerita from the Fielding School of Public Health at UCLA, is the author of "Gluten Free for Life: Celiac Disease, Medical Recognition, and the Food Industry." In discussing her book, Abel addressed how "health claims sell food, and the industry decided: Gluten-free, maybe this was something that could sell a lot of products." Dr. Abel opined that a lot of Gluten Free ultra-processed foods are worse than other Gluten-containing ultra-processed foods since the removal of Gluten "really hurts the flavor." Abel continued, "so to make these foods appealing, the manufacturers put in more fat, more salt, and more sugar."

Gluten is important for providing a "glue" so foods don't fall apart. Gluten also helps to maintain elasticity and structure in baked goods. For example, fermentation in bread baking is the process where yeast converts sugars into carbon dioxide and alcohol, causing the dough to rise and developing flavor, providing a light, airy structure and unique texture. 

Recreating the taste, texture, and nutritional profile of Gluten-containing foods in Gluten Free foods remains a challenge. Removing Gluten often requires techniques like fractionation, washing, or enzymatic hydrolysis, which can alter the food's nutritional value.

Gluten Free products typically use ingredients such as Rice, Corn, or Quinoa instead of Wheat, Barley, Rye and Oats. While naturally Gluten Free, these substitute ingredients often lack key nutrients found in Gluten containing grains, including Iron, Fiber and Vitamin B. Ultra-processed Gluten Free foods often contain emulsifiers, added sugars, sodium, unhealthy fats, artificial colors, preservative, and artificial sweeteners. Many Gluten Free foods rely on refined starches such as Tapioca or Rice, which can reduce energy levels (increase fatigue), impair cognitive function, and lead to poor digestive health.

Research shows that both children and adults on Gluten Free diets are at risk of nutrient deficiencies. A truly healthy Gluten Free diet involves more than just eliminating Gluten. It requires a focus on nutritional completeness, minimizing reliance on ultra-processed products, and meaningful attention to emotional and social well-being.

Make Our Children Healthy Again Assessment

When the White House released the Make Our Children Healthy Again Assessment on May 22, 2025, the MAHA Report declared that "the health of American children is in crisis" and cited that:

• "Between 1997 and 2018, childhood food‑allergy prevalence rose 88%."

• "Celiac disease rates have increased 5-fold in American children since the 1980s."

"Ultra-processed foods are driving our chronic disease epidemic. We must act boldly to eliminate the root causes of chronic illness and improve the health of our food supply. Defining ultra-processed foods with a clear, uniform standard will empower us even more to Make America Healthy Again." -- HHS Secretary Robert F. Kennedy, Jr. 

MAHA Report - The Food American Children are Eating

According to the MAHA Report, "Most American children's diets are dominated by ultra-processed foods (UPFs) high in added sugars, chemical additives, and saturated fats, while lacking sufficient intakes of fruits and vegetables. This modern diet has been linked to a range of chronic diseases, including obesity, type 2 diabetes, cardiovascular disease, and certain cancers. The excessive consumption of UPFs has led to a depletion of essential micronutrients and dietary fiber, while increasing the consumption of sugars and carbohydrates, which negatively affects overall health.

• Nearly 70% of an American child's calories today comes from ultra-processed foods (increased from zero 100 years ago), many of which are designed to override satiety mechanisms and increase caloric intake."

"I am delighted to lead this critical effort at the FDA. The threats posed to our health by foods often considered ultra-processed are clear and convincing, making it imperative that we work in lockstep with our federal partners to advance, for the first time ever, a uniform definition of ultra-processed foods." -- FDA Commissioner Marty Makary, M.D., M.P.H.

The MAHA Report's Definition of Ultra-Processed Foods

"While there is no single, universally accepted definition of UPFs, the term is most commonly associated with the NOVA food classification system, 'industrially manufactured food products made up of several ingredients (formulations) including sugar, oils, fats and salt and food substances of no or rare culinary use.' Food substances of no culinary use include additives such as flavors, colorants, non-sugar sweeteners, and emulsifiers. Although definitions vary, for the purposes of this [MAHA] assessment, UPFs refer broadly to packaged and ready-to-consume products that are formulated for shelf life and/or palatability but are typically high in added sugars, refined grains, unhealthy fats, and sodium and low in fiber and essential nutrients. Research suggests that the industrial processing required to create UPFs -- through additives and nutritional alterations -- is a key contributor to their harmful health effects in children."

"A closer examination of the statistics, particularly over time and in comparison with our global peers, reveals a troubling reality:

• Roughly 70% of the over 300,000 branded food products available in grocery stores today are ultra-processed.

• Over 50% of the calories consumed by Americans come from UPFs, while peer countries like Portugal, Italy, and France average UPF consumption rates of just 10–31%. Meanwhile, over 40% of Americans are obese, compared to less than 25% of the Portuguese, Italian, and French populations."

It's important to underscore that peer countries' consumption rates of UPFs range from 10-31% of calories consumed as compared with Americans who consume over 50% of their calories from UPFs (with American children consuming more than 70% of their calories from UPFs). Of those countries referenced above -- Portugal, Italy and France -- it's interesting to note that these same peer countries require the labeling of all Gluten containing grains.

As it pertains to the health and well-being of 3.3 million American Celiacs, it's time for the U.S. to catch up to the 87 other countries which require Gluten labeling, including Portugal, Italy and France. The U.S. is so far behind! The good news is that the United States can quickly catch up by implementing Jax's common sense solution to have Secretary Kennedy issue rulemaking to require the labeling of Gluten.

Journal of the American Medical Association

In an Opinion published in JAMA on the MAHA Commission Report and Diet-Related Diseases in Youth, Dr. Dariush Mozaffarian, Emily Callahan, and Dr. William Frist (former Senate Majority Leader) addressed the MAHA Report's focus on ultra-processed foods:

"This focus is pertinent and novel: prior federal reports, guidelines, and policies have generally considered nutrients, food groups, or diet patterns, but not processing. For example, highly processed grains are stripped of fiber, essential nutrients, and natural structure, producing adverse metabolic effects similar to those of sugars and exacerbating obesity, diabetes, and cardiovascular risk, a crucial insight for policy actions. Together, refined grains and added sugars represent approximately 1 in 3 calories in the national diet, with more calories from the former. Consumed in breads, breakfast cereals, desserts, bakery products, and snack foods, refined grains from wheat, rice, and corn are a major output of US agriculture, partly explaining prior reluctance to address them."

"An important caveat, however, is that not all ultraprocessed foods are created equal. They vary in how nutritious they are, and some ultraprocessed foods play an important role for vulnerable populations. For example, foods containing the slow-release carbohydrate sweetener sucromalt help people with diabetes prevent blood sugar spikes, and hypoallergenic infant formula can be lifesaving for infants that cannot digest milk at a young age." -- Dr. Paul Dawson, Clemson University 

Petition to Limit the Exposure of Refined Carbohydrates used in Industrial Processing in order to Prevent Obesity, Diabetes, and Cardiovascular Disease in Children and Adults

On 8/6/25, Dr. David A. Kessler, former FDA Commissioner, filed a Citizen Petition for the Trump Administration to address ultraprocessed foods by removing processed refined carbohydrates from the food supply on the basis that they should no longer be considered "Generally Recognized as Safe" (GRAS).

Dr. Kessler's petition "focuses on the regulatory status of the following substances: 1) refined sweeteners, including corn syrup, corn solids, glucose syrups, dextrose, invert sugar, xylose, maltose, and high fructose corn syrups; and maltodextrin 2) refined flour and starches that are subjected to food extrusion technology, including wheat, corn, tapioca, oat and potato flour, and starches that are processed by extraction or similar technology, and 3) sucrose, refined flours, or starches that are used with emulsifiers (e.g. mono- and diglycerides of fatty acids, DATEM, sodium stearoyl lactylate, polysorbates); dough conditioners and strengtheners (e.g. azodicarbonamide, L-cysteine, calcium peroxide); humectants (e.g. propylene glycol); stabilizers and gums (e.g. carboxymethylcellulose, methylcellulose); or modified starches and fillers (e.g. regelatinized starch, modified food starch, dextrins)."

According to Dr. Kessler's letter to Secretary Kennedy on 8/6/25,

"Just as nicotine causes millions to be addicted and sickened by tobacco, so do processed refined carbohydrates cause much of America's chronic disease. There is no expert consensus that refined carbohydrates in ultraprocessed foods are safe under present conditions of use. That leaves FDA with no choice but to determine that processed refined carbohydrates, as a matter of science and law can no longer be considered GRAS and thus must be removed from commerce. Mr. Secretary, the government has an opportunity, and a responsibility, to begin now the process of curbing processed refined carbohydrates in our food supply. On a larger scale, this petition triggers a remaking of the food supply. It will get companies to rethink and redesign the way they make food so that foods are not injurious to health."

If Secretary Kennedy granted Dr. Kessler's Citizen Petition, then the supply of ultraprocessed foods may contract, and that could negatively impact the Celiac community's access to products voluntarily labeled Gluten Free. To that end, we need the FDA to also grant Jax's Citizen Petition to require Gluten labeling with Barley, Rye and Oats as Major Food Allergens so that we know what products contain Gluten ingredients.

Back to the Future with FDA's 1985 Final Rule - Labeling Gluten Ingredients is More "Desirable" Than "Gluten Free" Labeling & Gluten Ingredients Must Be Declared on Food Labels

In 1985, the FDA issued a Final Rule affirming that "wheat gluten, corn gluten and zein are generally recognized as safe (GRAS) as direct human food ingredients" (Docket No: 82N-0259). Accompanying the FDA's Final Rule on Wheat Gluten, the FDA issued "Supplementary Information" that 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!

That was 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!

Common Sense Solution is Actionable Now

Following the MAHA Report Assessment, the Make Our Children Healthy Again Strategy (MAHA Report Strategy) will be released by August 12, 2025. The upcoming MAHA Report Strategy "shall address appropriately restructuring the Federal Government's response to the chronic childhood disease crisis, including by ending Federal practices that exacerbate the health crisis or unsuccessfully attempt to address it, and by adding powerful new solutions that will end childhood chronic disease." We respectfully call on HHS Secretary Robert F. Kennedy, Jr. to grant Jax's FDA Citizen Petition which presents a common sense solution with declaring Gluten as a Major Food Allergen and requiring the labeling of Gluten to better protect more than 729,000 American children with Gluten grain food allergies (FDA-2023-P-3942).

Additional Resources

"Gluten-Free Diet: Gaps and Needs for a Healthier Diet," Nutrients, Valentina Melini and Francesca Melini, 1/15/2019

"Navigating the Gluten-Free Boom: The Dark Side of Gluten Free Diet," Frontiers in Pediatrics, by Aaron Lerner, Thomas O'Bryan, Torsten Matthias, 10/15/2019

"Reasons to avoid the ultra-processed 'Free-From' aisle when you are gluten-free," Nature Doc, 6/25/2023