Is Gluten an Allergen in the USA?

November 27, 2025 •

4 min read

Celiac disease affects about 1% of the U.S. population and is an autoimmune condition caused by gluten. The question of whether gluten is an allergen in the USA involves different medical conditions and distinct immune responses, symptoms, and diagnoses.

Quick Summary

This article explains if gluten is an allergen in the U.S., detailing the differences between wheat allergy, celiac disease, and non-celiac gluten sensitivity. It covers how each condition involves different immune responses and affects diagnosis, treatment, and food labeling.

Key Points

Gluten is not a major allergen in the USA under federal law: Wheat is a major allergen that must be labeled, but gluten found in grains like barley and rye is not subject to the same mandatory labeling regulations.
Celiac disease is an autoimmune condition, not a food allergy: Unlike a wheat allergy, which is an immediate IgE-mediated response, celiac disease is a chronic autoimmune disorder that damages the small intestine upon gluten ingestion.
Non-Celiac Gluten Sensitivity (NCGS) is diagnosed by exclusion: This condition affects people who react to gluten but do not have celiac disease or a wheat allergy. Diagnosis relies on eliminating other possibilities and confirming symptom improvement on a gluten-free diet.
FDA regulates voluntary "gluten-free" labeling: Food manufacturers can voluntarily label products as "gluten-free," but they must meet FDA criteria, including containing less than 20 parts per million (ppm) of gluten.
Precise diagnosis is crucial for managing gluten-related disorders: Self-diagnosing can be misleading. Proper medical testing is essential to determine the correct condition and ensure the right long-term management plan, as treatments for a wheat allergy, celiac disease, and NCGS differ.
A strict gluten-free diet is the only treatment for Celiac Disease: For those with celiac disease, lifelong adherence to a gluten-free diet is the sole way to manage the condition and allow the small intestine to heal.

Understanding the Distinction: Allergy vs. Autoimmunity

In the United States, the Food and Drug Administration (FDA) requires major food allergens to be on food labels. Although wheat is considered a major allergen, gluten itself is not legally required to be labeled in the same way. This difference can confuse people managing their diets.

The main difference is between a true food allergy and an autoimmune disorder, like celiac disease. Food allergies involve an immediate, IgE-mediated immune response to a specific protein. In wheat allergies, this reaction isn't always to gluten, and severe cases can cause anaphylaxis. Celiac disease is a chronic autoimmune condition where gluten causes the immune system to attack the small intestine, leading to damage (villous atrophy) and health issues.

The Three Conditions: Wheat Allergy, Celiac Disease, and NCGS

Understanding the differences between wheat allergy, celiac disease, and non-celiac gluten sensitivity (NCGS) is important for diagnosis and management.

Wheat Allergy: This is an IgE-mediated allergy to wheat proteins, that may cause rapid, severe reactions like anaphylaxis. Symptoms include hives, swelling, and breathing problems. People with a wheat allergy may be able to tolerate gluten from other grains without wheat proteins.
Celiac Disease: An autoimmune disorder where gluten ingestion prompts the immune system to attack the small intestine, causing damage and poor nutrient absorption. Symptoms include digestive issues, fatigue, anemia, and joint pain. The only treatment is a strict, lifelong gluten-free diet.
Non-Celiac Gluten Sensitivity (NCGS): Individuals with NCGS react negatively to gluten, but do not have celiac disease or a wheat allergy. The cause and diagnostic markers are not fully understood. Diagnosis involves ruling out other conditions and observing symptom improvement on a gluten-free diet. Symptoms often mirror celiac disease but without intestinal damage.

The Role of the FDA and Food Labeling

The FDA requires labeling for wheat as a major allergen, but not for gluten in grains like barley and rye. This poses a risk for individuals with celiac disease who must avoid all gluten. The FDA regulates voluntary "gluten-free" labeling, requiring products to contain less than 20 ppm of gluten. This doesn't cover all gluten sources.

Commonly Confused Terms in Gluten-Related Disorders


Feature	Wheat Allergy	Celiac Disease	Non-Celiac Gluten Sensitivity (NCGS)
Immune Response	IgE-mediated allergic reaction to wheat protein(s)	Autoimmune response where immune system attacks small intestine	Non-autoimmune, non-allergic immune response (less understood)
Intestinal Damage	None	Damage to the intestinal villi (villous atrophy)	None
Symptom Onset	Typically minutes to hours after ingestion	Hours to days after ingestion	Hours to days after ingestion
Potential Severity	Can be life-threatening (anaphylaxis)	Life-long chronic illness with potential long-term complications	Can be debilitating but is not life-threatening
Diagnosis	Skin prick or blood test by an allergist	Blood test for antibodies, followed by intestinal biopsy	Diagnosis of exclusion; confirmed by dietary trial
Treatment	Avoidance of wheat; emergency epinephrine for severe reactions	Strict, lifelong gluten-free diet	Symptom improvement through dietary reduction or elimination of gluten

Diagnosis: A Necessary First Step

Accurate diagnosis by a healthcare professional is vital due to overlapping symptoms. Self-treating with a gluten-free diet before testing can hinder celiac disease diagnosis. A gastroenterologist can perform blood tests and biopsies for celiac disease, an allergist can test for wheat allergy, and NCGS is diagnosed through a supervised elimination diet.

Navigating a Gluten-Free Lifestyle

For those with celiac disease or NCGS, a strict gluten-free diet is essential. This means avoiding obvious sources and hidden gluten in processed foods, dressings, and sauces. Preventing cross-contamination is also crucial. Reading labels and understanding the FDA's "gluten-free" standard is important. Consulting a registered dietitian specializing in celiac disease can help ensure a nutritious, gluten-free diet.

Conclusion

In the U.S., gluten itself is not a legally mandated allergen, unlike wheat. The health issues related to gluten stem from three conditions: wheat allergy, celiac disease, and NCGS, each with distinct causes, diagnoses, and treatments. While avoiding gluten is medically necessary for celiac disease and NCGS, identifying the specific condition is key to proper management and long-term health.

The Call for Clearer Labeling

Advocacy groups are pushing for stronger U.S. labeling laws to protect individuals with celiac disease. They argue that the current system, which labels wheat but not other gluten-containing grains, endangers celiac patients. Mandatory labeling for all gluten sources, similar to regulations in other nations, would improve safety for millions. While voluntary "gluten-free" labeling is helpful, it doesn't cover all products. This remains a critical issue for the celiac community and those with NCGS.

Consumers Union: Comments on FDA Citizen Petition to Label Gluten as a Major Allergen

Frequently Asked Questions

No, they are not the same for allergen labeling. In the U.S., wheat is classified as a major food allergen, requiring mandatory labeling. However, gluten itself, including that found in barley and rye, is not on the mandatory allergen list.

Celiac disease is a chronic autoimmune condition where gluten damages the small intestine. A wheat allergy is a classic IgE-mediated allergic reaction to wheat proteins that can cause immediate, sometimes life-threatening symptoms.

NCGS is diagnosed by exclusion, meaning a doctor rules out celiac disease and wheat allergy first. The diagnosis is confirmed if symptoms improve on a gluten-free diet and return when gluten is reintroduced.

Yes, it is highly recommended to get tested before starting a gluten-free diet. The blood tests for celiac disease require active gluten consumption to be accurate, and going gluten-free prematurely can lead to a missed or delayed diagnosis.

The FDA's 'gluten-free' rule is voluntary but provides a clear standard. For a product to bear this label, it must contain less than 20 parts per million (ppm) of gluten. This standard helps consumers with gluten sensitivities and celiac disease identify safe products.

Symptoms can vary greatly but often include digestive issues like bloating, diarrhea, and abdominal pain. Other manifestations can include fatigue, headaches, joint pain, anemia, and 'brain fog,' depending on the specific condition.

Not necessarily. While a wheat allergy is specific to wheat proteins, some of those proteins are also part of the gluten complex. A person with a wheat allergy should consult an allergist to determine their specific triggers and discuss the safety of consuming other gluten-containing grains like barley and rye.