FDA issues Request for Information to shape future gluten labeling regulations

A new announcement from the US Food and Drug Administration (FDA) explains how the agency is aiming to increase transparency surrounding food labels and gluten.¹ The move is intended to adjust labeling practices and prevent cross-contamination of gluten in packaged foods, a January 21, 2026, press release explains, as a first step in the larger goal to improve transparency surrounding food allergens and ingredients that affect health conditions, such as celiac disease.

This move is in line with the Make America Healthy Again (MAHA) goals, Health and Human Services Secretary Robert Kennedy Jr. explains in the press release. “Today, we advance the MAHA Strategy’s directive by demanding radical transparency in packaged food ingredients that affect health conditions and diet-related allergies,” he stated. “Americans deserve clear, reliable information about what’s in their food and how it’s made. Public input calling for honest labeling will protect consumers, prevent harm, and Make America Healthy Again.”

The FDA’s Request for Information

The FDA issued a Request for Information (RFI) on adverse reactions from “ingredients of interest,” which are considered non-wheat gluten-containing grains (GCGs) including rye, barley, and oats that are cross-contact with GCGs. Specifically, the FDA is gathering information on the prevalence of products that do not disclose rye or barley contents, the severity of immunoglobulin E-mediated food allergy to rye and barley, concerns surrounding the gluten content of cross-contaminated oats, and related questions.

The RFI also requests input on labelling issues and concerns about identifying the “ingredients of interest” on US packaged foods.

“People with celiac disease or gluten sensitives have had to tiptoe around food, and are often forced to guess about their food options,” stated FDA Commissioner Marty Makary, M.D., M.P.H. “We encourage all stakeholders to share their experiences and data to help us develop policies that will better protect Americans and support healthy food choices.”

After receiving a citizen petition and reviewing available data, including reports from the Food and Agriculture Organization of the United Nations, the FDA had concluded that data gaps, including limited US information on adverse reactions to the “ingredients of interest,” are currently preventing a full evaluation of their public health importance.

Regulation and future actions

The information collected by the FDA in the RFI will be used to advise the agency’s labeling priorities related to gluten, and to inform future regulations to increase protections for individuals with celiac disease.

The RFI is scheduled to be published on January 22, 2026. Comments can be submitted electronically to the Federal eRulemaking Portal to Docket No. FDA-2023-P-3942, or by mail. The portal will be open for 60 days.

The FDA currently has labeling options for foods that do not contain gluten. Food manufacturers are able to include, on a voluntary basis, a label claim for “gluten free” foods.² Since 2014, the FDA has required foods with “gluten-free” label claim on its package meet specific standards—which are enforced by the FDA—including a requirement that the food contain less than 20 parts per million (ppm) of gluten.

Citizen petition on gluten as an allergen

The citizen petition, submitted by Jonathan H. Bari on behalf of the patient advocacy organization Celiac Journey, was originally posted by the FDA on September 14, 2023.^3,4 The 172-page document argues for the labeling of gluten as a major food allergen on all US packaged foods. Currently, wheat is required to be included on labels, though gluten is also found in barley, rye, and most oats, it explains. The petition also includes an analysis of how the lives millions of people in the US with celiac disease are impacted and how new labelling requirements on packaged foods would help protect this community.

References

US Food and Drug Administration. FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods. January 21, 2026. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-improve-gluten-ingredient-disclosure-foods (Accessed 2026-01-21).
US Food and Drug Administration. Gluten and Food Labeling https://www.fda.gov/food/nutrition-education-resources-materials/gluten-and-food-labeling (Accessed 2026-01-21).
US Food and Drug Administration. Citizen Petition from Jonathan H. Bari on behalf of Celiac Journey. September 14, 2023. https://www.regulations.gov/document/FDA-2023-P-3942-0001 (Accessed 2026-01-21).
Jonathan H. Bari. Citizen Petition for The Labeling of Gluten as a Major Food Allergen. (Accessed 2026-01-21)