And Why the Celiac Disease Foundation’s Global Leadership Helped Make This Moment Possible
Today, the U.S. Food and Drug Administration (FDA) announced a major step toward improving how gluten and gluten cross-contact are addressed on packaged food labels. The agency issued a Request for Information (RFI) focused on labeling and preventing cross-contact of gluten in packaged foods, an early but meaningful move toward greater transparency for people with celiac disease.
For our celiac community, this announcement reflects years of sustained advocacy, scientific leadership, and global collaboration, work the Celiac Disease Foundation has actively driven in the United States and internationally. Our patients, families, clinicians, and advocates have elevated the profile of celiac disease with congressional offices and federal agencies by sharing real-world experiences, participating in briefings, and pushing for policies grounded in science and lived experience. That collective effort has helped move celiac disease from the margins of food policy discussions to the center, creating the conditions for opportunities like this FDA action.
In the RFI, the FDA is asking for data and real-world experiences related to adverse reactions and labeling challenges involving what it calls “ingredients of interest.” These include:
- Rye and barley, which contain gluten but are not required to be declared as allergens under current U.S. law
- Oats, which are naturally gluten-free but frequently affected by gluten cross-contact
The agency is seeking information on:
- How often rye or barley may be present in foods without clear disclosure
- The severity and public health impact of reactions to rye and barley
- Ongoing concerns about gluten cross-contact in oats
Importantly, the FDA acknowledged that serious data gaps exist, particularly around adverse reactions in the U.S., a reality our celiac community has been advocating around for years. FDA Commissioner Marty Makary, M.D., M.P.H., captured this clearly, noting that people with celiac disease have long been forced to “tiptoe around food” and guess about safety. This RFI is an opportunity for patients, families, clinicians, researchers, and industry to shape what comes next.
This FDA action also follows an important international scientific milestone, one the Celiac Disease Foundation helped bring to the forefront. Last month, the Food and Agriculture Organization (FAO) of the United Nations and World Health Organization released new recommendations to reduce confusion around precautionary gluten labeling, such as “may contain gluten,” while reaffirming that the global gluten-free standard of less than 20 ppm remains appropriate and protective for people with celiac disease. That progress was reinforced when the Celiac Disease Foundation was invited to serve on the U.S. delegation at the 48th Session of the Codex Committee on Food Labelling (CCFL48), where our advocacy elevated gluten cross-contact and the need for celiac-specific reference doses within Codex discussions that helped prompt FAO and WHO to convene expert consultations, informing the recent international guidance.
Over the past year, the Foundation has led coordinated efforts with international partners at the Association of European Celiac Societies, the International Society for the Study of Celiac Disease, and global scientific experts to ensure that gluten and celiac disease were explicitly addressed in risk-based labeling discussions. This leadership helped advance the development of a celiac-specific reference dose for gluten, a long-missing scientific tool to guide when precautionary labels are warranted. One key outcome of this work is clearer separation between “gluten-free” and “may contain” labels, helping ensure that gluten-free claims remain meaningful and trustworthy worldwide.
The United States does not currently use precautionary allergen labeling for gluten. However, the FDA’s new RFI signals that the agency is actively evaluating how gluten cross-contact, oats, rye, and barley should factor into future labeling policy, informed in part by emerging global science and advocacy. By explicitly citing data gaps and seeking public input, the FDA is laying the groundwork for science-based, celiac-specific regulatory action.
This FDA announcement is an important first step, not a final decision. Any regulatory changes will take time. But the direction is clear: transparency, science, and lived experience are finally being brought together.
The Celiac Disease Foundation will be submitting formal comments to the FDA in response to this Request for Information, informed by the latest science, global regulatory developments, and the lived experiences of people with celiac disease. As a recognized leader in the space, the Foundation’s goal is to ensure that any future labeling policies are clear, evidence-based, and truly protective of the celiac community. The Foundation will share our submitted comments publicly once they are available and will continue to keep the community informed as this process moves forward.
Want to get involved?
Share your experience with the FDA by taking this brief survey: Consumer Perspectives on Gluten Avoidance, Purchasing Decisions, and Food Labeling