/>i- Today FDA announced that it has issued a pre-publication version of a request for information (RFI) regarding labeling and prevention of cross-contact of gluten in packaged foods.
- FDA’s action is in response to a citizen petition that asks FDA to take certain steps to better protect consumers with celiac disease and other sensitivities or intolerances from exposure to gluten (from wheat, barley, rye, and oats) in the diet. The petition itself asks FDA to (1) undertake rulemaking to require that all ingredients with gluten be listed by name in the ingredient lists of all foods, and (2) add gluten to the list of allergens in Section 555.250 of FDA’s Compliance Policy Guide entitled “Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens.”
- The RFI includes requests for information on prevalence, severity, and potency of reactions to non-wheat containing gluten products (wheat is already a major food allergen), data and information on gluten in oats (which the petitioner asserts is often contaminated with gluten from other grains), and data and information on undisclosed ingredients of interest (i.e., ingredients which may be labeled in a way that does not reveal the gluten-containing source).
- We note that celiac disease itself is not an IgE-mediated food allergy, and in contrast with IgE-mediated reactions, it elicits a delayed hypersensitivity reaction. See e.g. Celiac disease | Food Allergy Research & Resource Program | Nebraska.
- USDA’s Food Safety and Inspection Service (FSIS) has also shown increased awareness of gluten in the food supply and its latest version of FSIS Directive 7230.1 (“Ongoing Verification of Product Formulation and Labeling Targeting the Nine Most Common (‘Big 9’) Food Allergens”), published in September 2025, adds gluten as an ingredient for which FSIS will be verifying that establishments are accurately controlling and labeling.
- Comments on FDA’s RFI will be due 60 days after the date of publication in the Federal Register (with publication expected tomorrow, January 22, 2026).
FDA Issues RFI on Gluten-Cross Contact Issues
Wednesday, January 21, 2026
Current Public Notices
Published: 9 February, 2026
Published: 2 February, 2026
Published: 2 February, 2026
Published: 27 January, 2026
Published: 26 January, 2026
Published: 19 January, 2026
Published: 15 January, 2026
Published: 13 January, 2026
Published: 13 January, 2026
Current Legal Analysis
More from Keller and Heckman LLP
Upcoming Events
Feb
12
2026
Feb
12
2026
