FDA Seeks Public Input on Gluten Labeling to Aid Individuals with Celiac Disease

The U.S. Food and Drug Administration (FDA) has initiated a public comment period to gather information on gluten ingredient disclosure and the prevention of gluten cross-contact in packaged foods. This move is a preliminary step by the agency to enhance transparency for consumers managing health conditions and allergies. The FDA is particularly interested in understanding adverse reactions linked to ingredients that can cause issues for individuals sensitive to gluten, specifically non-wheat gluten-containing grains such as rye and barley, as well as oats due to potential cross-contact.

The agency is soliciting feedback on current labeling practices and any concerns regarding the identification of these “ingredients of interest” on food products sold in the United States. This request stems in part from a citizen petition received by the FDA and a review of available data, including reports from expert consultations. This review has highlighted significant gaps in current data concerning the public health implications of these ingredients, particularly regarding the extent of adverse reactions in the U.S. population.

The FDA is looking for detailed information on various aspects of rye and barley consumption and labeling. This includes the prevalence of products where rye or barley are not currently disclosed to consumers, the severity and potency of allergic reactions mediated by immunoglobulin E to these grains, and any issues related to the gluten content of oats due to cross-contamination during processing. The ultimate goal of this information gathering is to better inform the FDA’s priorities for gluten-related labeling and to guide potential future regulatory actions. By understanding the scope of these issues, the agency aims to develop policies that offer improved protection for consumers with celiac disease and other gluten sensitivities, thereby supporting healthier food choices.

The public has 60 days to submit comments. Electronic submissions can be made through the Federal eRulemaking Portal by referencing Docket No. FDA-2023-P-3942. Written comments should be mailed to the Dockets Management Staff (HFA-305) at the Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, also referencing Docket No. FDA-2023-P-3942. Confidential submissions should be clearly marked as such.

Article by Mel Anara, based upon information from the U.S. Food and Drug Administration

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