U.S. FDA Issues Request for Information on Gluten Labeling and Cross-Contact in Packaged Foods

The U.S. Food and Drug Administration (FDA) has issued a Request for Information (RFI) seeking public input on labeling practices and the prevention of gluten cross-contact in packaged foods. This initiative represents an initial step by the agency to enhance transparency in ingredient disclosures that affect individuals with specific health conditions, particularly celiac disease and gluten sensitivities, as well as consumers with other established food allergies.

The action aligns with the Make America Healthy Again (MAHA) Strategy, which emphasizes improved transparency in food labeling. According to U.S. Health and Human Services Secretary Robert Kennedy Jr., consumers deserve clear and reliable information about food ingredients and manufacturing practices, especially when those ingredients may impact health conditions or diet-related allergies. The FDA’s request aims to support informed consumer choice, reduce harm, and strengthen public health protections.

Scope of the Request for Information

The FDA is seeking detailed information on adverse reactions and labeling challenges related to specific “ingredients of interest,” including:

Non-wheat gluten-containing grains (GCGs) such as rye and barley, and

Oats, due to their potential cross-contact with rye and barley during cultivation, processing, or handling.

The agency is particularly interested in understanding how these ingredients are currently identified—or not identified—on U.S. packaged food labels, and whether existing labeling practices adequately protect consumers with gluten-related disorders.

Key Information Requested by FDA

The RFI requests data and stakeholder input on several issues, including:

The prevalence of packaged food products where rye or barley may be present but not explicitly disclosed on labels;

The severity and potency of immunoglobulin E (IgE)-mediated allergic reactions associated with rye and barley;

Concerns related to gluten contamination in oats resulting from cross-contact; and

Any additional scientific, clinical, or consumer experience data relevant to these ingredients and their public health impact.

Regulatory Context and Data Gaps

The FDA has noted that it has already received a citizen petition on this topic and has reviewed available scientific literature, including findings from the Food and Agriculture Organization of the United Nations (FAO) expert consultations. However, the agency has identified significant data gaps, particularly a lack of robust U.S.-specific data on adverse reactions linked to the identified ingredients, which currently limits comprehensive public health risk evaluation.

FDA’s Next Steps

According to FDA Commissioner Marty Makary, M.D., M.P.H., individuals with celiac disease or gluten sensitivities often face uncertainty when selecting food products. The FDA is encouraging manufacturers, healthcare professionals, researchers, advocacy groups, and consumers to submit information and experiences to help shape future policy decisions. The agency intends to use the information gathered through this RFI to determine potential future regulatory actions, including possible updates to gluten-related labeling requirements, to better protect affected consumers.

How to Submit Comments

Stakeholders may submit comments within 60 days of the RFI publication through the following channels:

Electronic submissions:

Via the Federal eRulemaking Portal

Docket No. FDA-2023-P-3942

Written submissions:

Dockets Management Staff (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852, USA