The U.S. Food and Drug Administration issued a Request for Information (RFI) on January 21 regarding labeling and preventing cross-contact of gluten in packaged foods. FDA aims to improve transparency in the disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.

FDA is seeking information on adverse reactions due to "ingredients of interest" [i.e., non-wheat gluten-containing grains (GCGs), such as rye and barley, as well as oats due to cross-contact with GCGs] and on labeling issues or concerns with identifying these ingredients of interest on packaged food products in the U.S.

The agency has received a citizen petition on the matter and has reviewed available data and reports, including the most recent reports by the Food and Agriculture Organization of the United Nations (FAO) expert consultation. FDA's review of this information indicates that there are several serious data gaps limiting the agency's ability to fully evaluate the public health importance of these ingredients, which include limited U.S. data on adverse reactions to ingredients of interest.

FDA is seeking detailed information on these ingredients including:

• The prevalence of products where rye or barley are not currently disclosed
• Information on the severity of and potency of immunoglobulin E-mediated food allergy to rye and barley
• Concerns around the gluten content of oats due to cross-contact
• Other questions related to these issues.  

"People with celiac disease or gluten sensitives have had to tiptoe around food, and are often forced to guess about their food options," said 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."

FDA intends to use the information to support a determination on the future regulatory actions it should take to better protect consumers with celiac disease. Comments on the RFI can be submitted through the Federal eRulemaking Portal to Docket No. FDA-2023-P-3942. The comment period is open for 60 days.