FDA Seeks Comments on Hidden Gluten, Other Grain Sensitivities

The FDA today (Jan. 21) issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. In particular, the agency is seeking information on adverse reactions to products with grains that shouldn’t be carrying wheat-containing gluten.

The “ingredients of interest” are non-wheat gluten containing grains, which are rye and barley, plus oats due to cross-contact with wheat gluten. Ultimate actions might be labeling issues or concerns with identifying these ingredients on packaged food products in the U.S.

“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. “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.”

The agency is responding to a citizen petition on this matter and has reviewed available data and reports. The FDA’s review of this information indicates there are several serious data gaps limiting the agency’s ability to fully evaluate the public health importance of these ingredients.

The FDA seeks detailed information such as 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 and other issues.

Comments can be submitted via the federal eRulemaking Portal (Regulations.gov) to Docket No FDA-2023-P-3942 (which will be open for 60 days), or written comments can be mailed to Dockets Management Staff (HFA-305); Food and Drug Administration; 5630 Fishers Lane, Rm. 1061; Rockville, MD 20852. Indicate comments are for Docket No. FDA-2023-P-3942.