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

“Today, we advance the MAHA Strategy’s directive by demanding radical transparency in packaged food ingredients that affect health conditions and diet-related allergies,” Health and Human Services Secretary Robert Kennedy Jr. said. “Americans deserve clear, reliable information about what’s in their food and how it’s made. Public input calling for honest labeling will protect consumers, prevent harm, and Make America Healthy Again.”

The agency is seeking information on adverse reactions due to “ingredients of interest” (i.e., non-wheat gluten containing grains (GCGs) which are rye and barley, and 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.

“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.”

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

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 questions related to these issues.  

The FDA is taking this action to help enhance transparency for consumers and inform the agency’s gluten-related labeling priorities and next steps. The FDA intends to use the information to support a determination on what type(s) of future regulatory actions we should take to better protect consumers with celiac disease.

How to Submit Comments

Electronic Submissions

Comments can be submitted via the Federal eRulemaking Portal to Docket No FDA-2023-P-3942 (open for 60 days).

Follow the instructions for submitting comments.  

Written Submissions

Written comments may be mailed to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Please ensure that all comments include Docket No. FDA-2023-P-3942. Confidential submissions should be appropriately marked.

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