Regulatory Watch
FDA Requests Information on Gluten Labeling

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 says it 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,” says Health and Human Services Secretary Robert Kennedy Jr. “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 to “ingredients of interest,” including non-wheat gluten-containing grains (GCGs) such as rye and barley, as well as oats due to cross-contact with GCGs. The FDA seeks information 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 sensitivities have had to tiptoe around food, and are often forced to guess about their food options,” says 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 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 says there are data gaps limiting its 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 inform its 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.
The FDA is accepting public comments through March 23.
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