FDA seeks industry input on stricter gluten labelling transparency

The US Food and Drug Administration (FDA) has launched a Request for Information (RFI) to tighten gluten labelling and boost ingredient transparency on packaged foods, as it ramps up protections for consumers with coeliac disease and food allergies.

Announced this week in Washington, the move marks an early step in strengthening labelling rules and preventing cross-contact with gluten-containing grains.

The FDA is calling on manufacturers, health professionals and consumers to submit evidence on adverse reactions, labelling challenges and data gaps linked to non-wheat gluten sources.

Health and Human Services Secretary Robert Kennedy Jr. said the initiative reflects a tougher stance on ingredient transparency.

Today, we advance the MAHA Strategy’s directive by demanding radical transparency in packaged food ingredients that affect health conditions and diet-related allergies.

Americans deserve clear, reliable information about what’s in their food and how it’s made. Public input calling for honest labelling will protect consumers, prevent harm, and Make America Healthy Again.”

The FDA is particularly seeking insight on rye and barley – which contain gluten but are not always clearly declared – as well as oats, which can be contaminated through cross-contact. It is also asking for data on the prevalence of undisclosed gluten-containing grains, the severity of allergic reactions, and the reliability of current labelling practices.

FDA commissioner Marty Makary added:

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

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 already reviewed a citizen petition alongside international evidence, including recent findings from the Food and Agriculture Organization of the United Nations. However, it says limited US-specific data is restricting its ability to fully assess public health risks.

Responses to the RFI will inform future regulatory action on gluten labelling. The FDA is accepting comments for 60 days via the Federal eRulemaking Portal under Docket No FDA-2023-P-3942, or by mail.