Regulatory action? US FDA scrutinizes gluten warnings on food labels

The US FDA is gathering information to improve the disclosure of gluten ingredients in foods amid cases of inaccurate labeling. The move is part of the Make America Healthy Again (MAHA) directive and demands radical transparency in packaged food ingredients that affect health conditions and diet-related allergies.

This development could be seen as an early regulatory step. 

Although the FDA has not proposed new rules, it is gathering information to inform possible future legislation by issuing a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. 

Allergens and gluten-free diets

The FDA — which is developing a raft of policies that it says will better protect US consumers and support healthy food choices — says this request is to improve transparency in ingredient disclosures that affect certain health conditions, such as gluten for those with celiac disease, and other food allergens. 

Celiac disease is an autoimmune disorder in which eating gluten (a protein in wheat, barley, and rye) triggers the immune system to damage the small intestine, preventing proper nutrient absorption. It affects roughly 1% of the population, around 2–3 million people. But many more cases are thought to be undiagnosed. 

Cross-contamination can be a major issue for people with food allergies, as even tiny amounts of gluten (as little as 10–50 milligrams) can trigger an immune reaction that damages the small intestine.

The increase in food allergies, including celiac disease, is being highlighted by the Department of Health and Human Services under Secretary Robert F. Kennedy Jr. and the wider MAHA campaign.

A call for consumer feedback

The agency is seeking information on adverse reactions due to “ingredients of interest.” This includes non-wheat gluten-containing grains (GCGs), such as rye, barley, and oats, due to cross-contact with GCGs. They also want information on labeling issues or concerns with identifying these “ingredients of interest” on packaged food products in the country.

“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.”

Current regulations require companies to disclose nine major allergens on food labels (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame). However, there are issues here because consumers with celiac disease or those following a gluten-free diet are looking at ingredient lists for grains like rye and barley, which aren’t required unless a product is specifically labeled as “gluten-free.”

An FDA statement says: “We seek 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.” 

Going beyond packaged food

This RFI focuses on packaged food ingredient disclosure, but the implications ripple out into the foodservice arena, especially for menu items in restaurants that are marketed as being “gluten-free.” 

Current FDA rules on gluten-free labeling apply only to packaged foods, not restaurants.

Restaurants and cafes are not required by federal law to label items as gluten-free, though some states or localities may have guidance.

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