Dive Brief:
- The FDA has taken a step toward requiring food manufacturers to disclose when their products contain gluten or other established food allergens.
- The agency is asking for more information from stakeholders to determine how to improve food labeling transparency for products containing gluten.
- The FDA is requesting data on adverse reactions to ingredients, including rye, barley and other non-wheat gluten-containing grains. It is also looking for information on how often food companies currently disclose when products contain gluten.
Dive Insight:
Gluten disclosures were among the few concrete policy proposals outlined in the Trump administration's "Make America Healthy Again" report last fall, which defined the White House's top priorities in addressing chronic childhood diseases. The strategy focused heavily on ingredient transparency, which signaled potential action on ultraprocessed foods or front-of-the-pack nutrition labels.
“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 in a statement. “Americans deserve clear, reliable information about what’s in their food and how it’s made."
In the U.S., companies are only required to disclose when products have one of nine major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans and sesame.
Rye and barley are not included in that list, leaving consumers with celiac disease or on gluten-free diets "to tiptoe around food,” and “forced to guess about their food options,” FDA Commissioner Marty Makary said in a statement.
The FDA said that "serious data gaps" have hindered its ability to craft regulation, including a lack of information on issues related to cross-contamination. The agency has asked for data on the gluten content of oats due to cross-contact.
The transfer of allergens is a major question for regulators in crafting policy. Many food products don't contain gluten, but may have been processed in a facility that also handles gluten-based ingredients. As a result, food companies often use the voluntary disclosure "may contain gluten" out of an abundance of caution, though the label has come under criticism for being overused and potentially confusing consumers.
In November, the Food and Agriculture Organization and the World Health Organization released new guidance setting thresholds for when companies should use the "may contain" label. The organizations reaffirmed that foods with no more than 20 parts per million of gluten can be called gluten-free. But products do not need the “may contain” label if accidental gluten in a single serving of a food does not exceed 4 milligrams.
In a statement, the Celiac Disease Foundation called the FDA's request for information an "early but meaningful move toward greater transparency."
"This FDA announcement is an important first step, not a final decision," the foundation added. "But the direction is clear: transparency, science, and lived experience are finally being brought together.”
