WASHINGTON, D.C. — The U.S. Food and Drug Administration is moving on two fronts to strengthen consumer protection, launching a public review of gluten labeling practices while reporting sharp gains from a new program designed to keep unsafe imported products out of the country.
On January 21, the FDA issued a Request for Information seeking public input on how gluten and gluten cross-contact are labeled on packaged foods, a step the agency said is aimed at improving transparency for people with celiac disease, gluten sensitivities, and other food-related health conditions.
The agency is asking for data on adverse reactions linked to non-wheat gluten-containing grains such as rye and barley, as well as oats that may be contaminated through cross-contact. Officials said they are particularly interested in gaps where these ingredients may not be clearly disclosed on labels, along with information on the severity and prevalence of allergic or immune responses.
Health and Human Services Secretary Robert F. Kennedy Jr. said the effort advances the administration’s Make America Healthy Again strategy by demanding clearer disclosure of ingredients that affect health and diet-related allergies.
FDA Commissioner Marty Makary said people with celiac disease or gluten sensitivities are often forced to guess about food safety, and urged stakeholders to share data and real-world experiences to help guide future policy decisions. The agency said its review has identified significant data gaps, including limited U.S. information on adverse reactions tied to these ingredients.
Comments may be submitted for 60 days through the Federal eRulemaking Portal at https://www.regulations.gov under Docket No. FDA-2023-P-3942, or by mail to the FDA’s Dockets Management Staff in Rockville, Maryland.
In a separate announcement the same day, the FDA released its initial assessment of the FDA ImportShield Program, a modernization initiative launched in August 2025 to overhaul how imported products are reviewed. In its first four months, the program increased processing speed by 66 percent, expanded monthly capacity by 33 percent, and cut staff hours by about 20 percent, saving roughly 3,388 hours each month.
ImportShield consolidated five regional import review teams into a single national operation, providing uniform oversight across all U.S. ports of entry. The centralized system allows the FDA to issue real-time alerts nationwide when high-risk products such as contaminated food or counterfeit drugs are detected at any port, preventing similar shipments from entering elsewhere.
Associate Commissioner for Inspections and Investigations Elizabeth Miller said the changes are critical as the FDA’s import workload has surged, with admissibility decisions rising from 58 million lines in 2024 to 75 million in 2025.
FDA officials said ImportShield is part of a broader technology modernization effort, including a new integrated review platform that will allow investigators faster access to multiple databases while maintaining coordination with U.S. Customs and Border Protection.
Together, the actions reflect what the agency described as an intensified focus on food transparency and border safety, using public input and technology upgrades to better protect American consumers.
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