FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods

Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food.

FDAOffice of the Commissioner

Background on Gluten and Current Regulations

Gluten is a family of proteins found in wheat, rye, and barley that gives dough its elastic texture. For the millions of Americans with celiac disease—an autoimmune disorder triggered by gluten—or with non-celiac gluten sensitivity, consuming even trace amounts can lead to serious health consequences. These range from damaging the small intestine and impairing nutrient absorption to causing symptoms like chronic pain, fatigue, and skin rashes.

To assist these consumers, the U.S. Food and Drug Administration (FDA) established a "gluten-free" labeling rule in 2013. This regulation stipulates that any packaged food bearing a "gluten-free" claim must contain less than 20 parts per million (ppm) of gluten, a threshold generally recognized as safe for most individuals with celiac disease. Importantly, this rule is a voluntary standard for manufacturers; it does not mandate that all foods be gluten-free. Furthermore, it only applies to foods making a "gluten-free" claim. For other products, the disclosure of gluten-containing ingredients like rye and barley is less stringent, creating potential gaps in consumer safety information.

FDA's New Initiative for Improved Gluten Disclosure

On January 21, 2026, the FDA announced a pivotal step toward improving food safety and transparency for individuals with gluten-related disorders. The agency has issued a formal Request for Information (RFI) to gather critical data from the public, researchers, and industry stakeholders. This action represents the FDA's first move in a broader initiative to enhance the disclosure of ingredients that impact health conditions, with a specific focus on gluten.

The primary goal of this RFI is to address significant data gaps in public health understanding. While wheat is a major food allergen that must be declared on labels under U.S. law, other gluten-containing grains like rye and barley do not share the same mandatory disclosure status. The FDA is seeking detailed information on several key issues:

• The prevalence of products where rye or barley ingredients are not clearly disclosed on labels.
• The severity and nature of adverse reactions to these grains, including IgE-mediated food allergies (distinct from celiac disease).
• Concerns regarding oats, which are naturally gluten-free but are frequently contaminated with gluten-containing grains like wheat during growing and processing.

This initiative is driven in part by a citizen petition and a review of international reports, which highlighted the limitations of current U.S. data. As FDA Commissioner Dr. Marty Makary stated, "People with celiac disease or gluten sensitivities have had to tiptoe around food, and are often forced to guess about their food options."

How to Participate and What Happens Next

The FDA is actively encouraging all stakeholders—including consumers, healthcare professionals, researchers, and the food industry—to share their experiences and scientific data. Submissions will be accepted for 60 days through the following channels:

• Electronic Submissions: Via the Federal eRulemaking Portal at Docket No. FDA-2023-P-3942.
• Written Submissions: Mailed to the FDA's Dockets Management Staff in Rockville, MD.

The information collected will be instrumental in shaping the agency's future regulatory actions. Potential outcomes could range from updated guidance for the food industry to the development of new rules requiring mandatory allergen-like labeling for rye and barley, or establishing clearer standards for oats labeled as gluten-free.

This move aligns with the "Make America Healthy Again" (MAHA) Strategy's emphasis on "radical transparency" in packaged foods, as noted by Health and Human Services Secretary Robert Kennedy Jr. By closing the existing information gaps, the FDA aims to empower consumers to make safer, healthier choices and better protect vulnerable populations from preventable harm.

Summary of Key Points