FDA requests information regarding labeling and preventing cross-contact of gluten in packaged foods

Background

The current allergen disclosure requirements, as well as regulation related to allergen cross-contact, are focused on the nine major food allergens, which are defined by Congress, and do not include gluten. Nonetheless, the gluten-containing “ingredients of interest” are subject to certain requirements under the current regulatory scheme in particular with respect to ingredient labeling and gluten-free claims. Below we provide high-level summary of how GCGs are regulated in the current landscape.

• Major Food Allergens. Wheat is a major food allergen and gluten is one of the major proteins found in wheat. Gluten from wheat falls within the definition of “major food allergen” and wheat is subject to a number of specific labeling and cross-contact requirements as a result. FDA acknowledges that only Congress can alter the list of major food allergens. Gluten, however, can be found in other grains such as barley, rye, and is commonly present in oats due to cross contact with wheat.
• FDA Authority for non-Major Food Allergens. Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), FDA has the authority to regulate the disclosure and labeling of non-major food allergens. The statute specifies that this authority applies to spices, flavorings, coloring, and incidental additives containing non-major allergens, and in a note Congress explains that this statutory authority should be understood to include all labeling of non-major food allergens, not just spices, flavorings, colors, and incidental additives.³ FDA relied on this statutory authority, in part, when it required cochineal extract to be declared by its “common or usual name, ‘cochineal extract’ or ‘carmine,’ in the statement of ingredients” because it can trigger an allergic reaction.⁴
• Ingredient Statement Disclosures. FDA’s labeling regulations require a food’s ingredients to be declared by their common or usual name in the ingredient statement. Because “flour” refers only to wheat flour, the presence of a non-wheat GCG flour is disclosed in the ingredient statement using the name of the grain (e.g., “barley flour,” “rye flour,” etc.). However, if gluten is present due to the use of a GCG in a spice, flavoring, coloring, or incidental additive, the presence of gluten is not required to be disclosed or subject to any special labeling requirements. For example, FDA notes that products containing malt extract or malt syrup can be derived from barley and this source would not need to be disclosed in the ingredient statement. Further, flavors, colors, and spices can in some cases be declared generically (e.g., “natural flavors”) without a requirement to disclose the source or common or usual name.
• Gluten-Free Claims. FDA has defined “gluten-free” claims for use in food labeling since 2013. Manufacturers can use the voluntary “gluten-free” claim when (1) the food does not contain a gluten containing grain or if the food contains a gluten containing grain, it is processed to remove gluten resulting in less than 20 parts per million (ppm) gluten; or (2) the food inherently does not contain gluten and any unavoidable presence of gluten is less than 20 ppm.⁵
• Allergen Cross-Contact Controls. FDA requires the implementation of allergen cross-contact controls as part of its good manufacturing practice (GMP) and Hazard Analysis and Risk-Based Preventive Controls regulations.⁶ These regulations only apply to cross-contact of major food allergens and therefore do not apply to the ingredients of interest at this time.

In January 2025, FDA published its Allergen Evaluation Guidance, which outlines the scientific factors and other information relevant to evaluating the public health importance of allergens not considered a major food allergen (non-listed food allergens). This guidance provides four scientific factors to consider when evaluating the public health importance of a non-listed food allergen, including (1) evidence of the food allergy, (2) prevalence of the allergen in the U.S. population, (3) severity of the allergy, and (4) the amount of the allergen required to cause a reaction. The agency’s questions in the RFI include questions tailored to assess the ingredients of interest against these factors.

FDA’s request for information

According to the RFI, FDA reviewed available data and reports, including recent reports by the Food and Agriculture Organization of the United Nations expert consultation, and concluded several data gaps limit the agency’s ability to fully evaluate the public health importance of these ingredients. The issued RFI is aimed at filling these gaps by requesting specific information and questions across four topics. The agency explains that it intends to use the requested information to inform what potential future regulatory action(s) FDA should take to better protect consumers with celiac disease. Below is a summary of these requests.

1. Data and information on IgE-mediated and non-IgE-mediated food allergies and adverse reactions to non-wheat GCGs, including data and information on the prevalence, severity, and potency of:
   1. Non-wheat GCGs causing IgE-mediated allergies or reactions in the United States.
   2. Clinically cross-reactive food allergies between wheat and non-wheat GCGs.
   3. Non-wheat GCGs causing non-IgE-mediated reactions in individuals with celiac disease or other food allergic conditions.
2. Data and information on gluten in oats and the prevalence, severity, and potency of IgE-mediated and non-IgE-mediated allergic and adverse reactions to oats, including:
   1. The extent to which oats (and other grains or ingredients) contain GCGs as a result of cross-contact and the amounts usually present.
   2. The prevalence, severity, and potency of adverse reactions due to pure or gluten-free oats alone or oats having cross-contact with GCGs.
   3. The extent to which oat products are labeled to indicate or not indicate the presence of GCGs.
   4. Potential challenges of requirements to eliminate, minimize, or label the presence of non-wheat GCGs in oat products.
3. Data and information on undisclosed ingredients of interest, including:
   1. Instances where ingredients of interest would be undisclosed on a food package and potentially cause an adverse reaction.
   2. The prevalence and severity of adverse reactions to undisclosed ingredients of interest in food products.
   3. Examples of undisclosed ingredients of interest in packaged or restaurant foods and the reason they were undisclosed (i.e., due to labeling practices, use as a processing aid, use as a color or spice, etc.).
   4. Potential challenges of requirements to label the presence of non-wheat GCGs and oats in foods that do not currently require their disclosure.
4. Data and information related to ingredients of interest and consumer perspectives and experiences, including:
   1. Studies regarding patient experiences regarding avoidance of certain foods containing ingredients of interest.
   2. Studies regarding consumer purchasing and consumption choices related to GCGs.

Next steps

It appears based on the nature of the information requested in the RFI that FDA intends to evaluate the relevant GCGs under the Allergen Evaluation Guidance and determine whether to issue regulations for these ingredients as non-listed allergens. This could potentially include requirements related to the labeling of these ingredients and/or guidance addressing gluten cross-contact under food safety plans that could require or prompt major changes in product labels and manufacturing practices. Comments and data related to the RFI must be submitted by March 23, 2026. We are available to assist with comments.

Authored by Veronica Colas, Martin Hahn, Elizabeth Fawell, and Erin Pannek.