Industry groups, certification bodies and regulatory experts broadly welcomed the last week’s Request for Information (RFI) from FDA on the labeling and prevention of gluten cross-contact in packaged foods, framing it as a meaningful step toward addressing long-standing gaps that affect individuals managing celiac disease and gluten-related disorders.
The RFI follows a September 2023 citizen petition filed by Jonathan Bari, co-founder of celiac disease awareness and education group Celiac Journey, that expressed concern that existing labeling rules may not fully encompass the public health risks posed by less obvious gluten sources and cross-contact during processing – an issue with implications for an estimated three million people in the US living with celiac disease.
The petition specifically asks that all gluten sources, including wheat, barley, rye and oats that have been cross-contaminated with gluten during manufacturing, be clearly listed by name on product labels, and that gluten be added to the major allergen list to ensure cross-contact controls.
Consumer and public health advocates behind the petition highlighted that current rules leave a gap: While wheat must be disclosed, barley and rye can appear under umbrella terms such as “malt extract,” “flavorings” or “spices,” making it difficult for consumers with celiac disease or gluten sensitivities to reliably avoid gluten.
The petition prompted the FDA to seek additional data and public input on the potential public health impact of these less obvious gluten sources and cross-contact during processing.
The regulatory gap around non-wheat gluten
Under the FDA’s 2013 Gluten-Free Labeling Final Rule, companies that voluntarily use a “gluten free” claim must ensure products contain less than 20 parts per million of gluten.
However, wheat is the only gluten-containing grain classified as a major food allergen, requiring explicit disclosure. Barley and rye, by contrast, may appear under umbrella terms such as “malt extract,” “flavorings” or “spices,” creating what food and agriculture testing and consulting firm Food & Ag Lab described as a regulatory gap that makes it difficult for consumers to reliably identify and avoid gluten-containing grains.
What the FDA’s RFI is asking now
The FDA’s current RFI seeks scientific data and public input to better understand the scope and impact of these gaps. The agency is requesting information related to reactions caused by non-wheat gluten sources, such as barley and rye, the extent of gluten cross-contact associated with oats during processing, and the challenges consumers face when gluten is in additives or processing aids.
Food & Ag Lab characterized the effort as an early but potentially meaningful step toward more transparent labeling, noting that the citizen petition behind the RFI calls for all gluten-containing ingredients to be listed by name and for gluten to be incorporated into allergen cross-contact controls.
Certification groups push for clearer, risk-based disclosure
The Gluten-Free Food Program (GFFP) said the FDA’s inquiry “reflects concerns long observed across manufacturing environments and within the gluten-free community.”
The organization highlighted “inconsistent labeling practices, undeclared gluten-containing grains and persistent oat cross-contact” as sources of uncertainty for consumers who rely on accurate disclosures for their health and safety.
GFFP emphasized that “clear, reliable ingredient information is not simply a regulatory preference but a public health necessity, particularly when it comes to identifying gluten sources beyond wheat, including rye, barley” and cross-contaminated oats.
For brands, GFFP said clearer gluten-free labeling could mean “enhanced supplier controls, stronger documentation and clearer labeling practices – steps that could ultimately support greater consistency and consumer trust across the marketplace.”
What expanded disclosure could mean for brands
Regulatory consultants highlighted the potential benefits and operational complexity of any changes that may emerge from the RFI.
FDA’s request is a “a step forward for individuals requiring a gluten-free diet, particularly given the difficulty of avoiding non-wheat gluten sources such as rye and barley under current labeling regulations unless a product voluntarily makes a ‘gluten free’ claim,” said Michelle Anstey, regulatory manager at regulatory and food safety consulting organization NSF.
She added that the RFI “creates space for critical stakeholder input and, if warranted, legislative changes to address those gaps,” while also noting that “the impact on industry compliance and the need for consumer education should be carefully considered.”
Other gluten sources include wheat, barley, triticale (a hybrid of wheat and rye) and rye, and many processed foods contain ingredients derived from these grains, added NSF’s Carey Allen, director of food claims.
While Allen noted that “declaring ingredients derived from gluten-containing sources would improve transparency and consumer safety,” she cautioned that processors could face “costs tied to reformulation, label changes, process controls and customer re-education.”
She also warned that clearer disclosure could cause some consumers to “avoid products they were previously tolerating due to extremely low or absent gluten residue.”
At the same time, Allen highlighted gluten-free certification as a way to maintain consumer confidence amid evolving disclosure expectations. Products affected by new requirements, she said, could pursue certification “to reassure consumers that they remain appropriate choices,” while some manufacturers may “implement certification protocols across facilities to better manage cross-contamination risk.”
