Wharton School Research Reveals Critical FDA Recall Gap for Undeclared Gluten Allergens in the United States

Jon Bari
11 minutes ago
5 min read

Jax Bari, Ben Franklin Bench, University of Pennsylvania

In responding to the FDA's Request for Information on Labeling and Preventing Cross-Contact of Gluten for Packaged Foods, the Wharton School's Marketing Undergraduate Students Establishment (MUSE) conducted research and submitted its findings to the FDA on April 22, 2026.

"An ounce of prevention is worth a pound of cure!" -- Ben Franklin

Summary of Wharton MUSE's Findings

The Wharton MUSE research paints a compelling picture: the absence of mandatory labeling for barley, rye, and oats is not simply a regulatory technicality -- it is a measurable gap in consumer protection. The current framework has created a documented data void, with at least 2,475 products in the U.S. marketplace containing Barley-, Rye-, or Malt-derived ingredients without a Gluten grain declaration. As a result, millions of Americans with Celiac Disease are often left unable to determine whether the foods they purchase include Gluten-containing grains.

The FDA's own recall data further illustrates this regulatory gap. Since mandatory allergen labeling took effect in 2006, the FDA has taken approximately 1,000 enforcement actions for products containing undeclared wheat, compared with just 14 recalls involving undeclared barley and rye combined. This striking disparity does not suggest that barley and rye pose little risk; rather, it reflects the lack of a mandatory labeling requirement that would trigger FDA enforcement, public notification, and recall accountability. Extending Major Food Allergen status to barley, rye, and oats would provide consumers with the same layered protections that currently exist for the Top 9 Major Food Allergens, including mandatory disclosure, regulatory oversight, recalls, and timely public alerts when undeclared allergens are identified.

Recall Safety Gap

According to the report, "the most concrete illustration of the regulatory gap is the FDA recall record." Wharton MUSE analyzed the FDA's FDA CFSAN Recall Database for all enforcement actions involving undeclared allergens from January 1, 2006 -- the effective date of FALCPA's mandatory allergen labeling requirements -- through April 14, 2026. The results are summarized in Table 1.

Table 1: FDA Food Recalls by Undeclared Allergen or Ingredient

Undeclared Ingredient	Number of Recalls	Regulatory Status
Milk	2,244	Major Food Allergen (Top 9)
Wheat	1,000	Major Food Allergen (Top 9)
Peanut	511	Major Food Allergen (Top 9)
Gluten (General)	65	Voluntary Framework Only
Barley	8	NOT a Major Food Allergen
Rye	6	NOT a Major Food Allergen

Source: FDA CFSAN Recall Database. Queried April 14, 2026. Highlights added. "The disparity is stark and legally meaningful. Wheat -- a mandated allergen under FALCPA -- has generated 1,000 recall enforcement actions for being undeclared. Barley, rye and oats combined have generated a total of 14. This near-zero figure does not indicate that barley and rye are safe or rarely present in the food supply. It indicates that FDA has no enforcement trigger: without a mandatory labeling requirement, there is no recall liability, no mechanism for consumer redress, and no data trail. The 14 recalls represent the floor of an otherwise invisible problem.

For context: when sesame was elevated to Major Food Allergen status under the FASTER Act, effective January 1, 2023, recall activity for undeclared sesame immediately and substantially increased -- not [just] because sesame suddenly became more prevalent, but because the regulatory framework finally created enforcement pressure. The same effect would be expected for barley, rye and oats under mandatory declaration.

The recall mechanism does more than generate enforcement data -- it generates public awareness. FDA Class I recall announcements are distributed through the agency’s MedWatch notification system and routinely covered by national food safety media, including Food Safety News and Food Safety Magazine, as well as major broadcast and print outlets. A 2025 Food Safety Magazine analysis found that undeclared allergens represented 39% of all food recall announcements that year — the single most common cause of recalls — with experts noting that "food recall awareness is critical because many recalls involve serious health risks, including those caused by allergens." A peer-reviewed analysis of FDA data from FY2013-2019 (Gendel & Zhu, Journal of Food Protection, 2023) documented 1,415 Major Food Allergen recalls in a seven-year window, each generating a public notice that reached consumers before further harm could occur.

The celiac and gluten-sensitive community is denied both layers of this protection. The primary safety net -- a mandatory label declaration requiring Barley, rye and oats to be identified on product packaging-- does not exist. And because it does not exist, the secondary safety net does not exist either: with no labeling mandate, there is no recall trigger, no press release, no news coverage, and no consumer alert when a product contains undisclosed gluten-containing grains. The thousands of public commenters in Docket FDA-2023-P-3942 who described hours spent scrutinizing grocery labels are performing manually -- and imperfectly -- what the mandatory recall and notification system does automatically for every other Major Food Allergen."

In the United Kingdom

87 other countries around the world require the labeling of Barley, Rye and Oats, including in Canada, in the United Kingdom and across the European Union.

Below are a few examples of how the United Kingdom's allergen recall protections and notifications work for undeclared Barley, Rye and Oats. It can be done in the United States too.

Product: Capsicana Easy Going Mild Salsa

Allergens: Barley, Gluten, Mustard

Risk Statement: "Barley (Gluten), Mustard This product contains barley (gluten) and mustard making it a possible health risk for anyone with an allergy to mustard and/or allergy or intolerance to barley or gluten, or with coeliac disease."

Product: 3D Trading recalls M&M's Pipoca (popcorn)

Allergens: Peanut, Gluten, Barley, Rye and Wheat

Risk Statement: "Barley (Gluten), Mustard This product contains barley (gluten) and mustard making it a possible health risk for anyone with an allergy to mustard and/or allergy or intolerance to barley or gluten, or with coeliac disease."

Product: Spoon Cereals recalls Cinnamon + Pecan Granola

Allergen: Oats

Risk Statement: "Oats (gluten) and peanuts This product contains gluten making it a possible health risk for anyone with an allergy or intolerance to oats or gluten, or with coeliac disease and or an allergy to peanuts."

The FDA would be well served to adopt the same regulations in the United States and follow the United Kingdom's lead. To that end, the FDA should follow the "Gluten Labelling Guidance: Best Practice for Prepacked Foods which Include or Exclude Cereals Containing Gluten."

The Labeling Gap and Its Downstream Data Consequence

The Wharton MUSE research also found that:

"Under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), only wheat is required to be declared as a Major Food Allergen among gluten-containing grains. Barley, rye, and oats carry no equivalent mandatory disclosure obligation. This creates what is, in practice, a data void: in the absence of a labeling requirement, there is no systematic mechanism for tracking the presence of these grains in the food supply, no enforcement trigger for their omission, and no recall liability when they appear undisclosed on product labels.

Our analysis of the Open Food Facts global product database (queried April 2026, world.openfoodfacts.org) found that 1,516 U.S. products containing barley or rye carry no gluten allergen declaration, and an additional 959 U.S. products containing malt-derived ingredients carry no gluten tag — a combined total of 2,475 products carrying no required gluten grain declaration, representing 3.01 times the international average across comparable economies (France, Germany, UK, Spain, Italy, Canada, and Australia). The domestic market's sheer scale means that even a high tag-rate percentage translates into the largest absolute volume of unlabeled hazards of any country examined.

Manufacturers are plainly capable of declaring allergens accurately: the same products that omit barley and malt often, for example, can correctly declare milk, soy, and sesame under current mandated frameworks. The omission of barley, rye and oats is not a technical failure, but predictable output of a voluntary system with no enforcement backstop."