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Celiac Safety Act Would Force Gluten onto US Allergen Labels, Triggering an 18-Month Redesign Scramble

A bill working its way through Congress could trigger one of the broader label revision exercises the US food industry has faced in years. The Celiac Safety Act of 2026, H.R.9048, introduced by Representatives Emanuel Cleaver II of Missouri and Betty McCollum of Minnesota, would require the FDA to designate “gluten-containing grains” as a major food allergen. If it passes, manufacturers and their packaging suppliers would have 18 months to update labels and processes.

For label printers, folding carton converters and flexible packaging suppliers, that timeline is the number to focus on. Eighteen months sounds generous until you consider how many SKUs sit inside a mid-sized food manufacturer’s portfolio.

The gap the bill closes

Roughly three million Americans have celiac disease, an autoimmune condition in which exposure to gluten, a protein found in wheat, barley and rye, causes the immune system to attack the lining of the small intestine. Millions more experience gluten intolerance. There is no cure; strict dietary avoidance is the only treatment. Untreated exposure carries long-term risks including iron-deficiency anaemia, osteoporosis, malnutrition and elevated risk of other autoimmune conditions and intestinal cancers.

Current US labelling law does not fully account for this. The FDA requires wheat to be declared as a major allergen, but barley and rye carry no equivalent requirement. Gluten-free claims are voluntary and may only be applied when a product tests below 20 parts per million. The result is a system where a consumer can read a compliant label carefully and still miss gluten hiding in prepackaged foods, beers, gravies and soy sauces, not to mention lip balms, toothpastes, supplements and some medicines.

Congressman McCollum, co-chair of the Celiac Disease Caucus, put the international comparison bluntly. “The United States is one of the only developed nations that doesn’t require food manufacturers to list gluten as a major allergen,” he said in a press release. “Our bill would change that, helping the nearly three million Americans with the disease to avoid gluten exposure and make informed choices about the food they consume.”

Australia, New Zealand, Canada, the United Kingdom and all 27 EU member states already require gluten to be declared as a major allergen. The Act would bring US practice into alignment.

Marilyn G. Geller, CEO of the Celiac Disease Foundation, welcomed the proposal, noting that “current labeling laws fail to recognize that risk with the same clarity afforded to other ingredients listed as major allergens.” Recategorizing gluten-containing grains as a major food allergen, she argued, “would strengthen transparency, reduce preventable medical harm, and help millions of Americans make safe food choices with confidence.”

How labels would actually change

The mechanics are more specific than the headline suggests. Any product containing wheat, barley or rye would need to declare “gluten-containing grains” as a major allergen, in the same manner milk, eggs and peanuts are currently declared. Wheat would additionally retain its own separate declaration. The format matches existing allergen disclosure conventions, though the specific grain triggering the label would not necessarily be spelled out.

Oats occupy an awkward middle ground. Pure oats contain no gluten naturally, but cross-contact during growing, transport or processing alongside wheat, barley or rye routinely introduces it. The Act does not set requirements for unintentional cross-contact; advocates expect the FDA’s separate request for information on the subject to address that gap.

The packaging implications

This is where an apparently modest regulatory change becomes an operational project. Adding a mandatory allergen declaration is rarely a matter of dropping a line of text into empty space. Food labels are dense, tightly regulated documents where nutrition panels, ingredient lists, allergen statements, claims, barcodes and brand assets already compete for limited real estate.

Adding a required element typically forces reflow of the entire information panel. That means new artwork, new proofing cycles, new plates or new digital print files, and revalidation of everything from font sizes to contrast ratios. Multiply that across a portfolio of several hundred SKUs and 18 months starts to look tight, particularly if the manufacturer is also managing packaging changes driven by state-level extended producer responsibility rules at the same time.

There is also an inventory question. Existing pre-printed packaging stock becomes obsolete at the compliance date. Brands with long print runs and deep warehouse inventories face a choice between writing off material or moving to shorter runs and digital printing well ahead of the deadline. That is precisely the calculation that has pushed food brands toward digital label and carton production in previous regulatory transitions.

What suppliers should do now

The Act is moving through Congress with bipartisan support, which improves its odds without guaranteeing passage. The prudent position for converters is neither to ignore it nor to act as though it were law.

Practically, that means three things. Identify which of your food and beverage customers have significant wheat, barley or rye exposure across their portfolios. Assess whether their current label layouts have the physical space to absorb an additional allergen declaration without full redesign. And open the conversation early, because a converter who raises the issue before the client’s regulatory team does is positioned as an advisor rather than an order-taker.

Regulatory change is one of the few reliable generators of packaging redesign work. The suppliers who benefit most are the ones already in the room when the planning starts.

Source: Packaging Digest, Joanna Cosgrove, “What the Celiac Safety Act Could Mean for US Gluten Labeling”, 28 July 2026.

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