Key takeaways:
- The FDA is reviewing gluten labelling to address gaps around hidden ingredients and cross-contact, with a consultation open until 22 April 2026.
- Current rules ensure ‘gluten-free’ claims meet strict thresholds, but inconsistent disclosure of barley, rye, oats and cross-contact still leaves consumers guessing.
- As gluten-free demand grows beyond medically diagnosed consumers, clearer labelling is becoming both a regulatory priority and a commercial necessity for food manufacturers.
For years, gluten has been one of the food industry’s most persistent blind spots. It’s widely understood, heavily regulated in some contexts and yet still surprisingly difficult to identify in many everyday products – not because it isn’t there, but because it isn’t always clearly disclosed.
Ingredient labels, even today, can read like a technical puzzle. Gluten doesn’t always appear as wheat, barley or rye in plain terms. It can sit behind malt extracts, flavourings, stabilisers and processing aids or enter the equation through cross-contact in shared supply chains. For consumers, that creates uncertainty and for those with medical needs, real risk.
For someone living with celiac disease, that uncertainty isn’t a minor inconvenience. Even small amounts can trigger symptoms and lead to more serious complications. The FDA estimates around 3 million people in the United States are affected, with risks ranging from nutrient deficiencies and osteoporosis to infertility and intestinal cancers if the condition isn’t properly managed.
And the net is wider still – studies suggest up to 30% of Americans are actively reducing or avoiding gluten for lifestyle reasons. Digestive health, lifestyle choices, general curiosity about ingredients – all of it has pulled gluten into a more mainstream conversation.
It’s against that backdrop that the FDA has opened a new Request for Information (RFI) on gluten labelling and cross-contact. The comment deadline, originally set to close in late March, has now been extended to 22 April.
The move, on the surface, looks like a fairly technical exercise in regulatory fine-tuning. While it’s specifically asking for input on how gluten is disclosed and how cross-contact is managed in packaged foods, it sits within a much wider push on labelling – one that also touches front-of-pack nutrition, ultra-processed foods (UPFs), sodium reduction and the use of claims such as ‘healthy’.
Transparency is no longer optional
Since 2013, manufacturers have been able to use the voluntary ‘gluten-free’ claim, provided products contain less than 20 parts per million (ppm) of gluten, a threshold aligned with international standards and widely considered safe for most people with coeliac disease. That rule was later expanded in 2020 to cover fermented and hydrolysed foods such as yoghurt, pickles, cheese and certain beers and wines, where detecting gluten is more complex.
In that sense, the system isn’t starting from scratch. It’s evolved over more than a decade and is generally considered reliable when used correctly. The problem is what happens outside that clearly defined space.
Wheat must be declared as an allergen, but barley and rye don’t always stand out in the same way, particularly when they’re processed into ingredients like malt. Cross-contact is even less consistent, with precautionary statements remaining voluntary and unevenly applied – some manufacturers flag the risk, others don’t.
Oats remain one of the more confusing areas. They don’t contain gluten naturally, but they’re often contaminated earlier in the supply chain. Unless a brand goes out of its way to explain that, it’s not something most consumers would pick up.
The FDA’s RFI zeroes in on these grey areas, seeking data, consumer experiences and industry input to determine whether clearer or more standardised disclosures are needed.
Health Secretary Robert F Kennedy Jr has framed the move as part of a wider push for transparency, stating: “Americans deserve clear, reliable information about what’s in their food and how it’s made.” FDA Commissioner Marty Makary added that “people with celiac disease or gluten sensitivities have had to tiptoe around food and are often forced to guess about their food options,” emphasising the need for better data to support future policy.
Advocacy groups have also welcomed the move, though with caution. The Celiac Disease Foundation said the RFI “signals that the agency is actively evaluating how gluten cross-contact, oats, rye, and barley should factor into future labelling policy,” adding it represents “an important first step, not a final decision.”
The response has been strong, with more than 5,000 comments already submitted. The extension gives both consumers and industry more time to weigh in.
Less about rules, more about clarity
The US gluten-free market alone is already worth billions – estimated at around $4.5bn in 2026 – and continues to grow as demand extends beyond medically diagnosed consumers. Globally, the category is on track to more than double in value over the next decade, with some analysts projecting it could reach $33.59bn by 2034.
What’s striking is who’s driving that growth. It’s no longer just people with coeliac disease, but a broader cohort of consumers who associate gluten-free with cleaner labels, better digestion or healthier lifestyles.
That shift has pushed gluten from a clinical concern into a commercial opportunity – but it’s also raised the stakes. As gluten-free becomes more mainstream, expectations around clarity and trust have risen with it. Consumers aren’t just looking for a claim; they want to understand what sits behind it.
Third-party certification has stepped in to provide reassurance where standard labelling can feel insufficient. The Gluten-Free Certification Organization, run by the Gluten Intolerance Group, applies a stricter threshold of 10 ppm and backs it up with testing and audits.
Still, certification isn’t universal. Plenty of products rely solely on ingredient lists, which brings things back to the same issue – how easy is it, really, to understand what you are buying?
For the bakery category, in particular, this isn’t a theoretical debate and cuts right to the core of how products are made. Gluten is fundamental to structure, texture and mouthfeel in many baked goods. Removing it is already technically challenging. Add the possibility of tighter disclosure rules around cross-contact, ingredient sourcing and processing, and the complexity increases.
At the same time, gluten-free is no longer a niche. It sits alongside standard products and often carries a price premium. Studies have shown that gluten-free options can be more expensive and less widely available, raising questions about access as well as labelling.
That creates a dilemma for manufacturers. More detailed disclosure, tighter controls and potentially more testing all come with cost.
But so does a lack of clarity. Consumers who feel unsure about a label are unlikely to stay loyal for long. There’s also a reputational angle – in a market where trust is everything, being vague on gluten is not just a compliance risk, it is a brand risk.
A slow burn
The FDA’s consultation will take time to translate into policy, if it does at all. But it may not be able to move slowly for long. More than 80 countries already require clearer labelling of gluten-containing grains, putting pressure on regulators to align with global norms.
Gluten isn’t going anywhere. The expectation around how it is explained, however, is. Labelling is moving away from a narrow ‘free-from’ claim towards a broader expectation of transparency – including how ingredients are sourced, processed and handled.
And as expectations continue to rise, the question for manufacturers may move beyond compliance. It becomes about whether the label actually does its job.
Studies:
Nash DT, Slutzky AR. Gluten sensitivity: new epidemic or new myth? Proc (Bayl Univ Med Cent). 2014 Oct;27(4):377-8. doi: 10.1080/08998280.2014.11929164. PMID: 25484517; PMCID: PMC4255872.
McInnes H, Klapan L, Moore U, Singh J, Whelan K. Limited Availability and Higher Cost of Gluten-Free Foods Continue in the United Kingdom: A Comparative Follow-Up Over More Than a Decade. J Hum Nutr Diet. 2026 Feb;39(1):e70209. doi: 10.1111/jhn.70209. PMID: 41626706; PMCID: PMC12862883.
