FALCPA Gluten-Free Claims: FDA Rules and What Food Brands Must Know
Gluten-free claims on food labels are regulated by the FDA separately from FALCPA. Here is what food brands need to know about making compliant gluten-free claims in the US.
Gluten-free claims are among the most commercially valuable claims a food brand can make. They are also regulated. The FDA's gluten-free labelling rule, distinct from FALCPA's allergen declarations, sets specific standards that must be met before a product can carry a gluten-free claim.
The FDA Gluten-Free Standard
Under FDA regulations, a food labelled as gluten-free must contain less than 20 parts per million (ppm) of gluten. This threshold is based on scientific evidence regarding the level at which most people with coeliac disease can tolerate gluten without adverse effects.
FALCPA and Gluten: An Important Distinction
FALCPA lists wheat as a major allergen requiring declaration. It does not list gluten as an allergen, and it does not address rye, barley, or oats specifically. A product could be FALCPA-compliant (declaring wheat) while still containing gluten from other sources. The gluten-free claim rule operates separately and requires the product to meet the <20ppm standard.
Oats and Gluten-Free Claims
Oats are naturally gluten-free but are frequently contaminated with gluten during growing and processing. For a product containing oats to carry a gluten-free claim, the oats must be specially produced to avoid gluten contamination and the finished product must still test below 20ppm.
Testing and Documentation
Brands making gluten-free claims must be able to substantiate those claims. This typically requires ingredient-level certification, production facility documentation, and periodic finished product testing.
Where Gluten Hides: Ingredients Brands Frequently Overlook
Many food brands focus their gluten review on obvious ingredients like wheat flour or barley malt, but gluten can enter a product through a range of less conspicuous sources. Malt vinegar, derived from barley, is a common offender that appears in condiments, crisps, and pickled products. Soy sauce made with wheat, certain starches, and hydrolysed vegetable proteins can all contribute measurable gluten to a finished product. Brands that assume an ingredient is gluten-free without supplier verification are taking on significant compliance risk.
Flavourings and seasoning blends present a particular challenge because their compositions are often considered proprietary by suppliers. A seasoning blend listed simply as "natural flavouring" may contain wheat-derived components that are not disclosed in the ingredient breakdown provided to the purchasing brand. This is why thorough supplier questionnaires and up-to-date specification sheets are essential for any brand intending to make a gluten-free claim. Relying on a label alone from an upstream supplier is not sufficient due diligence.
Modified food starches are another category worth scrutiny. In the United States, modified starch derived from wheat must be declared under FALCPA, which provides some protection, but starches from other gluten-containing grains may not always trigger the same mandatory disclosure. Brands should request the grain source for any modified starch in their formulation and document that information as part of their gluten-free substantiation file. Thorough ingredient-level review at the point of reformulation or supplier change is strongly recommended.
Cross-Contact Controls in Production Facilities
Even when every ingredient in a formulation is confirmed to be gluten-free at source, a product can still fail the 20ppm threshold due to cross-contact during manufacturing. Cross-contact occurs when a gluten-containing product shares equipment, production lines, or storage areas with a product intended to be gluten-free. Unlike cross-contamination caused by poor hygiene, cross-contact is often a structural issue tied to facility layout and scheduling, and it requires deliberate process controls to manage effectively.
Brands that co-manufacture or use shared facilities must obtain detailed information about what else is produced in those facilities and on what equipment. A facility that runs wheat pasta on Monday and gluten-free crackers on Tuesday using the same line is a cross-contact risk unless validated cleaning procedures are in place and tested. Third-party audits and facility-level gluten certifications from recognised bodies such as the Gluten-Free Certification Organization (GFCO) provide a higher level of assurance than supplier self-declarations alone.
For brands producing in their own facilities, written allergen and gluten control plans should document scheduling practices, cleaning validation protocols, and staff training requirements. The FDA expects brands making gluten-free claims to be able to demonstrate that their production processes support the claim. If a regulatory inquiry or product recall situation arises, a well-maintained gluten control plan is one of the most important documents a brand can produce. Investing in these controls upfront is far less costly than managing a recall after the fact.
How Gluten-Free Claims Appear on Packaging
The FDA's gluten-free rule does not mandate that brands make a gluten-free claim. It simply sets the standard that must be met if a brand chooses to make one. This means the claim is voluntary, but once it appears on packaging in any form, the product must comply with the less-than-20ppm requirement. The claim can appear as "gluten-free," "free of gluten," "no gluten," or "without gluten," and all four phrasings are treated equivalently under the regulation.
Brands should be aware that the gluten-free claim can appear not only on the principal display panel but anywhere on the label, including ingredient lists, nutrition fact panels, and back-of-pack descriptions. If a brand's marketing copywriter adds "gluten-free" to a product description without the formulation team's knowledge, the brand has made a regulatory claim it must be able to substantiate. This makes internal communication between marketing, product development, and compliance teams critically important for any business operating across multiple product lines.
Online product listings introduce an additional layer of complexity. When a brand sells through an e-commerce platform such as Shopify, the product description, tags, and metadata visible to consumers are all considered marketing claims. Displaying "gluten-free" in a product tag or filter without the formulation data to back it up carries the same regulatory exposure as printing it on a physical label. Brands selling online should apply the same rigour to digital claims as they do to physical packaging, ensuring that every gluten-free label displayed to a customer is supported by documented evidence.
Communicating Gluten-Free Status to Online Customers
Consumer trust in gluten-free claims is hard won and easily lost. For customers with coeliac disease or non-coeliac gluten sensitivity, a gluten-free claim is not a lifestyle preference marker but a health-critical piece of information. When a brand gets it right, it builds lasting loyalty among a highly engaged consumer group. When it gets it wrong, the consequences extend beyond regulatory enforcement to real harm for real people, and the reputational damage in online communities can be severe and long-lasting.
For Shopify merchants, presenting allergen and dietary information clearly on product pages is an important part of delivering that trust. Customers should be able to see at a glance whether a product is gluten-free, which ingredients it contains, and what allergens are present. Displaying this information consistently across an entire product catalogue, rather than burying it in a downloadable PDF or a footnote, reduces customer service enquiries and increases conversion among shoppers who need dietary assurance before purchasing. Tools like Allergen Matrix are designed specifically to help merchants manage and display this information accurately.
Brands should also think carefully about how they handle product updates. When a formulation changes, even slightly, the gluten-free status of a product must be reassessed. A supplier switch, a new seasoning source, or a facility change can all affect whether a product continues to meet the 20ppm threshold. Having a process in place to review and update online product information whenever a formulation or supply chain change occurs is essential. Stale or outdated allergen information displayed online is a liability both legally and ethically, and brands that treat their digital product data with the same care as their physical labels are in a much stronger position.
Selling Gluten-Free Products Across Borders
For brands selling into multiple markets, it is important to understand that gluten-free standards are not universally identical. The FDA's 20ppm threshold aligns with standards used in the European Union, Canada, and Australia, which provides a degree of consistency for brands with cross-border ambitions. However, the regulatory frameworks surrounding how claims must be presented, what supporting documentation is required, and how enforcement is conducted vary meaningfully between jurisdictions.
In the European Union, the gluten-free claim is governed by Regulation (EU) No 828/2014, which sets the same 20ppm threshold but operates within a broader food information framework that differs from US requirements. Brands exporting to the EU should confirm that their labelling and documentation meets EU-specific requirements, not simply that the product tests below 20ppm. Regulatory compliance is market-specific, and assuming that US-compliant labelling satisfies all international requirements is a common and costly mistake.
Brands that sell through Shopify stores targeting customers in multiple countries should ensure their online allergen and dietary disclosures reflect the correct regulatory context for each market. This includes being precise about which standard a gluten-free claim is made against, particularly when selling to customers who may be accustomed to different regulatory frameworks. Maintaining accurate, market-appropriate product information at scale is operationally challenging, which is why purpose-built tools for allergen and dietary claim management are valuable for growing food brands.
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SaltAI Team
SaltAI builds focused Shopify apps for food merchants and general merchants. Every app is tested in production at a real food store — including Vanda's Kitchen — before it ships.