Gluten-free labeling: correcting compliance mistakes

A “gluten-free” claim looks simple on the front of a package. In practice, it is a promise tied to a numerical threshold, an ingredient-by-ingredient review, production controls, and records that can support the claim long after the label has been printed.

That is why gluten free label compliance mistakes rarely come from one dramatic decision. More often, they begin with a supplier change, an incomplete allergen statement, a poorly controlled shared line, or an assumption that fermentation has somehow removed the regulatory problem. For manufacturers and private-label brands, the claim is voluntary. The responsibility behind it is not.

The 20 ppm Threshold: Defining Regulatory Boundaries

The number that anchors U.S. gluten-free labeling is 20 parts per million, or ppm. Under FDA rules, a packaged food may use claims such as “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” only when the food contains less than 20 ppm of gluten and meets the other requirements of the rule.

The FDA’s final rule was issued on August 2, 2013, and compliance became mandatory on August 5, 2014. The rule applies to foods that are naturally free of gluten, foods made without gluten-containing grains, and foods made with ingredients such as wheat starch that have been processed to remove gluten, provided the finished product meets the applicable requirements.

Twenty ppm does not mean zero gluten. It is a regulatory threshold, not a laboratory claim that no molecule of gluten is present. In practical terms, 20 ppm is equivalent to 20 milligrams per kilogram. In a 50-gram serving, a product at that concentration would contain approximately one milligram of gluten.

That distinction matters because a brand may be tempted to treat “gluten-free” as a formulation description: the recipe contains no wheat, barley, or rye. The FDA claim is broader than that. It concerns the finished food and the way it was made, including the possibility of cross-contact during receiving, storage, processing, rework, and packaging.

A “gluten-free” label is a regulatory promise that gluten remains below 20 ppm—not a guarantee of zero gluten, zero cross-contact, or zero manufacturing risk.

A product can fail the claim even when gluten is not an intentional ingredient. A shared conveyor, inadequately cleaned mixer, dust from a neighboring flour system, or an incorrectly identified flavor carrier can introduce enough gluten to create a compliance problem. The formula may look clean on paper while the process is not.

The European Union uses a related but not identical framework. Under Regulation (EU) No 828/2014, “gluten-free” may be used for foods containing no more than 20 milligrams per kilogram of gluten. The regulation also permits the claim “very low gluten” for processed foods made from one or more ingredients containing wheat, rye, barley, oats, or their crossbred varieties that have been specially processed to reduce gluten, when the food contains between 20 and 100 mg/kg of gluten.

That second claim is not simply an alternative translation of the U.S. claim. It belongs to a different labeling structure and does not carry the same meaning for consumers who need to avoid gluten as strictly as possible. A U.S. label cannot be copied into an EU market without reviewing the claim, the product category, the ingredient statement, and the language required for that market.

The most reliable compliance programs do not aim to land at the limit. They establish an internal operating margin below it. A result close to 20 ppm may still be technically within the limit, but it leaves little room for variation in raw materials, sampling, production conditions, or laboratory uncertainty.

Navigating Allergen Disclosures for Gluten-Removed Ingredients

Gluten-free labeling becomes more complicated when a product contains a wheat-derived ingredient that has been processed to remove gluten. The common example is specially processed wheat starch. If the finished food meets the FDA requirements for a gluten-free claim, the presence of the processed ingredient does not automatically prevent the claim. It does, however, affect the allergen disclosure.

Wheat is a major food allergen in the United States. When wheat is present in the ingredient list, the label must disclose it in accordance with the applicable allergen-labeling rules. A gluten-free claim does not erase the wheat allergen declaration, because gluten sensitivity and wheat allergy are different regulatory and medical issues.

When a product contains a wheat ingredient and also uses a gluten-free claim, the label needs a clear explanation that the wheat has been processed so the food meets FDA requirements for a gluten-free claim. The reference must be connected to the word “wheat,” commonly through an asterisk or another conspicuous device. The purpose is not to create a loophole or make the wheat disappear. It is to explain why a wheat-derived ingredient appears on a product carrying a gluten-free claim.

Several failures recur:

• The wheat ingredient is listed without the required clarification. A label may say “wheat starch” in the ingredient list and display “gluten-free” on the front, but omit the explanatory statement that connects the two.
• The explanation is technically present but practically invisible. Tiny type, weak contrast, an unclear asterisk, or placement far from the ingredient statement can make the disclosure difficult to read and difficult to interpret.
• The brand treats processing as an allergen exemption. Removing gluten does not mean removing the obligation to identify wheat when wheat remains the source of the ingredient.
• The ingredient specification is incomplete. “Processed starch” is not enough for a compliance review if the supplier documentation does not identify the source material and the process used to control gluten.
• The formula and label drift apart. A reformulated flavor, enzyme preparation, seasoning, or carrier may introduce wheat-derived material after the label has already been approved.

The ingredient review should therefore go beyond searching for the words “wheat,” “barley,” and “rye.” It should examine the source of every compound ingredient and processing aid that could contain gluten or create cross-contact. Malt and malt extract are familiar examples of barley-derived ingredients. Flavor systems, coatings, fermented components, and carrier materials can be less obvious.

Barley and rye also deserve separate attention. They may not appear in a prominent allergen statement in the same way wheat does, but they remain relevant to the gluten-free claim. A supplier’s general statement that an ingredient is “allergen friendly” is not a substitute for a specification that addresses gluten, source materials, manufacturing conditions, and change-control procedures.

A useful label review asks three questions at once:

1. Does the ingredient list accurately name the source of each ingredient?

2. Does the allergen statement meet the applicable wheat-disclosure requirements?

3. Does the finished product and its manufacturing process support the gluten-free claim?

Treating those as separate reviews is how gaps appear. The formula can be correct while the allergen statement is incomplete; the allergen statement can be correct while the process creates cross-contact; and the process can be controlled while a supplier quietly changes the ingredient source.

Compliance Pitfalls in Fermented and Hydrolyzed Products

Fermentation and hydrolysis create a particular problem for gluten cross contamination testing. In an intact grain protein, the relevant sequences may be easier for a standard immunoassay to recognize. Fermentation and hydrolysis break proteins into smaller peptides and other fragments. Those fragments may still matter for people with celiac disease, yet the analytical method may not measure them in the same way it measures intact gluten.

The result is a dangerous shortcut: a manufacturer sees a low or negative test result and assumes the product has been proved safe, even though the test may have limitations for that product matrix or processing method.

The FDA’s 2020 final rule addressed the use of gluten-free claims on fermented and hydrolyzed foods. For these products, manufacturers need a defensible system based on supplier records, process controls, product knowledge, and appropriate analytical information. Testing remains useful, but it cannot be treated as the only evidence when the product has changed the structure of the proteins being measured.

This is especially important for products such as:

• yogurt and kefir containing added cultures, flavor systems, or cereal-derived components;
• sauerkraut, pickles, and kimchi made in shared facilities;
• aged cheeses and cured meats with coatings, seasonings, or processing aids;
• kombucha and water kefir with flavorings or starter ingredients;
• vinegar and other fermented ingredients;
• beer and other alcoholic beverages made from different grain sources;
• hydrolyzed proteins, sauces, and flavor ingredients.

Fermentation itself does not make a gluten-containing raw material compliant. Beer made from barley is not transformed into a gluten-free product merely because fermentation has taken place. Likewise, a fermented food can pick up gluten from a starter, flavoring, seasoning blend, tank, hose, or shared filling line.

Distillation requires the same discipline. A finished spirit may be produced from a gluten-containing grain, but the relevant compliance assessment cannot rest on the assumption that distillation automatically resolves every concern. The materials used after distillation, including flavorings, colorants, sweeteners, and storage or finishing components, also need review. The production process must be understood rather than reduced to a slogan about purification.

For hydrolyzed products, the manufacturer should document the starting material, the hydrolysis process, the validation work supporting the claim, and the limitations of the analytical method used. A negative result from a method that is not well suited to the matrix does not carry the same meaning as a result from a validated approach that accounts for the product’s composition.

The practical evidence chain should include:

• specifications and certificates of analysis from ingredient suppliers;
• records showing the source and processing history of wheat-, barley-, oat-, and rye-related materials;
• controls for shared tanks, lines, hoses, utensils, and storage areas;
• validated cleaning procedures and changeover records;
• an explanation of why the chosen testing method is appropriate—or where it is limited;
• finished-product or process verification appropriate to the product category.

In fermented and hydrolyzed foods, a test result is one piece of the evidence. It is not a substitute for knowing what went into the product and what happened to it during processing.

The same principle applies to oats. Oats are not inherently the same regulatory problem as wheat, barley, or rye, but they can be affected by agricultural and manufacturing cross-contact. If oats are used in a gluten-free product, the supplier controls and identity of the oat ingredient need to support the claim. “Oat-based” and “gluten-free” are not interchangeable descriptions.

Debunking the Third-Party Certification Myth

Third-party certification can be valuable, but it is not a universal legal prerequisite for a gluten-free claim in the United States. The FDA does not require a brand to display a certification seal before it may use the claim. The manufacturer remains responsible for ensuring that the food meets the rule, whether or not a certification logo appears on the package.

That distinction matters because certification is often treated as if it transfers responsibility. It does not. A certification program may impose requirements that are stricter than the FDA minimum, including lower internal limits, audits, supplier review, testing schedules, and controls for dedicated or shared equipment. Those requirements can strengthen a program and provide a useful signal to retailers and consumers. They do not replace the manufacturer’s own obligation to control the product.

The most common certification mistakes are operational rather than legal:

• Confusing a seal with a compliance system. A logo cannot control a supplier change, a mislabeled tote, or a failed sanitation step.
• Assuming certification covers every product in a brand family. Certification normally applies to defined products, facilities, processes, and scopes. A seal on one SKU does not automatically cover a similar product.
• Stopping internal verification after approval. Audits occur at intervals, while production occurs continuously. A product can drift between audits if supplier controls and change management are weak.
• Treating an audit as a product guarantee. An audit evaluates a system at a point in time. It does not eliminate the need for lot-level decisions, investigation, and corrective action.
• Using a certification mark outside the program’s rules. The logo, placement, product scope, and claim language may all be controlled by the certification body.

Programs may set limits below the FDA threshold, but the exact requirements differ. A brand should verify the current standard rather than repeat a number from an old packaging brief or sales presentation. It should also distinguish between gluten-free certification and broader food-safety or quality-management certifications. A BRCGS, SQF, or similar audit may say important things about a facility’s management system, but it is not automatically a gluten-free certification.

The same caution applies in international markets. Certification may be demanded by a retailer, distributor, or private contract, even when the applicable law does not require it. That is a commercial requirement, not the same thing as a statutory labeling requirement. U.S. and EU claim systems should still be reviewed independently.

Data-Driven Risk: Why Voluntary Claims Require Vigilance

A voluntary claim creates a high evidentiary burden because it invites a specific consumer expectation. The consumer is not merely being told what the product does not contain intentionally. They are being told that the finished food meets a defined gluten limit.

Reported testing has found gluten above 20 ppm in a small proportion of foods carrying a gluten-free label, while a much larger proportion of foods without gluten-containing ingredients—but without a gluten-free claim—have also shown measurable gluten above that level. The figures are useful because they show two different problems.

First, a gluten-free claim can fail when the manufacturer’s control system fails. Second, the absence of a gluten-free claim does not prove that a food is suitable for someone who must avoid gluten. “No wheat listed” is not the same as “tested and labeled gluten-free.” Consumers and brands should not treat those statements as equivalent.

For manufacturers, the risk usually concentrates in a few parts of the operation.

Supplier changes

A supplier may change a flour blend, move production to another line, add a new carrier, or alter a cleaning schedule without changing the ingredient’s commercial name. A certificate of analysis from a prior lot cannot prove that a later lot is identical.

Supplier agreements should address notification of changes, gluten specifications, manufacturing sites, shared equipment, allergen controls, and the records available for review. Incoming material checks should also confirm that the delivered ingredient matches the approved specification.

Shared equipment and changeovers

Shared equipment is a predictable source of cross-contact. The risk is not limited to obvious flour dust. It can involve mixers, sifters, conveyors, gaskets, filters, scoops, storage bins, rework containers, and packaging equipment.

Cleaning should be validated for the actual equipment and product sequence. A visual inspection may be necessary but is not enough by itself. ATP testing can help assess general sanitation, while gluten-specific swabs can provide additional process information. Neither one, alone, proves that a finished product meets the regulatory threshold. They are tools within a broader verification program.

Sampling and testing

Testing is only as meaningful as the sample. Gluten may not be distributed evenly through a lot, and a single grab sample can miss localized contamination. The product matrix, extraction procedure, detection method, and laboratory competence all affect the result.

R5-based immunoassay methods are widely used for many gluten testing applications, but their performance can vary with hydrolyzed, fermented, or otherwise processed foods. The question is not simply whether a laboratory can produce a number. The question is whether the method and sampling plan can support the conclusion being drawn from that number.

Internal limits

The legal threshold is a ceiling, not a production target. A product that repeatedly approaches 20 ppm has little resilience. Small changes in raw material composition, production order, sanitation performance, or sampling can push a later lot over the limit.

Internal action levels should be set with the product and process in mind. A result that is still below the legal limit may justify an investigation if it is materially higher than the product’s established baseline. Trends matter more than isolated reassurance.

Documentation

A compliance program should be able to reconstruct how a claim was supported. That means retaining the relevant supplier specifications, certificates of analysis, receiving records, formulation approvals, sanitation and changeover records, testing results, deviations, corrective actions, and label reviews.

Documentation is not administrative decoration. It shows whether the claim was controlled as a system or simply assumed because the recipe looked appropriate. If a complaint or inspection raises a question, a manufacturer needs evidence of what was known, what was checked, and what action was taken when conditions changed.

Preventing Gluten Labeling Errors Before Release

The final label review should connect regulatory, technical, and production information rather than treating packaging as a separate marketing exercise. Before a product is released, the responsible team should be able to answer the following:

1. What exactly is the claim? “Gluten-free,” “no gluten,” and equivalent wording should be reviewed under the same substantive standard rather than treated as different levels of promise.

2. Which ingredients are derived from wheat, barley, rye, or oats? The review should include compound ingredients, carriers, flavorings, cultures, coatings, and processing aids.

3. Does the wheat allergen statement match the gluten-free claim? If a processed wheat ingredient is used, the required explanatory connection must be clear and conspicuous.

4. Where can cross-contact occur? Map the risk through receiving, storage, weighing, batching, processing, rework, sanitation, and packaging.

5. Is the testing method suitable for the product? Fermented and hydrolyzed foods require particular care because analytical results may not tell the whole story.

6. What happens when a supplier changes something? The change-control procedure should prevent a new ingredient, site, or process from entering production without review.

7. Is there an internal margin below 20 ppm? A product that only passes when every condition is perfect is not a robustly controlled product.

8. Does certification scope match the product being sold? A seal should never be treated as broader than the certification agreement allows.

9. Can the records support the claim months later? If the answer depends on someone’s memory rather than retained documentation, the system is fragile.

10. Are export labels reviewed separately? The EU “very low gluten” claim, with its 20–100 mg/kg range, is not a U.S. claim and should not be inserted into a U.S. label architecture.

The most effective programs also assign ownership. Procurement should control supplier information. Product development should identify risky ingredients and matrices. Operations should own sanitation and changeovers. Quality teams should set sampling and investigation rules. Regulatory reviewers should confirm that the label describes the product actually being made.

That division prevents a familiar failure pattern: marketing approves a claim based on the formula, purchasing changes a supplier, production runs the new material on shared equipment, and quality discovers the problem only after a complaint.

Gluten-free labeling is a narrow area of food regulation, but it exposes a broad truth about compliance. A short claim on a package depends on the entire chain behind it. The 20 ppm threshold defines the boundary, allergen disclosures explain the ingredients, process controls manage cross-contact, and records demonstrate that the claim was not an accident.

Third-party certification can add discipline. Laboratory testing can reveal problems. Supplier documentation can reduce uncertainty. None of them can replace a controlled system. When the label says “gluten-free,” the product, process, and paperwork all need to say the same thing.