FALCPA Common Violations: What the FDA Finds in Food Label Inspections
FDA inspections regularly identify FALCPA allergen labelling violations. Here are the most common issues found and how food businesses can avoid them.
The FDA's food labelling enforcement programme includes regular inspection of food manufacturing facilities and product labels. FALCPA violations appear consistently in FDA warning letters and recall notices. Understanding the most common violations helps food businesses avoid them.
Undeclared Allergens: The Most Serious Violation
The single most common and serious FALCPA violation is undeclared allergens — a product containing a major allergen that is not declared on the label. This typically results from:
- An ingredient change without a label update
- A shared facility contamination that was not disclosed on the label
- A formulation error where a sub-ingredient containing an allergen was overlooked
- Incorrect supplier-provided ingredient information
Undeclared allergen violations consistently account for the majority of FDA food recalls.
Incorrect Plain Language Declaration
FALCPA requires allergens to be declared in plain language that consumers can understand. "Casein" must be accompanied by "(milk)" if it is not otherwise clear. "Albumin" must be identified as "(egg)". Failure to use common allergen names is a labelling deficiency.
Missing Contains Statement Cross-Check
When a "Contains:" statement is used, it must be consistent with the ingredient list. If the ingredient list includes an allergen that is not in the Contains statement, that is a violation — and vice versa.
Failure to Update Labels After Formulation Changes
When a recipe or formulation changes to introduce a new major allergen, labels must be updated before the reformulated product is shipped. Many violations arise from timing failures in this process.
Sesame Misclassification Following the FASTER Act
The FASTER Act of 2021 elevated sesame to the ninth major allergen under FALCPA, with mandatory declaration requirements taking effect from 1 January 2023. Despite the extended transition period, FDA inspections have identified a significant number of food manufacturers who failed to update their labels in time. Products that contain sesame oil, sesame seeds, or sesame paste must now declare sesame by its common name, either within the ingredient list or in a separate "Contains: Sesame" statement. The transition created particular confusion for businesses that had previously included sesame in small quantities without formal allergen labelling.
A further complication arose from the practice of adding sesame to existing products specifically to avoid cross-contact claims, rather than as a deliberate ingredient. Some manufacturers took this route to sidestep precautionary advisory statements for shared equipment, which are voluntary under FALCPA. However, once sesame was added as a deliberate ingredient, it then required full FALCPA declaration regardless of the original motivation for its inclusion. FDA inspectors have flagged cases where sesame was present in a product but absent from both the ingredient list and any Contains statement, constituting a clear undeclared allergen violation.
Online food sellers face an additional layer of complexity because product listings on platforms such as Shopify must also reflect accurate allergen information. If a physical label has been updated for sesame compliance but the digital product description has not been revised, customers purchasing online may receive incomplete allergen information before committing to a purchase. Maintaining consistency between physical labels and digital listings is not just a matter of best practice — it is increasingly the expectation of regulators and allergen advocacy groups alike.
Sub-Ingredient and Compound Ingredient Failures
Many food products are manufactured using compound ingredients — that is, ingredients that are themselves made up of multiple components. A flavouring blend, a sauce base, or a seasoning mix supplied by a third party may contain one or more of the nine major allergens without that being immediately apparent on the supplier's documentation. FALCPA requires that all allergens present in a finished product are declared, regardless of whether they originate in a primary ingredient or a sub-ingredient. When manufacturers rely solely on a supplier's label without scrutinising the full ingredient breakdown, violations can easily result from overlooked sub-ingredients containing wheat, soy, or milk derivatives.
This problem is particularly acute when supplier formulations change without adequate notification to the purchasing manufacturer. A seasoning supplier may introduce a milk-based anti-caking agent or switch to a soy-derived carrier without formally alerting customers in their supply chain. The purchasing manufacturer, still operating from an earlier version of the ingredient specification sheet, may continue printing labels that do not reflect the new allergen content. FDA warning letters frequently cite exactly this kind of supply chain breakdown as the root cause of undeclared allergen violations, and the responsibility for verification ultimately rests with the manufacturer whose name appears on the finished product label.
Food businesses selling on Shopify and similar platforms that source from multiple suppliers should maintain an ingredient specification register that is reviewed every time a supplier updates their product documentation. This register should capture not just the allergen summary but the full sub-ingredient declaration for every compound ingredient used. Cross-referencing this register against live product labels and digital listings on a scheduled basis is one of the most effective controls a small food business can implement to avoid FALCPA violations before they become recalls.
Incorrect Font Size and Label Placement
FALCPA does not only govern what allergen information must appear on a label — it also sets expectations about how and where that information appears. Allergen declarations must be clearly legible and must appear on the same label panel as the ingredient list. While FALCPA does not specify a precise minimum font size in the same way that some other labelling regulations do, the FDA applies a general standard of conspicuousness, and inspectors have cited products where allergen information was printed in type so small or in a colour contrast so poor that it was effectively illegible to a consumer reading the label under normal conditions.
Placement errors are another source of violations. Some manufacturers, particularly those producing small-format packaging, have placed allergen declarations on a secondary or back panel in an attempt to manage space constraints, while positioning the ingredient list on a different panel entirely. This separation between the ingredient list and the associated allergen declaration does not satisfy FALCPA requirements. The Contains statement or parenthetical allergen declaration must appear immediately adjacent to, or as part of, the ingredient list rather than as a standalone notice elsewhere on the packaging.
For Shopify merchants selling packaged food products, it is worth remembering that label compliance failures discovered during an FDA inspection can result not only in warning letters but in mandatory recalls that carry significant reputational and financial costs. Reviewing label artwork before each production run — specifically checking font size, colour contrast, and panel placement of allergen information — is a low-cost preventive step that can prevent much more costly enforcement consequences down the line.
Precautionary Advisory Statements Used as Substitutes for Mandatory Declarations
Advisory statements such as "May contain traces of peanuts" or "Produced in a facility that also processes tree nuts" are voluntary under FALCPA and carry no regulatory weight as substitutes for a mandatory allergen declaration. However, FDA inspectors have consistently found products where manufacturers appear to have used precautionary advisory language in place of a formal FALCPA declaration when a major allergen is actually present as a deliberate ingredient. This is a fundamental misunderstanding of how the two types of statements operate, and it constitutes a direct violation of the Act.
The distinction matters enormously to allergen-sensitive consumers and to the FDA. A precautionary advisory statement communicates a possibility of unintended cross-contact; a FALCPA declaration communicates the certain presence of an allergen as an ingredient. Using advisory language for a known allergen ingredient misleads the consumer into believing the allergen may or may not be present, when in fact it is definitively present. This misrepresentation has been cited in FDA enforcement actions and in consumer complaints that have preceded voluntary recalls initiated by the manufacturer themselves.
Food businesses should audit their full product range to ensure that every product using a precautionary advisory statement has been reviewed to confirm whether the allergen in question is truly an incidental cross-contact risk or whether it is in fact a declared ingredient. Where any doubt exists, consulting the FDA's guidance documents on allergen labelling or seeking advice from a food safety specialist is strongly advisable. Accurate allergen labelling is not simply a regulatory obligation — it is a direct contribution to the safety of consumers who depend on that information to make life-critical purchasing decisions.
Batch-Level Inconsistencies Between Label Versions
A less frequently discussed but recurring source of FALCPA violations is the simultaneous circulation of multiple label versions for the same product. This occurs when a label is updated to add or remove an allergen declaration, but older label stock continues to be used on some production runs while the new artwork is applied to others. FDA inspectors examining distribution records and retail samples have identified cases where two versions of the same product — one compliant and one non-compliant — were available on shelf at the same time, creating consumer confusion and a clear regulatory violation.
Effective label version control requires a formal process for retiring outdated label stock at the point of a formulation or allergen change. This means physically quarantining or destroying old labels rather than allowing them to remain accessible in a production environment where they might be used inadvertently. It also means updating digital product listings, wholesale order documentation, and any third-party platforms concurrently with the physical label change, so that no channel continues to carry outdated allergen information after the transition date.
Keep allergen declarations accurate on your Shopify product pages with Allergen Matrix at saltai.app.
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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.