FALCPA 2025 Updates: What Has Changed and What Food Brands Need to Review

The most significant recent change to US allergen labelling law was the FASTER Act, which required sesame to be declared as a major allergen from 1 January 2023. Brands that did not update their labels by that deadline remain non-compliant. Here is a current compliance review checklist for 2025.

Sesame: Fully in Force Since January 2023

Sesame became the ninth major allergen under FALCPA on 1 January 2023. Every product containing sesame or sesame derivatives must now declare it as a major allergen. This includes:

• Sesame seeds (whole, hulled, toasted)
• Sesame oil
• Tahini
• Sesame flour
• Any ingredient derived from sesame

The declaration requirements are identical to other major allergens — either in-text or in a Contains statement.

The Sesame Cross-Contact Problem

The sesame declaration requirement created a specific challenge: some manufacturers who had not previously been concerned about sesame cross-contact now needed to address it to avoid inadvertent allergen declarations. Some manufacturers added sesame to products that did not previously contain it, in order to simplify labelling of shared-facility risk. This practice has been controversial but is technically permitted.

Current FALCPA Compliance Checklist

Review your product labels for:

• Sesame declared where present
• All nine major allergens covered
• Tree nuts individually named
• Plain language used for all allergen declarations
• Contains statement consistent with ingredient list
• Labels updated following any formulation change

Audit and update allergen information across your Shopify product catalogue with Allergen Matrix at saltai.app.

How Tree Nut Declarations Work Under Current Rules

Tree nuts remain one of the nine major allergens under FALCPA, but the declaration rules carry a specific requirement that catches many brands off guard: each tree nut must be individually named rather than grouped under the generic term "tree nuts." If your product contains almonds and cashews, your label must name both explicitly. Listing only "tree nuts" in a Contains statement is not sufficient for compliance and leaves the label open to regulatory challenge. This requirement applies whether the declaration appears inline or in a separate Contains block.

The practical implication for multi-product brands is significant. A granola range, for example, might use different nut combinations across its SKUs, and each variant requires its own accurate, specific declaration. A label copied from a similar product without reviewing the exact ingredient specification is a common source of error. Every formulation revision, even a minor one, must trigger a full allergen review to confirm that tree nut naming remains accurate and complete across all affected labels.

For Shopify merchants selling food products, maintaining accurate tree nut declarations across a growing product catalogue is an ongoing operational task rather than a one-time labelling project. When new SKUs are added or suppliers change, the allergen information attached to each product listing needs to reflect the updated specification. Using a structured tool to track this information product by product reduces the risk of an outdated declaration remaining live on a storefront after a formulation has changed.

Understanding What Counts as a Major Allergen Ingredient

FALCPA requires that major allergens be declared whenever they are present as an ingredient, a component of a compound ingredient, or a processing aid. This scope is broader than many brands initially assume, and it is a common source of non-compliance for products using complex or multi-component ingredients. If your spice blend contains a carrier derived from wheat, or your flavouring system includes a dairy-derived component, those allergens must appear on the finished product label regardless of how minor the quantity or how deeply embedded the allergen is in the supply chain.

The responsibility for tracing allergens through compound ingredients rests with the finished product manufacturer or brand owner, not with the ingredient supplier. Brands should request full compositional breakdowns from suppliers and review these for allergen-containing components before finalising labels. A supplier declaration that lists only top-level ingredients without disclosing sub-components is not sufficient due diligence. Brands that rely on incomplete supplier data expose themselves to both regulatory risk and the reputational harm that follows an allergen-related recall or consumer complaint.

When formulations involve imported ingredients or ingredients sourced from multiple suppliers, the allergen review process becomes more complex. Seasonal supply changes, ingredient substitutions, and supplier transitions can all introduce new allergens without a formal reformulation notification. Building an internal process that requires an allergen review at every point of supplier change — not just at scheduled label reviews — is the most reliable way to keep pace with what is actually in your products. Connecting that process to your product listings through a tool like Allergen Matrix helps ensure that your Shopify storefront reflects current, accurate allergen data at all times.

FALCPA and Online Product Listings: What Applies to Your Shopify Store

A question that frequently arises among food brands selling through Shopify is whether FALCPA labelling requirements apply to product information displayed online, or only to the physical label on packaged goods. The FDA's position is that the labelling requirements under FALCPA apply to the label on the packaged food product itself. However, food brands selling online are also subject to broader consumer protection obligations, and presenting inaccurate or incomplete allergen information on a product listing can constitute misleading representation regardless of whether it falls strictly within FALCPA's scope.

For practical purposes, your Shopify product pages should reflect the same allergen information that appears on your physical labels. If a product contains one of the nine major allergens, that information should be visible and accurate in the product description or a dedicated allergen field on the listing. Consumers with food allergies frequently use online product pages to assess safety before purchasing, and an allergen omission on a digital listing can have the same real-world consequences as an omission on a physical label. Treating your online storefront as an extension of your labelling programme rather than a separate channel is the responsible and commercially sensible approach.

Shopify does not include native functionality for structured allergen data management, which means brands must develop their own approach to maintaining and displaying this information. Entering allergen details manually into product descriptions creates inconsistency and makes bulk updates difficult. As a product range scales, the risk of an outdated or incorrect allergen entry on a live listing increases. A dedicated allergen management tool integrated with your Shopify store allows you to maintain structured, auditable allergen records that can be updated systematically when formulations change.

Preparing for Future Regulatory Changes

FALCPA has been amended twice since its original passage — first when it was enacted in 2004 and again with the FASTER Act in 2021. The regulatory landscape for allergen labelling in the United States continues to evolve, and food brands should monitor FDA activity and legislative developments rather than treating current requirements as fixed indefinitely. Ongoing FDA reviews of the scientific basis for major allergen designations mean that additional allergens could be added to the list in future legislation, and brands with complex supply chains will need to respond quickly when that happens.

Beyond potential expansions to the list of major allergens, the FDA periodically updates its guidance on compliance expectations, labelling formats, and enforcement priorities. Staying current with FDA communications, including guidance documents and warning letter patterns, provides early visibility into areas where the agency is focusing attention. Industry associations such as the Food Allergy Research and Education network and the Consumer Brands Association publish compliance resources that can help brands interpret regulatory updates in practical terms. Building relationships with a regulatory consultant or allergen specialist is worthwhile for brands operating at scale or selling into retail channels where buyer compliance requirements add a further layer of expectation.

For Shopify food brands, the most practical preparation for future changes is building labelling and allergen management processes that are easy to update. If your allergen information is embedded in static product descriptions and managed manually across dozens of SKUs, responding to a new regulatory requirement will be time-consuming and error-prone. A more structured approach — with allergen data held in dedicated fields, linked to ingredient specifications, and reviewable across your full catalogue — makes compliance updates faster and reduces the likelihood of an outdated declaration persisting on a live listing after a regulatory change takes effect.

Keeping Your Compliance Records Audit-Ready

Maintaining documentation that supports your allergen declarations is a best practice that applies regardless of your sales channel or business size. If an allergen complaint or regulatory query arises, the ability to produce ingredient specifications, supplier declarations, and a record of your label review process demonstrates that your compliance programme is genuine and systematic rather than reactive. For small and growing food brands, this documentation does not need to be complex, but it does need to exist in a form that can be retrieved and presented clearly.

An audit-ready compliance record typically includes current formulation documents for each SKU, supplier allergen declarations for every ingredient, dated records of allergen reviews, and copies of approved labels for each product version. When formulations change, the old records should be retained alongside the new ones so that the compliance history of each product is traceable over time. Keeping these records aligned with your active product listings reduces the administrative effort involved in responding to buyer audits, retail listings reviews, or regulatory enquiries.

For Shopify merchants managing an expanding range of food products, keeping compliance records aligned with live product listings is easier when both are managed through connected systems. Ad hoc documentation processes tend to fall behind as product ranges grow, and the gap between what is documented and what is actually selling creates compliance risk. A structured approach to allergen data management, integrated with your Shopify store, supports both consumer safety and the operational confidence that comes from knowing your records accurately reflect what is on sale.

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