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FALCPA & US Allergen Law22 January 20269 min read

FALCPA vs Natasha's Law: Key Differences for International Food Brands

Selling food in both the US and UK means navigating two different allergen regimes. Here's how FALCPA and Natasha's Law differ — and where they align.

Food businesses selling in both the United States and the United Kingdom must comply with two distinct allergen labelling regimes: FALCPA in the US and the UK's Food Information to Consumers (FIC) Regulation plus Natasha's Law in the UK. Understanding the differences — and the overlaps — is essential for international compliance.

Number of Allergens

FALCPA requires declaration of nine major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. UK/EU law requires declaration of 14 allergens: the FALCPA nine, plus celery, lupin, molluscs, mustard, and sulphur dioxide/sulphites. Food sold in the UK must declare all 14; food sold only in the US needs only the FALCPA nine. For businesses operating in both markets, designing labels to the UK's 14-allergen standard automatically satisfies FALCPA.

Emphasis Requirements

UK law requires allergens in the ingredient list to be emphasised — typically in bold — to distinguish them from non-allergenic ingredients. FALCPA has no such requirement; the common name in the ingredient list or a "Contains" statement satisfies the law. However, many US food businesses voluntarily bold allergens in ingredient lists as a matter of best practice.

PPDS and Natasha's Law

Natasha's Law introduced specific requirements for pre-packed for direct sale (PPDS) food — food packaged on the same premises where it is sold. FALCPA has no direct equivalent to PPDS labelling requirements; US law generally treats all packaged food the same regardless of where it was packaged. This is a significant difference for bakeries, delis, and food-to-go businesses.

Designing for Both Markets

If you sell on both markets, the most efficient approach is to design your labels and your Shopify product pages to the higher standard — UK's 14 allergens, emphasised in bold, with a "Contains" statement. This satisfies both regimes and eliminates the need for market-specific versions.

SaltAI's Allergen Matrix supports both UK and US allergen frameworks on your Shopify store.

Precautionary Allergen Labelling and "May Contain" Statements

Precautionary allergen labelling (PAL) — the familiar "may contain" or "made in a facility that also processes" statements — is handled differently under each regime. In the UK, Food Standards Agency guidance strongly discourages the overuse of PAL statements and encourages businesses to use them only where a genuine, assessed cross-contamination risk exists. The goal is to prevent blanket disclaimers that erode consumer trust and reduce the practical usefulness of the information. Businesses that apply "may contain" to every product regardless of actual risk face reputational challenges and potential regulatory scrutiny.

Under FALCPA, precautionary allergen statements are voluntary and entirely unregulated by the FDA. There is no federal standard governing when a "may contain" statement is appropriate, what language must be used, or how it should be displayed. This means US food businesses have considerably more discretion — but also considerably less consistency. Consumers in the US have grown accustomed to seeing widely varying PAL language, which can create confusion about the actual level of risk associated with any given product.

For international brands managing both markets, the practical recommendation is to align your PAL approach with the more rigorous UK standard even on your US-facing labels. Conduct a genuine cross-contamination risk assessment, document your findings, and apply precautionary statements only where the risk is real and material. This approach protects your brand reputation in both markets, reduces the likelihood of misleading customers, and provides a defensible paper trail should a complaint or incident arise. Your Shopify product pages should reflect the same assessed information that appears on your physical packaging.

Ingredient List Formatting and Legal Name Requirements

The formatting requirements for ingredient lists differ in ways that are easy to overlook but commercially important. UK FIC regulations require ingredients to be listed in descending order of weight as incorporated, using either their common name or a specific legal name defined in regulation. The legislation is explicit about the size and legibility of text, requiring a minimum x-height of 1.2mm on most packaging. Where space is very limited, specific derogations apply, but the default standard is notably prescriptive compared to US requirements.

FALCPA and broader FDA labelling rules also require descending-order ingredient lists, but the presentation rules are somewhat less prescriptive in practice. The key FALCPA-specific requirement is that the common name of the allergenic food must appear — either in the ingredient list itself or in a separate "Contains" statement immediately following. Where an ingredient is known by a name that does not clearly identify the allergenic source (for example, "casein" for milk), a parenthetical declaration must be added. This parenthetical approach is specific to FALCPA and has no direct UK equivalent, where emphasis rather than parenthetical clarification is the standard mechanism.

For Shopify merchants selling internationally, the safest approach is to build product descriptions and allergen information blocks that satisfy both sets of requirements simultaneously. Write ingredient lists using common names that are recognisable in both markets, apply bold emphasis to all 14 UK allergens, and include a "Contains" statement listing all relevant allergens by common name. Using a structured tool like Allergen Matrix to manage this information centrally means you can update a single data source and have it render correctly across different storefront markets without manually maintaining parallel versions of every product page.

Enforcement and Liability Landscape

The enforcement environment for allergen labelling differs substantially between the two countries, and understanding this difference matters for how seriously you should treat compliance gaps. In the United States, FALCPA enforcement sits with the FDA, which can issue warning letters, request voluntary recalls, or pursue mandatory recalls for mislabelled products. Civil liability exposure is also significant — FALCPA violations can form the basis of consumer protection claims and product liability lawsuits, particularly where a customer suffers an allergic reaction traceable to a labelling failure.

In the UK, enforcement is the responsibility of local authority Trading Standards officers and, in some cases, the Food Standards Agency directly. Following the introduction of Natasha's Law in October 2021, enforcement activity has increased, and local authorities have the power to issue improvement notices, prohibition orders, and financial penalties. The reputational consequences of a labelling failure in the UK food sector are also severe — incidents involving undeclared allergens receive significant media coverage, and the association with the events that prompted Natasha's Law means public and regulatory tolerance for errors is very low.

For businesses operating across both markets, treating allergen labelling compliance as a legal minimum rather than a commercial consideration is the wrong frame. The practical and reputational risks in both jurisdictions are high enough that building robust processes — including regular label audits, supplier ingredient verification, and documented staff training — is a business-critical investment. Shopify merchants should treat their online product descriptions with the same rigour as their physical packaging, since inaccurate digital allergen information carries equivalent legal and moral weight to a mislabelled packet.

Managing Allergen Information Across a Product Catalogue

Scaling allergen compliance across a large product catalogue presents operational challenges that go beyond understanding the law. For a Shopify merchant selling dozens or hundreds of SKUs across UK and US storefronts, manually updating allergen information in product descriptions is error-prone and time-consuming. A single supplier reformulation can render multiple product pages non-compliant overnight if there is no systematic process for tracking ingredient changes and pushing updates to customer-facing content. The operational risk here is real, and it compounds as catalogues grow.

Centralising allergen data in a structured format — rather than embedding it as unstructured text within product descriptions — makes catalogue management significantly more reliable. When allergen status is stored as a defined attribute for each product, you can query across the catalogue to identify which products contain a given allergen, which are free from a specific allergen group, and which require precautionary labelling. This kind of structured data also enables accurate allergen filtering on your storefront, which is increasingly expected by consumers and, in some contexts, required by platform terms of service.

Allergen Matrix is designed specifically to address this operational challenge for Shopify merchants. It provides a structured framework for recording allergen information against each product, supports both UK 14-allergen and US 9-allergen frameworks, and surfaces that information accurately on your storefront. For international brands managing compliance across both markets, having a single tool that understands both regulatory frameworks removes a significant layer of administrative complexity and reduces the risk of the kind of inconsistency that creates compliance exposure.

Cross-Border Labelling Strategy for Growing Brands

As food brands scale from a single domestic market into international sales, allergen labelling strategy needs to evolve from a reactive compliance exercise into a proactive part of product development. The most effective approach is to build allergen compliance considerations into new product development from the outset — before labels are designed, before Shopify listings are created, and before any marketing copy is written. Retrofitting compliance onto existing products and pages is always more costly and disruptive than designing to the highest standard from the start.

For brands entering the UK market from the US, the step up from nine to fourteen allergens, combined with the emphasis requirement and PPDS provisions, can feel significant. In practice, the transition is most manageable when it is treated systematically rather than product by product. Audit your entire catalogue against all 14 allergens, identify gaps, update your supplier documentation to capture the additional allergens, and build your Shopify product pages using a structured allergen data model. Doing this comprehensively once is far more efficient than addressing it incrementally.

For UK brands expanding into the US, the regulatory hurdle is somewhat lower in terms of allergen count, but the FDA's broader labelling framework introduces its own complexity. Understanding the parenthetical declaration requirement, the rules around "Contains" statements, and the FDA's specific guidance on sesame — added as the ninth major allergen under FASTER Act amendments effective January 2023 — is essential. A well-structured allergen management process built for the UK market will give you a strong foundation, but it needs to be explicitly mapped to FALCPA requirements before your US storefront goes live.

Try Allergen Matrix free at saltai.app — no credit card required.

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.