FALCPA Label Requirements: Formatting Allergen Declarations on US Food Products

FALCPA doesn't just require allergen disclosure — it specifies how that disclosure must be formatted. Getting the format wrong can result in FDA warning letters even if your actual allergen information is accurate. Here's exactly what the law requires for how allergens must appear on your food labels.

The Two Permitted Formats

FALCPA permits two methods for allergen declaration. The parenthetical method places the allergen name in brackets within the ingredient list itself — for example, "enriched flour (wheat)" or "casein (milk)". This works well when the ingredient name doesn't make the allergen obvious. The "Contains" statement method adds a separate declaration after the ingredient list: "Contains: Wheat, Milk, Soy." Both formats are fully compliant.

Formatting Requirements

The "Contains" statement must appear immediately after or adjacent to the ingredient list. The word "Contains" must be capitalised. The list of allergens must use the common name of each allergen (or the specific type for fish, shellfish, and tree nuts). The statement must be in a typeface and font size that is no less prominent than the ingredients list itself.

Common Formatting Mistakes

The most common errors are: using "Contains" in the middle of a label rather than after the ingredient list; failing to capitalise "Contains"; listing "tree nuts" rather than the specific nut; and omitting the "Contains" statement for an allergen that is clearly present but not named in an obvious way. Any of these can trigger FDA regulatory action. Use SaltAI's allergen tools on your Shopify store to ensure your online declarations are consistent with your physical labelling.

See how SaltAI's Allergen Matrix keeps your Shopify store compliant.

Combining Both Methods on a Single Label

Many food manufacturers choose to use both the parenthetical method and the "Contains" statement simultaneously on the same label, and this approach is entirely permitted under FALCPA. The parenthetical declarations within the ingredient list serve to clarify individual ingredients, while the "Contains" statement at the end provides a consolidated summary that shoppers can locate quickly. There is no regulatory prohibition against using both methods together, and for products with multiple major allergens, the combination approach often delivers the clearest communication to consumers.

When combining both methods, consistency is essential. Every allergen named in the "Contains" statement must also appear — either explicitly or via parenthetical — within the ingredient list itself. If your "Contains" statement lists wheat and milk, but your ingredient list has no parenthetical clarification for either, you have technically satisfied FALCPA, but the label may still attract scrutiny if the ingredient names are ambiguous. Consistency across both declaration points reduces the risk of consumer confusion and limits your exposure to regulatory challenge.

It is worth noting that using both methods does not allow you to omit an allergen from one location simply because it appears in the other. The "Contains" statement is a supplement to the ingredient list, not a replacement for it. If an ingredient name is scientific, highly technical, or entirely unfamiliar to a general consumer — for example, "albumin" for eggs — the parenthetical clarification within the ingredient list remains the most direct route to compliance, with the "Contains" statement providing a secondary confirmation of the allergen's presence.

The FASTER Act and Sesame: What Changed in 2023

The FASTER Act of 2021 added sesame as the ninth major food allergen under US law, effective 1 January 2023. This was the most significant expansion of FALCPA's allergen list since the original legislation passed in 2004. From that date, sesame must be declared using exactly the same formatting rules that apply to the other eight major allergens: parenthetical disclosure within the ingredient list, a "Contains" statement, or both. Labels produced before the compliance date that omit sesame declarations are now considered misbranded under FDA rules.

The addition of sesame created a particular challenge for food manufacturers because sesame had previously been used as a flavouring ingredient under the broad category of "natural flavours," without requiring specific disclosure. After 2023, any product where sesame — in any form, including sesame oil or tahini — is present as an ingredient must name it explicitly. Manufacturers who had relied on the "natural flavours" catch-all had to reformulate their labels entirely, and in some cases, had to reassess their supply chains to determine whether sesame was present in flavouring compounds supplied by third parties.

For Shopify merchants selling US food products online, the sesame update is particularly important to audit. If you launched products between 2020 and 2022 and have not reviewed your digital product listings since the FASTER Act came into force, your online allergen declarations may still reflect pre-2023 standards. Your physical labels may have been updated by your manufacturer or co-packer, while your Shopify product pages remain unchanged — creating a dangerous inconsistency between your physical and digital declarations. Allergen Matrix helps you audit and align those declarations across your entire product catalogue.

Font Size, Placement, and Visual Prominence Rules

FALCPA requires that allergen declarations — whether parenthetical or via a "Contains" statement — must be presented in a type size and typeface that is no less prominent than the ingredient list itself. This is a frequently misunderstood requirement. It does not mean the allergen declaration must be in bold or in a larger font than everything else on the label; it means it cannot be visually subordinate to the ingredient list through the use of smaller type, lighter weight, or lower-contrast colouring. The declaration must be equally easy to read as the list it accompanies or follows.

Placement rules are equally specific. The "Contains" statement must appear immediately after or adjacent to the ingredient list — not elsewhere on the label, not on the back panel if the ingredient list is on the side panel, and certainly not in a footnote or supplementary information section. The FDA has issued warning letters to manufacturers who placed allergen summaries on a separate panel for design reasons, treating the declaration as a marketing-friendly feature rather than a mandatory regulatory element. Proximity to the ingredient list is non-negotiable.

For online product listings, visual prominence translates differently than on a physical label. There is no regulatory requirement that mandates a specific font size for allergen information on a website product page, but the principle of parity with ingredient information is a sensible standard to follow. If your ingredient list is displayed in body text, your allergen declaration should not be buried in fine print or collapsed behind an expandable content block. Clear, accessible digital presentation reduces consumer risk and supports the broader compliance posture that regulators increasingly expect from e-commerce food sellers.

Cross-Contact Statements and Their Relationship to FALCPA Declarations

Cross-contact statements — phrases such as "May contain traces of peanuts" or "Manufactured in a facility that also processes tree nuts" — are entirely voluntary under FALCPA and are not governed by the same formatting rules as mandatory allergen declarations. The FDA does not require cross-contact disclosures, and there is no prescribed location, font size, or phrasing that must be used. However, this voluntary status does not mean cross-contact statements are unregulated in any broader sense; they must be truthful and not misleading, and the FDA has cautioned against using them as a substitute for proper allergen declarations.

The important distinction for label compliance is that cross-contact statements cannot replace mandatory FALCPA declarations. If a product contains wheat as a deliberate ingredient, you cannot satisfy FALCPA by writing "May contain wheat" on the label. The allergen must be declared because it is an ingredient, not merely a cross-contact risk. Many manufacturers include both a compliant mandatory declaration and a cross-contact advisory, which is permissible, but the mandatory declaration must be present regardless of whether any cross-contact language appears elsewhere on the label.

For e-commerce sellers, this distinction matters when updating digital listings. Product pages sometimes carry legacy copy that mixes mandatory and advisory allergen language in a way that obscures which allergens are confirmed ingredients and which are cross-contact risks. Shoppers with severe allergies rely on this distinction to make safe purchasing decisions. Keeping your mandatory FALCPA declarations clearly separated from any voluntary cross-contact advisory language is both a regulatory best practice and a meaningful step toward protecting your customers.

Applying FALCPA Standards to Your Shopify Product Listings

Physical label compliance and digital listing compliance are not automatically aligned. When you update a physical label to reflect a reformulation or an allergen change, that update does not automatically propagate to your Shopify product pages, your metafields, or any third-party marketplace listings you manage. For food brands selling direct-to-consumer through Shopify, maintaining synchronised allergen information across physical and digital channels requires a deliberate, systematic process — not a once-a-year audit.

Building that process starts with treating your Shopify product listings with the same rigour you apply to your physical labels. Every ingredient change, every supplier switch, and every formulation update should trigger a corresponding review of your digital allergen declarations. The FDA's expectations around allergen accuracy are format-agnostic — misbranded information on a website carries the same regulatory implications as misbranded information on a physical label, particularly as the agency increases its scrutiny of online food retail.

SaltAI's Allergen Matrix integrates directly with your Shopify store to help you manage allergen declarations at scale, flagging inconsistencies and keeping your digital listings aligned with your physical label data. Whether you manage five SKUs or five hundred, the tool is designed to make FALCPA compliance an operational routine rather than an emergency response. Try Allergen Matrix free at saltai.app — no credit card required.