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FALCPA & US Allergen Law26 February 20269 min read

FALCPA Compliance Checklist for US Shopify Food Sellers

If you're selling food products through a Shopify store to US customers, allergen labelling isn't optional — it's federal law. The Food Allergen Labeling and Consumer Protection Act (FALCPA), enac

If you're selling food products through a Shopify store to US customers, allergen labelling isn't optional — it's federal law. The Food Allergen Labeling and Consumer Protection Act (FALCPA), enacted in 2004 and expanded by the FASTER Act of 2021, requires that the nine major food allergens be clearly declared on every packaged food product sold in the United States. Getting this wrong doesn't just mean a warning letter from the FDA; it can mean costly product recalls, customer harm, and reputational damage that can take years to recover from.

The problem for most Shopify sellers is that compliance isn't a one-time task. Every time you update a recipe, add a new product, or change a supplier, your allergen declarations need to be reviewed and updated across your entire store. Many small food businesses treat labelling as an afterthought — something to sort out after launch — and end up scrambling when a customer asks a direct question or a retailer demands documentation.

This checklist is designed to give Shopify food sellers a structured, practical framework for FALCPA compliance. You'll learn which allergens must be declared, how to format your labels correctly, how to handle "may contain" statements, and how to manage allergen data across your product catalogue using the right tools.


Know the Nine Major Allergens Under FALCPA and the FASTER Act

Before you can label correctly, you need to know exactly what you're required to declare. Under FALCPA, the original eight major allergens were milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soy. The FASTER Act, which came into effect on 1 January 2023, added sesame as the ninth major allergen — making the US one of the first countries globally to give sesame the same mandatory declaration status as peanuts or milk.

Each of these allergens must be declared on your product label whenever they are present as an ingredient, a component of an ingredient, or a processing aid. This applies even if the allergen is present in a small amount, and even if it's part of a flavouring, spice blend, or additive that you purchase under a commercial name. If your vanilla extract contains a wheat-based carrier, wheat must appear on your label — it's not enough to list "natural flavour."

Many Shopify sellers are caught out by incidental additives and ingredient sub-components. If you're buying a pre-made spice mix or a compound butter and incorporating it into your product, you are responsible for understanding what's in it and declaring any major allergens accordingly. Request allergen declarations from every supplier in your supply chain, and update your product specifications every time a supplier changes their formulation.


Format Your Allergen Declarations Correctly on Every Label

FALCPA gives manufacturers two accepted methods for declaring allergens on packaging. The first is the ingredient list method, where the allergen source is named in parentheses directly after the ingredient name — for example, "casein (milk)" or "semolina (wheat)." The second is a "Contains" statement placed immediately after the ingredient list, such as "Contains: milk, wheat, soy." You can use either method, but you must be consistent and you cannot use the "Contains" statement as a replacement for an accurate ingredient list.

The "Contains" statement must list every major allergen present in the product, and it must appear in the same type size as the ingredient list — not smaller. A common mistake is using a very small "Contains" statement in a footer-style format while the product name and marketing copy dominate the label. The FDA expects allergen information to be conspicuous and legible, and inspectors do look at label hierarchy during reviews.

One practical tip: use bold formatting for allergen names within your ingredient list where local label printing allows it. While FALCPA does not legally require bold text, many manufacturers use it to reduce consumer error and demonstrate good faith in their labelling practices. For your Shopify product pages, mirror your physical label content as closely as possible — what appears online should never contradict what appears on the pack.


Handle "May Contain" and Cross-Contact Statements Responsibly

Cross-contact warnings — statements like "may contain traces of peanuts" or "produced in a facility that also processes tree nuts" — are not currently required by FALCPA. These are voluntary advisory statements, and the FDA does not regulate their exact wording. However, they are widely expected by consumers and retailers, and their absence (or misuse) can create serious liability.

The risk with advisory statements is overuse. If you print "may contain" warnings on every single product regardless of actual cross-contact risk, you erode consumer trust and make your labelling meaningless for the most allergic customers. The FDA's guidance is that advisory statements should only be used when there is a genuine, documented risk of cross-contact that cannot be eliminated through good manufacturing practices — not as a blanket disclaimer to avoid responsibility.

To use cross-contact statements correctly, document your cleaning and segregation procedures in writing, identify which allergens are genuinely at risk in your production environment, and apply advisory statements selectively and accurately. If you produce a peanut-free product on dedicated equipment that has never processed peanuts, a "may contain peanuts" warning on that product is inaccurate and potentially misleading. Be precise, be honest, and keep your risk assessments updated.


Audit Your Shopify Product Pages Against Your Physical Labels

Your Shopify store is, in many jurisdictions, considered a point of sale — and allergen information presented online must be accurate and consistent with your physical packaging. A product page that lists "gluten-free" while the physical label contains a wheat declaration is not just a compliance failure; it's a consumer safety issue. Many recalls and complaints originate not from the physical label but from incorrect or outdated information on the seller's website.

Conduct a formal label audit at least twice a year, or whenever a recipe or supplier changes. Create a master product specification sheet for each SKU that includes the full ingredient list, allergen declarations, and any advisory statements. This document becomes your single source of truth, and every channel — your Shopify store, your packaging, your wholesale documentation — should be updated from it simultaneously.

For Shopify sellers managing more than ten or fifteen products, manual auditing quickly becomes error-prone. Tools like Allergen Matrix are designed specifically to help food businesses centralise their allergen data, so that a single update to a recipe propagates correctly across all your product listings. Reducing the number of manual steps in your compliance workflow is not just an efficiency gain — it's a risk reduction strategy.


Manage Supplier Changes and Reformulations Proactively

One of the highest-risk moments for allergen compliance is a supplier change. If your current sunflower oil supplier is replaced by a new one who processes their oil on shared equipment with sesame, your sesame declaration requirements may change overnight — even though your recipe hasn't changed at all. This is a real scenario that has triggered product recalls for food businesses of all sizes, from artisan makers to national brands.

Build a formal supplier review process into your operations. Every ingredient supplier should provide you with a current allergen declaration on an annual basis at minimum, and you should request an updated declaration any time a supplier notifies you of a site change, equipment change, or reformulation. Keep these declarations on file and date-stamped so you can demonstrate due diligence if your labelling is ever challenged.

When you receive a new allergen declaration that changes your product's allergen status, update your physical labels and your Shopify product pages before the new batch reaches customers. Don't sell through existing stock with old labels if the allergen profile has materially changed — the short-term cost of reprinting labels is far smaller than the cost of a recall or an FDA enforcement action.


Train Your Team and Document Your Compliance Process

FALCPA compliance isn't just a labelling task — it's a business process that needs to be owned, documented, and understood by everyone who touches your products or your product listings. If you have staff updating your Shopify store, packing orders, or communicating with customers about ingredients, they need clear guidance on what your products contain and how to answer allergen questions accurately.

Create a simple internal document that outlines your allergen policy, lists the nine major allergens and which of your products contain each one, and sets out the steps to follow when a recipe or supplier changes. Review this document with your team at least annually and update it whenever your product range changes. Make it easy to find — not buried in a shared drive no one opens.

Customer-facing communication matters too. Train anyone responding to enquiries about allergens to direct customers to your most current product information rather than answering from memory. A well-meaning but inaccurate verbal response to an allergen question can have serious consequences if a customer acts on it. Your Shopify store's product descriptions, FAQ pages, and any email templates referencing ingredients should all be included in your regular compliance audit cycle.


Conclusion

FALCPA compliance for US Shopify food sellers comes down to four fundamentals: knowing which allergens must be declared, formatting your labels correctly, managing your supply chain proactively, and keeping your online store in sync with your physical packaging. The FASTER Act added sesame to the list in 2023, and the FDA continues to update its guidance — staying current is part of the job.

The businesses that handle allergen compliance well aren't necessarily the largest or the best-funded. They're the ones with clear processes, accurate documentation, and the right tools to manage information consistently across channels. A single missed declaration or outdated product page can have consequences far beyond the cost of getting it right in the first place.

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.