FALCPA Compliance Checklist for US Food Businesses
A practical checklist for US food businesses to audit FALCPA allergen labelling compliance — covering ingredients, labels, online product pages, and processes.
Use this checklist to audit your FALCPA allergen labelling compliance. It covers your ingredients, physical labels, online store, and operational processes.
Ingredient Audit
- Full specification sheets obtained from all ingredient suppliers
- All nine major allergens identified in every ingredient (including sub-components of compound ingredients)
- Processing aids and manufacturing adjuncts checked for allergens
- Cross-contact risks from shared equipment documented
- Allergen matrix created for all products
Physical Label Review
- All major allergens declared by common name in ingredient list or in "Contains" statement
- "Contains" statement capitalised and positioned immediately after ingredient list
- Fish and shellfish declared by specific type (e.g. "salmon", "shrimp")
- Tree nuts declared by specific variety (e.g. "almonds, cashews")
- Sesame declared for any product containing sesame in any form (effective January 2023)
- Advisory "may contain" statements included for cross-contact risks where appropriate
Shopify Product Pages
- Allergen information displayed on every food product page
- Allergen declarations match physical labels exactly
- Allergen information visible before checkout (not buried in tabs or downloads)
- Process in place to update product pages when recipes or labels change
Operational Processes
- Procedure in place for reviewing allergen declarations when recipes change
- Supplier change process includes allergen re-audit step
- Staff training on allergen handling documented
- Process for voluntary recalls in place if mislabelling is discovered
SaltAI's Allergen Matrix app helps keep your Shopify allergen declarations accurate and up to date.
Understanding the Nine Major Allergens Under FALCPA
FALCPA, the Food Allergen Labelling and Consumer Protection Act, mandates clear declaration of nine major food allergens on all packaged food products sold in the United States. Those allergens are milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame was added as the ninth major allergen through the FASTER Act, which came into full effect on 1 January 2023. Understanding exactly what falls within each category is a foundational step before you can confidently complete any audit checklist.
Each allergen category carries its own nuances that food businesses need to internalise. Tree nuts, for instance, include almonds, cashews, walnuts, pecans, pistachios, Brazil nuts, hazelnuts, macadamia nuts, and pine nuts, among others. Fish and shellfish are treated as distinct categories, and both require species-level specificity on labels — writing "fish" alone is not sufficient. Wheat covers all forms of wheat, including spelt and kamut, while milk covers all dairy derivatives such as casein, whey, and lactose. Knowing these definitions prevents omissions that could constitute a labelling violation.
Businesses are sometimes surprised to learn that FALCPA applies to highly refined oils derived from major allergens in most practical labelling contexts, and that ingredients such as lecithin derived from soy must still be declared. When you review your ingredient specification sheets, look beyond the headline ingredient name and scrutinise every sub-component. A compound sauce listed simply as "teriyaki sauce" from a supplier may contain wheat-based soy sauce and sesame oil, both of which require declaration on your finished product label.
How to Build and Maintain a Robust Allergen Matrix
An allergen matrix is a structured document — typically a spreadsheet — that maps every product you sell against every major allergen, indicating whether each allergen is present as an ingredient or poses a cross-contact risk. Building this document requires pulling together supplier specification sheets, your own recipes or formulations, and your facility's production schedule. When complete, it becomes the single source of truth for your allergen declarations and should feed directly into both your physical labels and your online product pages.
The matrix should be structured so that each row represents a finished product and each column represents one of the nine major allergens. Cells should be marked to distinguish between intentional inclusion, cross-contact risk, and confirmed absence. Colour-coding these three states makes the matrix easier to audit at a glance and reduces the chance of misreading a cell during a label review. You should also include a column that records when each row was last verified, so you can quickly identify products that have not been reviewed since a recipe or supplier change occurred.
Keeping the matrix accurate over time is where many businesses struggle. The matrix is only useful if it reflects the current state of your ingredients and production environment. Whenever a supplier notifies you of a formulation change, or whenever you introduce a new ingredient to your facility, the matrix should be updated before production resumes. Linking your allergen matrix to your Allergen Matrix app on Shopify means that updates to the document can flow through to your online store, reducing the risk of your website displaying outdated allergen information to customers.
Navigating Cross-Contact Risks and Advisory Statements
Cross-contact occurs when an allergen is unintentionally transferred from one food to another through shared equipment, production lines, or handling practices. Unlike cross-contamination in a food safety context, cross-contact specifically concerns allergen transfer, and even trace quantities can trigger severe reactions in sensitised individuals. FALCPA does not mandate advisory statements such as "may contain" or "produced in a facility that also processes," but these statements are widely used and carry significant legal and reputational weight when used — or misused.
The FDA has made clear that advisory statements should only be used when a genuine, scientifically substantiated risk of cross-contact exists. Using "may contain peanuts" on every product regardless of actual risk dilutes the value of the warning and can cause consumers to disregard it. Conversely, failing to include an advisory statement when cross-contact is genuinely possible may expose your business to liability if a customer has an allergic reaction. Conducting a thorough risk assessment of your production environment, including cleaning validation studies if applicable, is the responsible basis for deciding when to include these statements.
When you do include advisory statements, ensure they are worded consistently across your product range and placed in a logical position on the label, typically following the "Contains" statement. On your Shopify product pages, advisory information should be presented alongside your mandatory allergen declarations, not buried beneath additional product description text. Shoppers with severe allergies are specifically looking for this information before they make a purchase, and a clear, consistent presentation builds trust while also demonstrating your compliance commitment to any regulatory reviewers who might examine your online store.
Managing Allergen Compliance When Recipes or Suppliers Change
Recipe and supplier changes are among the most common triggers for unintentional allergen mislabelling. A business may carefully audit its products at launch, but if a supplier quietly reformulates an ingredient — or if an internal recipe tweak introduces a new allergen — the labels and online declarations can fall out of sync almost immediately. Building formal change-management procedures into your operations is not bureaucratic overhead; it is a practical safeguard that protects both your customers and your business from the consequences of a mislabelling event.
Your supplier change process should include a mandatory allergen review step triggered any time you switch to a new supplier, source a new ingredient, or receive a reformulation notice from an existing supplier. Request an updated specification sheet and compare it against the previous version with allergen declarations specifically in mind. Do not assume that a product described as "same specification" has not changed — request written confirmation that the allergen profile is unchanged, and keep that correspondence on file. If the allergen profile has changed, your internal allergen matrix, your physical labels, and your Shopify product pages must all be updated before that ingredient enters production.
For recipe changes driven internally, establish a pre-production sign-off process that includes an allergen review checkpoint. This might be as simple as a checklist that the person approving the recipe change must complete before new batch production begins. The checkpoint should confirm that the allergen matrix has been updated, that new labels have been approved and are available, and that online product pages have been amended. Documenting this process creates an audit trail that demonstrates due diligence, which is valuable both for regulatory purposes and in the event of a customer complaint or recall situation.
Training Your Team and Preparing for a Potential Recall
Staff training is a legal requirement in many food production contexts and an operational necessity in all of them. Every team member who handles ingredients, prepares products, applies labels, or manages your online store needs to understand what the nine major allergens are, why accurate declaration matters, and what to do if they identify a potential mislabelling issue. Training does not need to be complex, but it must be documented, repeated at appropriate intervals, and updated whenever allergen regulations change — as they did when sesame was added in 2023.
Practical training should cover how to read a specification sheet, how to identify allergens in compound ingredients, and how to escalate a concern if something looks wrong. Frontline staff should feel empowered to pause production or flag a discrepancy rather than proceeding and hoping for the best. Building a culture where allergen accuracy is treated as a non-negotiable standard — rather than a checkbox exercise — significantly reduces the likelihood of a serious mislabelling incident reaching your customers.
Even with excellent processes in place, the possibility of a mislabelling event should be planned for. The FDA operates a voluntary recall programme, and businesses that act quickly and transparently when they discover a mislabelling error are generally treated more favourably than those who delay. Your recall procedure should document who has authority to initiate a recall, how affected products will be identified and traced, how customers and retailers will be notified, and how the root cause will be investigated and remediated. Having this plan written down and accessible means you can act decisively under pressure, which protects consumers and limits the commercial impact on your business.
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.