Voluntary Allergen Precautionary Labelling: Best Practice for US Food Businesses
Precautionary allergen labelling ("may contain") is voluntary in the US — but how you use it affects both customer safety and your regulatory risk profile.
"May contain" advisory statements — also called precautionary allergen labelling (PAL) — are voluntary under FALCPA. But voluntary doesn't mean unimportant. How food businesses use PAL affects customer safety, regulatory risk, and commercial trust. Here's the best practice approach.
What PAL Should and Shouldn't Do
Precautionary allergen labelling should communicate a genuine, documented cross-contact risk. It should not be used as a blanket liability disclaimer to avoid investing in proper allergen control. The FDA has been increasingly critical of "defensive" PAL — businesses that put "may contain peanuts" on everything to avoid liability regardless of actual risk. The agency views this as potentially misleading to consumers who rely on the absence of advisory labels to identify safe products.
Documenting Your Cross-Contact Assessment
Best practice for PAL requires a documented assessment of cross-contact risk for each product. This assessment should identify: which allergenic ingredients are used in the facility; whether shared equipment is used; whether cleaning validation procedures have been tested; and whether airborne contamination is a risk (relevant for flour and powdered allergens). A product that passes this assessment can be legitimately labelled as not having a cross-contact risk; one that fails should carry a PAL statement.
Common PAL Formats
Common US formats: "May contain [allergen]"; "Produced in a facility that also processes [allergen]"; "Made on shared equipment with [allergen]". The most specific format ("made on shared equipment with peanuts") is more informative than a facility-level statement and is preferred by allergy organisations.
PAL on Your Shopify Product Pages
Whatever advisory statements appear on your physical labels should also appear on your Shopify product pages. Allergen-sensitive customers shopping online rely on this information to make safe purchasing decisions. SaltAI's Allergen Matrix supports "may contain" advisory declarations alongside required allergen information.
Display complete allergen and advisory information on your US Shopify food store with SaltAI.
When to Review and Update Your PAL Statements
PAL statements should not be set once and forgotten. Any change to your production environment — a new ingredient, a new supplier, a rearrangement of equipment, or an expansion of your product range — can alter the cross-contact risk profile for existing products. This means your documented assessment needs to be treated as a living record, reviewed and updated whenever something material changes in how or where your products are made.
Seasonal products present a particular challenge for small food businesses. If you produce a peanut-based holiday range on the same equipment used year-round for nut-free products, that changes the cross-contact risk for those nut-free lines during that production window. It may be necessary to temporarily apply a PAL statement for the duration of that season, even if the year-round risk assessment would not normally require one. Documenting this reasoning clearly protects you if questions arise later.
Review cycles should also be tied to supplier changes. If you switch to a new flour supplier or a new packaging co-packer, you cannot assume the allergen risk profile is identical to your previous source. Request allergen and cross-contact information from new suppliers as standard practice, and hold that documentation alongside your product assessment records. This paper trail is essential if the FDA or a retailer partner ever asks you to demonstrate due diligence in your allergen management.
The Difference Between "May Contain" and "Free From" Claims
Understanding PAL is only part of the picture — the other side is understanding what it means to make a positive "free from" claim. In the US, there is no federally regulated standard for claims like "peanut-free" or "nut-free," which means businesses using these phrases are setting their own bar and accepting full responsibility for meeting it. If your product carries a "peanut-free" claim alongside a "may contain peanuts" advisory, you have created a direct contradiction that will erode consumer trust and may attract regulatory scrutiny.
The practical guidance is to use PAL and "free from" language as mutually exclusive signals. A product that has passed a rigorous cross-contact assessment and can be manufactured consistently without allergen risk may legitimately carry a "free from" claim. A product that cannot meet that standard should carry a PAL statement and should not use "free from" language. This distinction matters enormously to the allergy community, where many consumers have learned to read labels carefully and will notice inconsistency.
Some businesses attempt to navigate this tension by using softer language such as "made without peanuts" rather than "peanut-free," on the reasoning that this refers to the recipe rather than the manufacturing environment. This approach has some logic to it, but it still requires you to ensure the ingredient list is genuinely free of the allergen in question. Whatever language you choose, it should be applied consistently across your physical labels and your online product listings, including your Shopify store, where customers may screenshot and share your claims widely.
Training Staff to Apply PAL Consistently
Labelling decisions that are made correctly in a spreadsheet can still fail if the people applying labels on the production floor or updating product pages on your Shopify admin do not understand the reasoning behind them. Staff training is a critical and often underestimated component of a sound allergen management programme. Employees who understand why a PAL statement exists are more likely to flag it when something changes that might affect its accuracy.
Training does not need to be elaborate to be effective. A brief written procedure explaining what PAL means, which products carry it and why, and what to do if a new ingredient or process change is introduced is sufficient for most small food businesses. The key is that this procedure exists in a documented form, is shared with relevant staff, and is updated whenever the underlying assessment changes. Verbal instruction alone is not sufficient, because it cannot be verified or audited.
For businesses selling on Shopify, it is worth including your online store manager or whoever updates product listings in your allergen training. Discrepancies between physical label information and online product page information are a common source of consumer complaints and can also trigger regulatory questions. The person responsible for your Shopify listings needs to understand that allergen and advisory information is not optional copy — it is a direct safety communication that must stay synchronised with your physical labels at all times.
Using PAL Transparently With Retail and Wholesale Partners
If you supply products to retail stores, foodservice operators, or other businesses, your PAL statements have implications beyond direct-to-consumer sales. Buyers and procurement teams at retail chains are increasingly asking suppliers to provide documented allergen management information, including evidence that PAL statements reflect real assessed risk rather than defensive labelling. A supplier that cannot produce documentation to support its advisory statements may find itself at a disadvantage during range reviews.
Transparency with wholesale partners also protects you commercially in the event of an incident. If a consumer has a reaction to a product that carried no PAL statement, and it later emerges that a cross-contact risk existed but was not disclosed, the liability exposure is significant — and it extends to the retailer who stocked the product. By contrast, a supplier with documented assessments, clear PAL where warranted, and consistent labelling across all sales channels is in a much stronger position to demonstrate that it acted responsibly.
For businesses using Shopify as a wholesale or trade channel — for example, through a separate trade-facing storefront or a B2B section of their store — the same rules apply. Advisory information displayed to trade buyers should be identical to what appears on physical labels and on your consumer-facing pages. Allergen Matrix supports consistent allergen and advisory declaration across your Shopify product catalogue, making it easier to keep all your listings aligned with your current label information regardless of which sales channel a buyer is using.
Record-Keeping Practices That Support Your PAL Decisions
Documentation is the foundation that makes every other aspect of best practice PAL defensible. Without records, even a genuinely careful allergen management programme cannot be demonstrated to the FDA, to retail partners, or in the event of a legal dispute. Record-keeping for PAL does not need to be complex, but it does need to be consistent and complete.
At minimum, your records should include: the cross-contact risk assessment for each product, dated and signed by the person responsible; notes on the cleaning validation procedures used for shared equipment; records of allergen information received from suppliers; and a log of any changes to ingredients, suppliers, or production processes that triggered a reassessment. These records should be retained for a meaningful period — many food businesses align their allergen documentation retention with their broader food safety record-keeping policy, typically two to five years.
Digital record-keeping tools make this significantly easier to manage, particularly for businesses with growing product ranges. Maintaining allergen records in a structured format that links each product to its assessment, its current label information, and its online listing helps ensure nothing falls out of sync. When you update your PAL statement for a product, a structured system makes it straightforward to verify that the change has been reflected everywhere it needs to appear — on your physical label artwork, in your customer-facing documentation, and on your Shopify product pages.
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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.